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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07047807
Acronym
PDAC-PATHWAYS
Enrollment
50
Registered
2025-07-02
Start date
2025-10-06
Completion date
2027-08-01
Last updated
2026-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PDAC - Pancreatic Ductal Adenocarcinoma

Brief 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).

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.

Interventions

BEHAVIORALPDAC-PATHWAYS

A digital app for patients initiating neoadjuvant therapy for PDAC

OTHERUsual Care

Routine treatment

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER
United States Department of Defense
CollaboratorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility: Enrollment rate10 weeks≥50% enrollment among consecutive eligible patients
Feasibility: intervention completion rate10 weeks≥50% completion of at least four app modules among those assigned to the intervention

Secondary

MeasureTime frameDescription
Acceptability10 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)

Countries

United States

Contacts

CONTACTKelsey Lau-Min, MD, MSCE
klau-min@mgh.harvard.edu617-724-4000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 30, 2026