Cancer Rehabilitation in Primary Health Care

NCT04316962 | Completed DMC

• 1 other identifier: F322
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer Survivors; All Cancers

Keywords

Cancer survivors; Complex rehabilitation; Mixed method; Adults; Longitudinal; Pilot; Feasibility; Adherence; Quality of life; Participation

Outcome Measures

Primary Outcomes (2)

• 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)

  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').

  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

  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)

• 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

  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

  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)

Other Outcomes (3)

• Satisfaction with program

  At the end of the program = 12 weeks after baseline (T3)

• Patients' experiences

  At the end of the program = 12 weeks after baseline (T3)

• Posttraumatic 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)

Study Arms (1)

Complex rehabilitation

EXPERIMENTAL

See intervention described elsewhere.

Other: Complex cancer rehabilitation

Interventions

Complex cancer rehabilitation 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.

Complex rehabilitation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Severe physical and/or mental comorbidity representing a contraindication for rehabilitation
• Insufficient cognitive or Language skills to answer study questionnaires and perform interviews.

Sponsors & Collaborators

• University of Bergen: lead
• Norwegian Extra Foundation for Health and Rehabilitation: collaborator
• Askøy Municipality: collaborator

Study Sites (2)

Center for Crisis Psychology, University of Bergen

Bergen, Vestland, 5020, Norway

Location

Askøy Municipality

Bergen, Vestland, 5300, Norway

Location

Related Publications (36)

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  BACKGROUND

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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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• The Norwegian Department of Health.2018. Living with cancer. National Cancer Strategy 2018-2022. Oslo

  BACKGROUND

• Silver JK. Integrating Rehabilitation Into the Cancer Care Continuum. PM R. 2017 Sep;9(9 Suppl 2):S291-S296. doi: 10.1016/j.pmrj.2017.07.075. No abstract available.

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• Hall AE, Boyes AW, Bowman J, Walsh RA, James EL, Girgis A. Young adult cancer survivors' psychosocial well-being: a cross-sectional study assessing quality of life, unmet needs, and health behaviors. Support Care Cancer. 2012 Jun;20(6):1333-41. doi: 10.1007/s00520-011-1221-x. Epub 2011 Jul 1.

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• 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.

  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.

  PMID: 36066332 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.

  PMID: 34310389 RESULT

Study Officials

• May Aa Hauken, Professor

  Center for Crisis Psychology, University of Bergen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking: only single group pre-post
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: March 20, 2020
• Study Start: April 26, 2016
• Primary Completion: November 30, 2019
• Study Completion: December 31, 2022
• Last Updated: December 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After the study has finished, earliest in December 2024
• Access Criteria: On request

Locations

NO (2)