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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04368130 |
Recruitment Status :
Withdrawn
(The anomaly detection system is still under development and is not ready to test.)
First Posted : April 29, 2020
Last Update Posted : October 14, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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) |
Actual Enrollment : | 0 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 : | September 1, 2022 |
Estimated Primary Completion Date : | September 1, 2023 |
Estimated Study Completion Date : | September 1, 2023 |
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. |
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.
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
United States, Massachusetts | |
Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02215 |
Principal Investigator: | Alexi A. Wright, MD | Dana-Farber Cancer Institute |
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 14, 2022 |
Last Verified: | October 2022 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Carcinoma |
Uterine Cancer Cervical Cancer Gynecologic Cancer |
Ovarian Neoplasms Uterine Cervical Neoplasms Fallopian Tube Neoplasms Uterine Neoplasms Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases Genital Diseases, Female Female Urogenital Diseases |
Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Neoplasms, Female Urogenital Neoplasms Genital Diseases Endocrine System Diseases Gonadal Disorders Uterine Cervical Diseases Uterine Diseases Fallopian Tube Diseases |