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

Sponsor

UNC Lineberger Comprehensive Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT04492007

Collaborator

(none)

Enrollment

Location

Arms

13.4

Actual Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Bladder Cancer Ovarian Cancer Cervical Cancer Uterine Cancer	Behavioral: Patient-Reported Outcomes-Informed Symptom Management System (PRISMS)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Nov 2, 2020

Actual Primary Completion Date :

Oct 21, 2021

Actual Study Completion Date :

Dec 15, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Recruitment rate [from study launching to ending, about 1 year]
Recruitment rate will be assessed by the percentage of potentially eligible participants who have consented to participate in the study
Enrollment rate [after T1 (baseline survey)]
Enrollment rate will be assessed by the percentage of potentially eligible participants who have completed the baseline survey.
Retention rate [after T2 (2-month followup survey)]
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.
Satisfaction with the PRISMS program [after T2 (2-month followup survey)]
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.
Perceived ease of use of the PRISMS program [after T2 (2-month followup survey)]
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.

Secondary Outcome Measures

Change of Quality of Life (QOL) [T1 (baseline survey) and T2 (2-month followup survey)]
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.
Healthcare Utilization Extracted From Electronic Medical Record [from study launching to ending, about 1 year]
The total number of ostomy-related followup visits, emergency room use and re-admissions.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts 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).