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Spots Global Cancer Trial Database for Feasibility Testing of Patient Reported Outcomes - Informed Symptom Management System (PRISMS)

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We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Feasibility Testing of Patient Reported Outcomes - Informed Symptom Management System (PRISMS)

Official Title: Feasibility Testing of Patient Reported Outcomes - Informed Symptom Management System (PRISMS)

Study ID: NCT04492007

Study Description

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 supportive care for cancer patients and caregivers during post-treatment care transition.

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 Management System (PRISMS) to enhance personalized supportive care for cancer patients and caregivers during post-treatment care transition. We will randomly assign 21 cancer patients with newly created ostomies for cancer treatment with curative intent and their primary caregivers to the PRISMS or usual care groups (21 patient-caregiver dyads, a total of 42 individuals). PRISMS is defined as a personalized psychoeducational website including monitoring and personal feedback. We will conduct pre- and post-assessments of QOL and PRO (symptoms) at baseline upon enrollment and 2 months later.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States

Contact Details

Name: Lixin Song, RN, PhD

Affiliation: University of North Carolina, Chapel Hill

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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