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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
University of East Anglia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Colorectal Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 21, 2016
    Last Updated
    April 21, 2016
    Sponsor
    University of East Anglia
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    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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