Connecting Breast Cancer Survivors for Exercise

NCT ID: NCT04771975

Last Updated: 2023-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-10

Study Completion Date

2022-01-30

Brief Summary

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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

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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.

Conditions

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Breast Cancer Breast Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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MatchQEP group

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.

Group Type EXPERIMENTAL

Exercise Counselling

Intervention Type BEHAVIORAL

Phase 1: See previous description for MatchQEP (Intervention) group. 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. Phase 2 participants had the option to extend their time in the study for an additional 8-weeks, which includes an online virtual (zoom) resistance training program with a qualified exercise professional (QEP) with a new study partner. The 8-week program was open to all participants from Phase 1 who choose to continue in the study, regardless of initial randomization status. Behavioural and exercise counselling were offered to phase 2 participants.

Partner Matching

Intervention Type BEHAVIORAL

Phase 1: All participants will be matched with another participant (fellow BCS) and will facilitate / support exercise with their partner for the duration of the study.

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. Phase 2 participants were rematched with different partner for this phase of the trial.

Participants will be matched based on personal and cancer-related characteristics.

Resistance training sessions led by a QEP

Intervention Type BEHAVIORAL

Phase 2: participants were offered the option to extend their time in the study for an additional 8-weeks, which includes an online virtual (zoom) resistance training program with a qualified exercise professional (QEP) with a new study partner.

Match group

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.

Group Type ACTIVE_COMPARATOR

Partner Matching

Intervention Type BEHAVIORAL

Phase 1: All participants will be matched with another participant (fellow BCS) and will facilitate / support exercise with their partner for the duration of the study.

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. Phase 2 participants were rematched with different partner for this phase of the trial.

Participants will be matched based on personal and cancer-related characteristics.

Resistance training sessions led by a QEP

Intervention Type BEHAVIORAL

Phase 2: participants were offered the option to extend their time in the study for an additional 8-weeks, which includes an online virtual (zoom) resistance training program with a qualified exercise professional (QEP) with a new study partner.

Interventions

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Exercise Counselling

Phase 1: See previous description for MatchQEP (Intervention) group. 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. Phase 2 participants had the option to extend their time in the study for an additional 8-weeks, which includes an online virtual (zoom) resistance training program with a qualified exercise professional (QEP) with a new study partner. The 8-week program was open to all participants from Phase 1 who choose to continue in the study, regardless of initial randomization status. Behavioural and exercise counselling were offered to phase 2 participants.

Intervention Type BEHAVIORAL

Partner Matching

Phase 1: All participants will be matched with another participant (fellow BCS) and will facilitate / support exercise with their partner for the duration of the study.

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. Phase 2 participants were rematched with different partner for this phase of the trial.

Participants will be matched based on personal and cancer-related characteristics.

Intervention Type BEHAVIORAL

Resistance training sessions led by a QEP

Phase 2: participants were offered the option to extend their time in the study for an additional 8-weeks, which includes an online virtual (zoom) resistance training program with a qualified exercise professional (QEP) with a new study partner.

Intervention Type BEHAVIORAL

Other Intervention Names

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QEP support

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Canadian Cancer Society (CCS)

OTHER

Sponsor Role collaborator

Jenna Smith

OTHER

Sponsor Role lead

Responsible Party

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Jenna Smith

Post Doctoral Fellow (Catherine Sabiston PI)

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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University of Toronto

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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Murray RM, O'Loughlin E, Smith-Turchyn J, Fong AJ, McDonough MH, Mina DS, Arbour-Nicitopoulos KP, Trinh L, Jones JM, Bender JL, Culos-Reed SN, Tomasone JR, Vani MF, Sabiston CM. Connecting women who are diagnosed and treated for breast cancer to engage in physical activity: a two-arm randomized controlled trial. BMC Sports Sci Med Rehabil. 2025 Apr 25;17(1):96. doi: 10.1186/s13102-025-01131-4.

Reference Type DERIVED
PMID: 40281585 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34649590 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/34649590/

Connecting breast cancer survivors for exercise: protocol for a two-arm randomized controlled trial

Other Identifiers

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I2I1

Identifier Type: -

Identifier Source: org_study_id

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