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

Mass General Brigham

Status: Not yet enrolling

Conditions: PDAC - Pancreatic Ductal Adenocarcinoma

Treatments: Other: Usual Care; Behavioral: PDAC-PATHWAYS

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT07047807

25-350

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

PDAC-PATHWAYS

Experimental group

Description:

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

Treatment:

Behavioral: PDAC-PATHWAYS

Usual care

Active Comparator group

Description:

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

Treatment:

Other: Usual Care