The HOPE Trial and the SMART Study

NCT03022032 | Completed Results DMC

• 2 other identifiers: 16-4771R21NR018532
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Gynecologic Cancer

Keywords

Gynecologic cancer

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (14)

• Anxiety as Assessed by GAD-7 (HOPE RCT)

  Baseline, 30 days, 90 days, 180 days (Phase II)

• Depression as Assessed by PHQ-9 (HOPE RCT)

  Baseline, 30 days, 90 days, 180 days (Phase II)

• Patient Well-being as Assessed by FACIT-Pal (HOPE RCT)

  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).

  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).

  Baseline, 30 days, 90 days, 180 days (Phase II)

Study Arms (6)

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

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

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

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

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

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.

Other: SMART Study Intervention

Interventions

Fitbit Zip DEVICE

Fitbit Zip

Comparing Steps Collected by Accelerometer (HOPE)

HOPE App OTHER

HOPE App

Comparing Steps Collected by Accelerometer (HOPE); Refined smartphone app (HOPE); Refined smartphone app and accelerometer (HOPE); Usual care (HOPE); Wearable accelerometer (HOPE)

Standard of Care OTHER

Standard of Care

Usual care (HOPE)

Fitbit Charge 2 DEVICE

Fitbit Charge 2

Comparing Steps Collected by Accelerometer (HOPE); Wearable accelerometer (HOPE)

SMART Study Intervention OTHER

SMART study app + Beiwe study app + Fitbit

SMART Study Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr. Alexi Wright
• Organization: Dana-Farber Cancer Institute

alexi_wright@dfci.harvard.edu

617-632-2334

Study Officials

• Alexi A Wright, MD MPH

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Alexi. A Wright, MD, MPH

Study Record Dates

• First Submitted: January 6, 2017
• First Posted: January 16, 2017
• Study Start: April 12, 2017
• Primary Completion: September 2, 2020
• Study Completion: September 2, 2020
• Last Updated: September 9, 2025
• Results First Posted: April 21, 2023

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)