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
Primary Outcome
Rate of enrollment
Condition
Ovarian Cancer
Intervention
SIGNAL
Study Arms / Comparison Groups
SIGNAL
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
20
Start Date
August 2020
Completion Date
March 31, 2021
Primary Completion Date
March 31, 2021
Eligibility Criteria
Inclusion Criteria:
- Women ≥18 years of age who plan to receive chemotherapy to treat recurrent, incurable
gynecologic cancers (i.e., ovarian, fallopian, primary peritoneal, uterine, cervical
cancer) that has recurred despite ≥1 prior treatment.
- Own a smart-phone (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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Alexi A. Wright, MD, 617-632-2334, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04368130
Organization ID
20-246
Secondary IDs
R21NR018532-02
Responsible Party
Principal Investigator
Study Sponsor
Dana-Farber Cancer Institute
Collaborators
National Institute of Nursing Research (NINR)
Study Sponsor
Alexi A. Wright, MD, Principal Investigator, Dana-Farber Cancer Institute
Verification Date
June 2020