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

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.

Study Overview

• Status: Completed
• Conditions: Cervical Cancer; Colorectal Cancer; Ovarian Cancer; Bladder Cancer; Uterine Cancer
• Intervention / Treatment: Behavioral: Patient-Reported Outcomes-Informed Symptom Management System (PRISMS)

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Behavioral: 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
NO_INTERVENTION: Usual Care; Participants assigned to this arm will receive the standard of care that is provided to all patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	Recruitment rate will be assessed by the percentage of potentially eligible participants who have consented to participate in the study	from study launching to completion
Enrollment rate	Enrollment rate will be assessed by the percentage of potentially eligible participants who have completed the baseline survey.	after T1 (baseline survey)
Retention rate	Retention rate will be assessed by the percentage of enrolled participants who have completed the 2-month followup survey at the end of the study period.	after T2 (2-month followup survey)
Satisfaction with the PRISMS program	Satisfaction with the PRISMS program will be assessed by the 9-item Participant Satisfaction Scale measuring the level of program satisfaction ranging from 1=not satisfied to 5=extremely satisfied. Higher total score indicates greater program satisfaction.	after T2 (2-month followup survey)
Perceived ease of use of the PRISMS program	Perceived ease of use of the PRISMS program will be assessed by the 23-item Usability Scale measuring the ease of use in three aspects: general, content, and navigation. The scales range from 1=strongly disagree to 5=strongly agree. Higher total score indicates greater ease of use.	after T2 (2-month followup survey)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Quality of Life (QOL)	Quality of Life (QoL) will be assessed using the Functional Assessment of Cancer Therapy General Scale (FACT-G) v.4, a 27-item measure yielding total score and scores for physical, social/family, emotional, and functional well-being of demonstrated reliability, validity, and sensitivity to change. FACT-G consists of 4 subscales: physical well-being (PWB), functional well-being (FWB), emotional well-being (EWB) and social well-being (SWB). Scores on the four subscales are summed to produce a total score ranging from 0 to 108 with higher scores indicating better quality of life. Change in the FACT-G scores from T1 (baseline survey) to T2 (2-month followup survey) will be calculated.	T1 (baseline survey) and T2 (2-month followup survey)
Healthcare Utilization Extracted From Electronic Medical Record	The total number of ostomy-related followup visits, emergency room use and re-admissions.	90 days past T1 (baseline survey)

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 2, 2020
• Primary Completion (ACTUAL): October 21, 2021
• Study Completion (ACTUAL): December 20, 2021

Study Registration Dates

• First Submitted: June 24, 2020
• First Submitted That Met QC Criteria: July 28, 2020
• First Posted (ACTUAL): July 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 1, 2022
• Last Update Submitted That Met QC Criteria: August 29, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: quality of life; self-management; caregiving; self-efficacy; telehealth; symptom; family research; ostomy (colostomy, urostomy, and ileostomy); post-treatment care transition
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Uterine Diseases; Uterine Neoplasms
• Other Study ID Numbers: LCCC1929

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a pilot study with very small sample size and specific inclusion criteria. Sharing data with others may increase the risk to patient confidentiality.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No