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Papers by Randi Karlsen

Research paper thumbnail of Is the health literacy of informal caregivers associated with the psychological outcomes of breast cancer survivors?

Journal of Cancer Survivorship, Nov 9, 2020

Purpose To investigate whether health literacy (HL) among informal caregivers of breast cancer (B... more Purpose To investigate whether health literacy (HL) among informal caregivers of breast cancer (BC) survivors is associated with patient psychological outcomes. Methods We used data (n = 340 pairs) from baseline questionnaires administered in the MyHealth trial investigating nurse-led BC follow-up. All BC survivors and their invited caregivers were included immediately after completion of primary treatment. We performed multivariate regression analyses to examine the association between caregiver HL (nine dimensions as measured by the Health Literacy Questionnaire) as exposure and patient depression, anxiety, and health-related quality of life (HQoL) as outcomes. We further examined whether any association differed according to type of caregiver, patient HL, and patient activation (skill in managing one's health). Results Three dimensions, "ability to engage with providers" (β = − 0.2), "navigating the system" (β = − 0.2), and "understand health information" (β = − 0.2), were significantly associated with lower patient depression (p < 0.05), while four dimensions, "having sufficient information" (β = 0.3), "navigating the system" (β = 0.2), "find health information" (β = 0.2), and "understand health information" (β = 0.2), were significantly associated with better patient HQoL (p < 0.05). No significant associations were found for anxiety. Patient HL and activation did not significantly modify the associations, while certain associations for depression were stronger in patients with non-partner caregivers. Conclusions The HL of informal caregivers may play an important role in optimizing psychological outcomes in cancer survivors. Implications for Cancer Survivors Involving informal caregivers, who can provide support related to health information and services, may be beneficial for the psychological well-being of cancer survivors.

Research paper thumbnail of Cohort profile of FALCON: a prospective nationwide cohort of families with minor children who have lost a parent in Denmark in 2019–2021

Death Studies, May 30, 2023

Research paper thumbnail of Influence of social factors on patient-reported late symptoms: Report from a controlled trial among long-term head and neck cancer survivors in Denmark

Head & neck, Nov 28, 2015

BackgroundThe incidence of head and neck cancer and morbidity and mortality after treatment are a... more BackgroundThe incidence of head and neck cancer and morbidity and mortality after treatment are associated with social factors. Whether social factors also play a role in the prevalence of late‐onset symptoms after treatment for head and neck cancer is not clear.MethodsThree hundred sixty‐nine survivors completed questionnaires on late symptoms and functioning.ResultsSurvivors with short education were more likely to report severe problems than those with medium or long education. In the fully adjusted model, the risk for problems with opening the mouth remained significantly increased (odds ratio [OR] = 3.20; 95% confidence interval [CI] = 1.18–8.63). For survivors who lived alone, the adjusted ORs were significantly increased for physical functioning (2.17; 95% CI = 1.01–4.68) and trouble with social eating (OR = 2.26; 95% CI = 1.14–4.47).ConclusionSelf‐reported severe late symptoms were more prevalent in survivors with short education and in those living alone, suggesting differences in perception of late symptoms between social groups. © 2015 Wiley Periodicals, Inc. Head Neck 38: E1713–E1721, 2016

Research paper thumbnail of Reconstructive Breast Implantation After Mastectomy for Breast Cancer

Archives of Surgery, Dec 1, 2005

Background: Clinical reports have raised concern about local complications following breast impla... more Background: Clinical reports have raised concern about local complications following breast implantation used in reconstructive or cosmetic surgery, but there is a shortage of epidemiological studies in this area. Objective: To assess in a prospective epidemiological manner the occurrence of short-term local complications in a nationwide implantation registry. Design, Setting, and Participants: The Danish Registry for Plastic Surgery of the Breast prospectively collects preoperative, perioperative, and postoperative information on Danish women undergoing breast augmentation. Through the registry, we collected data on short-term local complications among 574 women who underwent postmastectomy reconstruction with breast implants from

Research paper thumbnail of Do we reach the patients with the most problems? Baseline data from the WebCan study among survivors of head-and-neck cancer, Denmark

Journal of Cancer Survivorship, Jul 31, 2015

This study seeks to assess the differences in disease and socioeconomic characteristics, late eff... more This study seeks to assess the differences in disease and socioeconomic characteristics, late effects and long-term quality of life (QoL) after head-and-neck cancer (HNC) among participants and non-participants. Five hundred sixty recurrence-free survivors treated for HNC at least 6 months previously were invited to participate in a repeated measure, controlled intervention study of computerized Patient Reported Outcome (PRO), which is provided to treating physicians at the point of care. Two hundred sixty-six consented to participate, and 292 declined; of those who declined, 103 filled in the baseline questionnaire. Late effects and QoL were evaluated on the EORTC QLQ C-30 and EORTC QLQ H&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;N35 and HADS questionnaires, and an empirically derived symptom list was prepared with hospital clinicians. Participants were younger, had a higher educational level, were more likely to cohabit, less likely to smoke, used less alcohol and were more likely to have HPV than those who declined but did not differ by gender, cancer site, stage or time since diagnosis. Participants reported significantly better QoL and functioning and less severe symptoms than those who declined participation other than filling in the baseline questionnaire. Late symptoms are common in HNC survivors. A wide diversity of self-reported late effects was found in this trial with participants significantly less affected than non-participants. Generalizable data on non-participation may aid in the interpretation of studies on HNC survivors in general and may have relevance for targeting recruitment and maintenance in rehabilitation and follow-up care, outside clinical trials.

Research paper thumbnail of Men with cancer change their health behaviour: a prospective study from the Danish Diet, Cancer and Health Study

British Journal of Cancer, May 29, 2012

BACKGROUND: Health behaviour changes may improve the quality of life and survival among cancer su... more BACKGROUND: Health behaviour changes may improve the quality of life and survival among cancer survivors. We prospectively examined changes in health behaviour among and between men with prostate cancer (PC), men with cancers other than PC and cancer-free men. METHODS: We analysed data for 20 914 men (50-65 years), 426 with cancer, and 20 488 persons who were cancer-free between baseline (1993-1997) and follow-up (2000-2002) in multiple linear regression models to determine differences in changes in body mass index (BMI) and in alcohol and tobacco consumption. RESULTS Body mass index and tobacco and alcohol consumption decreased significantly (Po0.001) between baseline and follow-up among both men with cancer and cancer-free men. Men with cancers other than PC significantly decreased their BMI (b ¼ À 058; 95% confidence interval (CI): À 0.77, À 0.40) and tobacco consumption (b ¼ À 1.36; 95% CI: À 2.22, À 0.49) compared with cancer-free men and were significantly more likely to quit smoking and lose weight. CONCLUSION: Men with cancers other than PC decreased their tobacco consumption and BMI significantly more than cancer-free men. Men with cancer do change their health behaviour; clinicians should take this into account in planning follow-up care for cancer survivors.

Research paper thumbnail of Effects on long-term survival of psychosocial group intervention in early-stage breast cancer: follow-up of a randomized controlled trial

Acta Oncologica, Apr 3, 2023

Research paper thumbnail of Are education and cohabitation associated with health-related quality of life and self-management during breast cancer follow-up? A longitudinal study

Acta Oncologica, Apr 3, 2023

Research paper thumbnail of Changes in body mass index and alcohol and tobacco consumption among breast cancer survivors and cancer-free women: A prospective study in the Danish Diet, Cancer and Health Cohort

Acta Oncologica, Dec 17, 2012

A breast cancer diagnosis has been suggested as a teachable moment when a woman is more open to m... more A breast cancer diagnosis has been suggested as a teachable moment when a woman is more open to making healthier lifestyle changes. Little is known about the health behaviour changes women with breast cancer initiate compared to those made by other women. We examined changes in body mass index (BMI) and tobacco and alcohol consumption among women with a diagnosis of breast cancer and among cancer-free women. We used data from 23 420 women aged 50-64 years who participated in the Diet, Cancer and Health cohort, of whom 449 were diagnosed with breast cancer between baseline (1993-1997) and follow-up (2000-2002), and 22 971 remained cancer-free. We used multiple linear regression analysis to examine differences in BMI and alcohol and tobacco consumption between the two groups and to examine whether demographic and prognostic factors were associated with behavioural changes in women with breast cancer. There were no significant differences in changes in BMI, alcohol and tobacco consumption between the two groups. Only in sub-analyses among women who lost weight between baseline and follow-up, women with breast cancer lost more weight than cancer-free women (β = 0.2; CI 0.1; 0.4), but residual confounding from stage cannot be excluded. Among the women with breast cancer we found no significant changes in BMI, alcohol and tobacco consumption by level of education, marital status, chemotherapy, hormone therapy or radiation. Women with breast cancer did not reduce their BMI, or modify their alcohol use or tobacco consumption compared with cancer-free women. This study indicates that guidelines and interventions to change health behaviour are needed after a cancer diagnosis.

Research paper thumbnail of PSA testing without clinical indication for prostate cancer in relation to socio-demographic and clinical characteristics in the Danish Diet, Cancer and Health Study

Acta Oncologica, Aug 27, 2013

Background. Social differences in prostate cancer (PC) incidence and mortality might be related t... more Background. Social differences in prostate cancer (PC) incidence and mortality might be related to testing for prostatespecifi c antigen (PSA). Although routine PSA screening is not recommended in Denmark, testing without clinical indication increased during the past decade. We evaluated associations between socio-demographic or clinical characteristics and PSA testing without clinical indication. Material and methods. In the Danish Diet, Cancer and Health Cohort, we identifi ed 1051 men with PC diagnosed in 1993-2008. Diagnostic and clinical characteristics were obtained from medical records, and socio-demographic information was retrieved from administrative registers. We used general logistic regression analysis to estimate odds ratios (ORs) and 95% confi dence intervals (CIs) for associations between socio-demographic or clinical characteristics and PSA testing without clinical indication. Cox regression analysis was used to examine associations with mortality. Results. PSA testing without clinical indication was less likely among patients Ͼ 67 years (OR 0.7; 0.5-1.0). Men who were, PSA tested without clinical indication, were more likely to have vocational training (OR 1.8; 1.1-2.9) or higher education (OR 1.5; 0.9-2.5) and less likely to have advanced disease (OR 0.6; 0.4-0.9). PSA testing without clinical indication more often preceded therapy with curative intent (OR 1.8; 1.1-2.9) and less often palliative treatment (OR 0.6; 0.3-1.0). Men who were PSA tested without clinical indication had non-signifi cantly lower overall and PC-specifi c mortality [hazard ratios 0.8 (0.5-1.2) and 0.6 (0.3-1.1), respectively]. Conclusions. PSA testing without clinical indication was associated with higher educational level. PC detected by PSA testing with no clinical indication was more often localized and treated with curative intent.

Research paper thumbnail of NAVIGATE: improving survival in vulnerable patients with lung cancer through nurse navigation, symptom monitoring and exercise – study protocol for a multicentre randomised controlled trial

BMJ Open, Oct 1, 2022

Introduction and aim Low socioeconomic position (SEP) has been shown to be strongly associated wi... more Introduction and aim Low socioeconomic position (SEP) has been shown to be strongly associated with impaired lung cancer survival. Barriers related to receiving recommended treatment among patients with lung cancer with low SEP may include adverse health behaviour and limited physical and psychosocial resources influencing the ability to react on high-risk symptoms and to navigate the healthcare system. To address the underlying factors that drive both decisions of treatment, adherence to treatment and follow-up in vulnerable patients with lung cancer, we developed the Navigate intervention. The aim of this randomised controlled trial is to investigate the effect of the intervention on survival (primary outcome), lung cancer treatment adherence, health-related quality of life and other psychosocial outcomes as well as health costs and process evaluation (secondary outcomes) in a study population of vulnerable patients with lung cancer. Methods and analysis This two-armed multicentre randomised trial will recruit patients from five lung cancer clinics in Denmark identified as vulnerable according to a screening instrument with nine clinical and patientreported vulnerability criteria developed for the study. We will enrol 518 vulnerable patients >18 years old diagnosed with non-small cell lung cancer at all stages with a performance status <2. Participants will be randomly allocated to either standard treatment and intervention or standard treatment alone. The Navigate intervention is based on principles from motivational interviewing and includes three components of nurse navigation, systematic monitoring of patient-reported outcomes (PROs) and physical exercise in a person-centred delivery model. Data will be collected at baseline and 3, 6, 12 months after randomisation using questionnaires, clinical data and physical function tests. Ethics and dissemination Ethics Committee, Region Zealand (SJ-884/EMN-2020-37380) and the Data Protection Agency in Region Zealand (REG-080-2021) approved the trial. Participants will provide written informed consent. Results will be reported in peerreviewed journals. Trial registration number NCT05053997.

Research paper thumbnail of A controlled study of use of patient-reported outcomes to improve assessment of late effects after treatment for head-and-neck cancer

Radiotherapy and Oncology, May 1, 2016

Please cite this article in press as: Kjaer T et al. A controlled study of use of patient-reporte... more Please cite this article in press as: Kjaer T et al. A controlled study of use of patient-reported outcomes to improve assessment of late effects after treatment for head-and-neck cancer. Radiother Oncol (2016),

Research paper thumbnail of Follow-up strategies following completion of primary cancer treatment in adult cancer survivors

The Cochrane library, Nov 21, 2016

Background Most cancer survivors receive follow-up care a er completion of treatment with the pri... more Background Most cancer survivors receive follow-up care a er completion of treatment with the primary aim of detecting recurrence. Traditional followup consisting of fixed visits to a cancer specialist for examinations and tests are expensive and may be burdensome for the patient. Followup strategies involving non-specialist care providers, di erent intensity of procedures, or addition of survivorship care packages have been developed and tested, however their e ectiveness remains unclear. Objectives The objective of this review is to compare the e ect of di erent follow-up strategies in adult cancer survivors, following completion of primary cancer treatment, on the primary outcomes of overall survival and time to detection of recurrence. Secondary outcomes are health-related quality of life, anxiety (including fear of recurrence), depression and cost. Search methods We searched CENTRAL, MEDLINE, Embase, four other databases and two trials registries on 11 December 2018 together with reference checking, citation searching and contact with study authors to identify additional studies. Selection criteria We included all randomised trials comparing di erent follow-up strategies for adult cancer survivors following completion of curativelyintended primary cancer treatment, which included at least one of the outcomes listed above. We compared the e ectiveness of: 1) nonspecialist-led follow-up (i.e. general practitioner (GP)-led, nurse-led, patient-initiated or shared care) versus specialist-led follow-up; 2) less intensive versus more intensive follow-up (based on clinical visits, examinations and diagnostic procedures) and 3) follow-up integrating additional care components relevant for detection of recurrence (e.g. patient symptom education or monitoring, or survivorship care plans) versus usual care. Data collection and analysis We used the standard methodological guidelines by Cochrane and Cochrane E ective Practice and Organisation of Care (EPOC). We assessed the certainty of the evidence using the GRADE approach. For each comparison, we present synthesised findings for overall survival and time to detection of recurrence as hazard ratios (HR) and for health-related quality of life, anxiety and depression as mean di erences Follow-up strategies following completion of primary cancer treatment in adult cancer survivors (Review)

Research paper thumbnail of The association between education and fear of recurrence among breast cancer patients in follow-up – and the mediating effect of self-efficacy

Research paper thumbnail of Couple Counseling and Pelvic Floor Muscle Training for Men Operated for Prostate Cancer and for Their Female Partners: Results From the Randomized ProCan Trial

Sexual Medicine, 2021

Introduction Patients with prostate cancer (PC) who undergo radical prostatectomy (RP) experience... more Introduction Patients with prostate cancer (PC) who undergo radical prostatectomy (RP) experience impaired sexual and urinary function. Aim To compare the effect of early couple counseling and pelvic floor muscle training (PFMT) with usual care for sexual and urinary dysfunction after RP. Methods The ProCan study was a randomized controlled trial (RCT) with two parallel treatment arms and 1:1 allocation. Between January 2016 and December 2017, candidates for RP were invited to a longitudinal questionnaire study and provided baseline measures before surgery. Patients who underwent RP, had a female partner, and were sexually active were invited to the ProCan RCT. Couples who provided informed consent were allocated to usual care or usual care and up to six couple counseling sessions, up to three instructions in PFMT and a video home-training program. All couples filled in follow-up questionnaires at 8 and 12 months and non-participants provided 12 months’ follow-up. Linear mixed-effec...

Research paper thumbnail of The development and initial validation of the Breast Cancer Recurrence instrument (BreastCaRe)—a patient-reported outcome measure for detecting symptoms of recurrence after breast cancer

Quality of Life Research, 2021

Purpose Patient-reported outomes (PRO) may facilitate prompt treatment. We describe the developme... more Purpose Patient-reported outomes (PRO) may facilitate prompt treatment. We describe the development and psychometric properties of the first instrument to monitor for symptoms of breast cancer (BC) recurrence. Methods This study is nested in the MyHealth randomized trial of nurse-led follow-up based on electronically-collected PROs. We constructed items assessing symptoms of potential recurrence through expert interviews with six BC specialists in Denmark. Semi-structured cognitive interviews were carried out with a patient panel to assess acceptability and comprehensibility. Items were subsequently tested in a population of 1170 women 1-10 years after completing BC treatment. We carried out multiple-groups confirmatory factor analysis (CFA) and Rasch analysis to test dimensionality, local dependence (LD) and differential item functioning (DIF) according to sociodemographic and treatment-related factors. Clinical data was obtained from the Danish Breast Cancer Group registry. Results Twenty-two items were generated for the Breast Cancer Recurrence instrument (BreastCaRe). Cognitive testing resulted in clearer items. Seven subscales based on general, bone, liver, lung, brain, locoregional and contralateral recurrence symptoms were proposed. Both CFA and Rasch models confirmed the factor structure. No DIF was identified. Five item pairs showed LD but all items were retained to avoid loss of clinical information. Rasch models taking LD into account were used to generate a standardized scoring table for each subscale. Conclusions The BreastCaRe has good content and structural validity, patient acceptability and measurement invariance. We are preparing to examine the predictive validity of this new instrument.

Research paper thumbnail of MyHealth: specialist nurse-led follow-up in breast cancer. A randomized controlled trial – development and feasibility

Acta Oncologica, 2019

Background: Traditionally, women treated for breast cancer (BC) have been followed up through reg... more Background: Traditionally, women treated for breast cancer (BC) have been followed up through regular oncologist-led visits in outpatient clinics, focusing on detection of recurrences, new primary BC, symptom management, and psychological support. However, this follow-up routine is expensive and its effectiveness has been questioned. Consequently, alternative follow-up programs have been tested. The Guided Self-Determination method (GSD), which facilitates partnership between healthcare provider and patient, has been shown to improve self-management in patients with chronic conditions, including cancer. Patient-reported outcomes (PRO) is another increasingly used tool to improve patient-provider communication, symptom monitoring and control. In combination, GSD and PRO may have the potential to meet the objectives of BC follow-up. To test this, we developed the MyHealth study, a randomized controlled trial comparing a nurse-led follow-up program based on GSD, collection of PRO, and patient navigation with routine oncologist-led follow-up. Here we describe how we developed the intervention and are currently testing the feasibility of the MyHealth protocol in terms of recruitment, adherence to the intervention, collection of PRO, and patient navigation. Material and methods: We have invited the first 25 consecutively enrolled patients to test the MyHealth intervention. This consists of (1) 3-5 initial GSD appointments with a nurse, (2) collection of PRO, and (3) symptom management and patient navigation. The randomized trial was launched in January 2017 and is still recruiting. Results of the feasibility study: Of 32 patients invited, 25 accepted participation. At 18-month follow-up, two patients have withdrawn, 143 PRO questionnaires have been completed (mean 5.7/ patient) resulting in 59 nurse contacts (mean 2.4 per patient) and 14 project physician contacts (mean 0.6 per patient). Conclusion: A high recruitment rate and response rate to PRO indicate that follow-up led by specialist nurses, based on collection of PRO is feasible and acceptable for patients treated for early stage BC.

Research paper thumbnail of Recruiting newly referred lung cancer patients to a patient navigator intervention (PACO): lessons learnt from a pilot study

Acta Oncologica, 2017

Objectives: The incidence of and survival from lung cancer are associated with socioeconomic posi... more Objectives: The incidence of and survival from lung cancer are associated with socioeconomic position, and disparities have been observed in both curative and palliative treatment for lung cancer. 'Patient navigation' is valuable in addressing health disparity, with timely treatment and transition to care. We conducted a pilot study to test the feasibility of a patient navigator program (PAtient COach) for newly diagnosed lung cancer. We present the trial, the findings from the pilot study and discuss factors that might have affected recruitment rates. Material and methods: We invited 24 lung cancer patients referred for chemotherapy to the

Research paper thumbnail of Physical activity and survival in patients with breast cancer

Research paper thumbnail of Whose perspective is it anyway? Dilemmas of patient involvement in the development of a randomized clinical trial – a qualitative study

Acta Oncologica, 2019

Background: Patient and public involvement (PPI) is increasingly becoming a requirement in the ef... more Background: Patient and public involvement (PPI) is increasingly becoming a requirement in the effort to improve the relevance and quality of healthcare research. We examined how involving patients with lower education levels affected PPI in the development of the MyHealth randomized clinical trial of breast cancer follow-up from the perspectives of the patients and professionals. Material and methods: Eight women who had completed breast cancer treatment, four with fewer than 10 years of education, were recruited as members of a patient panel advising researchers in the development of the trial. We carried out individual and focus group interviews with panel members and recruiting nurses between April and September 2016. Researcher observations and changes made based on panel feedback were also documented. Patients were asked to evaluate the process according to a PPI theoretical framework with four dimensions: (i) ways of involvement, (ii) research vs. patient concerns, (iii) strength of the patient's voice, and (iv) degree of change. A combination of inductive and deductive thematic analysis was conducted whereby emerging themes were organized using the above framework. Results: All patient contributors reported high satisfaction with being involved and PPI improved trial materials and recruitment strategy. However, contradictory perspectives between lay and expert approaches to research led to dilemmas not related to educational background. Patients were often more concerned with unmet needs after cancer than with research, and the scientific hierarchy made it difficult for researchers to include the patient perspective if it challenged research requirements. Nurses also faced ethical dilemmas when recruiting patients as PPI contributors. Conclusions: Our findings challenged the assumption that PPI automatically leads to a broad range of patient perspectives that can directly improve research relevance and quality. This highlights the need for more research and better guidance on the use of PPI in research.

