PDAC - Pancreatic Ductal Adenocarcinoma
Conditions
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).
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.
Interventions
A digital app for patients initiating neoadjuvant therapy for PDAC
Routine treatment
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Enrollment rate | 10 weeks | ≥50% enrollment among consecutive eligible patients |
| Feasibility: intervention completion rate | 10 weeks | ≥50% completion of at least four app modules among those assigned to the intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability | 10 weeks | ≥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) |
Countries
United States