Cancer Rehabilitation in Primary Health Care

Cancer Survivors Clinical Trial

Official title:

Cancer Rehabilitation in Primary Health Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04316962
• Other study ID #: F322
• Status: Completed
• Phase: N/A
• Start date: April 26, 2016
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2023
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

More than 70 % of Norwegian cancer patients become longtime survivors. Even if research documents that a large number strive with physical and psychosocial late effects from cancer and cancer treatment, cancer rehabilitation is not an integrated part of the cancer trajectory. Especially, there is a lack of knowledge and research based cancer rehabilitation in primary health care. In this study, the researchers pilot a cancer rehabilitation program in primary health care using a mixed method with a longitudinal pre-post design and focus group interviews. The overall goal is to study the program's feasibility and adherence, as well as outcomes on quality of life and participation. The project will provide new and important knowledge of cancer rehabilitation in primary health care, as well as important knowledge in on planning and designing a larger RCT study on the topic.

Description:

This study focuses on piloting a cancer rehabilitation program for cancer survivors (18-70 years of age), conducted in primary health care in a Norwegian municipality. In Norway, more than 70 % of all cancer patients will be long time survivors. However, research documents that cancer survivors are at increased risk for physical and psychosocial late effects with negative consequences for survival, long-time health and quality of life. Still, there is a huge gap between cancer survivors' documented late-effects and unmet needs and cancer rehabilitation interventions. Background Current cancer treatment is usually multimodal, hard and long-lasting, whereby many cancer patients experience physical and psychosocial late-effects and challenges. Some late-effects are life threatening, such as cancer relapse, new cancers, or development of chronical diseases. Other late effects influence the individual's health and quality of life negatively, as for example pain, lymphedema, gastrointestinal problems, memory, concentration and cognitive problems, neuropathies, anxiety and depression etc. In addition, cancer survivors report of social, economic and work related challenges. However, fatigue is the most distressing late-effect reported by cancer survivors, as it influences all areas of life, and is regarded as a strong and independent predictor for impaired quality of life. Even if Norwegians' right to rehabilitation is assigned by law and cancer rehabilitation is a national focus area, cancer rehabilitation is not an integrated part of the cancer trajectory. Research indicate that healthcare providers have limited knowledge of cancer survivors' multidimensional challenges and effective elements in cancer rehabilitation. Consequently, cancer survivors experience lack of information about late-effects, inadequate follow-up and lack of understanding related to their physical and psychosocial challenges, as well as multidimensional rehabilitation interventions. Based on the law, cancer rehabilitation preferably should be conducted in municipalities nearby the patient's home. However, the few existing programs are criticized for being random, fragmented, not research based, only including single elements, and that survivors have to find such offers for themselves. This highlights the need to developed and pilot evidence based cancer rehabilitation programs - especially in primary health care. Cancer rehabilitation is defined as processes that support cancer survivors to achieve maximal physical, psychological, social and work function within the frames created by cancer and cancer treatment. Consequently, cancer rehabilitation builds on a bio-psychosocial view of health and health promotion. Even if cancer rehabilitation is a relatively new research field, research shows that effective elements in cancer rehabilitation are based on physical activity and psychosocial interventions. Physical activity is the single element with most evidence, showing positive effects on physical fitness, general health, quality of life, fatigue and return to work for most cancers and ages. Guidelines for cancer survivors recommend moderate physical activity 30 minutes a day, five days a week or more - and physical exercise as a combination of cardiovascular and strength exercise with gradual increase. Different types of psychosocial education have also shown effect on coping and stress reduction in cancer survivors. Such interventions, often called psychoeducation, most often include several elements such as education and illness specific information, emotional support, coping strategies, relaxing technics and discussions. Because cancer survivors challenges are multidimensional and individual, meeting the individual's need are crucial. Consequently, individual follow-up and goal setting are important means in promoting motivation, control and coping expectations that may promote positive physical and psychosocial health.Furthermore, research documents the importance of peer support in cancer rehabilitation, whereby peer support may promote positive changes, psychosocial function, empowerment and quality of life. New research indicates that a multidimensional approach in cancer rehabilitation that combines physical and psychosocial elements are more effective than single interventions related to physical function, quality of life, fatigue and distress. Research also indicate that positive effects of complex interventions are related to group rehabilitation after primary cancer treatment is finished, programs lasting more than three weeks, including several diagnosis and a multidisciplinary approach. Even if most of this research is conducted as in-rehabilitation in the specialist health care level, it seems evident that a complex rehabilitation program in primary healthcare should combine elements of physical activity, psychoeducation, peer support, goal setting and individual follow up for cancer survivors with different types of cancers after completion of primary cancer treatment. Study goal and research questions The overall goal of this pilot study is to increase the understanding and knowledge of cancer rehabilitation in primary health care by pilot testing a complex cancer rehabilitation program. Based on this, we have the following research questions: 1. What characterize the psychosocial health and what is participants motivation to attend the program? 2. How are the program's feasibility and adherence? 3. In what degree do the participants achieve their goals and do this lead to increased participation? 4. What are the participants' outcome on physical fitness? 5. What are the participants' short (12 weeks) and long-term outcomes (6 and 12 months) related to quality of life, physical function, fatigue and mental health? 6. What are the participants' experience of the rehabilitation process and what are the participants' recommendations for future programs?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 31, 2022
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Cancer survivors with any type of cancer

2. Aged 18- 70 years

3. Finished primary cancer treatment within the last three months to five years 4) referred to the study by oncologist or general practitioner assuring the need for, and capability to, to participate in the program 5) Able to speak and read Norwegian

Exclusion Criteria:

1. Severe physical and/or mental comorbidity representing a contraindication for rehabilitation

2. Insufficient cognitive or Language skills to answer study questionnaires and perform interviews.

Related Conditions & MeSH terms

• All Cancers
• Cancer Survivors

Intervention

Other:
• Complex cancer rehabilitation
The program is conducted as group rehabilitation, organized by four hour weekly over 12 weeks (approximately 50 hours) with 8-10 participants in each group over three years. The program is located in Askøy Municipality's 'Health Central' and conducted by a multidisciplinary team. The content of the program is based on prior research and clinical experience, consisting of five elements: Individual goal-setting Physical activity (2 hours/week) focusing on balance/coordination, cardio and strength. Psychoeducation: Five teaching sessions and discussions focusing on physical activity, fatigue and late-effects, nutrition, coping, social support and work/studies. In addition, two sessions (first and last) will also include next of kin. Individual follow-up: Mandatory session at the start and end of the program, otherwise based on individual request and need. Peer support.

Locations

Country	Name	City	State
Norway	Askøy Municipality	Bergen	Vestland
Norway	Center for Crisis Psychology, University of Bergen	Bergen	Vestland

Sponsors (3)

Lead Sponsor	Collaborator
University of Bergen	Askøy Municipality, Norwegian Extra Foundation for Health and Rehabilitation

Country where clinical trial is conducted

Norway, 

References & Publications (36)

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Ewertz M, Jensen AB. Late effects of breast cancer treatment and potentials for rehabilitation. Acta Oncol. 2011 Feb;50(2):187-93. doi: 10.3109/0284186X.2010.533190. — View Citation

Faller H, Schuler M, Richard M, Heckl U, Weis J, Kuffner R. Effects of psycho-oncologic interventions on emotional distress and quality of life in adult patients with cancer: systematic review and meta-analysis. J Clin Oncol. 2013 Feb 20;31(6):782-93. doi: 10.1200/JCO.2011.40.8922. Epub 2013 Jan 14. — View Citation

