Step Into Support for Endurance and Strength (SISTERS)

Gynecologic Cancer Clinical Trial

— SISTERS  

Official title:

Step Into Support for Endurance and Strength (SISTERS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04354454
• Other study ID #: 20-065
• Status: Completed
• Phase: N/A
• Start date: January 29, 2021
• Est. completion date: March 17, 2023

Study information

• Verified date: April 2023
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 17, 2023
• Est. primary completion date: December 12, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gynecologic Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Northern Light Cancer Care	Brewer	Maine
United States	Lifespan Comprehensive Cancer Center	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Enrollment	Feasibility will be demonstrated if =50% eligible participants enroll	3 months
Primary	Rate of Completion	Feasibility will be demonstrated if =75% of eligible participants complete the post-baseline outcome assessments.	3 months
Primary	Burden Rate	Acceptability will be defined as: =20% of participants reporting high study burden and =10% study withdrawal.	3 months
Primary	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