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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Standard of Care

    Other intervention

    Standard of Care

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Post-Implementation CohortExperimental treatment 1 intervention
Group B: Pre-Implementation CohortExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

safety and adverse events (AEs)

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Time frame
Through study completion; an average of 1 year.

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: