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The HOPE Trial and the SMART Study

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ClinicalTrials.gov Identifier: NCT03022032
Recruitment Status : Recruiting
First Posted : January 16, 2017
Last Update Posted : April 15, 2021
Sponsor:
Information provided by (Responsible Party):
Alexi A. Wright, Dana-Farber Cancer Institute

Tracking Information
First Submitted Date  ICMJE January 6, 2017
First Posted Date  ICMJE January 16, 2017
Last Update Posted Date April 15, 2021
Actual Study Start Date  ICMJE April 12, 2017
Estimated Primary Completion Date January 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2021)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 12, 2017)
  • 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The HOPE Trial and the SMART Study
Official Title  ICMJE The HOPE Trial: Helping Our Patients Excel, and The SMART Study: Symptom Management and Reporting
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.
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Gynecologic Cancer
Intervention  ICMJE
  • Device: Fitbit Zip
    Fitbit Zip
  • Other: HOPE App
    HOPE App
  • Other: Standard of Care
    Standard of Care
  • Device: Fitbit Charge 2
    Fitbit Charge 2
  • Other: SMART Study Intervention
    SMART study app + Beiwe study app + Fitbit
Study Arms  ICMJE
  • Experimental: Comparing Steps Collected by Accelerometer (HOPE)
    • 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
    Interventions:
    • Device: Fitbit Zip
    • Other: HOPE App
    • Device: Fitbit Charge 2
  • Usual care (HOPE)

    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
    Interventions:
    • Other: HOPE App
    • Other: Standard of Care
  • Experimental: Wearable 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
    Interventions:
    • Other: HOPE App
    • Device: Fitbit Charge 2
  • Experimental: Refined smartphone app (HOPE)
    • 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
    Intervention: Other: HOPE App
  • Experimental: Refined smartphone app and accelerometer (HOPE)
    • 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

    Intervention: Other: HOPE App
  • Experimental: SMART Study Arm
    • 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.
    Intervention: Other: SMART Study Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 29, 2021)
140
Original Estimated Enrollment  ICMJE
 (submitted: January 12, 2017)
110
Estimated Study Completion Date  ICMJE January 31, 2022
Estimated Primary Completion Date January 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alexi A Wright, MD MPH 617-632-2334 alexi_wright@dfci.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03022032
Other Study ID Numbers  ICMJE 16-477
CA166210 ( Other Grant/Funding Number: NCI )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Alexi A. Wright, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alexi A Wright, MD MPH Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP