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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Page 1 of 1 (3 locations)

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