Pharmacist-led Intervention on Adherence in Patients Undergoing Treatment With an Oral Oncology Medication
BSPAP
Evaluating Adherence and Persistence in Patients Receiving Oral Oncolytic Therapy in a Safety Net Hospital's Pharmacist-driven Medication Management Program
1 other identifier
interventional
216
1 country
1
Brief Summary
Boston Medical Center provides care to cancer patients on oral cancer medications through the use of Boston Medical Center Specialty Pharmacy (BMC SP). The use of oral medications in cancer treatments is relatively new and unfortunately, very little is known about adherence in cancer patients. This study will evaluate the influence of a pharmacist-driven medication management program on adherence and persistence rates. Boston Medical Center's Specialty Pharmacy Adherence Program (B-SPAP), will utilize a high-touch counseling model involving clinical pharmacist that will focus on educating patients about their oral cancer treatments. The program will require face-to-face counseling with a pharmacist, through the use of a proven patient teaching tool, prior to initiating treatment with oral oncolytic treatments and, periodically thereafter, based on protocol. This study will help improve our understanding of the role of the pharmacist in cancer patients. In addition, the study will help identify independent factors that may contribute or impact adherence. The outcomes of this program will be compared to a historical control group of patients that have already received treatment for their cancer through the BMC Specialty Pharmacy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2017
CompletedFirst Posted
Study publicly available on registry
April 7, 2017
CompletedStudy Start
First participant enrolled
May 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2019
CompletedAugust 1, 2019
July 1, 2019
1.8 years
March 23, 2017
July 30, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Medication Possession Ratio
MPR \>80%
Month 0(time of first dispense) to month 12 or discontinuation of medication, whichever occurs first
Persistence rate
allowance of 45 day time gap
Month 0(time of first dispense) to month 12 or discontinuation of medication, whichever occurs first
Secondary Outcomes (3)
Health-belief model
Month 0(time of first dispense) to month 12 or discontinuation of medication, whichever occurs first
Provider-patient relationship
Month 0(time of first dispense) to month 12 or discontinuation of medication, whichever occurs first
Pharmacist-patient relationship
Month 0(time of first dispense) to month 12 or discontinuation of medication, whichever occurs first
Study Arms (2)
Historical Control
PLACEBO COMPARATORPharmacy care was standard, high-touch model where an institutional specialty pharmacy contact patients via telephone. Standard adherence and counseling was offered over the phone to patients.
Pharmacist-intervention
EXPERIMENTALIn-person counseling with a clinical pharmacist prior and during treatment with an oral oncology medication. Patients meet with a clinical pharmacist prior, at month 3 and month 6 during the study.
Interventions
A clinical pharmacist provides patients with motivational counseling regarding their cancer treatments. Patients will be asked to complete three different surveys throughout the study; surveys focus on social support systems and both provider- and pharmacist-patient relationships
Patients that did not receive in-person motivational counseling support from a clinical pharmacist prior and during treatment
Eligibility Criteria
You may qualify if:
- Treatment with 1 or more oral oncology agents. Oral oncology agent defined as medication taken mouth with the purpose to treat a patient's cancer
- Treatment dispensed through the BMC Specialty Pharmacy
- Age\>18 years
- Life expectancy \>6 months
- Patients must have ability to give written consent, or, must have a legally authorized representative
You may not qualify if:
- Treatment indicated for neoadjuvant, adjuvant, peri-operative treatment
- Concurrent radiation treatment
- Patients that are unable to have oral oncology agents dispense through BMC Specialty Pharmacy
- Historical Control:
- controls:1 intervention match
- Matched to a patient in intervention group based on drug type
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Medical Centerlead
- Janssen Scientific Affairs, LLCcollaborator
Study Sites (1)
Boston Medical Center
Boston, Massachusetts, 02118, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
scott gould, PharmD
Boston Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2017
First Posted
April 7, 2017
Study Start
May 2, 2017
Primary Completion
February 15, 2019
Study Completion
February 15, 2019
Last Updated
August 1, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share