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.
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 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)
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
Name: Lixin Song, RN, PhD
Role: Principal Investigator
Affiliation: University of North Carolina, Chapel Hill
Name: Shenmeng Xu, PhD
Phone: 919-966-3119
Email: shenmeng@email.unc.edu
| 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 |
