The Feasibility of an Active Lifestyle Programme in Patients Recovering From Colorectal Cancer

NCT ID: NCT02751892

Last Updated: 2016-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-09-30

Brief Summary

Long-term maintenance of physical activity behaviour change post-intervention remains challenging. This study is investigating the feasibility of a behaviour change intervention based on Self-Determination Theory in people recovering from colorectal cancer and its effects on behaviour change 6 months post-intervention.

Detailed Description

This study was a randomized controlled feasibility trial consisting of a 3-months active lifestyle intervention and a 3-months follow-up period. Participants were allocated to an active lifestyle programme (ALP) or the standard (SC) care group. ALP was offered 12 supervised exercise sessions over 3 months and six supportive behaviour change workshops. SC was encouraged to continue with their usual lifestyle. The intervention was informed by Self-Determination Theory.

The supervised exercise sessions took place in small groups of maximum 7 participants and lasted approximately 1 hour. Exercise included aerobic and resistance exercises. The behaviour change workshops were delivered in a motivational interviewing style, also in small groups of maximum 7 participants.

Participants were followed-up at 6 months. There was no contact with participants during the post-intervention and follow-up period.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Active Lifestyle Programme

Supervised exercises for 3 months and motivational interviewing to facilitate physical activity behaviour change. Supervised exercise sessions took place twice per week for the first four weeks. This was tapered off to once per week for the second four weeks. During the last month of the intervention participants continued with the exercise at home and were encouraged to achieve 150min of moderate to vigorous PA per week.

Group Type: EXPERIMENTAL

Active lifestyle programme

Intervention Type: BEHAVIORAL

The intervention is an activity lifestyle programme to increase physical activity behaviour post-intervention and to facilitate behaviour change maintenance at 3 months post-intervention.

Standard Care

Received usual care. Was offered the intervention after the completion of the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Active lifestyle programme

The intervention is an activity lifestyle programme to increase physical activity behaviour post-intervention and to facilitate behaviour change maintenance at 3 months post-intervention.

Intervention Type: BEHAVIORAL

Other Intervention Names

MOVE

Eligibility Criteria

Inclusion Criteria

• a histologically confirmed diagnosis of colorectal cancer with Dukes stages A-C
• completed cancer treatment within the last 24 months,
• be able to understand spoken and written English
• score of 80 or more on the Karnofsky Performance Status Scale

Exclusion Criteria

• already meeting general PA guidelines of 150 min of moderate PA or 75 min of vigorous intensity PA per week,
• recent myocardial infarction
• uncontrolled hypertension
• a pacemaker
• or unstable angina.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of East Anglia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John M Saxton, PhD

Role: PRINCIPAL_INVESTIGATOR

Northumbria University, Newcastle, United Kingdom

Other Identifiers

13/EE/0060

Identifier Type: -

Identifier Source: org_study_id