N/A
N=46
Feasibility Testing of Patient Reported Outcomes - Informed Symptom Management System (PRISMS)
Colorectal Cancer · Bladder Cancer · Ovarian Cancer · Cervical Cancer · Uterine Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04492007 ↗Enrolled (actual)
46
Serious AEs
—
Results posted
Feb 2025
Primary outcome: Primary: Enrollment Number — 25 Number of dyad participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Patient-Reported Outcomes-Informed Symptom Management System (PRISMS) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Enrollment Number |
25 | — |
| PRIMARY Number of Potentially Eligible Dyads Participants Actually Enrolled in the Study |
23 | — |
| PRIMARY Number of Dyads Remained in the Study and Completed the Post-Intervention Follow-Up Survey. |
17 | — |
| PRIMARY Usability of Reported Outcomes - Patient Reported Outcomes - Informed Symptom Management System (PRISMS) |
17.00; 17.50; 20; 20.36; 19.75; 18.50 | — |
| PRIMARY Satisfaction With the PRISMS Program |
3.20; 3.20; 4.08; 3.83; 3.60; 4.20 | — |
| SECONDARY Difference of Quality of Life Change Over Time as Assessed by The Functional Assessment of Cancer Therapy - General (FACT-G). |
18.43; 13.57; 7.41; 9.53 | — |
| SECONDARY Difference of Anxiety Change Over Time as Assessed by PROMIS-Emotional Distress-Anxiety Short Form 7a |
6.56; 10.02; 13.42; 13.22 | — |
| SECONDARY Difference of Depression Change Over Time as Assessed by PROMIS-Emotional Distress-Depression Short From 8b |
14.77; 8.55; 20.94; 11.08 | — |
| SECONDARY Difference Pain Score Over Time as Assessed by PROMIS Pain Interference - Short Form 6b |
7.28; 24.85; 13.02; 7.72 | — |
| SECONDARY Difference of Fatigue Change Over Time as Assessed by PROMIS Fatigue -Short Form 7a |
8.73; 46.19; 10.86; 16.28 | — |
| SECONDARY Change in Sleep Among Caregivers. |
16.49; 0.40 | — |
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.
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).
Data sourced from ClinicalTrials.gov (NCT04492007). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.