The HOPE Trial and the SMART Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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The HOPE Trial: Helping Our Patients Excel, and The SMART Study: Symptom Management and Reporting

Conditions
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Gynecologic Cancer

Intervention / Treatment
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* Device: Fitbit Zip
* Other: HOPE App
* Other: Standard of Care
* Device: Fitbit Charge 2
* Other: SMART Study Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Comparing Steps Collected by Accelerometer (HOPE)<br>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 | Device: Fitbit Zip<br>* Fitbit Zip<br>Other: HOPE App<br>* HOPE App<br>Device: Fitbit Charge 2<br>* Fitbit Charge 2<br>|
| Other: Usual care (HOPE)<br>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 | Other: HOPE App<br>* HOPE App<br>Other: Standard of Care<br>* Standard of Care<br>|
| Experimental: Wearable accelerometer (HOPE)<br>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<br>* HOPE App<br>Device: Fitbit Charge 2<br>* Fitbit Charge 2<br>|
| Experimental: Refined smartphone app (HOPE)<br>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 | Other: HOPE App<br>* HOPE App<br>|
| Experimental: Refined smartphone app and accelerometer (HOPE)<br>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 | Other: HOPE App<br>* HOPE App<br>|
| Experimental: SMART Study Arm<br>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. | Other: SMART Study Intervention<br>* SMART study app + Beiwe study app + Fitbit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline, 30 days, 90 days, 180 days (Phase II) | 
| Patient Well-being as Assessed by FACT-O (HOPE RCT) | Patients' FACT-O measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. | Baseline, 30 days, 90 days, 180 days (Phase II) | 
| Patient Symptoms (Reported by Patients) as Assessed by PRO-CTCAE (HOPE RCT) | Patients' PRO-CTCAE measurements (reported by patients) taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. | 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 180 days) in the HOPE RCT. | Baseline, 30 days, 90 days, 180 days (Phase II) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gynecologic cancer