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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
132

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of British Columbia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Cancer Society (CCS)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 17, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 11, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 11, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 7, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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