Effect of Nurse-led Supportive Care on Caregiver Burden and Well-being

Not Applicable

Completed

• Conditions: Nurse-led Supportive Care
• Interventions: Behavioral: Nurse-led supportive care

• Registration Number: NCT05470543
• Lead Sponsor: Izmir Bakircay University

Brief Summary

Breast cancer is the most common type of cancer in women with a high mortality rate in the world. Women may experience many different physiological and psychological symptoms (such as pain, nausea-vomiting, fatigue, stress, anger, and isolation) during diagnosis and treatment process. Family members often become caregivers at the time of diagnosis, and treatment of breast cancer patients. Therefore, family caregivers experience burden and poor health-related quality of life.

Detailed Description

This a pragmatic, parallel group randomized controlled trial aimed that investigating the effect of nurse-led supportive care on caregiver burden and well-being among primary caregivers of women with breast cancer. This trial was conducted in the chemotherapy outpatient clinic of training and research hospital located in Turkey. All primary caregivers were family members.

Study Timeline

• Study Start: 2022-04-18
• Study First Submitted: 2022-07-19
• Study First Submitted QC: 2022-07-21
• Study First Posted: 2022-07-22
• Primary Completion: 2022-12-24
• Status Verified: 2023-01
• Study Completion: 2023-01-13
• Last Update Submitted: 2023-01-16
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Being the primary caregiver of breast cancer patients
• Literate
• Able to understand and complete the questionnaires
• Willingness to participate in the study

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nurse-led Supportive Care Group	Nurse-led supportive care	-

Primary Outcome Measures

Name	Time	Method
Zarit Burden Interview (ZBI)	Change from baseline Zarit Burden Interview score at 9th weeks.	The ZBI is a measure of caregiving burden developed by Zarit et al. (1980). The Turkish version of this scale has been validated by Inci and Erdem (2018). It consists of 22 items, and responses are recorded on a five-point Likert scale. The level of caregiver burden can be ascertained based on the total scale scores, which range from 0 to 88. Higher scores indicate a higher level of caregiver burden.The Cronbach's α of the Turkish version of this scale was 0.91 in Inci and Erdem (2018) validation study

Secondary Outcome Measures

Name	Time	Method
Caregiver Well-Being Scale	Change from baseline Caregiver Well-Being Scale score at 9th weeks.	The scale was developed by Berg-Weber et al. (2000) in order to measure the level of caregivers of patients with chronic diseases to meet their basic needs and activities of living. The scale is made up of two subscales, namely, basic needs and activities of living, which try to measure the daily activity level of the caregivers. It consists of 44 items, and responses are recorded on a five-point Likert scale. Higher scores indicate a higher level of well-being. The Cronbach's α of the Turkish version of this scale was 0.86 in Demirtepe and Bozo (2009) validation study.

Trial Locations

Locations (1)

Izmir Bakircay University Faculty of Health Sciences; 🇹🇷 Izmir, Turkey