Gynecologic CancerNCT03022032
The HOPE Trial and the SMART Study
A study testing Fitbit Zip, HOPE App and Fitbit Charge 2 in people with Gynecologic Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
This research study is evaluating a new smartphone application named the "Helping Our Patients Excel (HOPE)" app with a Fitbit device. The SMART Study is a sub-study of the HOPE Trial. 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 Zip, HOPE App and Fitbit Charge 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2017to 2 Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women ≥18 years of age
- Who plan to receive chemotherapy at DFCI to treat recurrent, incurable gynecologic cancers (ovarian, uterine, cervical) that have recurred despite ≥1 prior treatments.
- Own a smart-phone (Android or iOS)
- Capable of downloading and running the study app without assistance
- Can read and provide informed consent in English
- Do not have cognitive or visual impairments that would preclude use of the app.
Who cannot join
- Patients will be ineligible if they are participating in an investigational drug treatment trial that requires structured symptom or toxicity reporting at the time of enrollment.
- Patients with severe cognitively impairments
- Who appear too weak
- Emotionally distraught
- Agitated or ill to participate, as judged by either the research study staff or an oncology provider, will be excluded.
- Patients who are unable to provide informed consent in English will be excluded because the smartphone app intervention is only available in English at this time.
- Children and young adults up to age 18 will be excluded because the diagnosis of metastatic gynecologic cancers in this age group is rare and the proposed instruments are not designed for people of those ages.
- Patients with a life expectancy of ≤6 months, as determined by their oncology providers, will be excluded since they cannot participate in all of the required data collection
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: The HOPE Trial: Helping Our Patients Excel, and The SMART Study: Symptom Management and Reporting
This research study is evaluating a new smartphone application named the "Helping Our Patients Excel (HOPE)" app with a Fitbit device. The SMART Study is a sub-study of the HOPE Trial. Both studies evaluate an almost identical intervention using a Fitbit device and smartphone app(s) with the goal of improving quality-of-life for women with gynecologic cancers.
Read the detailed description
The HOPE Trial:
The first goal of this study is to adapt and refine an existing smartphone app, paired with a wearable accelerometer, to assess patients' symptoms in a population of patients with gynecologic cancers receiving palliative chemotherapy. An existing app will be customized to collect patient-reported toxicities using the Patient-Reported Outcome (PRO) version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) and offer patients feedback about how to manage their symptoms. Patient symptoms will be risk-stratified. Patients with low-risk toxicities (grades 1 \& 2) will receive tailored educational information, while patients with serious toxicities (grades 3 \& 4) will receive alerts to call their clinician. In the first phase of the study, we will conduct an initial assessment of the app with a diverse group of 10 patients to refine the app and test two different wearable accelerometers (i.e. Fitbit Zip and Fitbit Charge 2) before pilot testing.
The second goal of this study is to conduct a pilot randomized controlled trial (RCT) of the smartphone app and/or wearable accelerometer (i.e. Fitbit Zip or Fitbit Charge 2) to assess the feasibility, acceptability, and preliminary efficacy of our intervention. During the second phase of the study, we will conduct a 4-arm pilot RCT in 100 patients with gynecologic cancers receiving palliative chemotherapy to establish preliminary effect sizes. Participants will be randomized to: 1) Fitbit+active app, 2) Fitbit+passive app, 3) Active app, or 4) Passive app.
We expect that the results of this pilot RCT, which is supported by the National Cancer Institute, National Palliative Care Research Center, and the Dana-Farber Cancer Institute Department of Medical Oncology, will provide a low-cost, scalable system to assess patients' symptoms, address low-risk toxicities, and alert clinicians when patients have toxicities that require intervention with the goal of reducing patient suffering and the use of high-intensity, hospital-based health care.
The SMART Study:
The overall goals of this study are to test the combination of two smartphone research platforms and a wearable accelerometer for use in NCI Community Oncology Research Program (NCORP) sites to improve cancer patients' quality of life and symptom management. The SMART Study (Symptom Management and Reporting Toxicities) has a single-arm research design and aims to assess the feasibility, acceptability, and perceived efficacy of a wearable accelerometer and two smartphone apps in 30 patients receiving chemotherapy to treat recurrent gynecologic cancers.
- Conditions
- Gynecologic Cancer
- Being tested
- Fitbit Zip, HOPE App, Standard of Care, Fitbit Charge 2, SMART Study Intervention
- Keywords
- Gynecologic cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitbit ZipDevice
Fitbit Zip
HOPE AppOther
HOPE App
Standard of CareOther
Standard of Care
Fitbit Charge 2Device
Fitbit Charge 2
SMART Study InterventionOther
SMART study app + Beiwe study app + Fitbit
| Study group | Role | What they receive |
|---|---|---|
| Comparing Steps Collected by Accelerometer (HOPE) | Experimental | * 10 patients will be enrolled in stage 1 to refine the HOPE App intervention
* All participants will receive :
* HOPE App
* The Fitbit Zip
* The Fitbit Charge 2 The amount of step collected by each device will be compared. This will allow the team to identify which wearable accelerometer to use in stage 2 Receives: Device: Fitbit Zip; Other: HOPE App; Device: Fitbit Charge 2 |
| Usual care (HOPE) | Other | Stage 2 will consist of arm 2-5 and will enroll 100 randomized patients.
* Usual care
* The app will also collect passive data from the smartphone Receives: Other: HOPE App; Other: Standard of Care |
| Wearable accelerometer (HOPE) | Experimental | * Participants will be asked to wear the Fitbit
* The Hope App will measure daily steps
* The app will also collect passive data from the smartphone Receives: Other: HOPE App; Device: Fitbit Charge 2 |
| Refined smartphone app (HOPE) | Experimental | * Participants will be prompted to answer questions about their quality of life and physical health daily
* The HOPE App will present tailored advice to improve symptoms if one or more low-risk toxicities are reported. If the symptoms are determined to be high-risk, the App will prompt the patient to call their clinician.
* The app will also collect passive data from the smartphone Receives: Other: HOPE App |
| Refined smartphone app and accelerometer (HOPE) | Experimental | * Participants will be prompted to answer questions about their quality of life and physical health daily
* The HOPE App will present tailored advice to improve symptoms if one or more low-risk toxicities are reported. If the symptoms are determined to be high-risk, the App will prompt the patient to call their clinician.
Participants will be asked to wear the Fitbit
-The Hope App will measure daily steps The app will also collect passive data from the smartphone Receives: Other: HOPE App |
| SMART Study Arm | Experimental | * Two smartphone apps and a wearable accelerometer (Fitbit) in 30 patients with gynecologic cancers receiving chemotherapy at two NCI Community Oncology sites.
* The SMART intervention refers to the combination of both smartphone apps (SMART app and Beiwe app) and the accelerometer (Fitbit).
* The SMART app is the technology that is actively collecting symptom reporting information from patients (e.g. patients are receiving surveys, recording their symptoms daily, and receiving tailored symptom management materials on their phone in response).
* The Beiwe app is the technology involved in the passive data collection of participants' symptoms (GPS and accelerometer data) without their involvement. Receives: Other: SMART Study Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (≥60% Enrollment Rate of Eligible Patients; ≥70% Survey Adherence; ≥80% FitBit Adherence) and Acceptability (≥60% Would Recommend the Intervention; <30% Rate the Study as Burdensome/Wish They Had Not Participated) in HOPE Pre-Pilot (n=10)
This outcome was limited to the HOPE pre-pilot, consisting of 10 patients. This open pilot aimed to identify patient preference of Fitbit Zip or Fitbit Charge 2 and whether this study was burdensome. This outcome informed appropriate study procedures before launching to a larger study with four arms across multiple sites.
Feasibility defined as (1) greater than or equal to 60% enrollment rate among eligible patients approached, (2) greater than or equal to 70% adherence to daily smartphone surveys, (3) greater than or equal to 80% adherence to Fitbits at least 4 days per week. Acceptability defined as responses to 3 questions: (1) "Participating in this study placed a substantial burden on me." (2) "I wish I had not agreed to participate in this study." and (3) "I would recommend the application to a friend going through treatment."
Measured: 30 days
Number of Participants Who Preferred the FitBit Zip vs. Number of Participants Who Preferred the FitBit Charge HR in the HOPE Pre-Pilot Study (n=10)
This outcome was limited to the HOPE Pre-pilot, consisting of 10 patients. This open pilot aimed to identify patient preference of Fitbit Zip or Fitbit Charge 2 and whether this study was burdensome. This outcome informed appropriate study procedures before launching to a larger study with four arms across multiple sites.
This outcome is participant preference of the Fitbit Zip vs. Fitbit Charge in the HOPE Pre-Pilot study.
Measured: 30 days
Feasibility (i.e. ≥50% 3-month Adherence Rates to Both Smartphone Apps and the Wearable Accelerometer) in the SMART Study
SMART Study: Participants received the Fitbit Charge 2 and access to the smartphone app. The app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms.
Feasibility will be defined as greater than or equal to 50% 3-month adherence rates to both smartphone apps and the wearable accelerometer.
Measured: 90 days
Acceptability (i.e. ≥60% of Study Participants Would Recommend the Intervention to Other Patients; and <30% of Patients Rate the Study as Burdensome or Wish They Had Not Participated) in the SMART Study
SMART Study: Participants received the Fitbit Charge 2 and access to the smartphone app. The app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms.
Acceptability defined as responses to three questions: (1) "Participating in this study placed a substantial burden on me."; (2) "I wish I had not agreed to participate in this study."; and (3) "I would recommend the application to a friend going through treatment."
Measured: 90 days
Secondary outcomes (14)
Anxiety as Assessed by GAD-7 (HOPE RCT)
Patients' GAD-7 measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. [The General Anxiety Disorder-7 (GAD-7) total score has a minimum value of 0 and a maximum value of 21, with higher values corresponding to worse outcome.}
Measured: Baseline, 30 days, 90 days, 180 days (Phase II)
Depression as Assessed by PHQ-9 (HOPE RCT)
Patients' PHQ-9 measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {The Patient Health Questionnaire (PHQ-9) total score has a minimum value of 0 and a maximum value of 27, with higher values corresponding to worse outcome.}
Measured: Baseline, 30 days, 90 days, 180 days (Phase II)
Patient Well-being as Assessed by FACIT-Pal (HOPE RCT)
Patients' FACIT-Pal measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {The Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal) total score has a minimum value of 0 and a maximum value of 184, with higher values corresponding to better outcome.}
Measured: Baseline, 30 days, 90 days, 180 days (Phase II)
Constipation as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Participants reporting Grade 1-3 constipation at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}
Measured: Baseline, 30 days, 90 days, 180 days (Phase II)
Diarrhea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Participants reporting Grade 1-3 diarrhea at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}
Measured: Baseline, 30 days, 90 days, 180 days (Phase II)
Nausea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Participants reporting Grade 1-3 nausea at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}
Measured: Baseline, 30 days, 90 days, 180 days (Phase II)
Vomiting as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Participants reporting Grade 1-3 vomiting at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}
Measured: Baseline, 30 days, 90 days, 180 days (Phase II)
Numbness and Tingling as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Participants reporting Grade 1-3 numbness and tingling at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}
Measured: Baseline, 30 days, 90 days, 180 days (Phase II)
Dizziness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Participants reporting Grade 1-3 dizziness at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}
Measured: Baseline, 30 days, 90 days, 180 days (Phase II)
Abdominal Pain as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Participants reporting Grade 1-3 abdominal pain at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}
Measured: Baseline, 30 days, 90 days, 180 days (Phase II)
Anxiousness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Participants reporting Grade 2-3 anxiousness at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}
Measured: Baseline, 30 days, 90 days, 180 days (Phase II)
Sadness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Participants reporting Grade 2-3 sadness at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}
Measured: Baseline, 30 days, 90 days, 180 days (Phase II)
Fatigue as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Participants reporting Grade 2-3 fatigue at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}
Measured: Baseline, 30 days, 90 days, 180 days (Phase II)
Correlation Between Patient and Physician Estimates of Performance Status as Assessed by ECOG-PS (HOPE RCT)
Patients' and their physicians' ECOG-PS measurements taken at baseline and post-baseline (30 days, 90 days, and 180days) in the HOPE RCT. Weighted Kappa statistics calculated at each timepoint to assess correlation.
