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

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


  • Org Study ID: LCCC1929
  • Secondary ID:
  • NCT ID: NCT04492007
  • NCT Alias:
  • Sponsor: UNC Lineberger Comprehensive Cancer Center - Other
  • Source: 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.

Overal Status Start Date Phase Study Type
Recruiting November 2, 2020 N/A Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Recruitment rate

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

Primary Outcome 2 - Measure: Enrollment rate

Primary Outcome 2 - Time Frame: after T1 (baseline survey)

Primary Outcome 3 - Measure: Retention rate

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

Primary Outcome 4 - Measure: Satisfaction with the PRISMS program

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

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

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

Condition:

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

Eligibility

Criteria:
Inclusion Criteria:

Patients must:

- have been surgically treated for colorectal, bladder, ovarian, cervical, or uterine
cancer with curative intent;

- be within 2 weeks of hospital discharge of a newly created ostomy with curative
intent;

- be able to read and speak English;

- be 40 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).
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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: Shenmeng Xu, PhD

Phone: 919-966-3119

Email: shenmeng@email.unc.edu

Location

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