- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04368130
SIGNAL:Identifying Behavioral Anomalies Using Smartphones to Improve Cancer Care (SIGNAL)
Study Overview
Status
Conditions
Intervention / Treatment
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
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Dana Farber Cancer Institute
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of enrollment
Time Frame: 6 Months
|
Feasibility will be demonstrated if ≥50% of eligible participants enroll
|
6 Months
|
Rate of completion
Time Frame: 6 Months
|
Feasibility will be demonstrated if ≥50% of eligible participants adhere to the smartphone app
|
6 Months
|
Burden rate
Time Frame: 6 Months
|
Acceptability will be defined as: <30% of patients rate the study as burdensome.
|
6 Months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Alexi A. Wright, MD, Dana-Farber Cancer Institute
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Fallopian Tube Diseases
- Uterine Cervical Neoplasms
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Uterine Neoplasms
Other Study ID Numbers
- 20-246
- R21NR018532-02 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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