Measured: Baseline, 30 days, 90 days, 180 days (Phase II)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study start12 Apr 2017
- Primary completion2 Sep 2020
- Study completion2 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- 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
- NCT03022032
- Sponsor's protocol ID
- 16-477
- Other IDs
- 1R21NR018532
- Status last verified
- Sep 2025
- First submitted
- 6 Jan 2017
- Last updated
- 9 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The HOPE Trial: Helping Our Patients Excel, and The SMART Study: Symptom Management and Reporting
- ClinicalTrials.gov ID
- NCT03022032
- Acronym / sponsor ID
- 16-477
- Conditions
- Gynecologic Cancer
- Keywords
- Gynecologic cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 12 Apr 2017 (actual)
- Primary completion
- 2 Sep 2020 (actual)
- Study completion
- 2 Sep 2020 (actual)
- First posted
- 16 Jan 2017 (estimated)
- Results
- Posted 21 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is evaluating a new smartphone application named the "Helping Our Patients Excel (HOPE)" app with a Fitbit device. The SMART Study is a sub-study of the HOPE Trial. Both studies evaluate an almost identical intervention using a Fitbit device and smartphone app(s) with the goal of improving quality-of-life for women with gynecologic cancers.
Detailed description
The HOPE Trial:
The first goal of this study is to adapt and refine an existing smartphone app, paired with a wearable accelerometer, to assess patients' symptoms in a population of patients with gynecologic cancers receiving palliative chemotherapy. An existing app will be customized to collect patient-reported toxicities using the Patient-Reported Outcome (PRO) version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) and offer patients feedback about how to manage their symptoms. Patient symptoms will be risk-stratified. Patients with low-risk toxicities (grades 1 \& 2) will receive tailored educational information, while patients with serious toxicities (grades 3 \& 4) will receive alerts to call their clinician. In the first phase of the study, we will conduct an initial assessment of the app with a diverse group of 10 patients to refine the app and test two different wearable accelerometers (i.e. Fitbit Zip and Fitbit Charge 2) before pilot testing.
The second goal of this study is to conduct a pilot randomized controlled trial (RCT) of the smartphone app and/or wearable accelerometer (i.e. Fitbit Zip or Fitbit Charge 2) to assess the feasibility, acceptability, and preliminary efficacy of our intervention. During the second phase of the study, we will conduct a 4-arm pilot RCT in 100 patients with gynecologic cancers receiving palliative chemotherapy to establish preliminary effect sizes. Participants will be randomized to: 1) Fitbit+active app, 2) Fitbit+passive app, 3) Active app, or 4) Passive app.
We expect that the results of this pilot RCT, which is supported by the National Cancer Institute, National Palliative Care Research Center, and the Dana-Farber Cancer Institute Department of Medical Oncology, will provide a low-cost, scalable system to assess patients' symptoms, address low-risk toxicities, and alert clinicians when patients have toxicities that require intervention with the goal of reducing patient suffering and the use of high-intensity, hospital-based health care.
The SMART Study:
The overall goals of this study are to test the combination of two smartphone research platforms and a wearable accelerometer for use in NCI Community Oncology Research Program (NCORP) sites to improve cancer patients' quality of life and symptom management. The SMART Study (Symptom Management and Reporting Toxicities) has a single-arm research design and aims to assess the feasibility, acceptability, and perceived efficacy of a wearable accelerometer and two smartphone apps in 30 patients receiving chemotherapy to treat recurrent gynecologic cancers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Comparing Steps Collected by Accelerometer (HOPE) | Experimental | Device: Fitbit Zip, Other: HOPE App, Device: Fitbit Charge 2* 10 patients will be enrolled in stage 1 to refine the HOPE App intervention * All participants will receive : * HOPE App * The Fitbit Zip * The Fitbit Charge 2 The amount of step collected by each device will be compared. This will allow the team to identify which wearable accelerometer to use in stage 2 |
| Usual care (HOPE) | Other | Other: HOPE App, Other: Standard of CareStage 2 will consist of arm 2-5 and will enroll 100 randomized patients. * Usual care * The app will also collect passive data from the smartphone |
| Wearable accelerometer (HOPE) | Experimental | Other: HOPE App, Device: Fitbit Charge 2* Participants will be asked to wear the Fitbit * The Hope App will measure daily steps * The app will also collect passive data from the smartphone |
| Refined smartphone app (HOPE) | Experimental | Other: HOPE App* Participants will be prompted to answer questions about their quality of life and physical health daily * The HOPE App will present tailored advice to improve symptoms if one or more low-risk toxicities are reported. If the symptoms are determined to be high-risk, the App will prompt the patient to call their clinician. * The app will also collect passive data from the smartphone |
| Refined smartphone app and accelerometer (HOPE) | Experimental | Other: HOPE App* Participants will be prompted to answer questions about their quality of life and physical health daily * The HOPE App will present tailored advice to improve symptoms if one or more low-risk toxicities are reported. If the symptoms are determined to be high-risk, the App will prompt the patient to call their clinician. Participants will be asked to wear the Fitbit -The Hope App will measure daily steps The app will also collect passive data from the smartphone |
| SMART Study Arm | Experimental | Other: SMART Study Intervention* Two smartphone apps and a wearable accelerometer (Fitbit) in 30 patients with gynecologic cancers receiving chemotherapy at two NCI Community Oncology sites. * The SMART intervention refers to the combination of both smartphone apps (SMART app and Beiwe app) and the accelerometer (Fitbit). * The SMART app is the technology that is actively collecting symptom reporting information from patients (e.g. patients are receiving surveys, recording their symptoms daily, and receiving tailored symptom management materials on their phone in response). * The Beiwe app is the technology involved in the passive data collection of participants' symptoms (GPS and accelerometer data) without their involvement. |
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)
- Women ≥18 years of age
- Who plan to receive chemotherapy at DFCI to treat recurrent, incurable gynecologic cancers (ovarian, uterine, cervical) that have recurred despite ≥1 prior treatments.
- Own a smart-phone (Android or iOS)
- Capable of downloading and running the study app without assistance
- Can read and provide informed consent in English
Key exclusion criteria (8 listed)
- Patients will be ineligible if they are participating in an investigational drug treatment trial that requires structured symptom or toxicity reporting at the time of enrollment.
- Patients with severe cognitively impairments
- Who appear too weak
- Emotionally distraught
- Agitated or ill to participate, as judged by either the research study staff or an oncology provider, will be excluded.
