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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

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.