Colorectal CancerMOVENCT02751892
The Feasibility of an Active Lifestyle Programme in Patients Recovering From Colorectal Cancer
A study testing Active lifestyle programme in people with Colorectal Cancer, run by University of East Anglia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Active lifestyle programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: Feasibility of a Physical Activity Intervention Informed by Self-Determination Theory With Patients Recovering From Colorectal Cancer
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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- Active lifestyle programme
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active lifestyle programmeBehavioural
Also called MOVE
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Lifestyle Programme | Experimental | 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. Receives: Behavioral: Active lifestyle programme |
| Standard Care | No intervention | Received usual care. Was offered the intervention after the completion of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in minutes spent in moderate and vigorous intensity physical activity measure with the International Physical Activity Questionnaire long version
Measured: 0, 3, 6 months
Secondary outcomes (15)
Change in behavioural regulation measure with the Behavioural Regulation in Exercise Questionnaire version 2
Measured: 0, 3, 6 months
Change in psychological needs satisfaction measured with the psychological needs satisfaction in exercise scale
Measured: 0, 3, 6 months
Change in quality of life measure with the Functional Assessment of Cancer Therapy general
Measured: 0, 3, 6 months
Change in quality of life measure with the Functional Assessment of Cancer Therapy-colorectal
Measured: 0, 3, 6 months
Change in fatigue with the Functional Assessment of Cancer Therapy - fatigue
Measured: 0, 3, 6 months
Change in intention to exercise
assessed with Intention to exercise scale
Measured: 0, 3, 6 months
Change in barriers to exercise
assessed with Barriers to Exercise scale
Measured: 0, 3, 6 months
Change in physical fitness
assessed with the modified Bruce treadmill test
Measured: 0, 3, and 6 months
Change in upper body strength-grip strength
Assessed with grip dynanometer
Measured: 0, 3, 6 months
Change in upper body strength-upper arm strength
Assessed with biceps curl test
Measured: 0, 3, 6 months
Change in lower body strength
Assessed with 30 sec sit-to-stand test
Measured: 0, 3, 6 months
Changes in body composition (% body fat) assessed with bioelectrical impedance analysis
Measured: 0, 3, 6 months
Change in antropometric measures (waist circumference, hip circumference
Waist and hip circumference will be used to calculate the waist-to-hip ratio
Measured: 0, 3, 6 months
Changes in anthropometric measures (height, weight, BMI)
Body weight and body height will be used to calculate BMI
Measured: 0, 3, 6 months
Change in minutes spent in moderate and vigorous intensity physical activity with accelerometry
Measured: 0, 3, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startOct 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John M Saxton, PhD, Principal investigator, Northumbria University, Newcastle, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02751892
- Sponsor's protocol ID
- 13/EE/0060
- Acronym
- MOVE
- Status last verified
- Apr 2016
- First submitted
- 21 Apr 2016
- Last updated
- 26 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Physical Activity Intervention Informed by Self-Determination Theory With Patients Recovering From Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02751892
- Acronym / sponsor ID
- MOVE / 13/EE/0060
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 26 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Lifestyle Programme | Experimental | Behavioral: Active lifestyle programmeSupervised 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. |
| Standard Care | No intervention | –Received usual care. Was offered the intervention after the completion of the study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active lifestyle programmeAlso: MOVEThe intervention is an activity lifestyle programme to increase physical activity behaviour post-intervention and to facilitate behaviour change maintenance at 3 months post-intervention. | Behavioural | Active Lifestyle Programme |
Primary outcome
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
15 secondary outcomes
Change in behavioural regulation measure with the Behavioural Regulation in Exercise Questionnaire version 2
Time frame: 0, 3, 6 months
Change in psychological needs satisfaction measured with the psychological needs satisfaction in exercise scale
Time frame: 0, 3, 6 months
Change in quality of life measure with the Functional Assessment of Cancer Therapy general
Time frame: 0, 3, 6 months
Change in quality of life measure with the Functional Assessment of Cancer Therapy-colorectal
Time frame: 0, 3, 6 months
Change in fatigue with the Functional Assessment of Cancer Therapy - fatigue
Time frame: 0, 3, 6 months
Change in intention to exercise
Time frame: 0, 3, 6 months
Change in barriers to exercise
Time frame: 0, 3, 6 months
Change in physical fitness
Time frame: 0, 3, and 6 months
Change in upper body strength-grip strength
Time frame: 0, 3, 6 months
Change in upper body strength-upper arm strength
Time frame: 0, 3, 6 months
Change in lower body strength
Time frame: 0, 3, 6 months
Changes in body composition (% body fat) assessed with bioelectrical impedance analysis
Time frame: 0, 3, 6 months
Change in antropometric measures (waist circumference, hip circumference
Time frame: 0, 3, 6 months
Changes in anthropometric measures (height, weight, BMI)
Time frame: 0, 3, 6 months
Change in minutes spent in moderate and vigorous intensity physical activity with accelerometry
Time frame: 0, 3, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2016.
- Individual participant dataSharing planned: No
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John M Saxton, PhD principal investigator
Northumbria University, Newcastle, United Kingdom
Questions about this trial
What is this clinical trial studying?
A study testing Active lifestyle programme in people with Colorectal Cancer, run by University of East Anglia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2016.