Fors EA, Bertheussen GF, Thune I, Juvet LK, Elvsaas IK, Oldervoll L, Anker G, Falkmer U, Lundgren S, Leivseth G. Psychosocial interventions as part of breast cancer rehabilitation programs? Results from a systematic review. Psychooncology. 2011 Sep;20(9):909-18. doi: 10.1002/pon.1844. Epub 2010 Sep 6. — View Citation

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Harrington CB, Hansen JA, Moskowitz M, Todd BL, Feuerstein M. It's not over when it's over: long-term symptoms in cancer survivors--a systematic review. Int J Psychiatry Med. 2010;40(2):163-81. doi: 10.2190/PM.40.2.c. — View Citation

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Hauken MA, Larsen TMB, Holsen I. "Back on Track": A Longitudinal Mixed Methods Study on the Rehabilitation of Young Adult Cancer Survivors. Journal of Mixed Methods Research. 2017;13(3):339-360.

Hellbom M, Bergelt C, Bergenmar M, Gijsen B, Loge JH, Rautalahti M, Smaradottir A, Johansen C. Cancer rehabilitation: A Nordic and European perspective. Acta Oncol. 2011 Feb;50(2):179-86. doi: 10.3109/0284186X.2010.533194. Erratum In: Acta Oncol. 2011 Apr;50(3):480. Rautalathi, Matti [corrected to Rautalahti, Matti]. — View Citation

Hewitt M, Greenfield S, Stovall Ee. From cancer patient to cancer survivor. Lost in transition: Institute of Medicine and National Research Council; 2006.

Juvet LK, Elvsaas IKO, Leivseth G, Anker G, Bertheussen GF, Falkmer U, Fors EA, Lundgren S, Oldervoll LM, Thune I, Norderhaug IN. Rehabilitation of Breast Cancer Patients [Internet]. Oslo, Norway: Knowledge Centre for the Health Services at The Norwegian Institute of Public Health (NIPH); 2009 Mar. Report from Norwegian Knowledge Centre for the Health Services (NOKC) No. 02-2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK464742/ — View Citation

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Loken OU, Hauken MA. A Qualitative Study of Cancer Survivors' Experienced Outcomes of a Multidimensional Rehabilitation Program in Primary Healthcare. Cancer Nurs. 2022 May-Jun 01;45(3):E646-E654. doi: 10.1097/NCC.0000000000000989. Epub 2021 Sep 3. — View Citation

Schmitz KH, Courneya KS, Matthews C, Demark-Wahnefried W, Galvao DA, Pinto BM, Irwin ML, Wolin KY, Segal RJ, Lucia A, Schneider CM, von Gruenigen VE, Schwartz AL; American College of Sports Medicine. American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc. 2010 Jul;42(7):1409-26. doi: 10.1249/MSS.0b013e3181e0c112. Erratum In: Med Sci Sports Exerc. 2011 Jan;43(1):195. — View Citation

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Speck RM, Courneya KS, Masse LC, Duval S, Schmitz KH. An update of controlled physical activity trials in cancer survivors: a systematic review and meta-analysis. J Cancer Surviv. 2010 Jun;4(2):87-100. doi: 10.1007/s11764-009-0110-5. Epub 2010 Jan 6. Erratum In: J Cancer Surviv. 2011 Mar;5(1):112. — View Citation

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Stout NL, Silver JK, Raj VS, Rowland J, Gerber L, Cheville A, Ness KK, Radomski M, Nitkin R, Stubblefield MD, Morris GS, Acevedo A, Brandon Z, Braveman B, Cunningham S, Gilchrist L, Jones L, Padgett L, Wolf T, Winters-Stone K, Campbell G, Hendricks J, Perkin K, Chan L. Toward a National Initiative in Cancer Rehabilitation: Recommendations From a Subject Matter Expert Group. Arch Phys Med Rehabil. 2016 Nov;97(11):2006-2015. doi: 10.1016/j.apmr.2016.05.002. Epub 2016 May 27. — View Citation

