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

NCT ID: NCT07047807

Last Updated: 2025-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2027-08-31

Brief Summary

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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

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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.

Conditions

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PDAC - Pancreatic Ductal Adenocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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PDAC-PATHWAYS

PDAC-PATHWAYS is an informational and supportive care app for patients initiating neoadjuvant therapy for PDAC.

Group Type EXPERIMENTAL

PDAC-PATHWAYS

Intervention Type BEHAVIORAL

A digital app for patients initiating neoadjuvant therapy for PDAC

Usual care

Participants randomized to usual care will receive routine treatment with their oncology clinicians.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

Routine treatment

Interventions

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PDAC-PATHWAYS

A digital app for patients initiating neoadjuvant therapy for PDAC

Intervention Type BEHAVIORAL

Usual Care

Routine treatment

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kelsey S. Lau-Min, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Massachusetts General HospitaL

Boston, Massachusetts, United States

Site Status

Countries

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United States

Central Contacts

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Kelsey Lau-Min, MD, MSCE

Role: CONTACT

617-724-4000

Facility Contacts

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Kelsey Lau-Min, MD, MSCE

Role: primary

857-367-1486

Other Identifiers

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25-350

Identifier Type: -

Identifier Source: org_study_id

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