Impact of Routine Electronic Patient-Reported Outcome (ePRO)Symptom Monitoring During Neoadjuvant Therapy in Patients withPancreatic Adenocarcinoma on Patient Experience and ClinicalOutcomes: A Prospective Pre-Post Implementation Study

NCT07829471 — Not applicable, Not yet recruiting, 200 participants, M.D. Anderson Cancer Center

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RegistryNCT07829471
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; non randomized, single group, masking: none, supportive care
Enrollment200 (Estimated)
SponsorM.D. Anderson Cancer Center (Other)
ConditionsePRO, Symptom Monitoring, Neoadjuvant Therapy, Pancreatic Adenocarcinoma, Clinical Outcomes
InterventionsStandard of Care (Other)
Datesstart 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
Locations1 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

-Summary

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.

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+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
Post-Implementation CohortExperimentalOther: Standard of CareStandard Clinical Care + QW ePRO
Pre-Implementation CohortExperimentalOther: Standard of CareStandard Clinical Care
  • Standard of Care (Other): Standard of Care

+Outcome measures

Primary outcomes

  • safety and adverse events (AEs) [Through study completion; an average of 1 year.]: Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

+Eligibility

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

+Locations (1)

FacilityCityCountryStatus
UT MD Anderson Cancer CenterHouston, TexasUnited States

+Investigators