Cancer PreventionNCT03548636
Project MOVE: Increasing Physical Activity Among Breast Cancer Survivors
A study testing Single-Arm Feasibility Study in people with Cancer Prevention, run by University of British Columbia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cancer Prevention
- What is being tested?
- Single-Arm Feasibility Study
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- 17 Sep 2015to 11 Mar 2017
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female breast cancer survivors
- 18+ years old,
- Residing in the Okanagan region of British Columbia, Canada
Who cannot join
- No specific exclusion criteria
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer Prevention
- Being tested
- Single-Arm Feasibility Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Arm Feasibility StudyBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Single-Arm Feasibility Study | Experimental | Participant determined 6-month physical activity program Receives: Behavioral: Single-Arm Feasibility Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Program Feasibility (questionnaire)
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.
Measured: Post-intervention (6 months)
Program Feasibility (focus groups)
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.
Measured: Post-intervention (6 months)
Program Feasibility (interviews)
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.
Measured: 1-4 weeks post-intervention 6 month follow-up
Secondary outcomes (8)
Physical Activity Behaviour (Objective)
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.
Measured: Baseline, Post-intervention (6 months) and 12-month follow-up
Physical Activity Behaviour (Subjective)
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'.
Measured: Baseline, Post-intervention (6 months) and 12-month follow-up
Anthropometrics
Measured height and weight to calculate body mass index (BMI).
Measured: Baseline, Post-intervention (6 months) and 12-month follow-up
Sedentary Behaviour (Objective)
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.
Measured: Baseline, Post-intervention (6 months) and 12-month follow-up
Sedentary Behaviour (Subjective)
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).
Measured: Baseline, Post-intervention (6 months) and 12-month follow-up
Quality of Life
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.
Measured: Baseline, Post-intervention (6 months) and 12-month follow-up
Motivation to Engage in Exercise
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.
Measured: Baseline, Post-intervention (6 months) and 12-month follow-up
Social Support
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.
Measured: Baseline, Post-intervention (6 months) and 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2018
- Study start17 Sep 2015
- Primary completion11 Mar 2017
- Study completion11 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer PreventionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Responsible party
- Principal investigator, Cristina Caperchione, University of British Columbia
- Investigators
- Cristina Caperchione, PhD, Principal investigator, The University of British Columbia Okanagan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03548636
- Sponsor's protocol ID
- H14-02502
- Status last verified
- Jun 2018
- First submitted
- 8 May 2018
- Last updated
- 7 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Caperchione CM, Sabiston CM, Stolp S, Bottorff JL, Campbell KL, Eves ND, Ellard SL, Gotay C, Sharp P, Pullen T, Fitzpatrick KM. A preliminary trial examining a 'real world' approach for increasing physical activity among breast cancer survivors: findings from project MOVE. BMC Cancer. 2019 Mar 27;19(1):272. doi: 10.1186/s12885-019-5470-2.
PubMed 30917793
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- If THEY Build it, Will THEY Act? Novel Approaches to Increasing Physical Activity Among Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT03548636
- Acronym / sponsor ID
- H14-02502
- Conditions
- Cancer Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Study start
- 17 Sep 2015 (actual)
- Primary completion
- 11 Mar 2017 (actual)
- Study completion
- 11 Mar 2017 (actual)
- First posted
- 7 Jun 2018 (actual)
- 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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-Arm Feasibility Study | Experimental | Behavioral: Single-Arm Feasibility StudyParticipant determined 6-month physical activity program |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female breast cancer survivors
- 18+ years old,
- Residing in the Okanagan region of British Columbia, Canada
Key exclusion criteria (1 listed)
- No specific exclusion criteria
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 |
|---|---|---|
| Single-Arm Feasibility StudyGroups 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). | Behavioural | Single-Arm Feasibility Study |
Primary outcome
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.
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.
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.
8 secondary outcomes
Physical Activity Behaviour (Objective)
Time frame: 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
Anthropometrics
Time frame: 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
Sedentary Behaviour (Subjective)
Time frame: 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
Motivation to Engage in Exercise
Time frame: Baseline, Post-intervention (6 months) and 12-month follow-up
Social Support
Time frame: Baseline, Post-intervention (6 months) and 12-month follow-up
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 7 Jun 2018.
- Derived from this study: PubMed 30917793Caperchione CM, Sabiston CM, Stolp S, Bottorff JL, Campbell KL, Eves ND, Ellard SL, Gotay C, Sharp P, Pullen T, Fitzpatrick KM. A preliminary trial examining a 'real world' approach for increasing physical activity among breast cancer survivors: findings from project MOVE. BMC Cancer. 2019 Mar 27;19(1):272. doi: 10.1186/s12885-019-5470-2.
- Individual participant dataSharing planned: No. 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.
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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.
Cristina Caperchione, PhD principal investigator
The University of British Columbia Okanagan
Questions about this trial
What is this clinical trial studying?
A study testing Single-Arm Feasibility Study in people with Cancer Prevention, run by University of British Columbia.
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 3 inclusion and 1 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 7 Jun 2018. 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?
Program Feasibility (questionnaire) (time frame: Post-intervention (6 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03548636, which also lists 1 linked publication.
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 7 Jun 2018.