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Clinical Trials/NCT05399160
NCT05399160
Completed
Not Applicable

Effect of Nurse-led Supportive Care on Quality of Life in Women With Breast Cancer: An Assessor-blinded, Parallel Group, Randomized Controlled Trial

Izmir Bakircay University1 site in 1 country42 target enrollmentJanuary 3, 2022
ConditionsQuality of Life

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Quality of Life
Sponsor
Izmir Bakircay University
Enrollment
42
Locations
1
Primary Endpoint
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire-Core Questionnaire (QLQ-C30)
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Breast cancer is the most common type of cancer in women with a high mortality rate in the world. The several methods are used in the treatment of breast cancer. One or more of these methods can be preferred according to the characteristics of women with breast cancer. Women may experience many different physiological and psychological symptoms during each treatment process.This situation negatively affects the quality of life of women with breast cancer. For this reason, there is a need for an intervention that could improve quality of life in women with breast cancer. In the literature, it is stated that nurse-led supportive care can be an effective nursing intervention to improve the quality of life in women with breast cancer.

Detailed Description

This an assessor-blinded, parallel group randomized controlled trial aimed that investigating the effect of nurse-led supportive care on quality of life in women with breast cancer. This trial was conducted in the general surgery clinic of training and research hospital located in Turkey. All patients were women who had breast surgery.

Registry
clinicaltrials.gov
Start Date
January 3, 2022
End Date
June 10, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Izmir Bakircay University
Responsible Party
Principal Investigator
Principal Investigator

Pinar Zorba Bahceli, PhD RN

Asistant Professor

Izmir Bakircay University

Eligibility Criteria

Inclusion Criteria

  • 18 years and older women,
  • Stages II or III breast cancer
  • Having breast cancer surgery
  • Planned to receive chemotherapy
  • Able to use a phone
  • Who agreed to participate in the study

Exclusion Criteria

  • Having communication problems
  • Having psychological diseases
  • Receiving any supportive care

Outcomes

Primary Outcomes

European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire-Core Questionnaire (QLQ-C30)

Time Frame: Change from Baseline Quality of Life score at 9th weeks.

The scale was developed to assess the quality of life of cancer patients. It contains three domains that measure global health status/quality of life, functional and symptom status. Global quality of life is assessed using global health status and quality of life. Functional status consists of the following five subscales: physical function, role function, emotional function, cognitive function and social function. Symptom status consists of the following nine subscales: fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea and financial difficulties. The total score that can be obtained from the scale ranges from 0 to 100. The internal consistency of scale in the Turkish version was determined as 0.90.

Study Sites (1)

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