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 |
|---|---|---|
| Fitbit ZipFitbit Zip | Device | Comparing Steps Collected by Accelerometer (HOPE) |
| HOPE AppHOPE App | Other | Comparing Steps Collected by Accelerometer (HOPE), Refined smartphone app (HOPE), Refined smartphone app and accelerometer (HOPE), Usual care (HOPE), Wearable accelerometer (HOPE) |
| Standard of CareStandard of Care | Other | Usual care (HOPE) |
| Fitbit Charge 2Fitbit Charge 2 | Device | Comparing Steps Collected by Accelerometer (HOPE), Wearable accelerometer (HOPE) |
| SMART Study InterventionSMART study app + Beiwe study app + Fitbit | Other | SMART Study Arm |
Primary outcome
Feasibility (≥60% Enrollment Rate of Eligible Patients; ≥70% Survey Adherence; ≥80% FitBit Adherence) and Acceptability (≥60% Would Recommend the Intervention; <30% Rate the Study as Burdensome/Wish They Had Not Participated) in HOPE Pre-Pilot (n=10)
Time frame: 30 days
This outcome was limited to the HOPE pre-pilot, consisting of 10 patients. This open pilot aimed to identify patient preference of Fitbit Zip or Fitbit Charge 2 and whether this study was burdensome. This outcome informed appropriate study procedures before launching to a larger study with four arms across multiple sites. Feasibility defined as (1) greater than or equal to 60% enrollment rate among eligible patients approached, (2) greater than or equal to 70% adherence to daily smartphone surveys, (3) greater than or equal to 80% adherence to Fitbits at least 4 days per week. Acceptability defined as responses to 3 questions: (1) "Participating in this study placed a substantial burden on me." (2) "I wish I had not agreed to participate in this study." and (3) "I would recommend the application to a friend going through treatment."
Number of Participants Who Preferred the FitBit Zip vs. Number of Participants Who Preferred the FitBit Charge HR in the HOPE Pre-Pilot Study (n=10)
Time frame: 30 days
This outcome was limited to the HOPE Pre-pilot, consisting of 10 patients. This open pilot aimed to identify patient preference of Fitbit Zip or Fitbit Charge 2 and whether this study was burdensome. This outcome informed appropriate study procedures before launching to a larger study with four arms across multiple sites. This outcome is participant preference of the Fitbit Zip vs. Fitbit Charge in the HOPE Pre-Pilot study.
Feasibility (i.e. ≥50% 3-month Adherence Rates to Both Smartphone Apps and the Wearable Accelerometer) in the SMART Study
Time frame: 90 days
SMART Study: Participants received the Fitbit Charge 2 and access to the smartphone app. The app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms. Feasibility will be defined as greater than or equal to 50% 3-month adherence rates to both smartphone apps and the wearable accelerometer.
Acceptability (i.e. ≥60% of Study Participants Would Recommend the Intervention to Other Patients; and <30% of Patients Rate the Study as Burdensome or Wish They Had Not Participated) in the SMART Study
Time frame: 90 days
SMART Study: Participants received the Fitbit Charge 2 and access to the smartphone app. The app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms. Acceptability defined as responses to three questions: (1) "Participating in this study placed a substantial burden on me."; (2) "I wish I had not agreed to participate in this study."; and (3) "I would recommend the application to a friend going through treatment."
14 secondary outcomes
Anxiety as Assessed by GAD-7 (HOPE RCT)
Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)
Depression as Assessed by PHQ-9 (HOPE RCT)
Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)
Patient Well-being as Assessed by FACIT-Pal (HOPE RCT)
Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)
Constipation as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)
Diarrhea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)
Nausea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)
Vomiting as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)
Numbness and Tingling as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)
Dizziness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)
Abdominal Pain as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)
Anxiousness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)
Sadness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)
Fatigue as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)
Correlation Between Patient and Physician Estimates of Performance Status as Assessed by ECOG-PS (HOPE RCT)
Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitbit Zip, HOPE App and Fitbit Charge 2 in people with Gynecologic Cancer, run by Dana-Farber Cancer Institute at 1 site 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 8 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 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 21 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility (≥60% Enrollment Rate of Eligible Patients; ≥70% Survey Adherence; ≥80% FitBit Adherence) and Acceptability (≥60% Would Recommend the Intervention; <30% Rate the Study as Burdensome/Wish They Had Not Participated) in HOPE Pre-Pilot (n=10) (time frame: 30 days). 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 9 Sep 2025.