Status:
COMPLETED
Feasibility Testing of Patient Reported Outcomes - Informed Symptom Management System (PRISMS)
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
National Institute of Nursing Research (NINR)
Conditions:
Colorectal Cancer
Bladder Cancer
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
This is a proof-of-concept pilot randomized clinical trial to test the feasibility of the innovative Patient-Reported Outcomes-Informed Symptom Management System (PRISMS) to enhance personalized suppo...
Detailed Description
In this proof-of-concept study, our multidisciplinary team will conduct a pilot randomized clinical trial to test the feasibility of the innovative Patient-Reported Outcomes-Informed Symptom Managemen...
Eligibility Criteria
Inclusion
- Patients must:
- have been surgically treated for colorectal, bladder, ovarian, cervical, or uterine cancer with curative intent;
- be within one month of hospital discharge of a newly created ostomy with curative intent;
- be able to read and speak English;
- be 18 years or older;
- have a caregiver who is willing to participate in the study;
- Caregivers must:
- be 18 years or older;
- be able to read and speak English;
- be identified as the primary caregiver by the patient;
- have not themselves been diagnosed with cancer or received cancer treatment during the study (to ensure that patients and caregivers focus their efforts on care of the patient).
Exclusion
- Patients and their caregivers will be excluded if they:
- are unable to read, speak, or understand English;
- have more than one type of ostomy;
- have other cancer diagnosis (excluding non-melanomatous skin cancer); or
- have cognitive impairment (assessed by the Short Portable Mental Status Questionnaire).
Key Trial Info
Start Date :
November 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2021
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04492007
Start Date
November 2 2020
End Date
December 20 2021
Last Update
February 3 2025
Active Locations (1)
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1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599