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
- 3
- 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
研究组 & 干预措施
Fitbit
After the screening procedures confirm participation in the research study. Participants randomized into Fitbit only group.
-- Participants will track their daily steps for 4.5 months with use of a Fitbit
The study interventions involved in this research are:
- Fitbit (also known as a wearable accelerometer or fitness tracker)
- Way to Health platform
- Surveys/Interviews
干预措施: Fitbit (Other)
Fitbit + Game + Support from a Teammate
After the screening procedures confirm participation in the research study. Participants randomized into Fitbit + Game + Support from a Teammate.
- Participants will select a step goal, use a Fitbit to track daily activity, and select a teammate (e.g. family member or friend) who they think will help them achieve their goals.
- Participants will participate a 3-month game designed to increase activity and then followed for another 1.5 months to see if their increased activity can be maintained without the game.
The study interventions involved in this research are:
- Fitbit (also known as a wearable accelerometer or fitness tracker)
- Help from a Teammate (i.e. friend or family member chosen to help reach goals, if applicable
- Way to Health Platform
- Surveys/Interviews
干预措施: Fitbit + Game + Support from a Teammate (Other)
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