NCT04771975

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2020

Completed
12 months until next milestone

First Posted

Study publicly available on registry

February 25, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 10, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

8 months

First QC Date

February 28, 2020

Last Update Submit

August 15, 2023

Conditions

Breast CancerBreast Neoplasms

Keywords

exercisephysical activityoncologybreast cancersurvivorshipsocial supportresistance trainingbody imagephysical selfbody functionality

Outcome Measures

Primary Outcomes (3)

  • 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.

  • 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

  • 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 Outcomes (10)

  • Phase 1 and Phase 2: Change in exercise volume

    Baseline, 10-weeks post-baseline, 14-weeks post-baseline, 26-weeks post-baseline

  • Phase 1: Change in social support

    Baseline, 10-weeks post-baseline, 14-weeks post-baseline, 26-weeks post-baseline

  • Phase 1: 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

  • Phase 1: 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

  • Phase 1 and Phase 2: Cost of intervention arms

    10-weeks (post intervention)

  • +5 more secondary outcomes

Study Arms (2)

MatchQEP group

EXPERIMENTAL

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.

Behavioral: Exercise CounsellingBehavioral: Partner MatchingBehavioral: Resistance training sessions led by a QEP

Match group

ACTIVE COMPARATOR

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.

Behavioral: Partner MatchingBehavioral: Resistance training sessions led by a QEP

Interventions

Exercise CounsellingBEHAVIORAL

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.

Also known as: QEP support
MatchQEP group
Partner MatchingBEHAVIORAL

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.

Match groupMatchQEP group
Resistance training sessions led by a QEPBEHAVIORAL

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 groupMatchQEP group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Toronto

Toronto, Ontario, M5S 2W6, Canada

Location

Related Publications (2)

  • 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.

    PMID: 40281585DERIVED

  • 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.

    PMID: 34649590DERIVED

Related Links

MeSH Terms

Conditions

Breast NeoplasmsMotor ActivityNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Post Doctoral Fellow (Catherine Sabiston PI)

Study Record Dates

First Submitted

February 28, 2020

First Posted

February 25, 2021

Study Start

May 10, 2021

Primary Completion

December 30, 2021

Study Completion

January 30, 2022

Last Updated

August 21, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)