Search

INTRODUCTION: Patients may experience late complications following surgical treatment for colorectal and anal cancer, and we need instruments in Danish to plan treatment and person-centred follow-up treatment approaches. For this purpose, we chose the Measure Yourself Medical Outcome Profile (MYMOP) and Measure Yourself Concerns and Wellbeing (MYCaW). The aim of this study was to translate the two instruments into Danish and conduct a subsequent qualitative validation. METHODS: The translation process consists of five stages: forward translation, synthesis, back translation, expert panel review and pretesting. Qualitative validation included interview with target audience representatives, testing of face-validity and evaluation by lay persons. RESULTS: Through the translation process and qualitative validation, we produced Danish versions of the MYMOP and the MYCaW. CONCLUSIONS: The Danish versions of the two questionnaires are now ready for use in clinical practice and research after individual licensing consultation with the copyright holders.none. TRIAL REGISTRATION: not relevant.

Background: FURCA (Follow-Up after Rectal Cancer) is a multi-centre randomised trial comparing patient-led follow-up with standard outpatient follow-up. This paper reports one-year follow-up data from the FURCA trial on selected secondary outcomes including type and number of contacts, patient-reported involvement and satisfaction with health care services during follow-up. Material and methods: Patients with rectal cancer (stage < IV) from four Danish surgical centres were randomised (1:1) into intervention (education and self-referral to project nurse) or standard follow-up (routine clinical doctor visits). The present analysis involved data on hospital contacts during the first year after surgery, patient involvement and satisfaction measured at one year, and baseline patient-reported and clinical variables. Results: Of 512 eligible patients, 168 were allocated to patient-led follow-up (intervention) and 168 to standard follow-up (control). The total number of hospital contacts in the intervention arm did not differ significantly from the number of contacts in the control arm (p = 0.44). More patients had ≥15 contacts in the intervention arm than in the control arm (p = 0.004). The total number of outpatient doctor visits was significantly lower in the intervention arm (p < 0.001). Patients in both arms rated involvement and satisfaction high; yet patients in the intervention arm scored significantly higher on two of six items regarding involvement and all five items regarding satisfaction. Of the 168 patients in the intervention arm, 43% made direct contact (self-referral) to the project nurse, and 14 of these patients (8%) had ≥4 contacts. The primary reason for self-referral was bowel dysfunction. Discussion: The findings indicate the value of a patient-led follow-up program in terms of direct access and more individually tailored intervention based on patients’ needs, with most tasks being managed by nurses. Patient-led follow-up came with improved p

Background: The ongoing multi-center randomized FURCA-trial investigates the effect of patient-led follow-up after rectal cancer, aiming at improving management of late effects and survivorship care. The purpose of this present sub-study was to identify potential systematic differences between participants and non-participants in the FURCA-trial, in regard to demographic and clinical factors at baseline, and in quality of life (QoL) and fear of cancer recurrence (FCR) after one year. Material and methods: The population comprised patients invited to the FURCA-trial during the first 13 months' recruitment. Clinical and demographic data was obtained at baseline and differences were significance tested. Non-participants were requested to fill in a short survey one year after primary surgery, while participants received the questionnaires as part of more comprehensive one-year follow-up. Results: In the first 13 months of the trial, 113 out of the 262 patients invited, declined to participate. The main reason reported for this was lack of energy surplus. Participants were younger than non-participants (p < .01), and nonparticipation was particularly evident among patients ≥ 80 years. More than half of the invited females declined to participate. Good WHO Performance status was associated with participation (p = .01), yet there were no statistically significant differences in Charlson Comorbidity Index, type of surgery, oncological treatment or UICC stages between participants and non-participants. By one year after surgery, there was no difference in FCR-level (p = .92) and QoL (p = .25) between the non-participants and control group participants. Conclusion: The sub-study found that participants and non-participants differed at baseline in regard to age, gender and performance status, which is supported by results from other studies. No between-group differences were found in psychological factors after one year. These findings are important for the generalisabil

BACKGROUND: The main treatment for non-metastatic rectal cancer (RC) is surgical resection. Late adverse effects that are highly prevalent and negatively impact patients' symptom burden and quality of life are: bowel-, urological and sexual dysfunctions; psychological distress; fear of recurrence. Patients and clinicians have requested a more patient-centred follow-up, balancing the focus on detection of recurrence, and physiological and psychological late adverse effects. The current follow-up program primarily focuses on detection of recurrence, with less attention on late adverse effects. As a consequence, the randomized controlled trial Follow-up after Rectal Cancer (FURCA) has been launched, testing the effect of a new patient-led, follow-up program. The aim of this paper is to describe the methodology used in the FURCA study and to report results from the development of the patient-led, follow-up program. Adult patients, treated with curative intent for primary adenocarcinoma in the rectum are included from four Danish centers.MATERIAL AND METHODS: Patients are randomized into an intervention group, receiving standardized education and access to self-referral to an assigned project nurse, or a control group following the current follow-up program with routine medicals. The primary outcomes are symptom burden and quality of life, measured by the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) questionnaire. Other outcome and demographic data are collected as patient-reported measures and register-based data. Results from developing the intervention: The education program is based on data from two focus group interviews and the feedback from experts. An algorithm is developed in order to qualify the research nurses' responses to patients' self-referral. Discussion and perspectives: The results of the FURCA study will strengthen the evidence base for RC follow-up, and qualify the ongoing transformation in cancer follow-up programs.

OBJECTIVE: The aims of this study were to investigate the convergent and discriminative validity and reliability of the low anterior resection syndrome (LARS) score in an international setting. BACKGROUND: The LARS score is a simple self-administered questionnaire measuring bowel dysfunction after rectal cancer surgery. The score is intended to be commonly used in international research and clinical practice in the future. Therefore, a thorough validation in an international setting is of utmost importance. METHODS: The LARS score was translated using methods in keeping with current international recommendations. A total of 801 patients operated for rectal cancer in Sweden, Spain, Germany, and Denmark completed the LARS score questionnaire, including an anchor question assessing the impact of bowel function on quality of life. A subgroup of 218 patients completed the LARS score twice. Data were analyzed per country. RESULTS: The LARS score has demonstrated a high convergent validity in terms of a high correlation between LARS score and quality of life (P < 0.001). Sensitivity ranged from 67.7% to 88.3% and specificity from 58.1% to 86.3%. The LARS score was able to discriminate between groups of patients differing with regard to radiotherapy, surgery, and age (P < 0.05). The score also demonstrated high reliability at test-retest with narrow limits of agreement and no statistically significant difference between scores at the first and second test. CONCLUSIONS: The Swedish, Spanish, German, and Danish versions of the LARS score have proven to be valid and reliable tools for measuring LARS in European rectal cancer patients.

PURPOSE: General population reference data are useful in the interpretation of health-related quality of life (HRQoL) results, but for the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30), such data have been published for only seven countries. In 1992, Danish general population data were collected from women only for EORTC QLQ-C30 version 1. Since no Danish reference data exists for men and women for the QLQ-C30 version 3.0, the aims of this study were to generate such data and to investigate the associations between EORTC QLQ-C30 outcomes and age, gender and morbidity, as well as trends over time.METHODS: An age- and gender-stratified random sample of 3,080 Danes was drawn from the Danish Civil Registration System. The EORTC QLQ-C30 was administered electronically and by mail along with a short questionnaire concerning socio-demographics/morbidity.RESULTS: Responses were obtained from 1,832 individuals (60.1 % of 3,009 eligible individuals). Response rates varied across age groups, ranging from 41.9 % (20-29 years) to 76.1 % (70-79 years). The majority of subscales were strongly associated with age and morbidity. Between genders only small, but clinically meaningful and statistically significant differences were found in five out of fifteen scales. When comparing Danish women 20 years ago and today, a tendency toward slightly improved function/reduced symptoms was observed, but the differences were small and statistically significant in only three subscales.CONCLUSION: This study is the first to present Danish general population reference values for the EORTC QLQ-C30 version 3.0. Age and morbidity are important potential confounders that must be taken into account in HRQoL studies.