Viewing Study NCT05502302


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Study NCT ID: NCT05502302
Status: COMPLETED
Last Update Posted: 2024-07-03
First Post: 2022-08-12
Is NOT Gene Therapy: False
Has Adverse Events: True

Brief Title: App-Assisted Day Reconstruction to Reduce Logistic Toxicity in Cancer
Sponsor: Masonic Cancer Center, University of Minnesota
Organization:

Study Overview

Official Title: App-Assisted Day Reconstruction to Reduce Treatment Burden and Logistic Toxicity in Cancer Patients
Status: COMPLETED
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The number of new cases of cancer diagnosed in the U.S. was 1.7 million in 2017 and is expected to increase by 35% to 2.3 million in 2030\[1\]. Cancer treatments often create numerous logistic challenges in prioritizing and managing treatment and everyday life priorities and how these challenges affect their everyday lives and well-being (hence "logistic toxicity"). However, there are no established reliable tools to monitor patients' logistic challenges and the associated impacts; and logistic toxicity has been largely unaddressed in cancer care delivery. The objective is to develop the first digital health app for cancer patients to continuously monitor logistic toxicity in their daily lives. The app will combine objective data from mobile sensing with subjective self-reported data to form an app-assisted day reconstruction system that captures activity engagement and well-being information associated with cancer treatment-related activities and trips throughout the day.
Detailed Description: The proposed patient monitoring app that captures logistic toxicity information on an ongoing basis will empower patients to advocate for care that better fits their life, give providers new insights into potential reasons for treatment non-adherence and nonresponse, and allow health systems to design more patient-centered care regimens.

A participatory design approach will be used to inform the design of our system, performing in-depth interviews and follow-up surveys with 20 diverse patients undergoing treatment for cancer. Patients will supply examples of logistic toxicity and how they would like to measure and communicate logistic toxicity across scenarios. Follow-up surveys will ask participants to provide satisfaction ratings towards user interface sketches and app function narratives.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?:

Secondary ID Infos

Secondary ID Type Domain Link View
R41CA271962 NIH None https://reporter.nih.gov/quic… View