Protocol ID: NL I CARE STUDY. Improving Care After colon cancer treatment in the Netherlands

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1 I CARE STUDY Improving Care After colon cancer treatment in the Netherlands - Personalised care to Enhance quality of life -

2 PROTOCOL TITLE I CARE STUDY Improving Care After colon cancer treatment in the Netherlands. Personalised care to Enhance quality of life. Protocol ID NL Short title EudraCT number I CARE STUDY Not applicable Version 2.3 Date Coordinating investigator/project leader Dr. J. Wind Department of General Practice J2-218 Postbox DD Amsterdam The Netherlands Principal investigator(s) (in Dutch: hoofdonderzoeker/ uitvoerder) Prof. dr. H.C. van Weert Department of General Practice J2-118 Postbox DD Amsterdam The Netherlands Subsidising party Independent expert (s) KWF / Stichting Alpe DuZes Dr. P.J. Tanis

3 Department of Surgery G6-254 Postbox DD Amsterdam The Netherlands Laboratory sites Not applicable Pharmacy Not applicable

4 PROTOCOL SIGNATURE SHEET Name Signature Date Head of Department: Prof. dr. H.C. van Weert, GP head of the department. Department of General Practice Coordinating Investigator/Project leader: Dr. J. Wind, GP post-doc Department of General Practice Principal Investigator: Prof. dr. H.C. van Weert, GP head of the department. Department of General Practice

5 TABLE OF CONTENTS 1. SUMMARY 2. INTRODUCTION AND RATIONALE 3. OBJECTIVES AND RESEARCH QUESTIONS 3.1 Objectives 3.2 Research questions 4. STUDY DESIGN 5. STUDY POPULATION 5.1 Population (base) 5.2 Inclusion criteria 5.3 Exclusion criteria 5.4 Sample size calculation 6. TREATMENT OF SUBJECTS 6.1 Investigational product/treatment 6.2 Use of co-intervention (if applicable) 6.3 Escape medication (if applicable) 7. INVESTIGATIONAL PRODUCT 8. METHODS 8.1 Study parameters/endpoints Main study parameter/endpoint Secondary study parameters/endpoints (if applicable) 8.2 Randomisation, blinding and treatment allocation 8.3 Study procedures 8.4 Withdrawal of individual subjects 8.5 Replacement of individual subjects after withdrawal 8.6 Premature termination of the study 9. SAFETY REPORTING 9.1 Section 10 WMO event 9.2 AEs, SAEs and SUSARs Adverse events (AEs)

6 9.2.2 Serious adverse events (SAEs) Suspected unexpected serious adverse reactions (SUSARs) 9.3 Annual safety report 9.4 Follow-up of adverse events 9.5 Data Safety Monitoring Board (DSMB) 10. STATISTICAL ANALYSIS 10.1 Main study parameters 10.2 Economic evaluation analysis 10.3 Interim analysis 11. ETHICAL CONSIDERATIONS 11.1 Regulation statement 11.2 Recruitment and consent 11.3 Objection by minors or incapacitated subjects 11.4 Benefits and risks assessment, group relatedness 11.5 Compensation for injury 11.6 Incentives 12. ADMINISTRATIVE ASPECTS, MONITORING AND PUBLICATION 12.1 Handling and storage of data and documents 12.2 Amendments 12.3 Annual progress report 12.4 End of study report 12.5 Public disclosure and publication policy 13. PARTICIPATING CENTRES AND DEPARTMENTS. 14. REFERENCES 15. APPENDIX

7 1. SUMMARY Rationale It is expected that in 2020 more than patients with colorectal cancer will be diagnosed in the Netherlands. To date, after initial treatment patients are included in a surgeon-led programme with the main focus on recurrence detection. However, patients often experience multiple physical and psychosocial problems in this phase. Currently, in secondary care these problems are not always encountered and only a small number of distressed patients are identified and supported. Both the Dutch Health Council as the Dutch Cancer Foundation suggested more generalist care as a solution. Furthermore, for patients it would be preferable to be able to undergo rehabilitation as much as possible in their own environment. Evidence shows that web-based interventions for patient empowerment can improve care. An important development of these e-health facilities is the OncoKompas which is an e- health application which facilitates direct-to-user delivery of individualised healthcare. Objective and hypothesis The above mentioned developments are subject to the I CARE study. We hypothesize that general practitioner (GP) involvement improves both aftercare and preventive care resulting in improved quality of life and patients satisfaction. Furthermore, a GP-led recurrence detection programme leads to at least equal detection of recurrences. Also we hypothesize that the implementation of an e-health application (OncoKompas) to support patients in managing their own revalidation and aftercare and adapting to a healthier life leads to more attention for multi-morbidity, preventive care resulting in an improved quality of life and patients satisfaction. Finally, we hypothesize that GPs responsible for the recurrence detection programme will feel more responsible for aftercare which will enhance revalidation and quality of life. Study design The present study proposal consists of a multi-centre 2x2 factorial randomised controlled trial with a calculated total sample size of 300 patients, based on the EORTC QLQ-C30. Patients will be randomised in four groups; 1. usual follow-up visits and aftercare provided in secondary care (surgeon-led), 2. usual follow-up visits and aftercare provided in secondary care with additional use of the e-health application OncoKompas, 3. follow-up and aftercare in primary care (GP-led), and 4. follow-up and aftercare in primary care with additional use of the e-health application OncoKompas. Study population Version number: 2.3 METC, of 66

8 Patients with stage I, II, and III carcinoma located in the colon and rectosigmoid are eligible. Patients with temporary stoma and who receive adjuvant chemotherapy are also eligible. Main study parameters/endpoints Primary outcomes include quality of life and patient satisfaction. Secondary outcomes include physical outcomes, psychosocial outcomes, number of investigations, referrals and related communication between secondary and primary care, (time of) recurrence detection and protocol adherence, attention to preventive care, cost effectiveness, and preference of care at the end of the trial. Version number: 2.3 METC, of 66

9 2. INTRODUCTION AND RATIONALE It is expected that in 2020 more than patients with colorectal cancer will be diagnosed in the Netherlands.(1, 2) After curative treatment there are several reasons for contact with healthcare professionals including detection of recurrent disease, restoration of health and psychosocial well-being, and preventive care.(3) Currently, in the Netherlands after initial treatment patients are typically included in a surgeon-led programme with the main focus on detection of recurrence and metachronous tumours; in general this is called follow-up. There is evidence that intensive follow-up programmes improve survival of colorectal cancer patients.(4) The Dutch guideline includes periodic visits combined with a carcino-embryonal antigen (CEA) blood test, imaging of the liver, and colonoscopy during the first five years after curative treatment.(2) Considering the fact that this follow-up programme is convenient to carry out, it is only a small step to hand over management of follow-up to GPs, especially since most patients are familiar with their GP and primary healthcare use is increased the first five years (without a decline in this period) after colorectal cancer diagnosis as has been shown in the Netherlands.(5) Cancer patients often experience multiple physical, functional, and psychosocial symptoms and problems during and after the initial treatment phase.(6) These symptoms cause considerable distress. Care with the purpose to alleviate these symptoms is called aftercare.(3) Goals of aftercare are; increasing physical condition, finding emotional and social balance, coping with disabilities and restoration of autonomy by increasing selfefficacy and return of confidence.(7) Currently, follow-up visits in secondary care do not always encounter these aspects and studies suggest that only a small number of distressed patients are identified and supported.(8, 9) Recently, our research group conducted a large cross-sectional survey in the Netherlands among patients, surgeons, and GPs in which current surgeon-led aftercare and possible future GP-led aftercare were evaluated. Only half of the patients were satisfied with the identification and treatment of psychosocial problems. Moreover, three out of four surgeons stated that especially psychosocial problems possibly received not enough attention due to lack of time and experience.(10) Both the Dutch Health Council as the Dutch Cancer Foundation suggested more generalist care as a solution to these problems.(3, 11) The prevalence of cancer patients with co-morbidity is expected to increase as a result of aging of the general population.(11, 12) Most common co-morbid conditions in Dutch colorectal cancer patients are cardiovascular disease, hypertension, diabetes, and COPD. These co-morbid conditions in combination with colorectal cancer make patients more Version number: 2.3 METC, of 66

