Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

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.

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.

Active lifestyle programme

John M Saxton, PhD

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.

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.

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

Feasibility of a Physical Activity Intervention Informed by Self-Determination Theory With Patients Recovering From Colorectal Cancer

assessed with Intention to exercise scale

assessed with the modified Bruce treadmill test

Waist and hip circumference will be used to calculate the waist-to-hip ratio

Body weight and body height will be used to calculate BMI

University of East Anglia

Symptoms and General Pathology

Adenoma

Colonic Polyps

Polyps

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Herbal and Botanical

All Drugs and Chemicals

Cola

ALP will receive supervised exercise sessions twice per week for three months and once per week for the following three months. Participants will also take part in biweekly physical activity workshops for the period of the intervention. Each session consists of a warm-up (5-10min), aerobic (20-30min) and resistance exercises (15-20), and cool-down (5-10)stretches lasting in total 60min. The intensity of exercises will be at 65-85% of maximum heart rate as determined by maximal fitness test. Exercise will take place in small groups of two to five people. Behaviour change workshops to aid the uptake and maintenance of physical activity will be delivered every fortnight throughout the whole intervention period totalling 12 workshops. Workshops will also take place in small groups.

The standard care group will not be offered the intervention until the end of the study at 12 months. Participants in this group will be encouraged to continue with their usual lifestyle.

Active Lifestyle Programme

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.

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 months. Participants allocated to the ALP group will attend supervised exercise sessions at a facility at the University of East Anglia. These will take place twice per week for 3 months and once per week for an additional 3 months. These will be supplemented by home based exercise to achieve a total of 300 minutes of physical activity each week. Supervised exercise sessions will take place in small groups of maximum 7 participants, and last approximately 60 minutes. The exercise sessions will include a 5-10min warm-up period, followed by 20-30 min aerobic exercise, and 15-20 min resistance exercises. The target intensity of the exercises will be 65-85% of the maximum heart rate as determined by the cardiopulmonary fitness test. Intensity will be monitored with heart rate monitors and the rate of perceived exhaustion (Borg Scale). A short cool-down period will conclude the exercise sessions. In addition, participants will be offered physical activity counselling workshops which will be led in groups, and in a motivational interviewing style. All components of the intervention will be undermined by Self-determination Theory, that is to facilitate feelings of autonomy, competence and relatedness.

To further facilitate behaviour change, participants in the ALP group will be provided with pedometers and an educational workbook, which contains information about the benefits of physical activity in general and in regards to bowel cancer, aids to set personalised goals, and other information relevant to physical activity.

There will also be a purposefully selected sample chosen based on prior consent and demographic variables to take part in face to face interviews at 1 and 12 months. Furthermore 3 focus groups containing, participants from the EX and UC group will take place alongside a focus group with Health professionals after the intervention has taken place.

Recruitment and Consenting Potential participants will either hear about the study via posters and flyers at the Big C Cancer Charity at NNUH or they will be approached by a specialist nurse during a consultation appointment before their colonoscopy. However, the recruitment procedure will be the same for each path from the point of their pre-colonoscopy consultation appointment.On the day of the consultation, a nurse will inform the potential participants about the study and give them an invitation letter, and a participant information sheet. At this meeting, the nurse will also provide the patient with a consent form, asking for their agreement to be contacted by a researcher. If the patient gives consent to be contacted, a researcher will call the patient prior to their screening colonoscopy to provide further information about the study, and arrange an appointment to obtain consent for biopsies to be taken during their colonoscopy. If the patient is diagnosed with polyps during the screening colonoscopy, the researcher will arrange another appointment post-colonoscopy to carry out baseline assessments and obtain full study consent.

Baseline assessments will include a maximal fitness test, assessment of current physical activity using accelerometers and self-report, questionnaires assessing quality of life and psycho-social variables, and body composition.

After the completion of all baseline assessments, participants will be randomised to one of the two study arms. This will be carried out by a person not directly involved in the research. The person undertaking the maximal fitness test will be blinded to group allocation throughout the whole duration of the study. The person carrying out the intervention will not be blinded to group allocation.

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

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 High Risk for Colon Cancer

Physical activity diary used to assess compliance

Assessed with a maximal cardiopulmonary exercise test on a bicycle ergometer

Assessed with Barriers to Exercise questionnaire

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Feasibility of an Active Lifestyle Programme in Patients Recovering From Colorectal Cancer	NCT02751892	Colorectal Canc...	Active lifestyl...	-	University of East Anglia
Physical Activity Intervention With People at Increased Risk of Developing Colon Cancer	NCT02724306	Colon Polyps Colon Adenomas	Active Lifestyl...	60 Years -	University of East Anglia
The Feasibility of an Active Lifestyle Programme in Patients Recovering From Colorectal Cancer	NCT02751892	Colorectal Canc...	Active lifestyl...	-	University of East Anglia
Physical Activity Intervention With People at Increased Risk of Developing Colon Cancer	NCT02724306	Colon Polyps Colon Adenomas	Active Lifestyl...	60 Years -	University of East Anglia

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