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

Purpose

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).

Condition

  • PDAC - Pancreatic Ductal Adenocarcinoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Ageā‰„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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
PDAC-PATHWAYS 		PDAC-PATHWAYS is an informational and supportive care app for patients initiating neoadjuvant therapy for PDAC.
  • Behavioral: PDAC-PATHWAYS
    A digital app for patients initiating neoadjuvant therapy for PDAC
Active Comparator
Usual care 		Participants randomized to usual care will receive routine treatment with their oncology clinicians.
  • Other: Usual Care
    Routine treatment

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Kelsey Lau-Min, MD, MSCE
857-367-1486
klau-min@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Kelsey Lau-Min, MD, MSCE
617-724-4000
klau-min@mgh.harvard.edu

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.