10 vulnerable.(11, 13) Besides attention for pre-existent co-morbidity health care professionals should also be aware of newly developed co-morbidity after cancer treatment. Therefore, preventive care is important for all colorectal cancer survivors. Moreover, disease-free survival of colorectal cancer patients is increased in patients with higher levels of physical activity. Nevertheless, colorectal cancer survivors have the highest percentage sedentary lifestyles as compared to other malignancies.(14, 15) Furthermore, studies suggest that professionals miss opportunities to counsel cancer survivors, in particular colorectal cancer survivors about healthy behaviours.(16) This is unfortunate because for patients the cancer itself might be a strong motivator for lifestyle change. The guideline of the Dutch National Gastrointestinal Cancer group do not offer clear recommendations about which health care professional should coordinate care after initial treatment.(2) The Dutch Cancer Society s Signalling Committee on Cancer describes the importance of primary care in cancer management.(11) GPs with their generalist and broad view, accessibility, continuity of care, experience with chronic disease management, and wide network of health care providers might therefore be the favourite health care professional to provide aftercare.(17) According to the committee, care needs to be improved by enhancing collaboration between primary and secondary care and the role of GPs should be expanded. Few studies report on primary versus secondary care follow-up of breast and colonic cancer.(18-20) These studies show no significant difference for quality of life, recurrence rate, and anxiety. GP-led cancer follow-up was more cost-effective than hospital follow-up mainly due to a difference in organisational and physician costs. In 2014 a screening programme for colorectal cancer started nationwide in the Netherlands. Besides the demographic reasons already mentioned, this programme will generate an increase of incidence of detected colorectal cancer. Specialist care is expensive as compared to more generalist care and capacity problems might be anticipated. Furthermore, currently treatment and aftercare for cancer patients are mainly provided on a face-to-face basis which will not be feasible in the future to supply to all patients on a face-to-face basis only. Also, for patients it would be preferable to be able to undergo rehabilitation as much as possible in their own environment. The Chronic Care Model emphasizes the central role of the patient in management of his/ her own health.(21) Self-management or patient empowerment is defined as the individual s ability to manage symptoms, treatment, physical and psychosocial consequences and lifestyle changes inherent to living with a chronic condition.(22) Evidence shows that web-based interventions for patient empowerment can improve care for cancer patients.(23, 24) The aim of ICT-supported patient empowerment is to enable cancer patients to positively influence their treatment and rehabilitation, in keeping Version number: 2.3 METC, of 66

11 with the professional execution of survivorship care, by providing them with timely insight into, for instance, their individual state of health, their treatment stage or needs, and by offering personal lifestyle coaching based on their actual quality of life. An important development of these e-health facilities is the OncoKompas which is an e-health application which facilitates direct-to-user delivery of individualised preventive healthcare.(25) It is based on the Dutch guideline Cancer rehabilitation and Screening for the need of psychosocial care.(7, 26) The above mentioned developments are subjects of the I CARE study because to date robust research on a more prominent role for primary care and the use of e-health applications in the follow-up and aftercare for colon cancer patients after initial treatment, is missing and possible benefits in terms of patients satisfaction and quality of life should be further assessed. Version number: 2.3 METC, of 66

12 3. OBJECTIVES AND RESEARCH QUESTIONS 3.1 Objectives First, we hypothesize that GP involvement improves aftercare and preventive care all together resulting in improved quality of life and patients satisfaction. Furthermore we hypothesize that a GP-led recurrence detection programme (follow-up) for patients after curative treatment of colon cancer leads to at least equal detection of recurrences and subsequently equal number of curative recurrence resections. Second, we hypothesize that the implementation of the OncoKompas supports patients to manage their own revalidation and aftercare and to adapt to a healthier lifestyle, leading to more attention for multi-morbidity and preventive care resulting in improved quality of life. Third, we hypothesize that GPs responsible for the recurrence detection programme (followup) will feel more responsible for aftercare which will enhance revalidation and quality of life of colon cancer patients. 3.2 Research questions Can quality of life, patients satisfaction, and care for physical and psychosocial problems of patients with colon cancer during the first five years after initial treatment be improved in primary care compared to secondary care? Can quality of life, patients satisfaction, and care for physical and psychosocial problems of patients with colon cancer during five years after initial treatment be improved by implementation of the e-health application OncoKompas compared to usual aftercare? Is follow-up in primary care at least equal in terms of time and stage of recurrence detection and are there differences in number and types of additional diagnostic tests and referrals requested by GPs and surgeons. Is there a difference in cost-effectiveness between GP and surgeon led follow-up and aftercare? Are there specific patient characteristics which determine from which care model colon cancer survivors benefit the most (primary versus secondary care, patient empowerment versus usual aftercare)? Version number: 2.3 METC, of 66

