Connecting Breast Cancer Survivors for Exercise: A Randomized Controlled Trial Phase I and II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Phase 1 and Phase 2: Change in exercise volume
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Phase 1 and phase 2:
- •Inclusion Criteria:
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Exercise Counselling (Behavioral)
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.
干预措施: Partner Matching (Behavioral)
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.
干预措施: Partner Matching (Behavioral)
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.
干预措施: Resistance training sessions led by a QEP (Behavioral)
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.
干预措施: Resistance training sessions led by a QEP (Behavioral)
结局指标
主要结局
Phase 1 and Phase 2: Change in exercise volume
时间窗: 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).
Phase 1 and Phase 2: Change in exercise volume
时间窗: 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
时间窗: 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).
次要结局
- 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 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))
- Phase 1: Use of health care resources(10-weeks post-baseline, 14-weeks post-baseline, 26-weeks post-baseline)
- Phase 1 and Phase 2: Intervention adherence(10-weeks post-baseline)
- Phase 2: Resistance Exercise Self-Efficacy(Baseline, 8-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 2: Physical Self(Baseline, 8-weeks post-baseline, 26-weeks post-baseline)
- Phase 2: Body Functionality appreciation(Baseline, 8-weeks post-baseline, 26-weeks post-baseline)
研究者
Jenna Smith
Post Doctoral Fellow (Catherine Sabiston PI)
University of Toronto