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SMART Study Intervention for Gynecologic Cancers

N/A
Waitlist Available
Led By Alexi A Wright, MD MPH
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Do not have cognitive or visual impairments that would preclude use of the app.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 30 days, 90 days, 180 days (phase ii)
Awards & highlights

Study Summary

This trial is testing a new app and Fitbit device to see if it can improve quality of life for women with gynecologic cancers.

Who is the study for?
The HOPE Trial and SMART Study are for women over 18 with recurrent gynecologic cancers planning to receive chemotherapy. Participants must own a smartphone, be able to use the study app without help, and read English. Excluded are those with severe cognitive issues or participating in other drug trials requiring symptom reporting.Check my eligibility
What is being tested?
These studies test a 'Helping Our Patients Excel (HOPE)' app alongside a Fitbit device aiming to enhance life quality for women with gynecologic cancers. The intervention involves using these technologies together during their treatment process.See study design
What are the potential side effects?
Since this trial focuses on technology and apps rather than medication, traditional side effects like nausea or headaches aren't expected. However, participants may experience discomfort from wearing the Fitbit or stress if technical issues arise.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman over 18 with recurrent gynecologic cancer planning to receive chemotherapy.
Select...
I can use an app without issues related to thinking or seeing.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 30 days, 90 days, 180 days (phase ii)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 30 days, 90 days, 180 days (phase ii) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Feasibility (i.e. ≥50% 3-month Adherence Rates to Both Smartphone Apps and the Wearable Accelerometer) in the SMART Study
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)
+1 more
Secondary outcome measures
Anxiety as Assessed by GAD-7 (HOPE RCT)
Correlation Between Patient and Physician Estimates of Performance Status as Assessed by ECOG-PS (HOPE RCT)
Depression as Assessed by PHQ-9 (HOPE RCT)
+2 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Wearable accelerometer (HOPE)Experimental Treatment2 Interventions
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
Group II: Usual care (HOPE)Experimental Treatment2 Interventions
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
Group III: SMART Study ArmExperimental Treatment1 Intervention
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.
Group IV: Refined smartphone app and accelerometer (HOPE)Experimental Treatment1 Intervention
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
Group V: Refined smartphone app (HOPE)Experimental Treatment1 Intervention
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
Group VI: Comparing Steps Collected by Accelerometer (HOPE)Experimental Treatment3 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fitbit Zip
2016
N/A
~40
Fitbit Charge 2
2019
N/A
~90

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,846 Total Patients Enrolled
7 Trials studying Gynecologic Cancers
26,001 Patients Enrolled for Gynecologic Cancers
National Institute of Nursing Research (NINR)NIH
580 Previous Clinical Trials
10,376,462 Total Patients Enrolled
1 Trials studying Gynecologic Cancers
Alexi A Wright, MD MPHPrincipal InvestigatorDana-Farber Cancer Institute

Media Library

HOPE App Clinical Trial Eligibility Overview. Trial Name: NCT03022032 — N/A
Gynecologic Cancers Research Study Groups: Usual care (HOPE), Refined smartphone app (HOPE), SMART Study Arm, Refined smartphone app and accelerometer (HOPE), Wearable accelerometer (HOPE), Comparing Steps Collected by Accelerometer (HOPE)
Gynecologic Cancers Clinical Trial 2023: HOPE App Highlights & Side Effects. Trial Name: NCT03022032 — N/A
HOPE App 2023 Treatment Timeline for Medical Study. Trial Name: NCT03022032 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the eligibility window still available for potential participants?

"Clinicaltrials.gov has reported that this clinical study, first posted in April 2017 and last updated on March 28th 2022, is no longer recruiting participants. However, there are currently 72 other trials actively enrolling patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
The HOPE Trial and the SMART Study
Alexi A. Wright, MD 2017. "The HOPE Trial and the SMART Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03022032.
~13 spots leftby Apr 2025
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