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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colorectal Cancer, Bladder Cancer, Ovarian Cancer, Cervical Cancer, Uterine Cancer

Intervention / Treatment
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* Behavioral: Patient-Reported Outcomes-Informed Symptom Management System (PRISMS)


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRISMS<br>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)<br>* 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<br>|
| No Intervention: Usual Care<br>Participants assigned to this arm will receive the standard of care that is provided to all patients. | |

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ostomy (colostomy, urostomy, and ileostomy), symptom, self-management, caregiving, family research, telehealth, self-efficacy, quality of life, post-treatment care transition