Step Into Support for Endurance and Strength (SISTERS)

NCT04354454 | Completed DMC

• 1 other identifier: 20-065
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 3

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).

Conditions

Gynecologic Cancer

Keywords

Gynecologic Cancer; Mobile Health; Fitness Tracker; Survivorship; Quality of Life; Physical Activity; Feasibility Study; Pilot

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Fitbit

ACTIVE COMPARATOR

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

Fitbit + Game + Support from a Teammate

EXPERIMENTAL

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

Interventions

Fitbit OTHER

Participants will select a daily step goal and track their steps every day for 4.5 months.

Fitbit

Fitbit + Game + Support from a Teammate OTHER

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

Fitbit + Game + Support from a Teammate

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (3)

Northern Light Cancer Care

Brewer, Maine, 04412, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Lifespan Comprehensive Cancer Center

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Alexi A Wright, MD, MPH

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 21, 2020
• Study Start: January 29, 2021
• Primary Completion: December 12, 2022
• Study Completion: March 17, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (3)