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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • PDAC-PATHWAYS

    Behavioral

    A digital app for patients initiating neoadjuvant therapy for PDAC

  • Usual Care

    Other intervention

    Routine treatment

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: PDAC-PATHWAYSExperimental treatment 1 intervention
Group B: Usual careActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility: Enrollment rate

≥50% enrollment among consecutive eligible patients

Time frame
10 weeks
2

Feasibility: intervention completion rate

≥50% completion of at least four app modules among those assigned to the intervention

Time frame
10 weeks

Secondary outcomes

1

Acceptability

≥70% of patients in the intervention arm reporting Client Satisfaction Questionnaire-8 scores at or above the midpoint score of 20 on a scale from 8-32 (higher scores indicate higher satisfaction)

Time frame
10 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

United States Department of Defense

Collaborator