Clinical trial NCT02751892: The Feasibility of an Active Lifestyle Programme in Patients Recovering From Colorectal Cancer
Official title: Feasibility of a Physical Activity Intervention Informed by Self-Determination Theory With Patients Recovering From Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: University of East Anglia
Sponsor class: OTHER
First posted: 2016-04-26
Enrollment: 28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Change in minutes spent in moderate and vigorous intensity physical activity measure with the International Physical Activity Questionnaire long version
timeFrame: 0, 3, 6 months
Secondary outcomes:
measure: Change in behavioural regulation measure with the Behavioural Regulation in Exercise Questionnaire version 2
timeFrame: 0, 3, 6 months
measure: Change in psychological needs satisfaction measured with the psychological needs satisfaction in exercise scale
timeFrame: 0, 3, 6 months
measure: Change in quality of life measure with the Functional Assessment of Cancer Therapy general
timeFrame: 0, 3, 6 months
measure: Change in quality of life measure with the Functional Assessment of Cancer Therapy-colorectal
timeFrame: 0, 3, 6 months
measure: Change in fatigue with the Functional Assessment of Cancer Therapy - fatigue
timeFrame: 0, 3, 6 months
measure: Change in intention to exercise
timeFrame: 0, 3, 6 months
measure: Change in barriers to exercise
timeFrame: 0, 3, 6 months
measure: Change in physical fitness
timeFrame: 0, 3, and 6 months
measure: Change in upper body strength-grip strength
timeFrame: 0, 3, 6 months
measure: Change in upper body strength-upper arm strength
timeFrame: 0, 3, 6 months
measure: Change in lower body strength
timeFrame: 0, 3, 6 months
measure: Changes in body composition (% body fat) assessed with bioelectrical impedance analysis
timeFrame: 0, 3, 6 months
measure: Change in antropometric measures (waist circumference, hip circumference
timeFrame: 0, 3, 6 months
measure: Changes in anthropometric measures (height, weight, BMI)
timeFrame: 0, 3, 6 months
measure: Change in minutes spent in moderate and vigorous intensity physical activity with accelerometry
timeFrame: 0, 3, 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Northumbria University, Newcastle, United Kingdom
name: John M Saxton, PhD
role: PRINCIPAL_INVESTIGATOR
References: