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

UNC Lineberger Comprehensive Cancer Center

Status: Completed

Conditions: Uterine Cancer; Bladder Cancer; Ovarian Cancer; Cervical Cancer; Colorectal Cancer

Treatments: Behavioral: Patient-Reported Outcomes-Informed Symptom Management System (PRISMS)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04492007

LCCC1929

R01NR016990 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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46 participants in 2 patient groups

PRISMS

Experimental group

Description:

In addition to usual care, participants assigned to this arm will have access to our Patient-Reported Outcomes-Informed Symptom Management System (PRISMS) program.

Treatment:

Behavioral: Patient-Reported Outcomes-Informed Symptom Management System (PRISMS)

Usual Care

No Intervention group

Description:

Participants assigned to this arm will receive the standard of care that is provided to all patients.