The Feasibility of an Active Lifestyle Programme in Patients Recovering From Colorectal Cancer (MOVE)
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Active lifestyle programme
Sponsored by
About this trial
This is an interventional health services research trial for Colorectal Cancer
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Active Lifestyle Programme
Standard Care
Arm Description
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.
Received usual care. Was offered the intervention after the completion of the study.
Outcomes
Primary Outcome Measures
Change in minutes spent in moderate and vigorous intensity physical activity measure with the International Physical Activity Questionnaire long version
Secondary Outcome Measures
Change in behavioural regulation measure with the Behavioural Regulation in Exercise Questionnaire version 2
Change in psychological needs satisfaction measured with the psychological needs satisfaction in exercise scale
Change in quality of life measure with the Functional Assessment of Cancer Therapy general
Change in quality of life measure with the Functional Assessment of Cancer Therapy-colorectal
Change in fatigue with the Functional Assessment of Cancer Therapy - fatigue
Change in intention to exercise
assessed with Intention to exercise scale
Change in barriers to exercise
assessed with Barriers to Exercise scale
Change in physical fitness
assessed with the modified Bruce treadmill test
Change in upper body strength-grip strength
Assessed with grip dynanometer
Change in upper body strength-upper arm strength
Assessed with biceps curl test
Change in lower body strength
Assessed with 30 sec sit-to-stand test
Changes in body composition (% body fat) assessed with bioelectrical impedance analysis
Change in antropometric measures (waist circumference, hip circumference
Waist and hip circumference will be used to calculate the waist-to-hip ratio
Changes in anthropometric measures (height, weight, BMI)
Body weight and body height will be used to calculate BMI
Change in minutes spent in moderate and vigorous intensity physical activity with accelerometry
Full Information
NCT ID
NCT02751892
First Posted
April 21, 2016
Last Updated
April 21, 2016
Sponsor
University of East Anglia
1. Study Identification
Unique Protocol Identification Number
NCT02751892
Brief Title
The Feasibility of an Active Lifestyle Programme in Patients Recovering From Colorectal Cancer
Acronym
MOVE
Official Title
Feasibility of a Physical Activity Intervention Informed by Self-Determination Theory With Patients Recovering From Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of East Anglia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Lifestyle Programme
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Received usual care. Was offered the intervention after the completion of the study.
Intervention Type
Behavioral
Intervention Name(s)
Active lifestyle programme
Other Intervention Name(s)
MOVE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in minutes spent in moderate and vigorous intensity physical activity measure with the International Physical Activity Questionnaire long version
Time Frame
0, 3, 6 months
Secondary Outcome Measure Information:
Title
Change in behavioural regulation measure with the Behavioural Regulation in Exercise Questionnaire version 2
Time Frame
0, 3, 6 months
Title
Change in psychological needs satisfaction measured with the psychological needs satisfaction in exercise scale
Time Frame
0, 3, 6 months
Title
Change in quality of life measure with the Functional Assessment of Cancer Therapy general
Time Frame
0, 3, 6 months
Title
Change in quality of life measure with the Functional Assessment of Cancer Therapy-colorectal
Time Frame
0, 3, 6 months
Title
Change in fatigue with the Functional Assessment of Cancer Therapy - fatigue
Time Frame
0, 3, 6 months
Title
Change in intention to exercise
Description
assessed with Intention to exercise scale
Time Frame
0, 3, 6 months
Title
Change in barriers to exercise
Description
assessed with Barriers to Exercise scale
Time Frame
0, 3, 6 months
Title
Change in physical fitness
Description
assessed with the modified Bruce treadmill test
Time Frame
0, 3, and 6 months
Title
Change in upper body strength-grip strength
Description
Assessed with grip dynanometer
Time Frame
0, 3, 6 months
Title
Change in upper body strength-upper arm strength
Description
Assessed with biceps curl test
Time Frame
0, 3, 6 months
Title
Change in lower body strength
Description
Assessed with 30 sec sit-to-stand test
Time Frame
0, 3, 6 months
Title
Changes in body composition (% body fat) assessed with bioelectrical impedance analysis
Time Frame
0, 3, 6 months
Title
Change in antropometric measures (waist circumference, hip circumference
Description
Waist and hip circumference will be used to calculate the waist-to-hip ratio
Time Frame
0, 3, 6 months
Title
Changes in anthropometric measures (height, weight, BMI)
Description
Body weight and body height will be used to calculate BMI
Time Frame
0, 3, 6 months
Title
Change in minutes spent in moderate and vigorous intensity physical activity with accelerometry
Time Frame
0, 3, 6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John M Saxton, PhD
Organizational Affiliation
Northumbria University, Newcastle, United Kingdom
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Feasibility of an Active Lifestyle Programme in Patients Recovering From Colorectal Cancer
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