EHR-embedded OCDT in Breast or GI Cancer

Dana-Farber Cancer Institute

Status: Completed

Conditions: Breast Cancer; Oral Chemotherapy; Gastrointestinal Cancer; Oral Cancer Directed Therapy

Treatments: Other: Active Care Team Alert; Other: Passive Care Team Alert

Study type: Interventional

Funder types: Other

Identifiers

NCT03858712

18-571

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Passive Care Team Alert

Other group

Description:

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

Treatment:

Other: Passive Care Team Alert

Active Care Team Alert

Other group

Description:

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

Treatment:

Other: Active Care Team Alert