Breast CancerC4ENCT04771975
Connecting Breast Cancer Survivors for Exercise
A study testing Exercise Counselling, Partner Matching and Resistance training sessions led by a QEP in people with Breast Cancer and Breast Neoplasms, run by Jenna Smith at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Neoplasms
- What is being tested?
- Exercise Counselling, Partner Matching and Resistance training sessions led by a QEP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteCanada
- Study dates
- 10 May 2021to 30 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Connecting Breast Cancer Survivors for Exercise: A Randomized Controlled Trial Phase I and II
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.
Read the 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.
- Conditions
- Breast Cancer, Breast Neoplasms
- Being tested
- Exercise Counselling, Partner Matching, Resistance training sessions led by a QEP
- Keywords
- exercise, physical activity, oncology, breast cancer, survivorship, social support, resistance training, body image, physical self, body functionality
- Medical subject headings
- Breast Neoplasms, Motor Activity, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise CounsellingBehavioural
Also called QEP support
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 MatchingBehavioural
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 QEPBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Exercise Counselling; Behavioral: Partner Matching; Behavioral: 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. Receives: Behavioral: Partner Matching; Behavioral: Resistance training sessions led by a QEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 26-weeks post baseline
Secondary outcomes (10)
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.
Measured: Baseline, 10-weeks post-baseline, 14-weeks post-baseline, 26-weeks post-baseline
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.
Measured: 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
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.
Measured: 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)
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).
Measured: Baseline, 10-weeks post-baseline, 14-weeks post-baseline, 26-weeks post-baseline
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.
Measured: 10-weeks (post intervention)
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.
Measured: 10-weeks post-baseline, 14-weeks post-baseline, 26-weeks post-baseline
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.
Measured: 10-weeks post-baseline
Phase 2: Resistance Exercise Self-Efficacy
Guide for constructing self-efficacy scales
Measured: Baseline, 8-weeks post-baseline, 26-weeks post-baseline
Phase 2: Physical Self
Physical Self-Description Questionnaire:
Measured: Baseline, 8-weeks post-baseline, 26-weeks post-baseline
Phase 2: Body Functionality appreciation
Functionality Appreciation Scale:
Measured: Baseline, 8-weeks post-baseline, 26-weeks post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start10 May 2021
- Primary completion30 Dec 2021
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jenna Smith
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Responsible party
- Sponsor-investigator, Jenna Smith, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771975
- Sponsor's protocol ID
- I2I1
- Acronym
- C4E
- Status last verified
- Aug 2023
- First submitted
- 28 Feb 2020
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40281585Smith-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.
PubMed 34649590
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connecting Breast Cancer Survivors for Exercise: A Randomized Controlled Trial Phase I and II
- ClinicalTrials.gov ID
- NCT04771975
- Acronym / sponsor ID
- C4E / I2I1
- Conditions
- Breast Cancer, Breast Neoplasms
- Keywords
- exercise, physical activity, oncology, breast cancer, survivorship, social support, resistance training, body image
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Jenna SmithUniversity, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Study start
- 10 May 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MatchQEP group | Experimental | Behavioral: Exercise Counselling, Behavioral: Partner Matching, Behavioral: Resistance training sessions led by a QEPPhase 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. |
| Match group | Active comparator | Behavioral: Partner Matching, Behavioral: Resistance training sessions led by a QEPPhase 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female
- Breast cancer survivors
- Stage 1-4 cancer
- Aged >18 years
- Have been cleared for exercise
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise CounsellingAlso: QEP supportPhase 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. | Behavioural | MatchQEP group |
| Partner MatchingPhase 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. | Behavioural | Match group, MatchQEP group |
| Resistance training sessions led by a QEPPhase 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. | Behavioural | Match group, MatchQEP group |
Primary outcome
Phase 1 and Phase 2: Change in exercise volume
Time frame: Baseline, 10-weeks post baseline.
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).
Phase 1 and Phase 2: Change in exercise volume
Time frame: 14-weeks post baseline
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).
Phase 1 and Phase 2: Change in exercise volume
Time frame: 26-weeks post baseline
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).
10 secondary outcomes
Phase 1 and Phase 2: Change in exercise volume
Time frame: Baseline, 10-weeks post-baseline, 14-weeks post-baseline, 26-weeks post-baseline
Phase 1: Change in social support
Time frame: 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
Time frame: 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)
Time frame: Baseline, 10-weeks post-baseline, 14-weeks post-baseline, 26-weeks post-baseline
Phase 1 and Phase 2: Cost of intervention arms
Time frame: 10-weeks (post intervention)
Phase 1: Use of health care resources
Time frame: 10-weeks post-baseline, 14-weeks post-baseline, 26-weeks post-baseline
Phase 1 and Phase 2: Intervention adherence
Time frame: 10-weeks post-baseline
Phase 2: Resistance Exercise Self-Efficacy
Time frame: Baseline, 8-weeks post-baseline, 26-weeks post-baseline
Phase 2: Physical Self
Time frame: Baseline, 8-weeks post-baseline, 26-weeks post-baseline
Phase 2: Body Functionality appreciation
Time frame: Baseline, 8-weeks post-baseline, 26-weeks post-baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Derived from this study: PubMed 40281585Murray 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.
- Derived from this study: PubMed 34649590Smith-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.
- Connecting breast cancer survivors for exercise: protocol for a two-arm randomized controlled trialLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Counselling, Partner Matching and Resistance training sessions led by a QEP in people with Breast Cancer and Breast Neoplasms, run by Jenna Smith at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1 and Phase 2: Change in exercise volume (time frame: Baseline, 10-weeks post baseline.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04771975, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.