13 4. STUDY DESIGN The study consists of a Dutch multi-centre trial including eight Dutch centres (see participating centres) with a calculated total sample size of 300 patients, based on the EORTC QLQ-C30. The study is designed according to a 2x2 factorial randomised controlled trial with randomisation at patients level. Scheduled first inclusion is December Scheduled final inclusion is December 2016, the follow-up period is five years. In order to allow assessment of the effects a factorial design for randomisation by patient will be used. Two randomisation procedures (at the same moment) will be undertaken, one to create two groups for surgeon-led (usual care, i.e. control group) versus GP-led follow-up and aftercare and a second randomisation for allocation of the e-health application OncoKompas. This factorial design results in four groups: 1. Usual follow-up visits and aftercare provided in secondary care (surgeon-led) 2. Usual follow-up visits and aftercare provided in secondary care (surgeon-led) with additional use of the e-health application OncoKompas 3. Follow-up and aftercare in primary care (GP-led) 4. Follow-up and aftercare visits in primary care (GP-led) with additional use of the e- health application OncoKompas Randomization to 1 of 4 groups will be on a 1:1:1:1 ratio. If a patient (or GP) declines randomisation the patient is asked to participate in a patients preference group (see Figure 1). Randomisation will be performed centrally at the Academic Medical Centre using a minimization algorithm to balance patient characteristics within each group based on three variables: age, tumour stage, and including centre. Once allocated to the GP, all future patients of the same GP will be allocated to the GP-arm. Version number: 2.3 METC, of 66

14 5. STUDY POPULATION 5.1 Population base Eligible patients will be included postoperatively via the outpatient clinic of the participating centres. The logistic requirements have been set out within the multicentre collaboration of a previous cohort study that has succeeded in including 260 patients with previously treated colonic cancer with similar inclusion criteria in a study period of 10 months. The hospitals of this collaboration have been approached for patient inclusion. A total of eight hospitals have committed to I CARE study participation: AMC Amsterdam, OLVG Amsterdam, Lucas Andreas Hospital Amsterdam, Tergooi Hospital Hilversum, St. Antonius Hospital Nieuwegein, Vlietland Hospital Schiedam, Flevo Hospital Almere, Westfriesgasthuis Hoorn. The number of segmental colonic resections for cancer in the participating centres ranges between 60 and 160 patients per centre annually. Therefore, an accrual period of 24 months should be sufficient to include the needed number of patients. 5.2 Inclusion criteria In order to be eligible to participate in this study, a subject must meet all of the following criteria: Carcinoma located in the colon and rectosigmoid defined as a tumour located 15 cm above the anal verge by coloscopy or above the sacral promontory as seen preoperatively Stage 1, 2 and 3 carcinoma Surgical treatment with curative intent Qualified for routine follow-up attendance by surgeon according to the national guideline. Patients with temporary stoma and who received adjuvant chemotherapy are also eligible. 5.3 Exclusion criteria A potential subject who meets any of the following criteria will be excluded from participation in this study: Stage IV colorectal tumours Hereditary colorectal cancer Colorectal cancer in patients with inflammatory bowel disease Rectal cancer Version number: 2.3 METC, of 66

15 (Sub)total colectomy or proctocolectomy History of second primary cancer (except basal cell carcinoma of the skin) within the last 15 years Participation in other (clinical) research, which will affect the outcome measurements of this trial Permanent open wounds after surgery or other conditions where specialised care is needed Any other condition that warrants increased intensity of surveillance with respect to colon cancer follow-up Not able to speak Dutch or English 5.4 Sample size calculation In accordance with previous studies we consider an effect 10 units improvement of the EORTC QLQ C30 to be clinically relevant.(27) To detect an intervention effect of 10 units of change (SD 20) in quality of life we will need 64 participants in each group (alpha 0.05, power 80%). As we expect some drop-out we aim for 75 patients in each group. Version number: 2.3 METC, of 66

