Clinical Trial: Physical Activity Intervention With People at Increased Risk of Developing Colon Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomised Controlled Trial Investigating the Effect of a 12 Month Active Lifestyle Programme on Physiological Risk Markers and Physical Activity Behaviour in Those Diagnosed With Intermediate or Hi

Brief Summary:

The present study will use a randomised controlled trial design to investigate whether moderate to vigorous intensity physical activity (MVPA) will affect the physiological risk markers associated with the development of bowel cancer in individuals previously diagnosed with a bowel polyp. The study will also investigate the effects of the programme on long-term exercise behaviour and changes in psychological variables. A selected sample will also be part of individual interviews at baseline and 12 months to gauge narrative accounts of personal, psychological and sociological beliefs surrounding participation in physical activity. The findings of this study might inform better practices for the prevention of bowel cancer in high risk populations.

After a screening colonoscopy, eligible participants will be randomised to either an active lifestyle programme (ALP) or a standard care group (SC). Participants in ALP will be offered supervised exercise sessions and motivational interviewing for 6 months. Intervention components will cease after 6 months, but participants will be followed-up at 12 months to investigate maintenance to physical activity over the long-term. The SC will not be offered the intervention until the end of the study. Participants in both groups will be invited for assessments at baseline, 3, 6, 9, and 12 months. These include measurements of body composition, cardiopulmonary fitness, physical activity behaviour, and psycho-social variables.


Detailed Summary:

Purpose: A strong body of evidence suggests that lifestyle factors influence cancer risk, and there is now convincing evidence that a physically activity lifestyle is associated with reduced risk of developing colon cancer. However, low self-reported physical activity levels in elderly populations demonstrate the need for physical activity interventions for this patient group that evoke meaningful changes in physical activity behaviour for improvements in CC risk profile to occur.

The purpose of this study is to investigate the effects of a 6 month physical activity intervention on physical activity behaviour and biological markers of CC risk in individuals classified as being at elevated risk of developing the disease following surveillance colonoscopy. The physical activity intervention will be underpinned by Self Determination Theory to create an autonomy-supportive environment, an approach that was recently shown to evoke greater physical activity levels and weight loss than general health education in overweight women. Secondary outcomes will explore the impact of the intervention on aerobic fitness, health-related quality of life and psychological variables (self-efficacy, motivational regulation). In addition, interviews and focus groups will be used to obtain narrative accounts of patient experiences, their perceived health benefits from participating in the intervention and the barriers and facilitators influencing adherence.

Design The proposed study is a randomised controlled trial, with participants stratified for risk status (determined by number and size of polyps identified by colonoscopy). Participants will be randomly allocated to either the physical activity intervention (Active Lifestyle Programme: ALP) or the usual care control group (SC). Outcomes will be assessed at baseline, and after 3, 6, 9 and 12
Sponsor: University of East Anglia

Current Primary Outcome:

  • Change in DNA methylation in genes associated with inflammation and colon carcinogenesis [ Time Frame: 0, 6, 12 months ]
  • Compliance to intervention [ Time Frame: post-intervention (at 6months) ]
    Physical activity diary used to assess compliance
  • 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, 9,12 ]
  • Change in minutes spent in moderate and vigorous intensity leisure activity assessed with the Godin Leisure-Time Exercise Questionnaire [ Time Frame: 0, 3, 6, 9, 12 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in behavioural regulation measure with the Behavioural Regulation in Exercise Questionnaire version 2 [ Time Frame: 0, 3, 6, 9, 12 months ]
  • Change in Quality of life measure with the SF-36 questionnaire [ Time Frame: 0, 3, 6, 9, 12 months ]
  • Changes in anthropometric measures (height, weight, BMI) [ Time Frame: 0, 3, 6, 9, 12 months ]
    Body weight and body height will be used to calculate BMI
  • Change in physical fitness [ Time Frame: 0, 6, 12 months ]
    Assessed with a maximal cardiopulmonary exercise test on a bicycle ergometer
  • Change in intention to exercise [ Time Frame: 0, 3, 6, 9, 12 months ]
    Intention to exercise scale
  • Change in barriers to exercise [ Time Frame: 0, 3, 6, 9, 12 months ]
    Assessed with Barriers to Exercise questionnaire
  • Change in minutes of physical activity measured with objective measure (accelerometer, Actigraph) [ Time Frame: 0, 3, 6, 9, 12 months ]
  • Changes in body composition (% body fat) assessed with bioelectrical impedance analysis [ Time Frame: 0, 3, 6, 9, 12 months ]
  • Change in antropometric measures (waist circumference, hip circumference) [ Time Frame: 0, 3, 6, 9, 12 months ]
    Waist and hip circumference will be used to calculate the waist-to-hip ratio


Original Secondary Outcome: Same as current

Information By: University of East Anglia

Dates:
Date Received: February 12, 2016
Date Started: March 2011
Date Completion:
Last Updated: March 24, 2016
Last Verified: March 2016