| Registry | NCT07829471 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; non randomized, single group, masking: none, supportive care |
| Enrollment | 200 (Estimated) |
| Sponsor | M.D. Anderson Cancer Center (Other) |
| Conditions | ePRO, Symptom Monitoring, Neoadjuvant Therapy, Pancreatic Adenocarcinoma, Clinical Outcomes |
| Interventions | Standard of Care (Other) |
| Dates | start 2027-02-21 (estimated), primary completion 2030-07-01 (estimated), completion 2032-07-01 (estimated), first posted 2026-09-21, last updated 2026-09-21 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for ePRO All trials for Symptom Monitoring All trials of Standard of Care
To learn if routine symptom monitoring using questionnaires during chemotherapy and/or radiation therapy in patients with PDAC improves patient health-related quality of life and experience with care.
2.1 Primary Objectives • To determine whether implementing routine ePRO symptom monitoring during NAT in patients with PDAC improves patient health-related quality of life (HRQoL) and experience with care compared with the pre-implementation period.
o To capture participant HRQoL and experience, the primary outcomes will be measured using the PROMIS-16 and CAHPS Cancer Care Survey , respectively.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Post-Implementation Cohort | Experimental | Other: Standard of Care | Standard Clinical Care + QW ePRO |
| Pre-Implementation Cohort | Experimental | Other: Standard of Care | Standard Clinical Care |
Sex: All, ages: 18 Years to any
Eligibility Criteria * Age ≥18 years * Participants must have histologically confirmed PDAC that is respectable, borderline respectable, or locally advanced with potential for curative intent resection as defined by MD Anderson Cancer Center (Appendix V) * Participants must be eligible to receive systemic neoadjuvant therapy (chemotherapy +/- radiation therapy) with intent for curative resection * Participants who will receive neoadjuvant therapy at an MD Anderson facility including Texas Medical Center and Houston area locations * Participants must be able to understand English or Spanish * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria * Definitively unresectable or metastatic disease at enrollment * Participants who received pre-referral chemotherapy, chemoradiotherapy, or previously attempted resection * Participants who had prior curative intent surgery for pancreatic cancer before entering the study * Participant with cognitive deficits that would preclude understanding of consent form and/or questionnaires * Participants with psychiatric illness/social situations that would limit compliance with study requirements * Participants who do not understand English or Spanish * Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of alopecia * Participants with uncontrolled underlying medical conditions * Participants receiving chemotherapy outside of the MD Anderson system
| Facility | City | Country | Status |
|---|---|---|---|
| UT MD Anderson Cancer Center | Houston, Texas | United States |