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Project MOVE: Increasing Physical Activity Among Breast Cancer Survivors

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ClinicalTrials.gov Identifier: NCT03548636
Recruitment Status : Completed
First Posted : June 7, 2018
Last Update Posted : June 7, 2018
Sponsor:
Collaborator:
Canadian Cancer Society Research Institute (CCSRI)
Information provided by (Responsible Party):
Cristina Caperchione, University of British Columbia

Brief 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.

Condition or disease Intervention/treatment Phase
Cancer Prevention Behavioral: Single-Arm Feasibility Study Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: If THEY Build it, Will THEY Act? Novel Approaches to Increasing Physical Activity Among Breast Cancer Survivors
Actual Study Start Date : September 17, 2015
Actual Primary Completion Date : March 11, 2017
Actual Study Completion Date : March 11, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single-Arm Feasibility Study
Participant determined 6-month physical activity program
Behavioral: Single-Arm Feasibility Study
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).




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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'.

  3. Anthropometrics [ Time Frame: Baseline, Post-intervention (6 months) and 12-month follow-up ]
    Measured height and weight to calculate body mass index (BMI).

  4. 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.

  5. 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).

  6. 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.

  7. 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.

  8. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female breast cancer survivors
  • 18+ years old,
  • Residing in the Okanagan region of British Columbia, Canada

Exclusion Criteria:

  • No specific exclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03548636


Sponsors and Collaborators
University of British Columbia
Canadian Cancer Society Research Institute (CCSRI)
Investigators
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Principal Investigator: Cristina Caperchione, PhD The University of British Columbia Okanagan

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cristina Caperchione, Associate Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT03548636     History of Changes
Other Study ID Numbers: H14-02502
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No