Cancer Rehabilitation in Primary Health Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Bergen
- Enrollment
- 72
- Locations
- 4
- Primary Endpoint
- Participation
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Masking Description
No masking: only single group pre-post
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •Able to speak and read Norwegian
Exclusion Criteria
- •Severe physical and/or mental comorbidity representing a contraindication for rehabilitation
- •Insufficient cognitive or Language skills to answer study questionnaires and perform interviews.
Outcomes
Primary Outcomes
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').
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)
Secondary Outcomes
- Long term change in Quality of life(Change from baseline (T1) to 58 weeks (T8= 1 year after end of cancer rehabilitation))
- Physical fitness(Change masured in meters from baseline (T1) to the end of program=12 weeks after baseline (T3))
- Feasibility/adherence(Through study completion, on average of 1 year)
- Mental Health(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))
- 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))
- Work and leisure(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))
Investigators
May Aasebø Hauken
Professor
University of Bergen