Step Into Support for Endurance and Strength (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).

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Key information

Conditions

Gynecologic Cancer Behavior Motor Activity

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Northern Light Cancer Care, Brewer, Maine, United States

About this study

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

Fitbit (wearable accelerometer) or
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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FitBit

Other

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

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

Primary outcomes

Rate of Enrollment

Time frame: 3 months

Feasibility will be demonstrated if ≥50% eligible participants enroll
Rate of Completion

Time frame: 3 months

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

Time frame: 3 months

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

Time frame: 3 months

Perceived effectiveness will be defined as ≥70% of participants indicate that study participation motivated them to increase their activity levels.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Acronym: SISTERS

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2023
First posted: Apr 21, 2020
Registry last updated: Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed