Step Into Support for Endurance and Strength (SISTERS)

Dana-Farber Cancer Institute21 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Gynecologic Cancer

Interventions

FitbitOTHER

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

Fitbit + Game + Support from a TeammateOTHER

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Rate of Enrollment

Feasibility will be demonstrated if ≥50% eligible participants enroll

Time frame: 3 months

Rate of Completion

Feasibility will be demonstrated if ≥75% of eligible participants complete the post-baseline outcome assessments.

Time frame: 3 months

Burden Rate

Acceptability will be defined as: ≤20% of participants reporting high study burden and ≤10% study withdrawal.

Time frame: 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.

Time frame: 3 months

Data from ClinicalTrials.gov

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