Research paper thumbnail of Is the health literacy of informal caregivers associated with the psychological outcomes of breast cancer survivors?

Journal of Cancer Survivorship, Nov 9, 2020

Purpose To investigate whether health literacy (HL) among informal caregivers of breast cancer (B... more Purpose To investigate whether health literacy (HL) among informal caregivers of breast cancer (BC) survivors is associated with patient psychological outcomes. Methods We used data (n = 340 pairs) from baseline questionnaires administered in the MyHealth trial investigating nurse-led BC follow-up. All BC survivors and their invited caregivers were included immediately after completion of primary treatment. We performed multivariate regression analyses to examine the association between caregiver HL (nine dimensions as measured by the Health Literacy Questionnaire) as exposure and patient depression, anxiety, and health-related quality of life (HQoL) as outcomes. We further examined whether any association differed according to type of caregiver, patient HL, and patient activation (skill in managing one's health). Results Three dimensions, "ability to engage with providers" (β = − 0.2), "navigating the system" (β = − 0.2), and "understand health information" (β = − 0.2), were significantly associated with lower patient depression (p < 0.05), while four dimensions, "having sufficient information" (β = 0.3), "navigating the system" (β = 0.2), "find health information" (β = 0.2), and "understand health information" (β = 0.2), were significantly associated with better patient HQoL (p < 0.05). No significant associations were found for anxiety. Patient HL and activation did not significantly modify the associations, while certain associations for depression were stronger in patients with non-partner caregivers. Conclusions The HL of informal caregivers may play an important role in optimizing psychological outcomes in cancer survivors. Implications for Cancer Survivors Involving informal caregivers, who can provide support related to health information and services, may be beneficial for the psychological well-being of cancer survivors.

Research paper thumbnail of Cohort profile of FALCON: a prospective nationwide cohort of families with minor children who have lost a parent in Denmark in 2019–2021

Death Studies, May 30, 2023

Research paper thumbnail of Influence of social factors on patient-reported late symptoms: Report from a controlled trial among long-term head and neck cancer survivors in Denmark

Head & neck, Nov 28, 2015

BackgroundThe incidence of head and neck cancer and morbidity and mortality after treatment are a... more BackgroundThe incidence of head and neck cancer and morbidity and mortality after treatment are associated with social factors. Whether social factors also play a role in the prevalence of late‐onset symptoms after treatment for head and neck cancer is not clear.MethodsThree hundred sixty‐nine survivors completed questionnaires on late symptoms and functioning.ResultsSurvivors with short education were more likely to report severe problems than those with medium or long education. In the fully adjusted model, the risk for problems with opening the mouth remained significantly increased (odds ratio [OR] = 3.20; 95% confidence interval [CI] = 1.18–8.63). For survivors who lived alone, the adjusted ORs were significantly increased for physical functioning (2.17; 95% CI = 1.01–4.68) and trouble with social eating (OR = 2.26; 95% CI = 1.14–4.47).ConclusionSelf‐reported severe late symptoms were more prevalent in survivors with short education and in those living alone, suggesting differences in perception of late symptoms between social groups. © 2015 Wiley Periodicals, Inc. Head Neck 38: E1713–E1721, 2016

Research paper thumbnail of Reconstructive Breast Implantation After Mastectomy for Breast Cancer

Archives of Surgery, Dec 1, 2005

Background: Clinical reports have raised concern about local complications following breast impla... more Background: Clinical reports have raised concern about local complications following breast implantation used in reconstructive or cosmetic surgery, but there is a shortage of epidemiological studies in this area. Objective: To assess in a prospective epidemiological manner the occurrence of short-term local complications in a nationwide implantation registry. Design, Setting, and Participants: The Danish Registry for Plastic Surgery of the Breast prospectively collects preoperative, perioperative, and postoperative information on Danish women undergoing breast augmentation. Through the registry, we collected data on short-term local complications among 574 women who underwent postmastectomy reconstruction with breast implants from

Research paper thumbnail of Do we reach the patients with the most problems? Baseline data from the WebCan study among survivors of head-and-neck cancer, Denmark

Journal of Cancer Survivorship, Jul 31, 2015

This study seeks to assess the differences in disease and socioeconomic characteristics, late eff... more This study seeks to assess the differences in disease and socioeconomic characteristics, late effects and long-term quality of life (QoL) after head-and-neck cancer (HNC) among participants and non-participants. Five hundred sixty recurrence-free survivors treated for HNC at least 6 months previously were invited to participate in a repeated measure, controlled intervention study of computerized Patient Reported Outcome (PRO), which is provided to treating physicians at the point of care. Two hundred sixty-six consented to participate, and 292 declined; of those who declined, 103 filled in the baseline questionnaire. Late effects and QoL were evaluated on the EORTC QLQ C-30 and EORTC QLQ H&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;N35 and HADS questionnaires, and an empirically derived symptom list was prepared with hospital clinicians. Participants were younger, had a higher educational level, were more likely to cohabit, less likely to smoke, used less alcohol and were more likely to have HPV than those who declined but did not differ by gender, cancer site, stage or time since diagnosis. Participants reported significantly better QoL and functioning and less severe symptoms than those who declined participation other than filling in the baseline questionnaire. Late symptoms are common in HNC survivors. A wide diversity of self-reported late effects was found in this trial with participants significantly less affected than non-participants. Generalizable data on non-participation may aid in the interpretation of studies on HNC survivors in general and may have relevance for targeting recruitment and maintenance in rehabilitation and follow-up care, outside clinical trials.

Research paper thumbnail of Men with cancer change their health behaviour: a prospective study from the Danish Diet, Cancer and Health Study

British Journal of Cancer, May 29, 2012

BACKGROUND: Health behaviour changes may improve the quality of life and survival among cancer su... more BACKGROUND: Health behaviour changes may improve the quality of life and survival among cancer survivors. We prospectively examined changes in health behaviour among and between men with prostate cancer (PC), men with cancers other than PC and cancer-free men. METHODS: We analysed data for 20 914 men (50-65 years), 426 with cancer, and 20 488 persons who were cancer-free between baseline (1993-1997) and follow-up (2000-2002) in multiple linear regression models to determine differences in changes in body mass index (BMI) and in alcohol and tobacco consumption. RESULTS Body mass index and tobacco and alcohol consumption decreased significantly (Po0.001) between baseline and follow-up among both men with cancer and cancer-free men. Men with cancers other than PC significantly decreased their BMI (b ¼ À 058; 95% confidence interval (CI): À 0.77, À 0.40) and tobacco consumption (b ¼ À 1.36; 95% CI: À 2.22, À 0.49) compared with cancer-free men and were significantly more likely to quit smoking and lose weight. CONCLUSION: Men with cancers other than PC decreased their tobacco consumption and BMI significantly more than cancer-free men. Men with cancer do change their health behaviour; clinicians should take this into account in planning follow-up care for cancer survivors.

Research paper thumbnail of Effects on long-term survival of psychosocial group intervention in early-stage breast cancer: follow-up of a randomized controlled trial

Acta Oncologica, Apr 3, 2023

Research paper thumbnail of Are education and cohabitation associated with health-related quality of life and self-management during breast cancer follow-up? A longitudinal study

Acta Oncologica, Apr 3, 2023

Research paper thumbnail of Changes in body mass index and alcohol and tobacco consumption among breast cancer survivors and cancer-free women: A prospective study in the Danish Diet, Cancer and Health Cohort

Acta Oncologica, Dec 17, 2012

A breast cancer diagnosis has been suggested as a teachable moment when a woman is more open to m... more A breast cancer diagnosis has been suggested as a teachable moment when a woman is more open to making healthier lifestyle changes. Little is known about the health behaviour changes women with breast cancer initiate compared to those made by other women. We examined changes in body mass index (BMI) and tobacco and alcohol consumption among women with a diagnosis of breast cancer and among cancer-free women. We used data from 23 420 women aged 50-64 years who participated in the Diet, Cancer and Health cohort, of whom 449 were diagnosed with breast cancer between baseline (1993-1997) and follow-up (2000-2002), and 22 971 remained cancer-free. We used multiple linear regression analysis to examine differences in BMI and alcohol and tobacco consumption between the two groups and to examine whether demographic and prognostic factors were associated with behavioural changes in women with breast cancer. There were no significant differences in changes in BMI, alcohol and tobacco consumption between the two groups. Only in sub-analyses among women who lost weight between baseline and follow-up, women with breast cancer lost more weight than cancer-free women (β = 0.2; CI 0.1; 0.4), but residual confounding from stage cannot be excluded. Among the women with breast cancer we found no significant changes in BMI, alcohol and tobacco consumption by level of education, marital status, chemotherapy, hormone therapy or radiation. Women with breast cancer did not reduce their BMI, or modify their alcohol use or tobacco consumption compared with cancer-free women. This study indicates that guidelines and interventions to change health behaviour are needed after a cancer diagnosis.

Research paper thumbnail of PSA testing without clinical indication for prostate cancer in relation to socio-demographic and clinical characteristics in the Danish Diet, Cancer and Health Study

Acta Oncologica, Aug 27, 2013

Background. Social differences in prostate cancer (PC) incidence and mortality might be related t... more Background. Social differences in prostate cancer (PC) incidence and mortality might be related to testing for prostatespecifi c antigen (PSA). Although routine PSA screening is not recommended in Denmark, testing without clinical indication increased during the past decade. We evaluated associations between socio-demographic or clinical characteristics and PSA testing without clinical indication. Material and methods. In the Danish Diet, Cancer and Health Cohort, we identifi ed 1051 men with PC diagnosed in 1993-2008. Diagnostic and clinical characteristics were obtained from medical records, and socio-demographic information was retrieved from administrative registers. We used general logistic regression analysis to estimate odds ratios (ORs) and 95% confi dence intervals (CIs) for associations between socio-demographic or clinical characteristics and PSA testing without clinical indication. Cox regression analysis was used to examine associations with mortality. Results. PSA testing without clinical indication was less likely among patients Ͼ 67 years (OR 0.7; 0.5-1.0). Men who were, PSA tested without clinical indication, were more likely to have vocational training (OR 1.8; 1.1-2.9) or higher education (OR 1.5; 0.9-2.5) and less likely to have advanced disease (OR 0.6; 0.4-0.9). PSA testing without clinical indication more often preceded therapy with curative intent (OR 1.8; 1.1-2.9) and less often palliative treatment (OR 0.6; 0.3-1.0). Men who were PSA tested without clinical indication had non-signifi cantly lower overall and PC-specifi c mortality [hazard ratios 0.8 (0.5-1.2) and 0.6 (0.3-1.1), respectively]. Conclusions. PSA testing without clinical indication was associated with higher educational level. PC detected by PSA testing with no clinical indication was more often localized and treated with curative intent.

Research paper thumbnail of NAVIGATE: improving survival in vulnerable patients with lung cancer through nurse navigation, symptom monitoring and exercise – study protocol for a multicentre randomised controlled trial

BMJ Open, Oct 1, 2022

Introduction and aim Low socioeconomic position (SEP) has been shown to be strongly associated wi... more Introduction and aim Low socioeconomic position (SEP) has been shown to be strongly associated with impaired lung cancer survival. Barriers related to receiving recommended treatment among patients with lung cancer with low SEP may include adverse health behaviour and limited physical and psychosocial resources influencing the ability to react on high-risk symptoms and to navigate the healthcare system. To address the underlying factors that drive both decisions of treatment, adherence to treatment and follow-up in vulnerable patients with lung cancer, we developed the Navigate intervention. The aim of this randomised controlled trial is to investigate the effect of the intervention on survival (primary outcome), lung cancer treatment adherence, health-related quality of life and other psychosocial outcomes as well as health costs and process evaluation (secondary outcomes) in a study population of vulnerable patients with lung cancer. Methods and analysis This two-armed multicentre randomised trial will recruit patients from five lung cancer clinics in Denmark identified as vulnerable according to a screening instrument with nine clinical and patientreported vulnerability criteria developed for the study. We will enrol 518 vulnerable patients >18 years old diagnosed with non-small cell lung cancer at all stages with a performance status <2. Participants will be randomly allocated to either standard treatment and intervention or standard treatment alone. The Navigate intervention is based on principles from motivational interviewing and includes three components of nurse navigation, systematic monitoring of patient-reported outcomes (PROs) and physical exercise in a person-centred delivery model. Data will be collected at baseline and 3, 6, 12 months after randomisation using questionnaires, clinical data and physical function tests. Ethics and dissemination Ethics Committee, Region Zealand (SJ-884/EMN-2020-37380) and the Data Protection Agency in Region Zealand (REG-080-2021) approved the trial. Participants will provide written informed consent. Results will be reported in peerreviewed journals. Trial registration number NCT05053997.

Research paper thumbnail of A controlled study of use of patient-reported outcomes to improve assessment of late effects after treatment for head-and-neck cancer

Radiotherapy and Oncology, May 1, 2016

Please cite this article in press as: Kjaer T et al. A controlled study of use of patient-reporte... more Please cite this article in press as: Kjaer T et al. A controlled study of use of patient-reported outcomes to improve assessment of late effects after treatment for head-and-neck cancer. Radiother Oncol (2016),

Research paper thumbnail of Follow-up strategies following completion of primary cancer treatment in adult cancer survivors

The Cochrane library, Nov 21, 2016

Background Most cancer survivors receive follow-up care a er completion of treatment with the pri... more Background Most cancer survivors receive follow-up care a er completion of treatment with the primary aim of detecting recurrence. Traditional followup consisting of fixed visits to a cancer specialist for examinations and tests are expensive and may be burdensome for the patient. Followup strategies involving non-specialist care providers, di erent intensity of procedures, or addition of survivorship care packages have been developed and tested, however their e ectiveness remains unclear. Objectives The objective of this review is to compare the e ect of di erent follow-up strategies in adult cancer survivors, following completion of primary cancer treatment, on the primary outcomes of overall survival and time to detection of recurrence. Secondary outcomes are health-related quality of life, anxiety (including fear of recurrence), depression and cost. Search methods We searched CENTRAL, MEDLINE, Embase, four other databases and two trials registries on 11 December 2018 together with reference checking, citation searching and contact with study authors to identify additional studies. Selection criteria We included all randomised trials comparing di erent follow-up strategies for adult cancer survivors following completion of curativelyintended primary cancer treatment, which included at least one of the outcomes listed above. We compared the e ectiveness of: 1) nonspecialist-led follow-up (i.e. general practitioner (GP)-led, nurse-led, patient-initiated or shared care) versus specialist-led follow-up; 2) less intensive versus more intensive follow-up (based on clinical visits, examinations and diagnostic procedures) and 3) follow-up integrating additional care components relevant for detection of recurrence (e.g. patient symptom education or monitoring, or survivorship care plans) versus usual care. Data collection and analysis We used the standard methodological guidelines by Cochrane and Cochrane E ective Practice and Organisation of Care (EPOC). We assessed the certainty of the evidence using the GRADE approach. For each comparison, we present synthesised findings for overall survival and time to detection of recurrence as hazard ratios (HR) and for health-related quality of life, anxiety and depression as mean di erences Follow-up strategies following completion of primary cancer treatment in adult cancer survivors (Review)

Research paper thumbnail of The association between education and fear of recurrence among breast cancer patients in follow-up – and the mediating effect of self-efficacy

Research paper thumbnail of Couple Counseling and Pelvic Floor Muscle Training for Men Operated for Prostate Cancer and for Their Female Partners: Results From the Randomized ProCan Trial

Sexual Medicine, 2021

Introduction Patients with prostate cancer (PC) who undergo radical prostatectomy (RP) experience... more Introduction Patients with prostate cancer (PC) who undergo radical prostatectomy (RP) experience impaired sexual and urinary function. Aim To compare the effect of early couple counseling and pelvic floor muscle training (PFMT) with usual care for sexual and urinary dysfunction after RP. Methods The ProCan study was a randomized controlled trial (RCT) with two parallel treatment arms and 1:1 allocation. Between January 2016 and December 2017, candidates for RP were invited to a longitudinal questionnaire study and provided baseline measures before surgery. Patients who underwent RP, had a female partner, and were sexually active were invited to the ProCan RCT. Couples who provided informed consent were allocated to usual care or usual care and up to six couple counseling sessions, up to three instructions in PFMT and a video home-training program. All couples filled in follow-up questionnaires at 8 and 12 months and non-participants provided 12 months’ follow-up. Linear mixed-effec...

