SIGNAL:Identifying Behavioral Anomalies Using Smartphones to Improve Cancer Care (SIGNAL)

• ClinicalTrials.gov Identifier: NCT04368130
• Recruitment Status: Withdrawn
• First Posted: April 29, 2020
• Last Update Posted: October 14, 2022
• Sponsor: Dana-Farber Cancer Institute
• Collaborator: National Institute of Nursing Research (NINR)
• Information provided by (Responsible Party): Alexi A. Wright, Dana-Farber Cancer Institute

Tracking Information

• First Submitted Date: April 27, 2020
• First Posted Date: April 29, 2020
• Last Update Posted Date: October 14, 2022
• Estimated Study Start Date: September 1, 2022
• Estimated Primary Completion Date: September 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 5, 2020)

• Rate of enrollment [ Time Frame: 6 Months ]
  Feasibility will be demonstrated if ≥50% of eligible participants enroll
• Rate of completion [ Time Frame: 6 Months ]
  Feasibility will be demonstrated if ≥50% of eligible participants adhere to the smartphone app
• Burden rate [ Time Frame: 6 Months ]
  Acceptability will be defined as: <30% of patients rate the study as burdensome.

Original Primary Outcome Measures (submitted: April 27, 2020)

• Rate of enrollment [ Time Frame: 6 Months ]
  Feasibility will be demonstrated if ≥50% of eligible participants enroll
• Rate of completion [ Time Frame: 6 Months ]
  Feasibility will be demonstrated if ≥50% of eligible participants adhere to the smartphone app
• Intervention Satisfaction [ Time Frame: 6 Months ]
  Acceptability will be defined as: ≥60% of study participants would recommend the intervention to other patients
• Burden Rate [ Time Frame: 6 Months ]
  Acceptability will be defined as: <30% of patients rate the study as burdensome.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: SIGNAL:Identifying Behavioral Anomalies Using Smartphones to Improve Cancer Care
• Official Title: SIGNAL:Identifying Behavioral Anomalies Using Smartphones to Improve Cancer 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

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

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.

Study Arms

Experimental: SIGNAL

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.

Intervention: Behavioral: SIGNAL

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: June 21, 2022): 0
• Original Estimated Enrollment (submitted: April 27, 2020): 20
• Estimated Study Completion Date: September 1, 2023
• Estimated Primary Completion Date: September 1, 2023 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04368130
• Other Study ID Numbers: 20-246; R21NR018532-02 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (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

• Current Responsible Party: Alexi A. Wright, Dana-Farber Cancer Institute
• Original Responsible Party: Same as current
• Current Study Sponsor: Dana-Farber Cancer Institute
• Original Study Sponsor: Same as current
• Collaborators: National Institute of Nursing Research (NINR)

Investigators

• Principal Investigator: Alexi A. Wright, MD; Dana-Farber Cancer Institute

• PRS Account: Dana-Farber Cancer Institute
• Verification Date: October 2022