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OpenTrials
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NCT Number: NCT07829471

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT MD Anderson Cancer Center

Houston, Texas, 77044, United States

Location contact

Rebecca A Snyder, MD

CONTACT

[email protected]

713-792-0036

Rebecca A Snyder, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard of care

Other

Standard of Care

Primary outcomes

  1. safety and adverse events (AEs)

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Rebecca A Snyder, MD

CONTACT

[email protected]

713-792-0036

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2027
Primary completion
2030
Study completion
2032
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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