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

Primary Purpose

Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SIGNAL
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ovarian Cancer focused on measuring Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma, Uterine Cancer, Cervical Cancer, Gynecologic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Dana Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SIGNAL

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 27, 2020
Last Updated
October 13, 2022
Sponsor
Dana-Farber Cancer Institute
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT04368130
Brief Title
SIGNAL:Identifying Behavioral Anomalies Using Smartphones to Improve Cancer Care
Acronym
SIGNAL
Official Title
SIGNAL:Identifying Behavioral Anomalies Using Smartphones to Improve Cancer Care
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Withdrawn
Why Stopped
The anomaly detection system is still under development and is not ready to test.
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SIGNAL
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
SIGNAL
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of enrollment
Description
Feasibility will be demonstrated if ≥50% of eligible participants enroll
Time Frame
6 Months
Title
Rate of completion
Description
Feasibility will be demonstrated if ≥50% of eligible participants adhere to the smartphone app
Time Frame
6 Months
Title
Burden rate
Description
Acceptability will be defined as: <30% of patients rate the study as burdensome.
Time Frame
6 Months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexi A. Wright, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Learn more about this trial

SIGNAL:Identifying Behavioral Anomalies Using Smartphones to Improve Cancer Care

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