Clinical trial NCT04771975: Connecting Breast Cancer Survivors for Exercise
Official title: Connecting Breast Cancer Survivors for Exercise: A Randomized Controlled Trial Phase I and II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Breast Neoplasms
Keywords: exercise
physical activity
oncology
breast cancer
survivorship
social support
resistance training
body image
physical self
body functionality
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Cancer Society (CCS)
First posted: 2021-02-25
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Phase 1: 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, labelled Match.

Phase 2: The purpose of this study is to examine whether the addition of 8-weekly QEP-lead resistance training Zoom sessions with an exercise partner interacts with social support (i.e., tangible, informational, emotional) and how this interaction relates to overall exercise volume as an extension of Phase 1 (one year after phase 1 was completed). A secondary aim of Phase 2 is to examine the direct influence of resistance training on body image, self-efficacy, the physical self, and body functionality among the participants.

Detailed description: The purpose of this project is to examine naturally occurring social support as related to daily exercise behavior. In our ecological momentary assessment (EMA) study, the function of social support (tangible, informational, emotional) was be explored as independent variables, and exercise dose (minutes, intensity) and type (aerobic, resistance training, flexibility) will be examined as dependent variables. The associations will be used to inform motivational and behaviour change messaging in ActiveMatch, a program developed and run by the PI of this study, Dr. Catherine Sabiston. It is generally hypothesized that the provision of social support will be associated with greater exercise behaviour. In phase 1 of Connect for exercise, the RCT portion of this study, the addition of qualified exercise professional (QEP) support will be evaluated compared to social support from a participant match (exercise partner) alone. In Phase 2 of the Connect for exercise trial (pre-post design with no control group), we will examine whether the addition of 8-weekly QEP-lead resistance training Zoom sessions with an exercise partner interacts with social support (i.e., tangible, informational, emotional) and how this interaction relates to overall exercise volume (completed one-year post phase 1 completion). A secondary aim of Phase 2 is to examine the direct influence of resistance training on body image, self-efficacy, the physical self, and body functionality among the participants. There is evidence that resistance training improves these outcomes in women (Santa Barbara et al., 2017), but the relationship is understudied in breast cancer survivors. Improvements in these outcomes have, in turn, been related to increases in PA and sustainable positive PA outcomes. Considering the decreases in body image and body functionality appreciation reported by BCS during and after treatment (Resaei et al., 2016), this relationship warrants further investigation.

Eligibility criteria: Phase 1 and phase 2:

Inclusion Criteria:

* Female
* Breast cancer survivors
* Stage 1-4 cancer
* Aged \>18 years
* Have been cleared for exercise
* Have consistent access to an Internet-connected device
* Currently exercise ≤ 150 minutes per week.

Exclusion Criteria:

* Report contraindications to exercise such as physical disability
* Had recent or planned reconstructive surgery
* Have no consistent access to an Internet-connected device
* Are currently meeting exercise guidelines (performing \> 150 minutes of moderate-to- vigorous exercise)
* Have not been cleared to participate in exercise

Primary outcomes:
measure: Phase 1 and Phase 2: Change in exercise volume
timeFrame: Baseline, 10-weeks post baseline.
measure: Phase 1 and Phase 2: Change in exercise volume
timeFrame: 14-weeks post baseline
measure: Phase 1 and Phase 2: Change in exercise volume
timeFrame: 26-weeks post baseline
Secondary outcomes:
measure: Phase 1 and Phase 2: Change in exercise volume
timeFrame: Baseline, 10-weeks post-baseline, 14-weeks post-baseline, 26-weeks post-baseline
measure: Phase 1: Change in social support
timeFrame: Baseline, 10-weeks post-baseline, 14-weeks post-baseline, 26-weeks post-baseline
measure: Phase 1: Change in health-related quality of life assessed by the Short-Form-12
timeFrame: Baseline, 10-weeks post-baseline, 14-weeks post-baseline, 26-weeks post-baseline
measure: Phase 1: Change in quality of life assessed by the EuroQol-5 Dimension-3 level (EQ-5D-3L)
timeFrame: Baseline, 10-weeks post-baseline, 14-weeks post-baseline, 26-weeks post-baseline
measure: Phase 1 and Phase 2: Cost of intervention arms
timeFrame: 10-weeks (post intervention)
measure: Phase 1: Use of health care resources
timeFrame: 10-weeks post-baseline, 14-weeks post-baseline, 26-weeks post-baseline
measure: Phase 1 and Phase 2: Intervention adherence
timeFrame: 10-weeks post-baseline
measure: Phase 2: Resistance Exercise Self-Efficacy
timeFrame: Baseline, 8-weeks post-baseline, 26-weeks post-baseline
measure: Phase 2: Physical Self
timeFrame: Baseline, 8-weeks post-baseline, 26-weeks post-baseline
measure: Phase 2: Body Functionality appreciation
timeFrame: Baseline, 8-weeks post-baseline, 26-weeks post-baseline
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
References:
citation: Smith-Turchyn J, McCowan ME, O'Loughlin E, Fong AJ, McDonough MH, Santa Mina D, Arbour-Nicitopoulos KP, Trinh L, Jones JM, Bender JL, Culos-Reed SN, Tomasone JR, Vani MF, Sabiston CM. Connecting breast cancer survivors for exercise: protocol for a two-arm randomized controlled trial. BMC Sports Sci Med Rehabil. 2021 Oct 14;13:128. doi: 10.1186/s13102-021-00341-w. eCollection 2021.