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Trial record 3 of 22 for:    cancer | First posted from 04/21/2016 to 04/21/2016

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

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.
ClinicalTrials.gov Identifier: NCT02746666
Recruitment Status : Completed
First Posted : April 21, 2016
Last Update Posted : October 27, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Breast Cancer, Quality of Life Behavioral: Pharmacist's behavioral intervention

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Influence of a Clinical Pharmacist's Intervention on Quality of Life of a Breast Cancer Patient Under Adjuvant Chemotherapy
Study Start Date : April 2016
Primary Completion Date : June 2016
Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
More Information

Responsible Party: Robert Šeparović, MD PHD, University Hospital "Sestre milosrdnice"
ClinicalTrials.gov Identifier: NCT02746666     History of Changes
Other Study ID Numbers: 1705201504032016
First Posted: April 21, 2016    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases