SIGNAL:Identifying Behavioral Anomalies Using Smartphones to Improve Cancer Care (SIGNAL)
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|ClinicalTrials.gov Identifier: NCT04368130|
Recruitment Status : Not yet recruiting
First Posted : April 29, 2020
Last Update Posted : October 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Carcinoma Uterine Cancer Cervical Cancer Gynecologic Cancer||Behavioral: SIGNAL||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||SIGNAL:Identifying Behavioral Anomalies Using Smartphones to Improve Cancer Care|
|Estimated Study Start Date :||October 2020|
|Estimated Primary Completion Date :||March 31, 2021|
|Estimated Study Completion Date :||March 31, 2021|
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.
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368130
|Contact: Alexi A Wright, MD, MPH||617-632-2334||Alexi_Wright@dfci.harvard.edu|
|United States, Massachusetts|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Contact: Alexi A Wright, MD MPH 617-632-6863|
|Principal Investigator: Alexi A Wright, MD|
|Principal Investigator:||Alexi A. Wright, MD||Dana-Farber Cancer Institute|