16 6. TREATMENT OF SUBJECTS 6.1 Investigational product/treatment Intervention 1 (GP-led follow-up and aftercare): The included patients randomised to GP-led follow-up and aftercare will be referred to their GP for postoperative follow-up and aftercare according to the national guideline (see table 1 and table 2 below). An information letter provided by the treating surgeon will be given to the GP. This letter contains information about surgery, any complications, disease stage, the uses of chemotherapy, subsequent side effects, and risk of recurrence of the referred patient. If the treating surgeon or oncologist recommends an altered follow-up schedule they will give a clear advice. This letter will be sent to the GP after inclusion of a patient allocated to GP-led follow-up and aftercare. This letter will be accompanied by a detailed survival care plan (see appendix). This care plan contains general information about the national follow-up guideline, signs and symptoms of recurrence and behavioural strategy in the case of suspicion of a recurrence. Furthermore, this care plan contains information on physical and psychosocial problems patients might suffer with subsequent interventions. In case of questions regarding the information in the letter or in the survival care plan relevant contact information will be supplied. The survival care plan will also be available at our study website. Table 1: Follow-up after colon carcinoma resection with curative intent of carcinoma limited to submucosal involvement(t1n0m0). Table 2: Follow-up after colon carcinoma resection with curative intent of carcinoma extending beyond the submucosa but without distant metastasis (all stages with the exception of T1N0). Year 1 Year 2-5 Office visits every 6 months yearly Physical examination Coloscopy of: CT-colonography Only if indicated within 3 months postoperatively if preoperatively the colon was not visualized completely. 3 years after the last coloscopy, followed by subsequent coloscopies each 3-5 years depending on the number, size and localization of polyps If whole colon is visualized preoperatively coloscopy after 1 year. Note; the table is NOT applicable after endoscopic polypectomy of a T1 carcinoma. Version number: 2.3 METC, of 66

17 Year 1 Year 2 Year 3 Year 4-5 Office visits every 6 months every 6 every 6 Yearly months months Physical examination Only if indicated CEA monitoring Every 3-6 months Every 3-6 Every 3-6 every 6 months months months Abdominal ultrasonography (or CT abdomen*) every 6 months every 6 months Yearly Yearly Coloscopy of: CT-colography within 3 months postoperatively if preoperatively the colon was not visualized completely. presence of liver steatosis), or a CT scan can be considered in patients with a high risk of recurrence (T4N+) because of its higher sensitivity. 3 years after the last coloscopy, followed by subsequent coloscopies each 3-5 years depending on the number, size and localization of polyps If whole colon is visualized preoperatively coloscopy after 1 year. * CT-scan is indicated if an abdominal ultrasonography is not well interpretable (e.g. in the Intervention 2 (the use of the OncoKompas): An e-health application to facilitate and innovate supportive cancer care OncoKompas 2.0 is an integrated e-health application that supports cancer patients by finding and obtaining optimal supportive care, adjusted to their personal health status and preferences. One of the main goals of the OncoKompas 2.0 is to facilitate communication between the patient and professional healthcare by improving the assessment of health and cancer related problems and subsequently to provide interventions tailored to the individual patient. By means of OncoKompas 2.0 patients can monitor health related quality of life (HRQOL) and lifestyle. Data are processed in real-time. Participants can view their results by means of HRQOL-profiles. Supported by decision support algorithms, tailored advices are generated automatically concerning HRQOL and lifestyle. An embedded database with supportive care options allows personalised access to supportive cancer care, by directing patients towards guided self-help interventions (in case of minor problems) or towards professional care providers (in case of major problems). OncoKompas 2.0 comprises a generic module for all cancer survivors, targeting healthy lifestyle (smoking, alcohol use, exercising, nutrition, weight, stress), physical functioning (pain, sexuality, sleep, fatigue, body image, diarrhoea, constipation, hearing, loss of appetite, nausea/vomiting, neuropathy, lymph oedema, functioning in daily living), psychological Version number: 2.3 METC, of 66

18 functioning (anxiety, depression, fear of recurrence, cognitive functioning), social functioning (social life/ loneliness, relationships, relation with children, financial issues, return to work, communication with care providers), and life questions (meaning, religion, future perspectives). Furthermore, tumour specific modules will become available. A tumour specific module for colon cancer patients is under construction and will be available before the start of the study, targeting bladder and urinary problems, heredity, stools, ostomy, pain and abdominal bloating. A national database with supportive care options is under construction and will be available in This database will be built in into OncoKompas 2.0 to allow personalized access to supportive cancer care. OncoKompas 2.0 is developed according to a stepped care approach. All patients receive tailored information on their lifestyle, their physical, psychological, and social functioning, and existential issues; patients with minor problems are informed on self-help interventions, and on professional care if needed. Finally, it is important that the tailored information is not only based on the presence of health risks but more importantly also on patients preferences and motivation whether or not to tackle these problems 6.2 Use of co-intervention (if applicable) Not Applicable 6.3 Escape medication (if applicable) Not applicable Version number: 2.3 METC, of 66

19 7. INVESTIGATIONAL PRODUCT Not applicable Version number: 2.3 METC, of 66

20 8. METHODS 8.1 Study parameters/ endpoints Main study parameter/ endpoint Quality of life (generic and disease specific) Secondary study parameters/ endpoints 1) Physical outcomes: Recurrence rate and mortality, presence and duration of cancer related physical problems (pain, bowel function, fatigue, sexual problems, adverse sideeffects of chemotherapy, et cetera), number, sort and treatment of intercurrent signs and symptoms. 2) Psychosocial outcomes: Labour force participation, participation and experienced autonomy, emotional support, anxiety, depression and self-efficacy. 3) Number of diagnostic tests, referrals and related communication between secondary and primary care 4) Recurrence detection and protocol adherence 5) Attention to preventive care (change in smoking habits, physical activity, mean systolic blood pressure, and cholesterol levels) 6) Cost effectiveness 7) Patient satisfaction and preference of care at the end of the trial 8.2 Randomisation, blinding and treatment allocation Randomisation to one of four groups will be on a 1:1:1:1 ratio. Randomisation will be performed centrally at the Academic Medical Centre using a minimisation algorithm to balance patient characteristics within each group based on three variables: age, tumour stage, and including centre. Once allocated to the GP, all future patients of the same GP will be allocated to the GP-arm. Due to the nature of the intervention it is not possible to conceal the allocation group from either participants or clinicians. However, the primary researchers are not involved in subsequent follow-up/ aftercare appointments in any way. Recruited patients will not be informed about the other patients recruited in the same trial. Similarly, no information regarding trial progress and allocation will be revealed to the participating GPs or surgeons. All GPs working in the referral area of the participating centres will be informed before the start of the trial about the study design and the possibility that one of their future patients Version number: 2.3 METC, of 66

21 might be allocated to the GP-led study arm. GPs can decline participation by returning an opt-out reply . If a patient (or GP) declines randomisation the patient is asked to participate in a patients preference group (see Figure 1). In this arm similar data are gathered as compared to the randomised study arms but the allocation is only based on the patients treating surgeon and preference. Patients are asked for their informed consent postoperatively after the results of the pathological examination of the resection specimen with its consequences have been discussed with the patient. 8.3 Study procedures All involved departments of the participating centres have already given their approval to the study design. Approximately 3 4 weeks postoperatively patients will be seen at the surgical outpatients clinic. At this visit, a clinical examination will be performed and information about the histology and results of the surgery will be shared with each patient. Patients not receiving adjuvant chemotherapy and eligible for study inclusion will be asked for their informed consent. Also patients who need adjuvant chemotherapy and are eligible for study inclusion will be asked for their informed consent. However, before final inclusion in the study the patients will be referred to the oncologist for chemotherapeutic treatment. After completion of adjuvant chemotherapy subsequently these patients will be included definitively. After a patient has given informed consent also the GP is contacted if he/ she still wants to participate in the study. If also the GP participates the patients is randomised. If a patient declines randomisation (or the GP of the patient declines randomisation) the patient is asked to participate in a patients preference group. In this arm similar data are gathered as compared to the randomised study arms but the allocation is only based on the patients treating surgeon and preference. Patients allocated to GP-led follow-up may be referred back to the hospital at any time during the study. Similarly, patients in the surgeon-led groups are free to consult their GP any time during the study. Subjects can leave the study at any time for any reason if they wish to do so without any consequence. Data will be collected in both arms in identical ways and at identical time points. Changes in health status and valuation over time will be measured using the following questionnaires; 1. Generic and disease specific quality of life questionnaires (EORTC QLQ-C30, EORTC QLQ-CR29).(28, 29) Version number: 2.3 METC, of 66

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