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* Note: There are 36 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Satisfaction with program	Self-reported satisfaction with program: 7 questions, measured on a 4-point Likert scale measuring satisfaction with the content and structure of the program ranging from 0 (not satisfied at all) to 3 (Very satisfied)	At the end of the program = 12 weeks after baseline (T3)
Other	Patients' experiences	Focus group interviews with a semi-structured interview guide focusing on motivation for the program, satisfaction with content and structure, importance and experienced outcome.	At the end of the program = 12 weeks after baseline (T3)
Other	Posttraumatic Growth	Self-reported scale on posttraumatic growth: The Posttraumatic Growth Inventory Short Form (PTGI-SF) with 10 questions measured on a 6-point Likert scale ranging from 0 (not experienced) to 5 (to a very large extent). Max sum score = 50 where higher score indicate higher personal growth.	Short and longtime change from baseline (T1) to the end of program= 12 weeks after baseline (T3); and to six months and one year after program (T4 and T5)
Primary	Change in Quality of life after cancer rehabilitation	Self reported quality of life scale: European Organization for Research and Treatment of Cancer (EORTC QLQ C30), 30 questions, 4-point Likert scale 0-3 for 28 items, 0-6 for two items, total score 0-100 (100=highest Level of function/best score)	Change from baseline (T1) to the end of the program = 12 weeks after baseline (T3)
Primary	Participation	Participation scale (goal achievement) administrated by professionals: Canadian Occupational Performance Measure (COPM): Participants rate problems in the three areas of self-care, productivity and leisure. Then they rate the importance of each problem and score performance and satisfaction with performance on a 10-point scale ranging from 1 ('not able to do it' or 'not satisfied at all') to 10 ('able to do it extremely well' or 'extremely satisfied').	Change from baseline (T1) to the end of the program=12 weeks after baseline (T3)
Secondary	Long term change in Quality of life	Self reported quality of life scale: European Organization for Research and Treatment of Cancer (EORTC QLQ C30), 30 questions, 4-point Likert scale 0-3 for 28 items, 0-6 for two items, total score 0-100 (100=highest Level of function/best score)	Change from baseline (T1) to 58 weeks (T8= 1 year after end of cancer rehabilitation)
Secondary	Physical fitness	6 minutes walking test: Participant walk a predefined route, walk for 6 minutes and number of meter are measured.	Change masured in meters from baseline (T1) to the end of program=12 weeks after baseline (T3)
Secondary	Fatigue	Self reported fatigue scale: Fatigue Questionnaire (FQ), 13 items, whereby 7 items measure physical fatigue, 4 items measure mental fatigue, and two items are related to timeframe. 4-point Likert scale for all items scored from 0-4. Sum score > 4 and more than 6 months duration are defined as fatigue.	Short and longtime change from baseline (T1) to end of program= 12 weeks after baseline (T3); and to six months and one year after end of program (T4 and T5)
Secondary	Mental Health	Self reported mental health scale: Hospital Anxiety and Depression Scale (HADS), including 7 questions of anxiety (HADS -A) and seven question of depression (HADS-B). Scored on a 4-point Likert Scale (0-4) where a sum score of 11 or more are defined as anxiety/depression.	Short and longtime change from baseline (T1) to the end of program = 12 weeks after baseline (T3); and to six months and one year after program (T4 and T5)
Secondary	Work and leisure	Self-reported work/leisure scale: Work and Social Adjustment Scale (WSAS) with five questions, 8- point Likert Scale from 0 (not impaired at all) to 8 (seriously impaired). Max sum score = 40 (seriously impaired function), where scores > 20 indicates seriously psychopathology and scores 10- 20 is associated with significant impaired function.	Short and longtime change from baseline (T1) to the end of program = 12 weeks after baseline (T3); and to six months and one year after program (T4 and T5)
Secondary	Feasibility/adherence	Registration of study flow during the program: attendance on physical exercise, physical testing, attendance of psychoeducation sessions, dropout (number/reason), adverse events and missing data in questionaires	Through study completion, on average of 1 year