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NCT Number: NCT03022032

The HOPE Trial and the SMART Study

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.

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Key information

Conditions

Gynecologic Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fitbit Zip

Device

Fitbit Zip

HOPE App

Other

HOPE App

Standard of care

Other

Standard of Care

Fitbit Charge 2

Device

Fitbit Charge 2

SMART Study Intervention

Other

SMART study app + Beiwe study app + Fitbit

Primary outcomes

  1. 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)

    Time frame: 30 days

    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."

  2. 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)

    Time frame: 30 days

    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.

  3. Feasibility (i.e. ≥50% 3-month Adherence Rates to Both Smartphone Apps and the Wearable Accelerometer) in the SMART Study

    Time frame: 90 days

    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.

  4. 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

    Time frame: 90 days

    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."

Secondary outcomes

  1. Anxiety as Assessed by GAD-7 (HOPE RCT)

    Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)

    Patients' GAD-7 measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. [The General Anxiety Disorder-7 (GAD-7) total score has a minimum value of 0 and a maximum value of 21, with higher values corresponding to worse outcome.}

  2. Depression as Assessed by PHQ-9 (HOPE RCT)

    Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)

    Patients' PHQ-9 measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {The Patient Health Questionnaire (PHQ-9) total score has a minimum value of 0 and a maximum value of 27, with higher values corresponding to worse outcome.}

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

    Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)

    Patients' FACIT-Pal measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {The Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal) total score has a minimum value of 0 and a maximum value of 184, with higher values corresponding to better outcome.}

  4. Constipation as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

    Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)

    Participants reporting Grade 1-3 constipation at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}

  5. Diarrhea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

    Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)

    Participants reporting Grade 1-3 diarrhea at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}

  6. Nausea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

    Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)

    Participants reporting Grade 1-3 nausea at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}

  7. Vomiting as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

    Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)

    Participants reporting Grade 1-3 vomiting at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}

  8. Numbness and Tingling as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

    Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)

    Participants reporting Grade 1-3 numbness and tingling at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}

  9. Dizziness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

    Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)

    Participants reporting Grade 1-3 dizziness at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}

  10. Abdominal Pain as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

    Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)

    Participants reporting Grade 1-3 abdominal pain at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}

  11. Anxiousness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

    Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)

    Participants reporting Grade 2-3 anxiousness at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}

  12. Sadness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

    Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)

    Participants reporting Grade 2-3 sadness at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}

  13. Fatigue as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

    Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)

    Participants reporting Grade 2-3 fatigue at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}

  14. Correlation Between Patient and Physician Estimates of Performance Status as Assessed by ECOG-PS (HOPE RCT)

    Time frame: Baseline, 30 days, 90 days, 180 days (Phase II)

    Patients' and their physicians' ECOG-PS measurements taken at baseline and post-baseline (30 days, 90 days, and 180days) in the HOPE RCT. Weighted Kappa statistics calculated at each timepoint to assess correlation.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 16, 2017
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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