An interventional study of Fitbit and Fitbit + Game + Support from a Teammate in Gynecologic Cancer, sponsored by Dana-Farber Cancer Institute. Completed at 3 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-18.
Sponsored by Dana-Farber Cancer Institute · Not applicable, Interventional, and Supportive care
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
The study interventions involved in this research are:
It is expected that about 50 people will take part in this research study.
2,658 studies on the registry are indexed under Motor Activity; 1,204 are open to participants now.
This study's enrollment of 21 is below the median of 60 across 2,312 interventional studies indexed under Motor Activity.
Browse Motor Activity studies →Dana-Farber Cancer Institute is the lead sponsor of 833 studies on the registry; 121 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.
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Exclusion Criteria:
The following special populations will be excluded from this research:
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
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
Participants will select a daily step goal and track their steps every day for 4.5 months.
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
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
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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