Cancer Rehabilitation in Primary Health Care

December 7, 2023 updated by: May Aasebø Hauken, University of Bergen
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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?

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Vestland
      • Bergen, Vestland, Norway, 5020
        • Center for Crisis Psychology, University of Bergen
      • Bergen, Vestland, Norway, 5300
        • Askøy Municipality

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Complex rehabilitation
See intervention described elsewhere.
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:

  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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Change from baseline (T1) to the end of the program = 12 weeks after baseline (T3)
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 from baseline (T1) to the end of the program=12 weeks after baseline (T3)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long term change in Quality of life
Time Frame: Change from baseline (T1) to 58 weeks (T8= 1 year after end of 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 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)
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)
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)
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)
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)
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)
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)
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)
Feasibility/adherence
Time Frame: Through study completion, on average of 1 year
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction with program
Time Frame: At the end of the program = 12 weeks after baseline (T3)
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)
Patients' experiences
Time Frame: At the end of the program = 12 weeks after baseline (T3)
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)
Posttraumatic Growth
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bergen

Collaborators

Norwegian Extra Foundation for Health and Rehabilitation
Askøy Municipality

Investigators

  • Principal Investigator: May Aa Hauken, Professor, Center for Crisis Psychology, University of Bergen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2016

Primary Completion (Actual)

November 30, 2019

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

March 17, 2020

First Submitted That Met QC Criteria

March 19, 2020

First Posted (Actual)

March 20, 2020

Study Record Updates

Last Update Posted (Estimated)

December 14, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • F322

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We plan to make IPD available to other researchers on NSD (Norwegian Scientific Data)

IPD Sharing Time Frame

After the study has finished, earliest in December 2024

IPD Sharing Access Criteria

On request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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