Connecting Breast Cancer Survivors for Exercise
Study Details
Study Description
Brief Summary
The purpose of this study is to examine interpersonal and individual effects of partnering BCS with a peer and a qualified exercise professional (QEP) on self-reported exercise volume (MVPA; primary outcome), and device-measured exercise volume (MVPA; Fitbit), social support, and HRQOL (secondary outcomes). Cost-effectiveness and intervention adherence will also be explored as tertiary outcomes. The effects of a peer and QEP-support intervention group, labelled MatchQEP, will be compared to a control group of BCS who are matched with a peer, but not a QEP, labeled Match.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MatchQEP group All participants will receive an 'Exercise Peer Support Guide' that provides suggestions for supporting their exercise partner and a one-page document describing current exercise guidelines for cancer survivors [16-18]. All participants will also be given a Fitbit device, which will be used for device-measured MVPA. Participants in the MatchQEP group will receive exercise information and program sessions tailored by a qualified exercise professional (QEP) specifically for each BCS in the dyad. Dyads will meet with the QEP via Zoom once per week for 10 weeks for up to 60 minutes. For four weeks following the 10-week intervention period, the QEP will be available for consultation (i.e., a post-intervention tapering period) as needed by the MatchQEP group participants. |
Behavioral: Exercise Counselling
See previous description for MatchQEP (Intervention) group.
Other Names:
Behavioral: Partner Matching
All participants will be matched with another participant (fellow BCS) and will facilitate / support exercise with their partner for the duration of the study.
Participants will be matched based on personal and cancer-related characteristics.
|
| Active Comparator: Match group All participants will receive an 'Exercise Peer Support Guide' that provides suggestions for supporting their exercise partner and a one-page document describing current exercise guidelines for cancer survivors [16-18]. All participants will also be given a Fitbit device, which will be used for device-measured MVPA. Participants in the Match (control) group will independently communicate and support each other around exercise for 10 weeks. They will not have any contact with a QEP during this time. |
Behavioral: Partner Matching
All participants will be matched with another participant (fellow BCS) and will facilitate / support exercise with their partner for the duration of the study.
Participants will be matched based on personal and cancer-related characteristics.
|
Outcome Measures
Primary Outcome Measures
- Change in exercise volume [Baseline, 10-weeks post baseline.]
The Godin Leisure Time Exercise Questionnaire will be used to measure exercise volume over 1 week. It is a self-report measure which asks respondents to give weekly frequencies and durations of strenuous, moderate, and mild aerobic activities and resistance training sessions. Together responses are summed to determine a total weekly leisure activity score. It is shown to be reliable and valid (r=.53) when classifying respondents into 'insufficiently active' and 'active' categories (Amireault & Godin, 2015; Amireault et al., 2015; Amireault et al., 2015; Godin & Shephard, 1985b). Respondents are classified as 'active' by exceeding a score of 24 on this scale (Amireault & Godin, 2015; Amireault et al., 2015; Amireault et al., 2015).
- Change in exercise volume [14-weeks post baseline]
The Godin Leisure Time Exercise Questionnaire will be used to measure exercise volume over 1 week. It is a self-report measure which asks respondents to give weekly frequencies and durations of strenuous, moderate, and mild aerobic activities and resistance training sessions. Together responses are summed to determine a total weekly leisure activity score. It is shown to be reliable and valid (r=.53) when classifying respondents into 'insufficiently active' and 'active' categories (Amireault & Godin, 2015; Amireault et al., 2015; Amireault et al., 2015; Godin & Shephard, 1985b). Respondents are classified as 'active' by exceeding a score of 24 on this scale (Amireault & Godin, 2015; Amireault et al., 2015; Amireault et al., 2015).
- Change in exercise volume [26-weeks post baseline]
The Godin Leisure Time Exercise Questionnaire will be used to measure exercise volume over 1 week. It is a self-report measure which asks respondents to give weekly frequencies and durations of strenuous, moderate, and mild aerobic activities and resistance training sessions. Together responses are summed to determine a total weekly leisure activity score. It is shown to be reliable and valid (r=.53) when classifying respondents into 'insufficiently active' and 'active' categories (Amireault & Godin, 2015; Amireault et al., 2015; Amireault et al., 2015; Godin & Shephard, 1985b). Respondents are classified as 'active' by exceeding a score of 24 on this scale (Amireault & Godin, 2015; Amireault et al., 2015; Amireault et al., 2015).
Secondary Outcome Measures
- Change in exercise volume [Baseline, 10-weeks post-baseline, 14-weeks post-baseline, 26-weeks post-baseline]
Exercise volume will also be assessed using a tracking device (Fitbit Inspire® 2 accelerometer). Adherence to Fitbit's use in cancer survivors is high [58,59] and Fitbit exercise data has demonstrated high correlation to Actigraph measures in this population [58]. Fitbit devices will be mailed to BCS at study inception and will be required to be worn for 7 consecutive days during the four primary data collections to determine their average daily and weekly minutes of MVPA and step count. BCS are not required to wear the device outside of the data collection timeframes, but can wear them if they choose.
- Change in social support [Baseline, 10-weeks post-baseline, 14-weeks post-baseline, 26-weeks post-baseline]
A 14-item breast cancer-specific version of the Social Support Survey (SSS) will be used to assess seven dimensions of social support including: listening support, task challenge, emotional support, esteem support, reality confirmation, tangible assistance, and understanding breast cancer support. Respondents will be asked to score questions on a five-point Likert scale for each type of support rated from 1=very dissatisfied to 5=very satisfied. Higher scores represent a better outcome.
- Change in health-related quality of life assessed by the Short-Form-12 [Baseline, 10-weeks post-baseline, 14-weeks post-baseline, 26-weeks post-baseline]
The Short-Form-12 (SF-12) will be used to assess HRQOL. The SF-12 is a self-administered questionnaire including 12 items addressing eight domains of health: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. A composite index is scaled from 0 to 100 and normalized to approximately 50 with a higher score indicating better health.
- Change in quality of life assessed by the EuroQol-5 Dimension-3 level (EQ-5D-3L) [Baseline, 10-weeks post-baseline, 14-weeks post-baseline, 26-weeks post-baseline]
The EQ-5D-3L will also be used to assess HRQOL. The EQ-5D-3L is a two-part measure. The first part using a three-level scale (1=no problems, 2=some problems, 3=unable) to assess five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Lower scores represent better HRQOL. The second part assesses responder's perception of their health on a visual analogue scale from 0 (worst imaginable health) to 10 (best imaginable health).
- Cost of intervention arms [10-weeks (post intervention)]
The costs of the MatchQEP program will be calculated and compared to traditional face-to face costs of QEP services. Program costs related to MatchQEP include labour, equipment, and consumables. The cost of training staff will also be excluded as staff will already be qualified for their role. Labour costs will by calculated by assessing the number of contact hours between the QEP and survivor over the 10-week program, and the unit cost of 1 hour of work by the QEP. For each 1-hour contact session, 1.5 hours of labour will be allocated to account for preparation time needed by the QEP during the phone sessions. Equipment related costs to run the MatchQEP program will include any form of device that a survivor may purchase for use at home based on the QEP recommendations (for example TheraBand or weights) and a computer and telephone for the QEP.
- Use of health care resources [10-weeks post-baseline, 14-weeks post-baseline, 26-weeks post-baseline]
The use of health care resources will be compared between the two groups at follow up time points using a piloted questionnaire assessing number of health care facility visits, doctor visits, procedures received, support services used, loss of work, and prescription medications used.
- Intervention adherence [10-weeks post-baseline]
The QEP will track MatchQEP group adherence by completing a weekly session log. The QEP will record attendance of each BCS at the virtual QEP session as well as whether each individual completed the goals set from the previous session. MatchQEP group adherence is defined as the number of sessions attended divided by the total number of sessions. Match group adherence will be determined by the number of times the peers connect during the 10-week intervention period.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Female
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Breast cancer survivors
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Stage 1-4 cancer
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Aged >18 years
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Have been cleared for exercise
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Have consistent access to an Internet-connected device
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Currently exercise ≤ 150 minutes per week.
Exclusion Criteria:
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Report contraindications to exercise such as physical disability
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Had recent or planned reconstructive surgery
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Have no consistent access to an Internet-connected device
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Are currently meeting exercise guidelines (performing > 150 minutes of moderate-to- vigorous exercise)
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Have not been cleared to participate in exercise
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Toronto | Toronto | Ontario | Canada | M5S 2W6 |
Sponsors and Collaborators
- Jenna Smith
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- I2I1