Project MOVE: Increasing Physical Activity Among Breast Cancer Survivors
|ClinicalTrials.gov Identifier: NCT03548636|
Recruitment Status : Completed
First Posted : June 7, 2018
Last Update Posted : June 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cancer Prevention||Behavioral: Single-Arm Feasibility Study||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||132 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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).
- 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.
- 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.
- 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'.
- Anthropometrics [ Time Frame: Baseline, Post-intervention (6 months) and 12-month follow-up ]Measured height and weight to calculate body mass index (BMI).
- 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.
- 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).
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03548636
|Principal Investigator:||Cristina Caperchione, PhD||The University of British Columbia Okanagan|