SIGNAL:Identifying Behavioral Anomalies Using Smartphones to Improve Cancer Care

Dana-Farber Cancer Institute

Status: Withdrawn

Conditions: Uterine Cancer; Primary Peritoneal Carcinoma; Gynecologic Cancer; Fallopian Tube Cancer; Ovarian Cancer; Cervical Cancer

Treatments: Behavioral: SIGNAL

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04368130

20-246

R21NR018532-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

This is a pilot study of patients with advanced gynecologic cancers and oncology providers from the Dana-Farber Cancer Institute's Gynecologic Oncology Program to explore the feasibility and acceptability of a smartphone-based real-time behavioral anomaly detection system (SIGNAL).

The research study procedures include screening for eligibility and study interventions including smartphone data collection, surveys, and a brief interview once you have completed the study to learn more about your experiences on the study.

Participants will download the adapted Beiwe app for a 6-month period and the investigators will collect passive smartphone sensor data and active PRO data bi-weekly.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

SIGNAL

Experimental group

Description:

Program to explore the feasibility and acceptability of a smartphone-based real-time behavioral anomaly detection system (SIGNAL). Patients will download the adapted Beiwe app onto their smartphones for a 6-month period and investigators will collect passive smartphone sensor data and active PRO data bi-weekly.

Treatment:

Behavioral: SIGNAL