Cancer SurvivorsNCT04316962
Cancer Rehabilitation in Primary Health Care
A study testing Complex cancer rehabilitation in people with Cancer Survivors and All Cancers, run by University of Bergen at 2 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cancer Survivors, All Cancers
- What is being tested?
- Complex cancer rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesNorway
- Study dates
- 26 Apr 2016to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cancer survivors with any type of cancer
- Aged 18- 70 years
- 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
Who cannot join
- Severe physical and/or mental comorbidity representing a contraindication for rehabilitation
- Insufficient cognitive or Language skills to answer study questionnaires and perform interviews.
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Center for Crisis Psychology, University of Bergen
Bergen, Vestland, 5020
Askøy Municipality
Bergen, Vestland, 5300
About this study
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.
Read the detailed 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:
- What characterize the psychosocial health and what is participants motivation to attend the program?
- How are the program's feasibility and adherence?
- In what degree do the participants achieve their goals and do this lead to increased participation?
- What are the participants' outcome on physical fitness?
- 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?
- What are the participants' experience of the rehabilitation process and what are the participants' recommendations for future programs?
- Conditions
- Cancer Survivors, All Cancers
- Being tested
- Complex cancer rehabilitation
- Keywords
- Cancer survivors, Complex rehabilitation, Mixed method, Adults, Longitudinal, Pilot, Feasibility, Adherence, Quality of life, Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex cancer rehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Complex rehabilitation | Experimental | See intervention described elsewhere. Receives: Other: Complex cancer rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Change from baseline (T1) to the end of the program = 12 weeks after baseline (T3)
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').
Measured: Change from baseline (T1) to the end of the program=12 weeks after baseline (T3)
Secondary outcomes (6)
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)
Measured: Change from baseline (T1) to 58 weeks (T8= 1 year after end of cancer rehabilitation)
Physical fitness
6 minutes walking test: Participant walk a predefined route, walk for 6 minutes and number of meter are measured.
Measured: Change masured in meters from baseline (T1) to the end of program=12 weeks after baseline (T3)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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
Measured: Through study completion, on average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start26 Apr 2016
- Primary completion30 Nov 2019
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Cancer SurvivorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Extra Foundation for Health and Rehabilitation, Askøy Municipality
- Responsible party
- Principal investigator, May Aasebø Hauken, University of Bergen
- Investigators
- May Aa Hauken, Professor, Principal investigator, Center for Crisis Psychology, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04316962
- Sponsor's protocol ID
- F322
- Status last verified
- Dec 2023
- First submitted
- 17 Mar 2020
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to make IPD available to other researchers on NSD (Norwegian Scientific Data)
Publications
Cancer Registry of Norway. Cancer in Norway 2018 - Cancer incidence, mortality, survival and prevalence in Norway. Oslo: Cancer Registry of Norway; 2019.
Bennion AE, Molassiotis A. Qualitative research into the symptom experiences of adult cancer patients after treatments: a systematic review and meta-synthesis. Support Care Cancer. 2013 Jan;21(1):9-25. doi: 10.1007/s00520-012-1573-x. Epub 2012 Sep 13.
PubMed 22972487Bibby H, White V, Thompson K, Anazodo A. What Are the Unmet Needs and Care Experiences of Adolescents and Young Adults with Cancer? A Systematic Review. J Adolesc Young Adult Oncol. 2017 Mar;6(1):6-30. doi: 10.1089/jayao.2016.0012. Epub 2016 Jul 25.
PubMed 27454408Stricker CT, Jacobs LA. Physical late effects in adult cancer survivors. Oncology (Williston Park). 2008 Jul;22(8 Suppl Nurse Ed):33-41.
PubMed 19856569Brearley SG, Stamataki Z, Addington-Hall J, Foster C, Hodges L, Jarrett N, Richardson A, Scott I, Sharpe M, Stark D, Siller C, Ziegler L, Amir Z. The physical and practical problems experienced by cancer survivors: a rapid review and synthesis of the literature. Eur J Oncol Nurs. 2011 Jul;15(3):204-12. doi: 10.1016/j.ejon.2011.02.005. Epub 2011 Apr 13.
PubMed 21489873Hewitt M, Greenfield S, Stovall Ee. From cancer patient to cancer survivor. Lost in transition: Institute of Medicine and National Research Council; 2006.
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.
PubMed 21231779Harrington 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.
PubMed 20848873Simard S, Thewes B, Humphris G, Dixon M, Hayden C, Mireskandari S, Ozakinci G. Fear of cancer recurrence in adult cancer survivors: a systematic review of quantitative studies. J Cancer Surviv. 2013 Sep;7(3):300-22. doi: 10.1007/s11764-013-0272-z. Epub 2013 Mar 10.
PubMed 23475398Ewertz 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.
PubMed 21231780Soon J, Anton A, Torres J, et al. The Spectrum of Late Effects in Survivors of Stage I Seminoma: A Systematic Review. Asia-Pacific Journal of Clinical Oncology. Aug 2017;13:73-73.
Bifulco G, De Rosa N, Tornesello ML, Piccoli R, Bertrando A, Lavitola G, Morra I, Di Spiezio Sardo A, Buonaguro FM, Nappi C. Quality of life, lifestyle behavior and employment experience: a comparison between young and midlife survivors of gynecology early stage cancers. Gynecol Oncol. 2012 Mar;124(3):444-51. doi: 10.1016/j.ygyno.2011.11.033. Epub 2011 Nov 23.
PubMed 22119994Bilodeau K, Tremblay D, Durand MJ. Exploration of return-to-work interventions for breast cancer patients: a scoping review. Support Care Cancer. 2017 Jun;25(6):1993-2007. doi: 10.1007/s00520-016-3526-2. Epub 2017 Jan 4.
PubMed 28054145Bevilacqua LA, Dulak D, Schofield E, Starr TD, Nelson CJ, Roth AJ, Holland JC, Alici Y. Prevalence and predictors of depression, pain, and fatigue in older- versus younger-adult cancer survivors. Psychooncology. 2018 Mar;27(3):900-907. doi: 10.1002/pon.4605. Epub 2018 Jan 25.
PubMed 29239060Campos MPO, Hassan BJ, Riechelmann R, Del Giglio A. Cancer-related fatigue: a practical review. Ann Oncol. 2011 Jun;22(6):1273-1279. doi: 10.1093/annonc/mdq458. Epub 2011 Feb 16.
PubMed 21325448
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Rehabilitation in Primary Health Care
- ClinicalTrials.gov ID
- NCT04316962
- Acronym / sponsor ID
- F322
- Conditions
- Cancer Survivors, All Cancers
- Keywords
- Cancer survivors, Complex rehabilitation, Mixed method, Adults, Longitudinal, Pilot, Feasibility, Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- Norwegian Extra Foundation for Health and Rehabilitation, Askøy Municipality
- Study start
- 26 Apr 2016 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 20 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- What characterize the psychosocial health and what is participants motivation to attend the program?
- How are the program's feasibility and adherence?
- In what degree do the participants achieve their goals and do this lead to increased participation?
- What are the participants' outcome on physical fitness?
- 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?
- What are the participants' experience of the rehabilitation process and what are the participants' recommendations for future programs?
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Complex rehabilitation | Experimental | Other: Complex cancer rehabilitationSee intervention described elsewhere. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cancer survivors with any type of cancer
- Aged 18- 70 years
- 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
Key exclusion criteria (2 listed)
- Severe physical and/or mental comorbidity representing a contraindication for rehabilitation
- Insufficient cognitive or Language skills to answer study questionnaires and perform interviews.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complex cancer rehabilitationThe 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. | Other | Complex rehabilitation |
Primary outcome
Change in Quality of life after cancer rehabilitation
Time frame: Change from baseline (T1) to the end of the program = 12 weeks after baseline (T3)
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)
Participation
Time frame: Change from baseline (T1) to the end of the program=12 weeks after baseline (T3)
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').
6 secondary outcomes
Long term change in Quality of life
Time frame: Change from baseline (T1) to 58 weeks (T8= 1 year after end of cancer rehabilitation)
Physical fitness
Time frame: Change masured in meters from baseline (T1) to the end of program=12 weeks after baseline (T3)
Fatigue
Time frame: 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)
Mental Health
Time frame: 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)
Work and leisure
Time frame: 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)
Feasibility/adherence
Time frame: Through study completion, on average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- BackgroundCancer Registry of Norway. Cancer in Norway 2018 - Cancer incidence, mortality, survival and prevalence in Norway. Oslo: Cancer Registry of Norway; 2019.
- Background: PubMed 22972487Bennion AE, Molassiotis A. Qualitative research into the symptom experiences of adult cancer patients after treatments: a systematic review and meta-synthesis. Support Care Cancer. 2013 Jan;21(1):9-25. doi: 10.1007/s00520-012-1573-x. Epub 2012 Sep 13.
- Background: PubMed 27454408Bibby H, White V, Thompson K, Anazodo A. What Are the Unmet Needs and Care Experiences of Adolescents and Young Adults with Cancer? A Systematic Review. J Adolesc Young Adult Oncol. 2017 Mar;6(1):6-30. doi: 10.1089/jayao.2016.0012. Epub 2016 Jul 25.
- Background: PubMed 19856569Stricker CT, Jacobs LA. Physical late effects in adult cancer survivors. Oncology (Williston Park). 2008 Jul;22(8 Suppl Nurse Ed):33-41.
- Background: PubMed 21489873Brearley SG, Stamataki Z, Addington-Hall J, Foster C, Hodges L, Jarrett N, Richardson A, Scott I, Sharpe M, Stark D, Siller C, Ziegler L, Amir Z. The physical and practical problems experienced by cancer survivors: a rapid review and synthesis of the literature. Eur J Oncol Nurs. 2011 Jul;15(3):204-12. doi: 10.1016/j.ejon.2011.02.005. Epub 2011 Apr 13.
- BackgroundHewitt M, Greenfield S, Stovall Ee. From cancer patient to cancer survivor. Lost in transition: Institute of Medicine and National Research Council; 2006.
- Background: PubMed 21231779Hellbom 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.
- Background: PubMed 20848873Harrington 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.
- Background: PubMed 23475398Simard S, Thewes B, Humphris G, Dixon M, Hayden C, Mireskandari S, Ozakinci G. Fear of cancer recurrence in adult cancer survivors: a systematic review of quantitative studies. J Cancer Surviv. 2013 Sep;7(3):300-22. doi: 10.1007/s11764-013-0272-z. Epub 2013 Mar 10.
- Background: PubMed 21231780Ewertz 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.
- BackgroundSoon J, Anton A, Torres J, et al. The Spectrum of Late Effects in Survivors of Stage I Seminoma: A Systematic Review. Asia-Pacific Journal of Clinical Oncology. Aug 2017;13:73-73.
- Background: PubMed 22119994Bifulco G, De Rosa N, Tornesello ML, Piccoli R, Bertrando A, Lavitola G, Morra I, Di Spiezio Sardo A, Buonaguro FM, Nappi C. Quality of life, lifestyle behavior and employment experience: a comparison between young and midlife survivors of gynecology early stage cancers. Gynecol Oncol. 2012 Mar;124(3):444-51. doi: 10.1016/j.ygyno.2011.11.033. Epub 2011 Nov 23.
- Individual participant dataSharing planned: Yes. We plan to make IPD available to other researchers on NSD (Norwegian Scientific Data)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
May Aa Hauken, Professor principal investigator
Center for Crisis Psychology, University of Bergen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complex cancer rehabilitation in people with Cancer Survivors and All Cancers, run by University of Bergen at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of life after cancer rehabilitation (time frame: Change from baseline (T1) to the end of the program = 12 weeks after baseline (T3)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04316962, which also lists 36 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023.