App and Fitbit for Gynecologic Cancers

Overseen By Alexi A Wright, MD MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Severe cognitive impairments, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

102 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Alexi A. Wright

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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.

Inclusion Criteria

I am a woman over 18 with recurrent gynecologic cancer planning to receive chemotherapy.

Capable of downloading and running the study app without assistance

Own a smart-phone (Android or iOS)

Exclusion Criteria

I am currently in a drug trial that needs me to report symptoms or side effects.

Patients with severe cognitive impairments

Patients who appear too weak, emotionally distraught, agitated, or ill to participate, as judged by either the research study staff or an oncology provider

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment

Initial assessment of the app with a diverse group of 10 patients to refine the app and test two different wearable accelerometers

4 weeks

Pilot Randomized Controlled Trial

Conduct a 4-arm pilot RCT in 100 patients with gynecologic cancers receiving palliative chemotherapy to establish preliminary effect sizes

90 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Fitbit Charge 2
• Fitbit Zip
• HOPE App
• SMART Study Intervention

Trial Overview 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.

Participant Groups

Group I: Wearable accelerometer (HOPE) Experimental Treatment 2 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 Treatment 2 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 Arm Experimental Treatment 1 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 Treatment 1 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 Treatment 1 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 Treatment 3 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

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+