Step Into Support for Endurance and Strength (SISTERS)

Not Applicable

Completed

• Conditions: Gynecologic Cancer
• Interventions: Other: Fitbit; Other: Fitbit + Game + Support from a Teammate

• Registration Number: NCT04354454
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

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).

Detailed Description

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

1. Fitbit (wearable accelerometer) or

2. 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)

It is expected that about 50 people will take part in this research study.

Study Timeline

• Study First Submitted: 2020-04-17
• Study First Submitted QC: 2020-04-17
• Study First Posted: 2020-04-21
• Study Start: 2021-01-29
• Primary Completion: 2022-12-12
• Study Completion: 2023-03-17
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 21

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fitbit	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
Fitbit + Game + Support from a Teammate	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

Primary Outcome Measures

Name	Time	Method
Burden Rate	3 months	Acceptability will be defined as: ≤20% of participants reporting high study burden and ≤10% study withdrawal.
Rate of Activity	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	3 months	Feasibility will be demonstrated if ≥50% eligible participants enroll
Rate of Completion	3 months	Feasibility will be demonstrated if ≥75% of eligible participants complete the post-baseline outcome assessments.

Trial Locations

Locations (3)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Northern Light Cancer Care; 🇺🇸 Brewer, Maine, United States

Lifespan Comprehensive Cancer Center; 🇺🇸 Providence, Rhode Island, United States