SIGNAL: Identifying Behavioral Anomalies Using Smartphones to Improve Cancer Care

NOT ENROLLING
Protocol # :
20-246
Conditions
Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Carcinoma
Uterine Cancer
Cervical Cancer
Gynecologic Cancer
Phase
Feasibility / Pilot
Disease Sites
Soft Tissue
Cervix
Corpus Uteri
Ovary
Principal Investigator
Wright, Alexi, A

Trial Description

This research study is testing the use of a smartphone app to identify clinically meaningful
changes in the behaviors of patients' with gynecological cancers by using passively collected
smartphone data.

Eligibility Requirements

Inclusion Criteria:

- Women >18 years of age with newly diagnosed ovarian cancer (i.e. prior to completion
of cytoreductive surgery-whether primary or interval cytoreductive surgery).

- Own a smartphone (Android or iOS).

- Capable of downloading and running the study apps.

- 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 cognitive impairments or 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 is only available in English at this time.

- Children and young adults up to age 17 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.

20-246