Pharmacist's Influence on Breast Cancer Patient Quality of Life (PIBC)

October 26, 2016 updated by: Robert Šeparović, University Hospital "Sestre Milosrdnice"

Influence of a Clinical Pharmacist's Intervention on Quality of Life of a Breast Cancer Patient Under Adjuvant Chemotherapy

The purpose of this study is to investigate the impact of pharmacist behavioral intervention's influence on breast cancer patients' quality of life. Croatian randomized controlled trial. Targeted population: general population of breast cancer patients under the first adjuvant anthracycline chemotherapy. Primary outcome: difference in EORTC QLQ-BR23 questionnaire result from the baseline to after 3 week cycle.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Early breast cancer
  • First adjuvant chemotherapy
  • Chemotherapy protocol: anthracycline x 4

Exclusion Criteria:

  • Cardiovascular comorbidities
  • Regular nausea or vomiting during six months before enrollment
  • Unable to answer the quality of life questionnaire on their own

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Under pharmacist's behavioral intervention
Behavioral: Pharmacist's behavioral intervention
Pharmacist's 30 min counselling on antiemetic therapy, causes of nausea or vomiting and ways to prevent them during chemotherapy.
No Intervention: Control
No pharmacist's behavioral intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
changes in quality of life of a breast cancer patient under chemotherapy, after a clinical pharmacist's behavioral intervention, measured by EORTC B23 questionnaire
Time Frame: up to two months
up to two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital "Sestre Milosrdnice"

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

April 9, 2016

First Submitted That Met QC Criteria

April 20, 2016

First Posted (Estimate)

April 21, 2016

Study Record Updates

Last Update Posted (Estimate)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1705201504032016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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