Step Into Support for Endurance and Strength (SISTERS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 6
- 主要终点
- Burden Rate
研究概览
简要总结
The Step into Support for Endurance and Strength (SISTERS) research study is evaluating whether a mobile health game designed to increase physical activity is feasible and acceptable in patients with gynecologic cancers.
-SISTERS is testing a mobile health intervention can help increase physical activity. Participants will be randomized to receive either 1) a Fitbit or 2) a Fitbit + a game + help from a friend or family member whom you chose will help the participant reach their goals. (i.e. a Teammate).
详细描述
This study is a two-arm randomized controlled pilot study designed to test the feasibility and acceptability of using a wearable accelerometer (Fitbit) vs. a wearable accelerometer (FItbit) + a game designed to help participants increase physical activity + social support improves participants' average daily step counts.
Eligible Participants will be randomly assigned into 1 of 2 groups
- Fitbit (wearable accelerometer) or
- Fitbit (wearable accelerometer) + game + help from a self-selected teammate
The study interventions involved in this research are:
- Surveys/Interviews
- Fitbits (also known as a wearable accelerometers or fitness trackers)
- Way to Health Platform
- Help from a Teammate (i.e. a friend or family member that participants choose to help them reach their goals)
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients ≥18 years of age with a gynecologic cancer (ovarian, fallopian tube, primary peritoneal carcinoma, uterine, or cervical) who have completed cancer treatment ≥ 6 weeks prior.
- •Own a smartphone (Android or iOS).
- •Can read and provide informed consent in English.
- •Do not have cognitive, visual, or orthopedic impairments that preclude participation, as evaluated by the research staff or oncology provider.
- •Insufficiently active, as indicated by a score of <14 on the Leisure Score Index of Godin Leisure-Time Exercise Questionnaire (LSI).
- •No future chemotherapy planned (except maintenance treatments; e.g. PARP inhibitors or endocrine therapy)
排除标准
- •Patients already participating in a mobile health intervention.
- •Patients who do not own a smartphone or computer to transmit data from the wearable tracker.
- •Self-reported inability to walk 2 blocks (at any pace).
- •Patients who are unable to identify a social support partner (i.e. family member, friend, or partner) to participate in the study (if selected for the intervention arm).
- •The following special populations will be excluded from this research:
- •Adults unable to consent
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women
- •Prisoners
结局指标
主要结局
Burden Rate
时间窗: 3 months
Acceptability will be defined as: ≤20% of participants reporting high study burden and ≤10% study withdrawal.
Rate of Activity
时间窗: 3 months
Perceived effectiveness will be defined as ≥70% of participants indicate that study participation motivated them to increase their activity levels.
Rate of Enrollment
时间窗: 3 months
Feasibility will be demonstrated if ≥50% eligible participants enroll
Rate of Completion
时间窗: 3 months
Feasibility will be demonstrated if ≥75% of eligible participants complete the post-baseline outcome assessments.
次要结局
未报告次要终点
研究者
Alexi A. Wright, MD
Principal Investigator
Dana-Farber Cancer Institute