Study Results
Results pending
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Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
72 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-04-26
Study Completion Date
2022-12-31
Brief Summary
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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.
Detailed Description
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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?
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?
Conditions
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Cancer Survivors
All Cancers
Keywords
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Cancer survivors
Complex rehabilitation
Mixed method
Adults
Longitudinal
Pilot
Feasibility
Adherence
Quality of life
Participation
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
A pilot study using mixed method with a longitudinal explanatory pre-post design, whereby quantitative data are collected longitudinal and qualitative data are collected in means of focus groups at the end of the rehabilitation program (after 12 weeks). Mixed methods design are reckoned to be a new and important research paradigm because the use of both quantitative and qualitative data may provide an increased insight in both processes and outcomes and thereby provide a more nuanced and complete understanding of the topic in focus, here, cancer rehabilitation.
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
NONE
No masking: only single group pre-post
Study Groups
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Complex rehabilitation
See intervention described elsewhere.
Group Type
EXPERIMENTAL
Complex cancer rehabilitation
Intervention Type
OTHER
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:
1. Individual goal-setting
2. Physical activity (2 hours/week) focusing on balance/coordination, cardio and strength.
3. 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.
4. Individual follow-up: Mandatory session at the start and end of the program, otherwise based on individual request and need.
5. Peer support.
Interventions
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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:
1. Individual goal-setting
2. Physical activity (2 hours/week) focusing on balance/coordination, cardio and strength.
3. 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.
4. Individual follow-up: Mandatory session at the start and end of the program, otherwise based on individual request and need.
5. Peer support.
Intervention Type
OTHER
Eligibility Criteria
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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
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.
2. Insufficient cognitive or Language skills to answer study questionnaires and perform interviews.
Minimum Eligible Age
18 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Norwegian Extra Foundation for Health and Rehabilitation
OTHER
Sponsor Role
collaborator
Askøy Municipality
UNKNOWN
Sponsor Role
collaborator
University of Bergen
OTHER
Sponsor Role
lead
Responsible Party
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May Aasebø Hauken
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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May Aa Hauken, Professor
Role: PRINCIPAL_INVESTIGATOR
Center for Crisis Psychology, University of Bergen
Locations
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Center for Crisis Psychology, University of Bergen
Bergen, Vestland, Norway
Site Status
Askøy Municipality
Bergen, Vestland, Norway
Site Status
Countries
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Norway
References
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Cancer Registry of Norway. Cancer in Norway 2018 - Cancer incidence, mortality, survival and prevalence in Norway. Oslo: Cancer Registry of Norway; 2019.
Reference Type
BACKGROUND
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BACKGROUND
Stricker CT, Jacobs LA. Physical late effects in adult cancer survivors. Oncology (Williston Park). 2008 Jul;22(8 Suppl Nurse Ed):33-41.
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Hewitt M, Greenfield S, Stovall Ee. From cancer patient to cancer survivor. Lost in transition: Institute of Medicine and National Research Council; 2006.
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BACKGROUND
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.
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BACKGROUND
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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.
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Brandenbarg D, Korsten JHWM, Berger MY, Berendsen AJ. The effect of physical activity on fatigue among survivors of colorectal cancer: a systematic review and meta-analysis. Support Care Cancer. 2018 Feb;26(2):393-403. doi: 10.1007/s00520-017-3920-4. Epub 2017 Oct 23.
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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/
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BACKGROUND
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.
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Spence RR, Heesch KC, Brown WJ. Exercise and cancer rehabilitation: a systematic review. Cancer Treat Rev. 2010 Apr;36(2):185-94. doi: 10.1016/j.ctrv.2009.11.003. Epub 2009 Dec 4.
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BACKGROUND
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.
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BACKGROUND
Ahmedzai HH, Oldervoll LM, Sweetmore AH, Hauken MA. Community-Based Multidimensional Cancer Rehabilitation in Norway: A Feasibility Study. Cancer Nurs. 2024 Mar-Apr 01;47(2):E123-E133. doi: 10.1097/NCC.0000000000001161. Epub 2022 Dec 11.
Reference Type
RESULT
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.
Reference Type
RESULT
Other Identifiers
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F322
Identifier Type: -
Identifier Source: org_study_id