The HOPE Trial and the SMART Study
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ClinicalTrials.gov Identifier: NCT03022032 |
Recruitment Status :
Active, not recruiting
First Posted : January 16, 2017
Last Update Posted : March 29, 2022
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Condition or disease | Intervention/treatment | Phase |
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Gynecologic Cancer | Device: Fitbit Zip Other: HOPE App Other: Standard of Care Device: Fitbit Charge 2 Other: SMART Study Intervention | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 140 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | The HOPE Trial: Helping Our Patients Excel, and The SMART Study: Symptom Management and Reporting |
Actual Study Start Date : | April 12, 2017 |
Actual Primary Completion Date : | January 4, 2022 |
Estimated Study Completion Date : | January 31, 2023 |
Arm | Intervention/treatment |
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Experimental: Comparing Steps Collected by Accelerometer (HOPE)
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Device: Fitbit Zip
Fitbit Zip Other: HOPE App HOPE App Device: Fitbit Charge 2 Fitbit Charge 2 |
Usual care (HOPE)
Stage 2 will consist of arm 2-5 and will enroll 100 randomized patients.
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Other: HOPE App
HOPE App Other: Standard of Care Standard of Care |
Experimental: Wearable accelerometer (HOPE)
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Other: HOPE App
HOPE App Device: Fitbit Charge 2 Fitbit Charge 2 |
Experimental: Refined smartphone app (HOPE)
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Other: HOPE App
HOPE App |
Experimental: Refined smartphone app and accelerometer (HOPE)
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 |
Other: HOPE App
HOPE App |
Experimental: SMART Study Arm
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Other: SMART Study Intervention
SMART study app + Beiwe study app + Fitbit |
- Feasibility and acceptability of the HOPE app and the wearable accelerometers [ Time Frame: 2 years ]In phase I, qualitative post-baseline surveys assessing participant experiences with HOPE study, HOPE app, Fitbits. In both phases: quantity of relevant missing data and data quality from HOPE app, Fitbits, and study instruments. Correlations of HOPE app and wearable accelerometer data with clinical outcomes as expanded upon below.
- Comparison of two wearable accelerometers (Fitbit Zip and Fitbit Charge HR) for use in pilot RCT. [ Time Frame: 2 Years ]Correlations of step counts and other accelerometer data with clinical outcomes (ECOG-PS and patient-reported quality of life and physical health as measured by the PROMIS Global-10 items 2 and 3).
- Change from baseline in health-related quality of life (comparing patient-reported baseline and post-baseline EuroQoL EQ-5D). [ Time Frame: Phase 1: 1 month, Phase 2: 6 months ]
- SMART Enrollment and Adherence Rate [ Time Frame: 3-months ]Feasibility will be defined as ≥50% approach to enroll rate, and ≥50% 3-month adherence rates to both smartphone apps and the wearable accelerometer.
- SMART Intervention Recommendation and Participant Burden [ Time Frame: 3-months ]Acceptability will be defined as: ≥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.
- Correlations between data collected from the HOPE app and the wearable accelerometers with additional clinical outcomes: PRO-CTCAE, CTCAE, and EQ-5D-5L [ Time Frame: Phase 1: 1 month, Phase 2: 6 months ]
- Health care utilization (medical chart abstractions to capture number of ER visits, hospital/ICU admissions, palliative care visits, hospice referrals, chemotherapy treatments, change in chemotherapy treatments) [ Time Frame: Phase 1: 1 month, Phase 2: 6 months ]
- Correlation between patient and physician estimates of performance status as assessed by ECOG-PS [ Time Frame: Phase 1: 1 month, Phase 2: 6 months ]Patients' and their physicians' ECOG-PS measurements taken at baseline and post-baseline.
- Anxiety as assessed by GAD-7 [ Time Frame: Phase 1: 1 month, Phase 2: 6 months ]Patients' GAD-7 measurements taken at baseline and post-baseline
- Depression as assessed by PHQ-9 [ Time Frame: Phase 1: 1 month, Phase 2: 6 months ]Patients' PHQ-9 measurements taken at baseline and post-baseline.
- Patient well-being as assessed by FACT-O [ Time Frame: Phase 1: 1 month, Phase 2: 6 months ]Patients' FACT-O measurements taken at baseline and post-baseline.
- Patient symptoms (reported by patients) as assessed by PRO-CTCAE [ Time Frame: Phase 1: 1 month, Phase 2: 6 months ]Patients' PRO-CTCAE measurements (reported by patients) taken at baseline and post-baseline.
- Patient symptoms (reported by physicians) as assessed by CTCAE [ Time Frame: Phase 1: 1 month, Phase 2: 6 months ]Patients' CTCAE measurements (reported by physicians) taken at baseline and post-baseline.
- Emotional acceptance of terminal illness as assessed by PEACE [ Time Frame: Phase 1: 1 month, Phase 2: 6 months ]Patients' PEACE measurements taken at baseline and post-baseline.
- Treatment preferences and goals as assessed by qualitative survey [ Time Frame: Phase 1: 1 month, Phase 2: 6 months ]Qualitative survey measurement of treatment preferences and goals, including 1 quantitative item adapted from LA Women's Health Study addressing patient perceived impact of chemotherapy. Scores taken at baseline and post-baseline.
- Participant evaluation of health as assessed by PEH [ Time Frame: Phase 1: 1 month, Phase 2: 6 months ]Patients' scores on PEH scale taken at baseline and post-baseline.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03022032
United States, Massachusetts | |
Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Alexi A Wright, MD MPH | Dana-Farber Cancer Institute |
Responsible Party: | Alexi A. Wright, Alexi. A Wright, MD, MPH, Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT03022032 |
Other Study ID Numbers: |
16-477 CA166210 ( Other Grant/Funding Number: NCI ) |
First Posted: | January 16, 2017 Key Record Dates |
Last Update Posted: | March 29, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Gynecologic cancer |