SIGNAL:Identifying Behavioral Anomalies Using Smartphones to Improve Cancer Care

Ovarian Cancer Clinical Trial

— SIGNAL  

Official title:

SIGNAL:Identifying Behavioral Anomalies Using Smartphones to Improve Cancer Care

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04368130
• Other study ID #: 20-246
• Secondary ID: R21NR018532-02
• Status: Withdrawn
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: October 2022
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Gynecologic Cancer
• Ovarian Cancer
• Ovarian Neoplasms
• Primary Peritoneal Carcinoma
• Uterine Cancer
• Uterine Cervical Neoplasms
• Uterine Neoplasms

Intervention

Behavioral:
• SIGNAL
SIGNAL is a smartphone-based mobile health intervention designed to improve important outcomes in cancer patient patients (e.g., symptom burden, physical functioning). Patients will download the adapted Beiwe app for a 6-month period and investigators will collect passive smartphone sensor data and active PRO data bi-weekly.

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of enrollment	Feasibility will be demonstrated if =50% of eligible participants enroll	6 Months
Primary	Rate of completion	Feasibility will be demonstrated if =50% of eligible participants adhere to the smartphone app	6 Months
Primary	Burden rate	Acceptability will be defined as: <30% of patients rate the study as burdensome.	6 Months