Connecting Breast Cancer Survivors for Exercise (C4E)

Jenna Smith

Status: Completed

Conditions: Breast Cancer; Breast Neoplasms

Treatments: Behavioral: Resistance training sessions led by a QEP; Behavioral: Exercise Counselling; Behavioral: Partner Matching

Study type: Interventional

Funder types: Other

Identifiers

NCT04771975

I2I1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

108 participants in 2 patient groups

MatchQEP group

Experimental group

Description:

Phase 1: 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. Phase 2: Was not an RCT (i.e., all Phase 1 participants were approached to participate in Phase 2). Phase 2 is a pre-post intervention design, with no control group.

Treatment:

Behavioral: Resistance training sessions led by a QEP

Behavioral: Exercise Counselling

Behavioral: Partner Matching

Match group

Active Comparator group

Description:

Phase 1: 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. Phase 2: Was not an RCT (i.e., all Phase 1 participants were approached to participate in Phase 2). Phase 2 is a pre-post intervention design, with no control group.

Treatment:

Behavioral: Resistance training sessions led by a QEP

Behavioral: Partner Matching