Step Into Support for Endurance and Strength (SISTERS) (SISTERS)

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).

Study Overview

• Status: Completed
• Conditions: Gynecologic Cancer
• Intervention / Treatment: Other: Fitbit; Other: Fitbit + Game + Support from 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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maine
    • Brewer, Maine, United States, 04412
      • Northern Light Cancer Care
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana-Farber Cancer Institute
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Lifespan Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Other: Fitbit; Participants will select a daily step goal and track their steps every day for 4.5 months.
Experimental: 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	Other: Fitbit + Game + Support from a Teammate; Daily Fitbit tracking for 4.5 months, divided into 2 parts.; 3 months on "active intervention" with Fitbit, a Game, and Support from a self-selected Teammate and pre-designed game.; 1.5 month follow-up period with Fitbit and social support teammate only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Enrollment	Feasibility will be demonstrated if ≥50% eligible participants enroll	3 months
Rate of Completion	Feasibility will be demonstrated if ≥75% of eligible participants complete the post-baseline outcome assessments.	3 months
Burden Rate	Acceptability will be defined as: ≤20% of participants reporting high study burden and ≤10% study withdrawal.	3 months
Rate of Activity	Perceived effectiveness will be defined as ≥70% of participants indicate that study participation motivated them to increase their activity levels.	3 months

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Alexi A Wright, MD, MPH, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2021
• Primary Completion (Actual): December 12, 2022
• Study Completion (Actual): March 17, 2023

Study Registration Dates

• First Submitted: April 17, 2020
• First Submitted That Met QC Criteria: April 17, 2020
• First Posted (Actual): April 21, 2020

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Physical Activity; Quality of Life; Mobile Health; Gynecologic Cancer; Survivorship; Feasibility Study; Pilot; Fitness Tracker
• Other Study ID Numbers: 20-065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No