CompletedNot Applicable

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

United States46 participantsStarted 2020-11-02

Plain-language 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.

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Enrollment Number

Timeframe: Baseline

Number of Potentially Eligible Dyads Participants Actually Enrolled in the Study

Timeframe: Baseline, after consent

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)

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

Timeframe: Up to 2 months (Follow up survey)

Satisfaction With the PRISMS Program

Timeframe: 2-month followup survey

Trial details

NCT IDNCT04492007

SponsorUNC Lineberger Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-10-21

Results submitted2024-06-03

View on ClinicalTrials.gov More Colorectal Cancer trials