NCT07047807

Brief Summary

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
15mo left

Started Oct 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Oct 2025Aug 2027

First Submitted

Initial submission to the registry

June 24, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 2, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

October 6, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

1.6 years

First QC Date

June 24, 2025

Last Update Submit

April 15, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Feasibility: Enrollment rate

    ≥50% enrollment among consecutive eligible patients

    10 weeks

  • Feasibility: intervention completion rate

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

    10 weeks

Secondary Outcomes (1)

  • Acceptability

    10 weeks

Study Arms (2)

PDAC-PATHWAYS

EXPERIMENTAL

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

Behavioral: PDAC-PATHWAYS

Usual care

ACTIVE COMPARATOR

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

Other: Usual Care

Interventions

PDAC-PATHWAYSBEHAVIORAL

A digital app for patients initiating neoadjuvant therapy for PDAC

PDAC-PATHWAYS

Routine treatment

Usual care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Comorbid health condition that would interfere with study participation, as identified by the cancer care team

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Central Study Contacts

Kelsey Lau-Min, MD, MSCE

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 24, 2025

First Posted

July 2, 2025

Study Start

October 6, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

April 20, 2026

Record last verified: 2026-04

Locations