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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PDAC-PATHWAYS | Experimental | PDAC-PATHWAYS is an informational and supportive care app for patients initiating neoadjuvant therapy for PDAC. |
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| Usual care | Active Comparator | Participants randomized to usual care will receive routine treatment with their oncology clinicians. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PDAC-PATHWAYS | Behavioral | A digital app for patients initiating neoadjuvant therapy for PDAC |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | ≥75% of patients in the intervention arm reporting Client Satisfaction Questionnaire-8 scores above the midpoint score of 20 on a scale from 8-32 (higher scores indicate higher satisfaction) | 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kelsey Lau-Min, MD, MSCE | Contact | 617-724-4000 | klau-min@mgh.harvard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| Usual Care | Other | Routine treatment |
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