PDAC-PATHWAYS: A Digital Informational and Supportive Care App for Patients Initiating Neoadjuvant Therapy for Pancreatic Ductal Adenocarcinoma

NCT07047807 — Not applicable, Recruiting, 50 participants, Massachusetts General Hospital

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RegistryNCT07047807, acronym PDAC-PATHWAYS
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, supportive care
Enrollment50 (Estimated)
SponsorMassachusetts General Hospital (Other); collaborators: United States Department of Defense
ConditionsPDAC - Pancreatic Ductal Adenocarcinoma
InterventionsPDAC-PATHWAYS, Usual Care (Behavioral, other)
Datesstart 2025-10-06, primary completion 2027-05-01 (estimated), completion 2027-08-01 (estimated), first posted 2025-07-02, last updated 2026-07-29
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for PDAC - Pancreatic Ductal Adenocarcinoma All trials of PDAC-PATHWAYS All trials of Usual Care

-Summary

This study aims to refine and pilot test PDAC-PATHWAYS, a digital informational and supportive care app for patients who are initiating neoadjuvant therapy for pancreatic ductal adenocarcinoma (PDAC).

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+Detailed description

There are two parts of this study. Study Part 1 is an open pilot study to refine PDAC-PATHWAYS prior to larger-scale testing in a randomized controlled trial (RCT) setting. Study Part 1 is purely descriptive, as the investigators will use the data to refine PDAC-PATHWAYS before proceeding to Study Part 2.

Study Part 2 is a pilot RCT to assess the feasibility and acceptability of conducting a randomized trial of PDAC-PATHWAYS versus usual care. Participants will complete a baseline survey and then be randomized to PDAC-PATHWAYS versus usual care. This record reflects the clinical trial component (Study Part 2), as feasibility and acceptability outcomes will be collected for this phase only.

+Arms and interventions

ArmTypeInterventionsDescription
PDAC-PATHWAYSExperimentalBehavioral: PDAC-PATHWAYSPDAC-PATHWAYS is an informational and supportive care app for patients initiating neoadjuvant therapy for PDAC.
Usual careActive comparatorOther: Usual CareParticipants randomized to usual care will receive routine treatment with their oncology clinicians.
  • PDAC-PATHWAYS (Behavioral): A digital app for patients initiating neoadjuvant therapy for PDAC
  • Usual Care (Other): Routine treatment

+Outcome measures

Primary outcomes

  • Feasibility: Enrollment rate [10 weeks]: ≥50% enrollment among consecutive eligible patients
  • Feasibility: intervention completion rate [10 weeks]: ≥50% completion of at least four app modules among those assigned to the intervention

Secondary outcomes

  • Acceptability [10 weeks]: ≥70% of patients in the intervention arm reporting Client Satisfaction Questionnaire-8 scores at or above the midpoint score of 20 on a scale from 8-32 (higher scores indicate higher satisfaction)

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Age≥18 years
* Within 8 weeks of a documented decision to pursue neoadjuvant therapy for newly diagnosed, non-metastatic PDAC
* Able to comprehend and speak English

Exclusion Criteria:

* Comorbid health condition that would interfere with study participation, as identified by the cancer care team

+Locations (1)

FacilityCityCountryStatus
Massachusetts General HospitalBoston, MassachusettsUnited StatesRecruiting