Gynecologic CancerSISTERSNCT04354454
Step Into Support for Endurance and Strength (SISTERS)
A study testing Fitbit and Fitbit + Game + Support from a Teammate in people with Gynecologic Cancer, run by Dana-Farber Cancer Institute at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancer
- What is being tested?
- Fitbit and Fitbit + Game + Support from a Teammate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Jan 2021to 17 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Northern Light Cancer Care
Brewer, Maine, 04412
Lifespan Comprehensive Cancer Center
Providence, Rhode Island, 02903
About this study
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).
Read the 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
- Fitbit (wearable accelerometer) or
- 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.
- Conditions
- Gynecologic Cancer
- Being tested
- Fitbit, Fitbit + Game + Support from a Teammate
- Keywords
- Gynecologic Cancer, Mobile Health, Fitness Tracker, Survivorship, Quality of Life, Physical Activity, Feasibility Study, Pilot
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FitbitOther
Participants will select a daily step goal and track their steps every day for 4.5 months.
Fitbit + Game + Support from a TeammateOther
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
| Study group | Role | What they receive |
|---|---|---|
| Fitbit | Active comparator | 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 Receives: Other: Fitbit |
| Fitbit + Game + Support from a Teammate | Experimental | 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 Receives: Other: Fitbit + Game + Support from a Teammate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Enrollment
Feasibility will be demonstrated if ≥50% eligible participants enroll
Measured: 3 months
Rate of Completion
Feasibility will be demonstrated if ≥75% of eligible participants complete the post-baseline outcome assessments.
Measured: 3 months
Burden Rate
Acceptability will be defined as: ≤20% of participants reporting high study burden and ≤10% study withdrawal.
Measured: 3 months
Rate of Activity
Perceived effectiveness will be defined as ≥70% of participants indicate that study participation motivated them to increase their activity levels.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start29 Jan 2021
- Primary completion12 Dec 2022
- Study completion17 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexi A. Wright, MD, Dana-Farber Cancer Institute
- Investigators
- Alexi A Wright, MD, MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04354454
- Sponsor's protocol ID
- 20-065
- Acronym
- SISTERS
- Status last verified
- Apr 2023
- First submitted
- 17 Apr 2020
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Step Into Support for Endurance and Strength (SISTERS)
- ClinicalTrials.gov ID
- NCT04354454
- Acronym / sponsor ID
- SISTERS / 20-065
- Conditions
- Gynecologic Cancer
- Keywords
- Gynecologic Cancer, Mobile Health, Fitness Tracker, Survivorship, Quality of Life, Physical Activity, Feasibility Study, Pilot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 29 Jan 2021 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 17 Mar 2023 (actual)
- First posted
- 21 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Fitbit (wearable accelerometer) or
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fitbit | Active comparator | Other: FitbitAfter 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 |
| Fitbit + Game + Support from a Teammate | Experimental | Other: Fitbit + Game + Support from a TeammateAfter 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (9 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FitbitParticipants will select a daily step goal and track their steps every day for 4.5 months. | Other | Fitbit |
| Fitbit + Game + Support from a TeammateDaily 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 | Other | Fitbit + Game + Support from a Teammate |
Primary outcome
Rate of Enrollment
Time frame: 3 months
Feasibility will be demonstrated if ≥50% eligible participants enroll
Rate of Completion
Time frame: 3 months
Feasibility will be demonstrated if ≥75% of eligible participants complete the post-baseline outcome assessments.
Burden Rate
Time frame: 3 months
Acceptability will be defined as: ≤20% of participants reporting high study burden and ≤10% study withdrawal.
Rate of Activity
Time frame: 3 months
Perceived effectiveness will be defined as ≥70% of participants indicate that study participation motivated them to increase their activity levels.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexi A Wright, MD, MPH principal investigator
Dana-Farber Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitbit and Fitbit + Game + Support from a Teammate in people with Gynecologic Cancer, run by Dana-Farber Cancer Institute at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Enrollment (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023; AzTrials last refreshed its copy on 31 Oct 2026.