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

Colorectal Cancer Clinical Trial

— PRISMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04492007
• Other study ID #: LCCC1929
• Status: Completed
• Phase: N/A
• Start date: November 2, 2020
• Est. completion date: December 20, 2021

Study information

• Verified date: August 2022
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 20, 2021
• Est. primary completion date: October 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Enrollment rate	Enrollment rate will be assessed by the percentage of potentially eligible participants who have completed the baseline survey.	after T1 (baseline survey)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)