Clinical trial NCT03858712: EHR-embedded OCDT in Breast or GI Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Cancer Directed Therapy
Breast Cancer
Gastrointestinal Cancer
Oral Chemotherapy
Keywords: Oral Cancer Directed Therapy
Breast Cancer
Gastrointestinal Cancer
oral chemotherapy
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Hybrid type 3 implementation study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: ePRO Oral Response Rate
timeFrame: 30 days
Secondary outcomes:
measure: ePRO Oral Response Rate
timeFrame: 60 days
measure: ePRO Oral Response Rate
timeFrame: 90 days
measure: Average number of ePRO oral questionnaires completed per week
timeFrame: 90 Days
measure: Proportion of Participants reporting ePRO grade 3+ toxicity
timeFrame: 90 Days
measure: Proportion of Participants with an ePRO Intervention
timeFrame: 90 Days
measure: Participant Report of OCDT Frequency
timeFrame: 90 Days
measure: Participant Report of OCDT Frequency
timeFrame: 30 Days
measure: ePRO oral willingness
timeFrame: 90 Days
measure: ePRO oral ease of use
timeFrame: 90 Days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Nadine McCleary, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: