Clinical trial NCT04492007: Feasibility Testing of Patient Reported Outcomes - Informed Symptom Management System (PRISMS)
Official title: Feasibility Testing of Patient Reported Outcomes - Informed Symptom Management System (PRISMS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Bladder Cancer
Ovarian Cancer
Cervical Cancer
Uterine Cancer
Keywords: ostomy (colostomy, urostomy, and ileostomy)
symptom
self-management
caregiving
family research
telehealth
self-efficacy
quality of life
post-treatment care transition
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institute of Nursing Research (NINR)
First posted: 2020-07-30
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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).

Primary outcomes:
measure: Enrollment Number
timeFrame: Baseline
measure: Number of Potentially Eligible Dyads Participants Actually Enrolled in the Study
timeFrame: Baseline, after consent
measure: Number of Dyads Remained in the Study and Completed the Post-Intervention Follow-Up Survey.
timeFrame: Up to 3 months (2-month follow up survey)
measure: Usability of Reported Outcomes - Patient Reported Outcomes - Informed Symptom Management System (PRISMS)
timeFrame: Up to 2 months (Follow up survey)
measure: Satisfaction With the PRISMS Program
timeFrame: 2-month followup survey
Secondary outcomes:
measure: Difference of Quality of Life Change Over Time as Assessed by The Functional Assessment of Cancer Therapy - General (FACT-G).
timeFrame: baseline , 2 months
measure: Difference of Anxiety Change Over Time as Assessed by PROMIS-Emotional Distress-Anxiety Short Form 7a
timeFrame: Baseline and 2 months
measure: Difference of Depression Change Over Time as Assessed by PROMIS-Emotional Distress-Depression Short From 8b
timeFrame: Baseline, 2 months
measure: Difference Pain Score Over Time as Assessed by PROMIS Pain Interference - Short Form 6b
timeFrame: Baseline, 2 months
measure: Difference of Fatigue Change Over Time as Assessed by PROMIS Fatigue -Short Form 7a
timeFrame: Baseline, 2 months
measure: Change in Sleep Among Caregivers.
timeFrame: Baseline, 2 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Lixin Song, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References: