Step Into Support for Endurance and Strength (SISTERS)

Not Applicable

Completed

• Conditions: Gynecologic Cancer

• 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

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)

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

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

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