Gynecologic Cancer
Conditions
Keywords
Gynecologic Cancer, Mobile Health, Fitness Tracker, Survivorship, Quality of Life, Physical Activity, Feasibility Study, Pilot
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 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).
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 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.
Interventions
OTHERFitbit
Participants will select a daily step goal and track their steps every day for 4.5 months.
OTHERFitbit + 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
Sponsors
Dana-Farber Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Enrollment | 3 months | Feasibility will be demonstrated if ≥50% eligible participants enroll |
| Rate of Completion | 3 months | Feasibility will be demonstrated if ≥75% of eligible participants complete the post-baseline outcome assessments. |
| Burden Rate | 3 months | Acceptability will be defined as: ≤20% of participants reporting high study burden and ≤10% study withdrawal. |
| Rate of Activity | 3 months | Perceived effectiveness will be defined as ≥70% of participants indicate that study participation motivated them to increase their activity levels. |
Countries
United States
Outcome results
None listed