Clinical trial NCT04354454: Step Into Support for Endurance and Strength (SISTERS)
Official title: Step Into Support for Endurance and Strength (SISTERS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Cancer
Keywords: Gynecologic Cancer
Mobile Health
Fitness Tracker
Survivorship
Quality of Life
Physical Activity
Feasibility Study
Pilot
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Enrollment
timeFrame: 3 months
measure: Rate of Completion
timeFrame: 3 months
measure: Burden Rate
timeFrame: 3 months
measure: Rate of Activity
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brewer
country: United States
facility: Northern Light Cancer Care
state: Maine
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Providence
country: United States
facility: Lifespan Comprehensive Cancer Center
state: Rhode Island
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Alexi A Wright, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: