Clinical trial · Interventional
Feasibility Testing of Patient Reported Outcomes - Informed Symptom Management System (PRISMS)
NCT04492007CI-TRIAL-00085384PRISMScompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Uterine Cancer | Malignant Uterine Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patient-Reported Outcomes-Informed Symptom Management System (PRISMS) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PRISMS
- description
- In addition to usual care, participants assigned to this arm will have access to our Patient-Reported Outcomes-Informed Symptom Management System (PRISMS) program.
- interventionNames
- Behavioral: Patient-Reported Outcomes-Informed Symptom Management System (PRISMS)
- type
- NO_INTERVENTION
- label
- Usual Care
- description
- Participants assigned to this arm will receive the standard of care that is provided to all patients.
Primary outcomes (5)
- measure
- Enrollment Number
- timeFrame
- Baseline
- description
- The enrollment rate is defined as the number of potentially eligible couples (dyads) who have consented to participate in the study. 1 Dyad = 1 participant + their caregiver. Potentially eligible dyads (subjects and their caregivers) were approached and informed about the study. then the number of dyads who consented and completed.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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).
References
Publications (1)
- DERIVEDXu S, Tan X, Ma C, McElyea RS, Shieh K, Stover AM, Smith A, Stitzenberg K, Basch E, Song L. An eHealth symptom and complication management program for cancer patients with newly created ostomies and their caregivers (Alliance): a pilot feasibility randomized trial. BMC Cancer. 2023 Jun 10;23(1):532. doi: 10.1186/s12885-023-10919-x. PMID 37301841