EHR-embedded OCDT in Breast or GI Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03858712
• Other study ID #: 18-571
• Status: Completed
• Phase: N/A
• Start date: March 13, 2019
• Est. completion date: November 23, 2021

Study information

• Verified date: May 2022
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 23, 2021
• Est. primary completion date: November 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult age 18 or older

• Male or Female

• Scheduled visit at DF/HCC within the BOC or GCC

• Diagnosis of advanced breast cancer or gastrointestinal cancer

• Prescribed any OCDT within prior 5 days of screening

• English as the primary language (as documented in the EHR, written or spoken, and patient interpreter needed flag = no)

• Mobile number listed in EHR to allow participation in ePP portion of the study

• Women of any pregnancy status

• Patients diagnosed with an advanced cancer will be eligible to participate in the study until discontinuation of OCDT or death, whichever occurs first

Exclusion Criteria

• Adults unable to provide verbal consent

• Pediatric patients

• Patients without access to a electronic device (including tablet, computer, aptop or smartphone)

Related Conditions & MeSH terms

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

Intervention

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).
• 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.

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ePRO Oral Response Rate	proportion of participants responding to at least 50% of ePRO oral questionnaires at 30 days	30 days
Secondary	ePRO Oral Response Rate	proportion of participants responding to at least 50% of ePRO oral questionnaires at 60 days	60 days
Secondary	ePRO Oral Response Rate	proportion of participants responding to at least 50% of ePRO oral questionnaires at 90 days	90 days
Secondary	Average number of ePRO oral questionnaires completed per week	average number of ePRO oral questionnaires completed per week until discontinuation of OCDT or end of study (whichever occurs first)	90 Days
Secondary	Proportion of Participants reporting ePRO grade 3+ toxicity	proportion of participants reporting grade 3+ toxicity on at least one ePRO oral questionnaire among participants who responded to at least one ePRO oral questionnaire	90 Days
Secondary	Proportion of Participants with an ePRO Intervention	proportion of participants who were called by an office practice nurse for toxicity, had an OCDT dose modification, urgent clinic visit, ED visit or unplanned hospitalization among participants who responded to at least one ePRO oral questionnaire	90 Days
Secondary	Participant Report of OCDT Frequency	proportion of participants who reported missing >20% of prescribed OCDT doses for reasons other than toxicity on at least one ePRO oral report among participants who responded to at least one ePRO oral questionnaire; measured by participant weekly report of dates and time (AM, PM) of missed doses of the prescribed OCDT regimen	90 Days
Secondary	Participant Report of OCDT Frequency	Among participant who self-reported missing =20%/<20% of prescribed OCDT doses via ePRO oral, the proportion for whom EHR prescriptions also indicated non-adherence/adherence; EHR prescriptions measured by Proportion of Days Covered (PDC) = proportion of days covered by OCDT prescription claims divided by 30 days	30 Days
Secondary	ePRO oral willingness	proportion of participants reporting that they were willing or very willing to use ePRO oral again in the future among participants who responded to at least one ePRO oral questionnaire	90 Days
Secondary	ePRO oral ease of use	Proportion of participants reporting that ePRO oral was either easy or very easy to use among participants who responded to at least one ePRO oral questionnaire	90 Days