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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04368130
Recruitment Status : Not yet recruiting
First Posted : April 29, 2020
Last Update Posted : October 8, 2020
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Alexi A. Wright, Dana-Farber Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Carcinoma Uterine Cancer Cervical Cancer Gynecologic Cancer Behavioral: SIGNAL Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
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


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.

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.





Primary Outcome Measures :
  1. Rate of enrollment [ Time Frame: 6 Months ]
    Feasibility will be demonstrated if ≥50% of eligible participants enroll

  2. Rate of completion [ Time Frame: 6 Months ]
    Feasibility will be demonstrated if ≥50% of eligible participants adhere to the smartphone app

  3. Burden rate [ Time Frame: 6 Months ]
    Acceptability will be defined as: <30% of patients rate the study as burdensome.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Alexi A Wright, MD, MPH 617-632-2334 Alexi_Wright@dfci.harvard.edu

Locations
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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         
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Alexi A. Wright, MD Dana-Farber Cancer Institute
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Responsible Party: Alexi A. Wright, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT04368130    
Other Study ID Numbers: 20-246
R21NR018532-02 ( U.S. NIH Grant/Contract )
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (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
Statistical Analysis Plan (SAP)
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexi A. Wright, Dana-Farber Cancer Institute:
Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Carcinoma
Uterine Cancer
Cervical Cancer
Gynecologic Cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Uterine Cervical Neoplasms
Fallopian Tube Neoplasms
Uterine Neoplasms
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Uterine Cervical Diseases
Uterine Diseases
Fallopian Tube Diseases