Clinical trial · Interventional
The HOPE Trial and the SMART Study
The HOPE Trial: Helping Our Patients Excel, and The SMART Study: Symptom Management and Reporting
NCT03022032CI-TRIAL-00094785completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fitbit Charge 2 | Device | — | UNRESOLVED |
| Fitbit Zip | Device | — | UNRESOLVED |
| HOPE App | Other | — | UNRESOLVED |
| SMART Study Intervention | Other | — | UNRESOLVED |
| Standard of Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Comparing Steps Collected by Accelerometer (HOPE)
- description
- * 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
- interventionNames
- Device: Fitbit Zip
- Other: HOPE App
- Device: Fitbit Charge 2
- type
- OTHER
- label
- Usual care (HOPE)
- description
- 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
- interventionNames
- Other: HOPE App
- Other: Standard of Care
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.