The HOPE Trial:Helping Our Patients Excel



Status:Recruiting
Conditions:Cervical Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:20 - Any
Updated:3/1/2019
Start Date:April 12, 2017
End Date:January 2022
Contact:Alexi A Wright, MD MPH
Email:alexi_wright@dfci.harvard.edu
Phone:617-632-2334

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This research study is evaluating a new smartphone application named the "Helping Our
Patients Excel (HOPE)" app with Fitbit devices. The HOPE app was designed to learn about
improving quality of life

One of the goals of palliative chemotherapy treatments is to make patients feel better by
reducing their symptoms. Sometimes chemotherapy treatments cause side effects and it can be
hard to figure out how to manage these side effects at home, and even when to call the
doctor. Clinicians may also have a hard time monitoring patients' symptoms and activity
levels when they are at home, away from clinic. The HOPE Trial is testing a new smartphone
application—the HOPE app—in women with incurable gynecologic cancers.

It is designed to collect information about study participants' health and behaviors in
between clinic visits and to help participants manage their symptoms at home. It will also
give participants information about their symptoms and side effects for them—and the
investigators encourage the participants to share this information with their doctor, though
the participants are not required to do so if the participant choose to participate in the
study.

The app is being tested with two wearable accelerometers: the Fitbit Zip and the Fitbit
Charge HR. Wearable accelerometers are devices that are worn on the hip or wrist to track a
participant's movement—for example, how many steps the participant walk in a day—or their
heart rate.

This research is being done to improve participants' quality of life. the investigators hope
that the app and wearable accelerometer will help reduce participants' symptoms and increase
their activity. It is also being done to understand participants' experiences while using the
HOPE app and Fitbits in order to see if the investigators can improve the app and to
determine which Fitbit model works best.

Inclusion Criteria:

- Women >20 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 with 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 20 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
We found this trial at
1
site
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Alexi A Wright, MD MPH
Phone: 617-632-2334
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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