Innovative Smart-phone-enabled Health Coaching Intervention (iMOVE) to Promote Long-term Maintenance of Physical Activity Behavior in Breast Cancer Survivors: Study Protocol for a Feasibility Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Retention Rate
研究概览
简要总结
While physical activity (PA) appears to play an important role in disease control and the promotion of long-term health and well-being of cancer survivors, the large majority of breast cancer survivors are not physically active. Addressing this problem requires exercise promotion and an additional method of supporting long term exercise adherence. In response, an innovative health coaching intervention which uses mobile technology (iMOVE) to promote long-term PA in breast cancer survivors (BrCa) was developed. Project description: 107 inactive BrCa survivors will be randomized to receive a 12-week exercise program (CONTROL) OR a 12 week exercise program plus a concurrent health coaching program (iMOVE) consisting of telephone-based coaching sessions and interactive software delivered through a smart-phone and Fit-bit (wearable fitness technology) (INTERVENTION). Information on the feasibility and acceptability of the methods and intervention and examine the impact on fitness (primary), patient-reported, anthropometric, and physical (secondary) outcomes will be collected. Impact and relevance: PA has increasingly been identified as a modifiable factor that has the potential to impact cancer outcomes and improve quality of life. iMOVE is an innovative intervention with the potential to promote and maintain physical activity for breast cancer survivors. This study will be the first step in the evaluation of iMOVE and will help to determine whether a larger randomized controlled trial is needed.
详细描述
In order to advance PA adoption and maintenance in BrCaS, an innovative health coaching intervention which uses mobile, wearable technologies (iMOVE) was developed. This pilot study will evaluate iMOVE and inform the design of a larger pragmatic randomized controlled trial (RCT).
Main Hypotheses: 1) The study will be adequately recruit (>40%) and retain (>75%) participants, and 2) the intervention will be highly acceptable to participants and result in substantial sustained fitness improvements.
Aims of the Pilot Study Aim 1: To evaluate feasibility of the methods employed as defined by a) ability to recruit >40% of those eligible; b) adequate retention, operationalized as 6-month assessment completion by >75% of participants; c) adequate adherence, operationalized as ≥70% of intervention components completed.
Aim 2: To evaluate acceptability feedback for the final refinement and optimization of the intervention.
Aim 3: To determine preliminary intervention efficacy on fitness (primary) and on patient-reported, anthropometric and physical (secondary) outcomes.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Within 2 years of completion of adjuvant therapy, with the exception of hormone therapy, for early stage (0-IIIA) BrCa
- •Baseline participation of < 60 min of weekly pre-planned PA
- •Physician permission for moderate PA participation 4)Able to read and write English
- •Able to attend in-person exercise training sessions and physiologic assessments at prescribed intervals.
排除标准
- •Plans to join a weight-loss or exercise program within 9 months)
- •Current pregnancy or planned pregnancy within 9 months)
- •Planned surgery during study; 4) not willing to be randomized.
研究组 & 干预措施
Exercise Only
Participants receive 12-weeks PA training (1x/week - 60 min) group sessions with a CEP/RKin, and a progressively structured home-based exercise program based on the American College of Sports Medicine (ACSM) guidelines.It combines aerobic-resistance exercise with flexibility training, and progresses towards increased in intensity and improved fitness. The goal is at least 150 min/week of moderate-intensity aerobic activity. Participants are also asked to complete 3-5 additional home-based sessions of aerobic, and resistance activities each week. Initial intensity is based on the performance of the exercises during a group session and is self-monitored via the 10-point rating of perceived exertion, with a prescribed training zone of 4-7.
干预措施: Exercise Only (Behavioral)
Exercise + iMOVE
Participants will receive the same exercise program at the Exercise Only group + 1) one-on-one telephone-based counselling (10 x 30-minute telephone: weeks 1, 2, 3, 4, 5, 6, 8, and 12 (during the exercise program) and at weeks 20,28 (post-exercise program booster sessions)); 2) supportive software on smart-phone devices (the HealthCoach program), 3) use of Fit-bit and corresponding software. The iMOVE intervention was designed to enhance sustained behavior change. The theoretical constructs employed are based on promoting motivation and establishing: a) exercise self-efficacy, b) social support for exercise and c) positive exercise-induced feelings during the acute intervention (12 weeks) and post-exercise program period (6 months).
干预措施: Fit bit Device (Device)
Exercise + iMOVE
Participants will receive the same exercise program at the Exercise Only group + 1) one-on-one telephone-based counselling (10 x 30-minute telephone: weeks 1, 2, 3, 4, 5, 6, 8, and 12 (during the exercise program) and at weeks 20,28 (post-exercise program booster sessions)); 2) supportive software on smart-phone devices (the HealthCoach program), 3) use of Fit-bit and corresponding software. The iMOVE intervention was designed to enhance sustained behavior change. The theoretical constructs employed are based on promoting motivation and establishing: a) exercise self-efficacy, b) social support for exercise and c) positive exercise-induced feelings during the acute intervention (12 weeks) and post-exercise program period (6 months).
干预措施: Exercise Only (Behavioral)
Exercise + iMOVE
Participants will receive the same exercise program at the Exercise Only group + 1) one-on-one telephone-based counselling (10 x 30-minute telephone: weeks 1, 2, 3, 4, 5, 6, 8, and 12 (during the exercise program) and at weeks 20,28 (post-exercise program booster sessions)); 2) supportive software on smart-phone devices (the HealthCoach program), 3) use of Fit-bit and corresponding software. The iMOVE intervention was designed to enhance sustained behavior change. The theoretical constructs employed are based on promoting motivation and establishing: a) exercise self-efficacy, b) social support for exercise and c) positive exercise-induced feelings during the acute intervention (12 weeks) and post-exercise program period (6 months).
干预措施: Connected Wellness HealthCoach Software (Behavioral)
Exercise + iMOVE
Participants will receive the same exercise program at the Exercise Only group + 1) one-on-one telephone-based counselling (10 x 30-minute telephone: weeks 1, 2, 3, 4, 5, 6, 8, and 12 (during the exercise program) and at weeks 20,28 (post-exercise program booster sessions)); 2) supportive software on smart-phone devices (the HealthCoach program), 3) use of Fit-bit and corresponding software. The iMOVE intervention was designed to enhance sustained behavior change. The theoretical constructs employed are based on promoting motivation and establishing: a) exercise self-efficacy, b) social support for exercise and c) positive exercise-induced feelings during the acute intervention (12 weeks) and post-exercise program period (6 months).
干预措施: Health Coaching (Behavioral)
结局指标
主要结局
Retention Rate
时间窗: Through study completion, average of 2 years
To optimize retention and prevent attrition, stability (with some flexibility) is aimed for with group exercise in terms of class time/location, combined with careful selection and training of Health Coaches, short referral times
Capture of Outcomes - proportion of participants from whom complete information is derived on clinical outcomes.
时间窗: through study completion, average of 2 years
As another major facet of feasibility, we assess the proportion of participants from whom complete information is derived on clinical outcomes, at which assessment time-points and then document rates of missing data. This outcome is measured in terms of frequency of completion not in the units of the measures themselves.
Recruitment Rate
时间窗: Through study completion, average of 2 years
Based on CONSORT criteria, a screening log enables data collection on eligible consented (pre- and post-initial screen) and non-recruited participants with reasons for non-recruitment recorded.
Treatment Implementation and Fidelity - length, number and quality of health coaching phone sessions
时间窗: through study completion, average of 2 years
For the experimental group, health coaching session lengths/numbers are recorded. The health coach will document use of health coaching techniques and tools, and the barriers identified. Use of the health coaching software is stored on the secure server and will be used to measure and analyze self-report and health coach activity.
Acceptability:Participants perceptions regarding their experience of the study and if they liked it
时间窗: through study completion, average of 2 years
To assess acceptability and inform future refinement, telephone interviews will be conducted with a purposefully selected sub-sample of experimental participants following intervention completion. The goal of the qualitative interviews is: 1) to explore participant perspectives of feasibility/acceptability of the health coaching intervention, and 2) to gain an understanding of specific experiences/attitudes among those successful and unsuccessful at PA maintenance PA. An interpretive description qualitative methodology will be used to meet this objective \[154\]. We will purposefully select participants, ensuring equal representation from participants who report exercise behavior has increased or decreased or stayed the same. We anticipate interviewing between 6-10 participants per group. A record of participation in the latter will be kept to distinguish these participants from those who were not chosen to participate. The semi-structured interviews will be 45-60 minutes in length.
次要结局
- Change in fear of recurrence - Fear of Recurrence Questionnaire (FRQ)(baseline, 12 weeks, 36 weeks)
- Group cohesion measure - Physical Activity Group Environment Questionnaire (PAGEQ)(12 weeks)
- Change in Cardiorespiratory fitness - "VO2"(oxygen consumption) Peak (mlO2/kg/min)(baseline, 12 week, and 36 weeks)
- Change in exercise frequency - Leisure-Time Exercise Questionnaire (LTEQ)(baseline, 12 week, and 36 weeks)
- Change in state of depressive symptoms - The Center for Epidemiological Studies-Depression Scale Short Form (CESD-SF)(baseline, 12 weeks, 36 weeks)
- Change in breast cancer related fatigue - Functional Assessment of Cancer Therapy-Fatigue (FACT-F) subscale(baseline, 12 weeks, 36 weeks)
- Change in body mass index (kg/m2)(baseline, 12 week, and 36 weeks)
- Change in waist circumference (WC) (cm)(baseline, 12 week, and 36 weeks)
- Change in breast cancer related physical symptoms - The Breast Cancer Prevention Trial (BCPT) Symptoms Scale(baseline, 12 weeks, 36 weeks)
- Change in quality of life - Functional Assessment of Cancer Therapy-Breast (FACT-B)(baseline, 12 weeks, 36 weeks)
- Change in indices of anxiety - Spielberger's State-Trait Anxiety Inventory-State (STAI-S)(baseline, 12 weeks, 36 weeks)
- Change in body fat percentage (%)(baseline, 12 weeks, 36 weeks)
- Change in grip strength (kg of force)(baseline, 12 weeks, 36 weeks)