The HOPE Trial and the SMART Study

Dana-Farber Cancer Institute

Status: Completed

Conditions: Gynecologic Cancer

Treatments: Device: Fitbit Charge 2; Other: HOPE App; Other: SMART Study Intervention; Device: Fitbit Zip; Other: Standard of Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03022032

1R21NR018532 (U.S. NIH Grant/Contract)

16-477

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 6 patient groups

Comparing Steps Collected by Accelerometer (HOPE)

Experimental group

Description:

* 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

Treatment:

Device: Fitbit Zip

Other: HOPE App

Device: Fitbit Charge 2

Usual care (HOPE)

Other group

Description:

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

Treatment:

Other: Standard of Care

Other: HOPE App

Wearable accelerometer (HOPE)

Experimental group

Description:

* 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

Treatment:

Other: HOPE App

Device: Fitbit Charge 2

Refined smartphone app (HOPE)

Experimental group

Description:

* 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

Treatment:

Other: HOPE App

Refined smartphone app and accelerometer (HOPE)

Experimental group

Description:

* 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

Treatment:

Other: HOPE App

SMART Study Arm

Experimental group

Description:

* 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.

Treatment:

Other: SMART Study Intervention