Status:
COMPLETED
Step Into Support for Endurance and Strength (SISTERS)
Lead Sponsor:
Dana-Farber Cancer Institute
Conditions:
Gynecologic Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
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 ...
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 d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 17 2023
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04354454
Start Date
January 29 2021
End Date
March 17 2023
Last Update
April 18 2023
Active Locations (3)
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1
Northern Light Cancer Care
Brewer, Maine, United States, 04412
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
Lifespan Comprehensive Cancer Center
Providence, Rhode Island, United States, 02903