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The HOPE Trial:Helping Our Patients Excel

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03022032
Recruitment Status : Recruiting
First Posted : January 16, 2017
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Alexi A. Wright, Dana-Farber Cancer Institute

Brief Summary:
This research study is evaluating a new smartphone application named the "Helping Our Patients Excel (HOPE)" app with Fitbit devices. The HOPE app was designed to learn about improving quality of life

Condition or disease Intervention/treatment Phase
Gynecologic Cancer Device: Fitbit Zip Other: HOPE App Other: Standard of Care Device: Fitbit Charge 2 Not Applicable

Detailed Description:

One of the goals of palliative chemotherapy treatments is to make patients feel better by reducing their symptoms. Sometimes chemotherapy treatments cause side effects and it can be hard to figure out how to manage these side effects at home, and even when to call the doctor. Clinicians may also have a hard time monitoring patients' symptoms and activity levels when they are at home, away from clinic. The HOPE Trial is testing a new smartphone application-the HOPE app-in women with incurable gynecologic cancers.

It is designed to collect information about study participants' health and behaviors in between clinic visits and to help participants manage their symptoms at home. It will also give participants information about their symptoms and side effects for them-and the investigators encourage the participants to share this information with their doctor, though the participants are not required to do so if the participant choose to participate in the study.

The app is being tested with two wearable accelerometers: the Fitbit Zip and the Fitbit Charge HR. Wearable accelerometers are devices that are worn on the hip or wrist to track a participant's movement-for example, how many steps the participant walk in a day-or their heart rate.

This research is being done to improve participants' quality of life. the investigators hope that the app and wearable accelerometer will help reduce participants' symptoms and increase their activity. It is also being done to understand participants' experiences while using the HOPE app and Fitbits in order to see if the investigators can improve the app and to determine which Fitbit model works best.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The HOPE Trial:Helping Our Patients Excel
Actual Study Start Date : April 12, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Experimental: Comparing Steps Collected by Accelerometer
  • 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
Fitbit Zip

Other: HOPE App
HOPE App

Other: Standard of Care
Standard of Care

Device: Fitbit Charge 2
Fitbit Charge 2

Usual care

Stage 2 will consist of arm 2-5 and will enroll 100 patients randomized.

  • Usual care
  • The app will also collect passive data from the smartphone
Other: Standard of Care
Standard of Care

Experimental: Wearable accelerometer
  • 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
Device: Fitbit Charge 2
Fitbit Charge 2

Experimental: Refined smartphone 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
Other: HOPE App
HOPE App

Experimental: Refined smartphone app and accelerometer
  • 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
HOPE App

Device: Fitbit Charge 2
Fitbit Charge 2




Primary Outcome Measures :
  1. 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.

  2. 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).

  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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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.

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women >20 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 with 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 20 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

Information from the National Library of Medicine

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


Contacts
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Contact: Alexi A Wright, MD MPH 617-632-2334 alexi_wright@dfci.harvard.edu

Locations
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United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Alexi A Wright, MD MPH    617-632-2334      
Principal Investigator: Alexi A Wright, MD MPH         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
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Principal Investigator: Alexi A Wright, MD MPH Dana-Farber Cancer Institute
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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: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexi A. Wright, Dana-Farber Cancer Institute:
Gynecologic cancer