SIGNAL:Identifying Behavioral Anomalies Using Smartphones to Improve Cancer Care

NCT04368130 | Withdrawn

• 2 other identifiers: 20-246R21NR018532-02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• Rate of enrollment

  Feasibility will be demonstrated if ≥50% of eligible participants enroll

  6 Months

• Rate of completion

  Feasibility will be demonstrated if ≥50% of eligible participants adhere to the smartphone app

  6 Months

• Burden rate

  Acceptability will be defined as: \<30% of patients rate the study as burdensome.

  6 Months

Study Arms (1)

SIGNAL

EXPERIMENTAL

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.

Behavioral: SIGNAL

Interventions

SIGNAL BEHAVIORAL

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.

SIGNAL

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms; Uterine Neoplasms; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases; Uterine Diseases; Uterine Cervical Diseases

Study Officials

• Alexi A. Wright, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: April 29, 2020
• Study Start: September 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: October 14, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (1)