Clinical trial NCT04316962: Cancer Rehabilitation in Primary Health Care
Official title: Cancer Rehabilitation in Primary Health Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Survivors
All Cancers
Keywords: Cancer survivors
Complex rehabilitation
Mixed method
Adults
Longitudinal
Pilot
Feasibility
Adherence
Quality of life
Participation
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: Norwegian Extra Foundation for Health and Rehabilitation
name: Askøy Municipality
First posted: 2020-03-20
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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?

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Quality of life after cancer rehabilitation
timeFrame: Change from baseline (T1) to the end of the program = 12 weeks after baseline (T3)
measure: Participation
timeFrame: Change from baseline (T1) to the end of the program=12 weeks after baseline (T3)
Secondary outcomes:
measure: Long term change in Quality of life
timeFrame: Change from baseline (T1) to 58 weeks (T8= 1 year after end of cancer rehabilitation)
measure: Physical fitness
timeFrame: Change masured in meters from baseline (T1) to the end of program=12 weeks after baseline (T3)
measure: Fatigue
timeFrame: 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)
measure: Mental Health
timeFrame: 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)
measure: Work and leisure
timeFrame: 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)
measure: Feasibility/adherence
timeFrame: Through study completion, on average of 1 year
Other outcomes:
measure: Satisfaction with program
timeFrame: At the end of the program = 12 weeks after baseline (T3)
measure: Patients' experiences
timeFrame: At the end of the program = 12 weeks after baseline (T3)
measure: Posttraumatic Growth
timeFrame: 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)
Locations:
city: Bergen
country: Norway
facility: Center for Crisis Psychology, University of Bergen
state: Vestland
city: Bergen
country: Norway
facility: Askøy Municipality
state: Vestland
Study officials:
affiliation: Center for Crisis Psychology, University of Bergen
name: May Aa Hauken, Professor
role: PRINCIPAL_INVESTIGATOR
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