- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03548636
Project MOVE: Increasing Physical Activity Among Breast Cancer Survivors
June 6, 2018 updated by: Cristina Caperchione, University of British Columbia
If THEY Build it, Will THEY Act? Novel Approaches to Increasing Physical Activity Among Breast Cancer Survivors
The purpose of this research is to implement and evaluate the feasibility of Project MOVE, a program aimed to increase physical activity among breast cancer survivors through microgrants and financial incentives.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Despite the physical and psychological health benefits associated with physical activity for breast cancer survivors, up to 70% of female breast survivors are not meeting minimum recommended physical activity guidelines.
The purpose of this research was to develop, implement and assess the feasibility of Project MOVE, an innovative approach to increase physical activity among breast cancer survivors through the use of Action Grants, a combination of microgrants (small amounts of money awarded to groups of individuals to support a physical activity initiative) and financial incentives.
Twelve groups of 8-12 adult women who are breast cancer survivors (N=132) were recruited for the study via face-to-face meetings with breast cancer-related stakeholders, local print and radio media, social media, and pamphlets and posters at community organisations and medical clinics.
Each group submitted a microgrant application outlining their proposed physical activity initiative.
Successful applicants were determined by a grant review panel and informed of a financial incentive upon meeting their physical activity goals.
Primary (program feasibility) and secondary (physical activity, quality of life, motivation to exercise and social connection) outcome measures were evaluated using a mixed-methods approach including focus groups, self-reported questionnaires, semi-structured telephone interviews and objective physical activity measures.
Measures were collected at baseline, post-intervention (6 months) and 12-month follow-up.
Findings from this study were used to asses the implementation and feasibility of Project MOVE as a strategy for increasing physical activity among breast cancer survivors.
Study Type
Interventional
Enrollment (Actual)
132
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female breast cancer survivors
- 18+ years old,
- Residing in the Okanagan region of British Columbia, Canada
Exclusion Criteria:
- No specific exclusion criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single-Arm Feasibility Study
Participant determined 6-month physical activity program
|
Groups of 8 to 12 participants, consisting of >50% breast cancer survivors, were invited to apply for up to $2000 to enable access to equipment, resources, facilities, instruction and/or transportation to implement a physical activity intervention.
Applicants were assessed by a Grant Review Panel.
Successful applicants were informed that they would receive an additional $500 incentive if they increased their group's mean physical activity at six month follow-up (assessed via accelerometry).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Program Feasibility (questionnaire)
Time Frame: Post-intervention (6 months)
|
Program feasibility will be evaluated using mixed-methods, including a questionnaire, focus groups and semi-structured telephone interviews.
A 5-point Likert-scale questionnaire with 1 being "strongly disagree" and 5 being "strongly agree" will be one method used to measure feasibility.
Questions will focus on program satisfaction, program appropriateness and participant's perceived confidence to engage in physical activity and continue to engage in physical activity in the long term.
|
Post-intervention (6 months)
|
Program Feasibility (focus groups)
Time Frame: Post-intervention (6 months)
|
Program feasibility will also be measured using focus groups.
Focus groups with each of the Project MOVE groups (ranging 8 to 12 participants per group) will be conducted at the 6-month follow-up.
All group members will be invited to participate.
Questions will pertain to participants' experiences of Project MOVE specific to adoption, implementation, and maintenance.
The focus groups will be audio recorded with a digital SonyTM recorder (ICD-PX333) and transcribed verbatim.
|
Post-intervention (6 months)
|
Program Feasibility (interviews)
Time Frame: 1-4 weeks post-intervention 6 month follow-up
|
Program feasibility will also be measured using semi-structured interviews with each of the group leaders.
Phone interviews will be scheduled within 1-4 weeks after the 6-month follow-up data collection period.
Open ended questions will be utilized and will focus on the microgrant application process, challenges and enablers to leading a Project MOVE group, and the leader's perception of group member's experiences with Project MOVE.
Phone interviews will be recorded using the digital SonyTM recorder (ICD-PX333) and transcribed verbatim.
|
1-4 weeks post-intervention 6 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Activity Behaviour (Objective)
Time Frame: Baseline, Post-intervention (6 months) and 12-month follow-up
|
Measured using an Actigraph GT3X™ accelerometer, which is the 'gold standard' measure of physical activity in adults.
The Actigraph GT3X™ accelerometer was worn by all participants during all waking hours over 7 consecutive days.
The accelerometers were initialised to record steps, inclination and acceleration counts in triaxial mode, using 60s epochs.
Established cut-off points were used to calculate daily minutes of moderate (2691-6166 counts/min) and vigorous (>6167counts/min) physical activity while controlling for the number of days the accelerometer was worn.
Data are included in the analyses if there are no extreme counts (>20000) and if data are available for at least 600min wear time per day on 5 days.
Participants with invalid data were asked to wear the activity monitor for a further 7 days.
|
Baseline, Post-intervention (6 months) and 12-month follow-up
|
Physical Activity Behaviour (Subjective)
Time Frame: Baseline, Post-intervention (6 months) and 12-month follow-up
|
Measured by self-report using a modified version of the Godin Leisure-Time Exercise Questionnaire (GLTEQ).
Participants were asked to indicate the frequency and type of intensity (i.e.
light, moderate, vigorous) of their daily physical activity per week and the duration (min) of these sessions.
All responses were converted to minutes and calculated in accordance with the metabolic equivalent (MET) minutes method.
A cut-off point of ≥600 MET minutes was used to dichotomise participants as 'adequately active for health benefit' or 'inadequately active'.
|
Baseline, Post-intervention (6 months) and 12-month follow-up
|
Anthropometrics
Time Frame: Baseline, Post-intervention (6 months) and 12-month follow-up
|
Measured height and weight to calculate body mass index (BMI).
|
Baseline, Post-intervention (6 months) and 12-month follow-up
|
Sedentary Behaviour (Objective)
Time Frame: Baseline, Post-intervention (6 months) and 12-month follow-up
|
Measured using Actigraph GT3X™ accelerometer (using a 30s epoch).
Sedentary time was determined as <100 counts/min, adjusted for non-wear time operationalised as at least 60 min of consecutive zeros.
|
Baseline, Post-intervention (6 months) and 12-month follow-up
|
Sedentary Behaviour (Subjective)
Time Frame: Baseline, Post-intervention (6 months) and 12-month follow-up
|
Measured by self-report using the Marshall Sitting Questionnaire (MSQ).
The MSQ assesses time spent sitting on weekdays and weekend days at work, travelling and at home.
Data from the sitting time questionnaire was used to create an estimate of total weekday and weekend-day sitting times (min/day) by summing the time reported in each domain (higher total hours are indicative of more time spent sedentary).
|
Baseline, Post-intervention (6 months) and 12-month follow-up
|
Quality of Life
Time Frame: Baseline, Post-intervention (6 months) and 12-month follow-up
|
Assessed using the SF 36 Medical Outcomes Study Survey (SF-36/RAND 36), a 36-item tool used to measure overall quality of life across eight domains, including physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue and general health perceptions.
Pre-coded numeric values are assigned to each scale, and all items are then scored on a 0 to 100 range, with a high score representing a more favourable health state.
Additionally, items in each of the eight domains are averaged together to create eight separate domain scores.
|
Baseline, Post-intervention (6 months) and 12-month follow-up
|
Motivation to Engage in Exercise
Time Frame: Baseline, Post-intervention (6 months) and 12-month follow-up
|
Measured using the Behavioral Regulation in Exercise Questionnaire-version 3 (BREQ-3).
The BREQ-3 measures external regulation (e.g.
'I exercise because other people say I should'), introjected regulation (e.g.
'I feel guilty when I don't exercise'), identified regulation (e.g.
'I value the benefits of exercise') and intrinsic regulation (e.g.
'I exercise because it's fun') of exercise behaviour.
Participant responses were scored using an item aggregation approach, which involves summarising participant responses by averaging the items of each individual subscale into six unique scores.
|
Baseline, Post-intervention (6 months) and 12-month follow-up
|
Social Support
Time Frame: Baseline, Post-intervention (6 months) and 12-month follow-up
|
Assessed using the 6-item 'Positive Relationship with Others' subscale of the Ryff Scales of Psychological Well-being (RSPW), which measures multiple facets of psychological well-being.
The subscale presents statements regarding one's personal relationships with others.
Participants were asked to rate statements on a scale of 1-6, with 1 indicating strong disagreement and 6 indicating strong agreement.
|
Baseline, Post-intervention (6 months) and 12-month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Cristina Caperchione, PhD, The University of British Columbia Okanagan
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 17, 2015
Primary Completion (Actual)
March 11, 2017
Study Completion (Actual)
March 11, 2017
Study Registration Dates
First Submitted
May 8, 2018
First Submitted That Met QC Criteria
June 6, 2018
First Posted (Actual)
June 7, 2018
Study Record Updates
Last Update Posted (Actual)
June 7, 2018
Last Update Submitted That Met QC Criteria
June 6, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- H14-02502
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Only the principal investigators and UBC research team members will have access to the raw data.
CO-I's external to UBC will not require access to raw participant data.
Any data that are shared will be aggregate data and have all identifiers removed.
All of these individuals have training in issues concerning privacy, confidentiality, and are aware of their responsibilities to maintain these.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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