N/A
Completed N=102
The HOPE Trial and the SMART Study
Source: ClinicalTrials.gov NCT03022032 ↗Enrolled (actual)
102
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcomePrimary: 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) — 10; 7; 9; 1 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
10; 7; 9; 1; 1 | — |
| PRIMARY 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) |
9; 1 | — |
| PRIMARY Feasibility (i.e. ≥50% 3-month Adherence Rates to Both Smartphone Apps and the Wearable Accelerometer) in the SMART Study |
4 | — |
| PRIMARY 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 |
0; 0; 4 | — |
| SECONDARY Anxiety as Assessed by GAD-7 (HOPE RCT) |
3.43; 3.74; 5.45; 4.10; 3.17; 5.09 | — |
| SECONDARY Depression as Assessed by PHQ-9 (HOPE RCT) |
4.43; 3.70; 4.95; 5.59; 3.20; 4.58 | — |
| SECONDARY Patient Well-being as Assessed by FACIT-Pal (HOPE RCT) |
142.1; 147.0; 139.7; 139.4; 150.7; 145.7 | — |
| SECONDARY Constipation as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). |
10; 6; 10; 11; 5; 2 | — |
| SECONDARY Diarrhea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). |
10; 8; 7; 11; 5; 3 | — |
| SECONDARY Nausea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). |
12; 7; 11; 12; 7; 4 | — |
| SECONDARY Vomiting as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). |
2; 1; 4; 5; 2; 0 | — |
| SECONDARY Numbness and Tingling as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). |
10; 14; 11; 15; 8; 10 | — |
| SECONDARY Dizziness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). |
6; 5; 3; 7; 5; 0 | — |
| SECONDARY Abdominal Pain as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). |
12; 8; 10; 16; 5; 3 | — |
| SECONDARY Anxiousness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). |
7; 7; 7; 7; 4; 2 | — |
| SECONDARY Sadness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). |
5; 3; 7; 3; 3; 1 | — |
| SECONDARY Fatigue as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). |
7; 7; 12; 15; 3; 4 | — |
| SECONDARY Correlation Between Patient and Physician Estimates of Performance Status as Assessed by ECOG-PS (HOPE RCT) |
0.70; 0.48; 0.35; 0.39; 0.24; 0.59 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03022032). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.