Back to Clinical Trials

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

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

INTRODUCTION

  • Org Study ID: LCCC1929
  • Secondary ID: N/A
  • NTC ID: NCT04492007
  • Sponsor: UNC Lineberger Comprehensive Cancer Center

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.

  • Overall Status
    Recruiting
  • Start Date
    November 2, 2020
  • Phase
    Not Applicable
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Recruitment rate

Primary Outcome 1 - Timeframe: from study launching to ending, about 1 year

Primary Outcome 2 - Measure: Enrollment rate

Primary Outcome 2 - Timeframe: after T1 (baseline survey)

Primary Outcome 3 - Measure: Retention rate

Primary Outcome 3 - Timeframe: after T2 (2-month followup survey)

Primary Outcome 4 - Measure: Satisfaction with the PRISMS program

Primary Outcome 4 - Timeframe: after T2 (2-month followup survey)

Primary Outcome 5 - Measure: Perceived ease of use of the PRISMS program

Primary Outcome 5 - Timeframe: after T2 (2-month followup survey)

CONDITION

  • Colorectal Cancer
  • Bladder Cancer
  • Ovarian Cancer
  • Cervical Cancer
  • Uterine Cancer

ELIGIBILITY

Inclusion Criteria:
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 Criteria:
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).

Gender: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Lixin Song, RN, PhD

Role: Principal Investigator

Affiliation: University of North Carolina, Chapel Hill

Overall Contact

Name: Lixin Song, RN, PhD

Phone: 919-966-3119, 919-966-3119

Email: shenmeng@email.unc.edu, kshieh12@email.unc.edu

LOCATION

Facility Status Contact
Facility: University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
United States
Status: Recruiting Contact: Contact
Lixin Song, PhD
919-966-3612
lsong@unc.edu