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

NCT ID: NCT04492007

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-02
• Study Completion Date: 2021-12-20

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.

Conditions

Colorectal Cancer; Bladder Cancer; Ovarian Cancer; Cervical Cancer; Uterine Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

PRISMS

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

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

Participants will receive personalized self-care information and guidance based on their symptoms and signs of complications (e.g., skin infection, fatigue) from the web-based telehealth PRISMS program. They will also have access through this website a peer support online forum that is moderated by a research nurse as well as professional support through videoconferencing/telephone from the research nurse and also their healthcare providers at the hospital(s) if they experience moderate to severe symptoms and/or abnormal sign (e.g., body temperature is greater than 98.6 C

Usual Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Participants will receive personalized self-care information and guidance based on their symptoms and signs of complications (e.g., skin infection, fatigue) from the web-based telehealth PRISMS program. They will also have access through this website a peer support online forum that is moderated by a research nurse as well as professional support through videoconferencing/telephone from the research nurse and also their healthcare providers at the hospital(s) if they experience moderate to severe symptoms and/or abnormal sign (e.g., body temperature is greater than 98.6 C

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lixin Song, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

References

Xu S, Tan X, Ma C, McElyea RS, Shieh K, Stover AM, Smith A, Stitzenberg K, Basch E, Song L. An eHealth symptom and complication management program for cancer patients with newly created ostomies and their caregivers (Alliance): a pilot feasibility randomized trial. BMC Cancer. 2023 Jun 10;23(1):532. doi: 10.1186/s12885-023-10919-x.

Reference Type: DERIVED

PMID: 37301841 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01NR016990

Identifier Type: NIH

Identifier Source: secondary_id

View Link

LCCC1929

Identifier Type: -

Identifier Source: org_study_id