NCT03858712

EHR-embedded OCDT in Breast or GI Cancer

Nonrandomized Phase II Hybrid Type 3 Implementation Study: Feasibility and Acceptance of an EHR-embedded Oral Cancer Directed Therapy Toxicity and Adherence Program for Patients With Breast or Gastrointestinal Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is research study is for participants with advanced breast or gastrointestinal cancer who have been taking oral chemotherapy medication (Oral Cancer Directed Therapy). This study is to help researchers better understand gaps in assessing oral chemotherapy patient toxicity at home, adherence to treatment and integrate toxicity/adherence reporting.

Detailed description

For patients with advanced breast or gastrointestinal cancer prescribed Oral Cancer Directed Therapy. * Participants will complete ePRO clinic for all medical oncology scheduled provider appointments during the study period per standard practice * Participants between clinic visits, will be asked to complete the oral weekly survey at home via the mobile or web based patient portal. The survey can be completed on a computer, tablet or smartphone at home or on a tablet at the time of scheduled visit. * The first 100 participants to complete the survey will receive a passive care team alert for responses (per DFHCC policy) * The second 100 participants to complete the survey will receive an active care team alert for responses.

Conditions

• Oral Cancer Directed Therapy
• Breast Cancer
• Gastrointestinal Cancer
• Oral Chemotherapy

Interventions

Type	Name	Description
OTHER	Active Care Team Alert	2\) Active care team alert via office practice nurse monitoring of ePRO oral responses scored at 3, indicating moderate-severe (grade ≥3) toxicity. Office practice nurses will monitor ePRO oral responses and respond to those scored at 3 per disease center symptom management protocol. The ePRO oral responses from the remaining participants will additionally be monitored by office practice nurses who will respond to ePRO responses with scores of 3, indicating a moderate-severe toxicity (grade 3 or higher).
OTHER	Passive Care Team Alert	Primary care teams are assigned an EHR inBasket pool through which PP messages are delivered. Providers will be responsible for reviewing ePRO responses via inBasket, selecting "mark as reviewed" button as mandated for all clinical messages within 48 hours per policy.

Timeline

• Start date: 2019-03-13
• Primary completion: 2021-11-23
• Completion: 2021-11-23
• First posted: 2019-03-01
• Last updated: 2022-05-12

Locations

1 site across 1 country: United States