Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Phase 1 and Phase 2: Change in exercise volume |
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). |
Baseline, 10-weeks post baseline. |
|
| Primary |
Phase 1 and Phase 2: Change in exercise volume |
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). |
14-weeks post baseline |
|
| Primary |
Phase 1 and Phase 2: Change in exercise volume |
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). |
26-weeks post baseline |
|
| Secondary |
Phase 1 and Phase 2: Change in exercise volume |
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. |
Baseline, 10-weeks post-baseline, 14-weeks post-baseline, 26-weeks post-baseline |
|
| Secondary |
Phase 1: Change in social support |
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. |
Baseline, 10-weeks post-baseline, 14-weeks post-baseline, 26-weeks post-baseline |
|
| Secondary |
Phase 1: Change in health-related quality of life assessed by the Short-Form-12 |
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. |
Baseline, 10-weeks post-baseline, 14-weeks post-baseline, 26-weeks post-baseline |
|
| Secondary |
Phase 1: Change in quality of life assessed by the EuroQol-5 Dimension-3 level (EQ-5D-3L) |
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). |
Baseline, 10-weeks post-baseline, 14-weeks post-baseline, 26-weeks post-baseline |
|
| Secondary |
Phase 1 and Phase 2: Cost of intervention arms |
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. |
10-weeks (post intervention) |
|
| Secondary |
Phase 1: Use of health care resources |
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. |
10-weeks post-baseline, 14-weeks post-baseline, 26-weeks post-baseline |
|
| Secondary |
Phase 1 and Phase 2: Intervention adherence |
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. |
10-weeks post-baseline |
|
| Secondary |
Phase 2: Resistance Exercise Self-Efficacy |
Guide for constructing self-efficacy scales |
Baseline, 8-weeks post-baseline, 26-weeks post-baseline |
|
| Secondary |
Phase 2: Physical Self |
Physical Self-Description Questionnaire: |
Baseline, 8-weeks post-baseline, 26-weeks post-baseline |
|
| Secondary |
Phase 2: Body Functionality appreciation |
Functionality Appreciation Scale: |
Baseline, 8-weeks post-baseline, 26-weeks post-baseline |
|
