Clinical trial · Interventional
Step Into Support for Endurance and Strength (SISTERS)
NCT04354454CI-TRIAL-00065755SISTERScompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fitbit | Other | — | UNRESOLVED |
| Fitbit + Game + Support from a Teammate | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Fitbit
- description
- 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
- interventionNames
- Other: Fitbit
- type
- EXPERIMENTAL
- label
- Fitbit + Game + Support from a Teammate
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.