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Pharmacist-led Intervention on Adherence in Patients Undergoing Treatment With an Oral Oncology Medication (BSPAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03104114
Recruitment Status : Completed
First Posted : April 7, 2017
Last Update Posted : August 1, 2019
Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Boston Medical Center

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.

Condition or disease Intervention/treatment Phase
Adherence, Medication Behavioral: pharmacist-intervention Behavioral: Historical control Not Applicable

Detailed Description:
Boston Medical Center's Specialty Pharmacy Adherence Program (B-SPAP) will focus on improving adherence and persistence through the implementation of a high-touch program. In order to be eligible for the program, patients must be initiated on oral chemotherapy or targeted therapy with a life expectancy >6 months. All patients will be administered a Patient Activation Measure (PAM) 13 survey prior to consultation. Patients eligible for our program will receive a 30-60 minute pharmacist consultation prior to initiation of treatment. The pharmacy consultation includes, but is not limited to the dissemination of medical information utilizing a standardized counseling checklist, supplying of patient education materials, pharmacist-led interventions, and/or the use of other materials or devices that may improve patient adherence. All counseling checklists and monitoring will be standardized and approved by a multidisciplinary oncology team. At week 1, 2, and 4, patients will be contacted by the pharmacist for an assessment of treatment goals; monthly contacts will continue thereafter by either a specialty pharmacist or certified pharmacy technician. Scheduled follow up visits with the consulting pharmacist will be made at months 3, 6 and 12. Prior to the scheduled pharmacist consultation, patients will be administered the PAM 13 survey. Patients with a treatment gap >37 days will be referred to the consulting pharmacist for follow up. The consulting pharmacist will attempt to contact the patient via telephone for an assessment of adherence and adverse drug-related events. If patients experience a treatment gap >45, then the patient will be contacted and scheduled for a pharmacist consultation, additionally, the prescribing provider will be notified. All consultations and interventions will be documented in the hospital's electronic medical record system, EPIC®.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pharmacist-led intervention group vs historical-control group
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluating Adherence and Persistence in Patients Receiving Oral Oncolytic Therapy in a Safety Net Hospital's Pharmacist-driven Medication Management Program
Actual Study Start Date : May 2, 2017
Actual Primary Completion Date : February 15, 2019
Actual Study Completion Date : February 15, 2019

Arm Intervention/treatment
Placebo Comparator: Historical Control
Pharmacy 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.
Behavioral: Historical control
Patients that did not receive in-person motivational counseling support from a clinical pharmacist prior and during treatment

Experimental: Pharmacist-intervention
In-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.
Behavioral: pharmacist-intervention
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

Primary Outcome Measures :
  1. Medication Possession Ratio [ Time Frame: Month 0(time of first dispense) to month 12 or discontinuation of medication, whichever occurs first ]
    MPR >80%

  2. Persistence rate [ Time Frame: Month 0(time of first dispense) to month 12 or discontinuation of medication, whichever occurs first ]
    allowance of 45 day time gap

Secondary Outcome Measures :
  1. Health-belief model [ Time Frame: Month 0(time of first dispense) to month 12 or discontinuation of medication, whichever occurs first ]
    PAM-13 surveys

  2. Provider-patient relationship [ Time Frame: Month 0(time of first dispense) to month 12 or discontinuation of medication, whichever occurs first ]
    Trust-in-physician survey

  3. Pharmacist-patient relationship [ Time Frame: Month 0(time of first dispense) to month 12 or discontinuation of medication, whichever occurs first ]
    Pharmacist satisfaction survey

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Pharmacist-intervention group

Inclusion Criteria:

  1. 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
  2. Treatment dispensed through the BMC Specialty Pharmacy
  3. Age>18 years
  4. Life expectancy >6 months
  5. Patients must have ability to give written consent, or, must have a legally authorized representative

Exclusion Criteria:

  1. Treatment indicated for neoadjuvant, adjuvant, peri-operative treatment
  2. Concurrent radiation treatment
  3. Patients that are unable to have oral oncology agents dispense through BMC Specialty Pharmacy

Historical Control:

  1. 2 controls:1 intervention match
  2. Matched to a patient in intervention group based on drug type

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03104114

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United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Janssen Scientific Affairs, LLC
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Principal Investigator: scott gould, PharmD Boston Medical Center

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Responsible Party: Boston Medical Center Identifier: NCT03104114     History of Changes
Other Study ID Numbers: H-35671
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No