Research paper thumbnail of The development and initial validation of the Breast Cancer Recurrence instrument (BreastCaRe)—a patient-reported outcome measure for detecting symptoms of recurrence after breast cancer

Quality of Life Research, 2021

Purpose Patient-reported outomes (PRO) may facilitate prompt treatment. We describe the developme... more Purpose Patient-reported outomes (PRO) may facilitate prompt treatment. We describe the development and psychometric properties of the first instrument to monitor for symptoms of breast cancer (BC) recurrence. Methods This study is nested in the MyHealth randomized trial of nurse-led follow-up based on electronically-collected PROs. We constructed items assessing symptoms of potential recurrence through expert interviews with six BC specialists in Denmark. Semi-structured cognitive interviews were carried out with a patient panel to assess acceptability and comprehensibility. Items were subsequently tested in a population of 1170 women 1-10 years after completing BC treatment. We carried out multiple-groups confirmatory factor analysis (CFA) and Rasch analysis to test dimensionality, local dependence (LD) and differential item functioning (DIF) according to sociodemographic and treatment-related factors. Clinical data was obtained from the Danish Breast Cancer Group registry. Results Twenty-two items were generated for the Breast Cancer Recurrence instrument (BreastCaRe). Cognitive testing resulted in clearer items. Seven subscales based on general, bone, liver, lung, brain, locoregional and contralateral recurrence symptoms were proposed. Both CFA and Rasch models confirmed the factor structure. No DIF was identified. Five item pairs showed LD but all items were retained to avoid loss of clinical information. Rasch models taking LD into account were used to generate a standardized scoring table for each subscale. Conclusions The BreastCaRe has good content and structural validity, patient acceptability and measurement invariance. We are preparing to examine the predictive validity of this new instrument.

Research paper thumbnail of MyHealth: specialist nurse-led follow-up in breast cancer. A randomized controlled trial – development and feasibility

Acta Oncologica, 2019

Background: Traditionally, women treated for breast cancer (BC) have been followed up through reg... more Background: Traditionally, women treated for breast cancer (BC) have been followed up through regular oncologist-led visits in outpatient clinics, focusing on detection of recurrences, new primary BC, symptom management, and psychological support. However, this follow-up routine is expensive and its effectiveness has been questioned. Consequently, alternative follow-up programs have been tested. The Guided Self-Determination method (GSD), which facilitates partnership between healthcare provider and patient, has been shown to improve self-management in patients with chronic conditions, including cancer. Patient-reported outcomes (PRO) is another increasingly used tool to improve patient-provider communication, symptom monitoring and control. In combination, GSD and PRO may have the potential to meet the objectives of BC follow-up. To test this, we developed the MyHealth study, a randomized controlled trial comparing a nurse-led follow-up program based on GSD, collection of PRO, and patient navigation with routine oncologist-led follow-up. Here we describe how we developed the intervention and are currently testing the feasibility of the MyHealth protocol in terms of recruitment, adherence to the intervention, collection of PRO, and patient navigation. Material and methods: We have invited the first 25 consecutively enrolled patients to test the MyHealth intervention. This consists of (1) 3-5 initial GSD appointments with a nurse, (2) collection of PRO, and (3) symptom management and patient navigation. The randomized trial was launched in January 2017 and is still recruiting. Results of the feasibility study: Of 32 patients invited, 25 accepted participation. At 18-month follow-up, two patients have withdrawn, 143 PRO questionnaires have been completed (mean 5.7/ patient) resulting in 59 nurse contacts (mean 2.4 per patient) and 14 project physician contacts (mean 0.6 per patient). Conclusion: A high recruitment rate and response rate to PRO indicate that follow-up led by specialist nurses, based on collection of PRO is feasible and acceptable for patients treated for early stage BC.

Research paper thumbnail of Recruiting newly referred lung cancer patients to a patient navigator intervention (PACO): lessons learnt from a pilot study

Acta Oncologica, 2017

Objectives: The incidence of and survival from lung cancer are associated with socioeconomic posi... more Objectives: The incidence of and survival from lung cancer are associated with socioeconomic position, and disparities have been observed in both curative and palliative treatment for lung cancer. 'Patient navigation' is valuable in addressing health disparity, with timely treatment and transition to care. We conducted a pilot study to test the feasibility of a patient navigator program (PAtient COach) for newly diagnosed lung cancer. We present the trial, the findings from the pilot study and discuss factors that might have affected recruitment rates. Material and methods: We invited 24 lung cancer patients referred for chemotherapy to the

Research paper thumbnail of Physical activity and survival in patients with breast cancer

Research paper thumbnail of Whose perspective is it anyway? Dilemmas of patient involvement in the development of a randomized clinical trial – a qualitative study

Acta Oncologica, 2019

Background: Patient and public involvement (PPI) is increasingly becoming a requirement in the ef... more Background: Patient and public involvement (PPI) is increasingly becoming a requirement in the effort to improve the relevance and quality of healthcare research. We examined how involving patients with lower education levels affected PPI in the development of the MyHealth randomized clinical trial of breast cancer follow-up from the perspectives of the patients and professionals. Material and methods: Eight women who had completed breast cancer treatment, four with fewer than 10 years of education, were recruited as members of a patient panel advising researchers in the development of the trial. We carried out individual and focus group interviews with panel members and recruiting nurses between April and September 2016. Researcher observations and changes made based on panel feedback were also documented. Patients were asked to evaluate the process according to a PPI theoretical framework with four dimensions: (i) ways of involvement, (ii) research vs. patient concerns, (iii) strength of the patient's voice, and (iv) degree of change. A combination of inductive and deductive thematic analysis was conducted whereby emerging themes were organized using the above framework. Results: All patient contributors reported high satisfaction with being involved and PPI improved trial materials and recruitment strategy. However, contradictory perspectives between lay and expert approaches to research led to dilemmas not related to educational background. Patients were often more concerned with unmet needs after cancer than with research, and the scientific hierarchy made it difficult for researchers to include the patient perspective if it challenged research requirements. Nurses also faced ethical dilemmas when recruiting patients as PPI contributors. Conclusions: Our findings challenged the assumption that PPI automatically leads to a broad range of patient perspectives that can directly improve research relevance and quality. This highlights the need for more research and better guidance on the use of PPI in research.