Clinical trial NCT04368130: SIGNAL:Identifying Behavioral Anomalies Using Smartphones to Improve Cancer Care
Official title: SIGNAL:Identifying Behavioral Anomalies Using Smartphones to Improve Cancer Care
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Carcinoma
Uterine Cancer
Cervical Cancer
Gynecologic Cancer
Keywords: Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Carcinoma
Uterine Cancer
Cervical Cancer
Gynecologic Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2020-04-29
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Rate of enrollment
timeFrame: 6 Months
measure: Rate of completion
timeFrame: 6 Months
measure: Burden rate
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Alexi A. Wright, MD
role: PRINCIPAL_INVESTIGATOR
References: