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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Gastrointestinal Cancer; Oral Cancer Directed Therapy; Oral Chemotherapy
• Intervention / Treatment: Other: Passive Care Team Alert; Other: Active Care Team Alert

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Passive Care Team Alert; DFCI patients with advanced breast or gastrointestinal cancer prescribed Oral Cancer Directed Therapy.; Screening: ePRO Clinic:-- complete ePRO clinic for all medical oncology scheduled provider appointments during the study period per standard practice; ePRO Home: -- ePRO oral between visits at home.; Passive care team alert -- EHR inBasket notification	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.
OTHER: Active Care Team Alert; DFCI patients with advanced breast or gastrointestinal cancer prescribed Oral Cancer Directed Therapy.; Screening: ePRO Clinic:-- complete ePRO clinic for all medical oncology scheduled provider appointments during the study period per standard practice; ePRO Home: -- ePRO oral between visits at home.; Active care team alert -- practice nurse monitoring of ePRO home responses score = 3 indicating a moderate-severe toxicity (grade 3 or higher	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ePRO Oral Response Rate	proportion of participants responding to at least 50% of ePRO oral questionnaires at 30 days	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ePRO Oral Response Rate	proportion of participants responding to at least 50% of ePRO oral questionnaires at 60 days	60 days
ePRO Oral Response Rate	proportion of participants responding to at least 50% of ePRO oral questionnaires at 90 days	90 days
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Nadine McCleary, MD, MPH, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 13, 2019
• Primary Completion (ACTUAL): November 23, 2021
• Study Completion (ACTUAL): November 23, 2021

Study Registration Dates

• First Submitted: February 27, 2019
• First Submitted That Met QC Criteria: February 27, 2019
• First Posted (ACTUAL): March 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 12, 2022
• Last Update Submitted That Met QC Criteria: May 11, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Breast Cancer; Gastrointestinal Cancer; Oral Cancer Directed Therapy; oral chemotherapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Stomatognathic Diseases; Mouth Diseases; Gastrointestinal Neoplasms; Mouth Neoplasms
• Other Study ID Numbers: 18-571

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No