Step Into Support for Endurance and Strength (SISTERS)

NCT ID: NCT04354454

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-29
• Study Completion Date: 2023-03-17

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.

Conditions

Gynecologic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Fitbit

Intervention Type: OTHER

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

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

Group Type: EXPERIMENTAL

Fitbit + Game + Support from a Teammate

Intervention Type: 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

Interventions

Fitbit

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

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Alexi A. Wright, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexi A Wright, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

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

Countries

United States

Other Identifiers

20-065

Identifier Type: -

Identifier Source: org_study_id