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NCT Number: NCT07047807

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

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).

Recruiting

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Key information

Conditions

PDAC - Pancreatic Ductal Adenocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Kelsey Lau-Min, MD, MSCE

CONTACT

[email protected]

857-367-1486

Kelsey Lau-Min, MD, MSCE

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PDAC-PATHWAYS

Behavioral

A digital app for patients initiating neoadjuvant therapy for PDAC

Usual Care

Other

Routine treatment

Primary outcomes

  1. Feasibility: Enrollment rate

    Time frame: 10 weeks

    ≥50% enrollment among consecutive eligible patients

  2. Feasibility: intervention completion rate

    Time frame: 10 weeks

    ≥60% completion of at least three of the five app modules among those assigned to the intervention

Secondary outcomes

  1. Acceptability

    Time frame: 10 weeks

    ≥75% of patients in the intervention arm reporting Client Satisfaction Questionnaire-8 scores above the midpoint score of 20 on a scale from 8-32 (higher scores indicate higher satisfaction)

Study contacts

Contact information is provided by the study sponsor or research team.

Kelsey Lau-Min, MD, MSCE

CONTACT

[email protected]

617-724-4000

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • United States Department of Defense

Registry information

Acronym: PDAC-PATHWAYS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 2, 2025
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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