Pharmacist's Influence on Breast Cancer Patient Quality of Life

Breast Cancer, Quality of Life Clinical Trial

— PIBC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02746666
• Other study ID #: 1705201504032016
• Status: Completed
• Phase: N/A
• First received: April 9, 2016
• Last updated: October 26, 2016
• Start date: April 2016
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: University Hospital "Sestre milosrdnice"
• Contact: n/a
• Is FDA regulated: No
• Health authority: Croatia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer, Quality of Life
• Breast Neoplasms

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital "Sestre milosrdnice"

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in quality of life of a breast cancer patient under chemotherapy, after a clinical pharmacist's behavioral intervention, measured by EORTC B23 questionnaire		up to two months	No