Rehabilitation - Physical Activity and Coping (RPAC)

The project is a non-randomized intervention study with group-based physical exercise. Cancer survivors who have participated in the rehabilitation program at the Center for Education and Rehabilitation are included in the study.

The cancer and cancer treatment have led to patients struggling with physical, mental and social late effects which prevent them from functioning in everyday life and return to work. The purpose of the project is to investigate whether one municipal group training measure can help to lower the threshold for the user to maintain good exercise habits and return to work / everyday life, as well as the effect on the user's physical form and quality of life and the transition between health level and the body itself measure.

Study Overview

• Status: Active, not recruiting
• Conditions: Cancer Survivors
• Intervention / Treatment: Behavioral: Exercise training

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway, 5021
    • Helse Bergen,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years
• Women and men
• Regardless of cancer diagnosis
• Resident in Bergen municipality
• Finishes their rehabilitation at The Cancer Center for Education and Rehabilitation spring/summer 2019.

Exclusion Criteria:

• Patients who do not speak or understand Norwegian
• Unable to express themselves in writing
• Unable to perform basic daily tasks
• Display cognitive disorder or severe emotional instability
• Suffer from other debilitating illnesses / conditions that may inhibit physical exercise (heart failure, chronic obstructive pulmonary disease, orthopedic conditions, neurological disorders or the like) will be excluded from the study. -

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise; 18 weeks supervised strength and aerobic exercise training	Behavioral: Exercise training; 18 weeks supervised strength and aerobic exercise training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objectively recorded physical activity level	Change in objectively recorded physical activity level, measured with the SenseWear ™ Mini Armband (SWA) (BodyMedia Inc. Pittsburgh, PA, USA) as average minutes of moderate- to vigorous intensity physical activity (MVPA) from before intervention to after completion of the intervention.	18 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in maximal oxygen uptake measured by VO2max	Change in VO2max, measured by a maximal incremental exercise test on a treadmill, from before training intervention to post training intervention.	18 weeks
Change in maximal strength	Change in 1 repetition maximum strength in upper and lower body measured from before intervention and after completion of the intervention.	18 weeks
Change in quality of life measured by Short Form Health Survey (SF-36)	Change in scores on the Short Form Health Survey (SF-36) from before intervention to after completion of the intervention.	18 weeks
Change in fatigue scores using the Chalder Fatigue Questionaire (FQ)	Change in scores on the Chalder Fatigue Questionaire (FQ) from before intervention to after completion of the intervention.	18 weeks

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Investigators: Study Director: Cecilia Arving, PhD, Helse Bergen, Cancer Center for Education and Rehabilitation

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2019
• Primary Completion (Actual): August 26, 2019
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: January 16, 2020
• First Submitted That Met QC Criteria: January 26, 2020
• First Posted (Actual): January 29, 2020

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Rehabilitation; Fatigue; Physical exercise; Cancer survivors; Return to work
• Other Study ID Numbers: 2019/620

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All individual participant data (IPD) that underlie results in a publication are to be shared with two master students and their professors/supervisors/researchers who take part in the study.
• IPD Sharing Time Frame: The data will become available from February 2020 to October 31. 2024
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No