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

Effect of Nurse-led Supportive Care on Caregiver Burden and Well-being Among Primary Caregivers of Women With Breast Cancer: A Pragmatic Parallel Group Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Nurse-led Supportive Care
• Intervention / Treatment: Behavioral: Nurse-led supportive care

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Izmir, Turkey, 35560
    • Izmir Bakircay University Faculty of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nurse-led Supportive Care Group	Behavioral: Nurse-led supportive care; Nurse-led supportive care was given to primary caregivers of women with breast cancer. Nurse-led supportive care was applied to primary caregivers for eight weeks in the form of face-to-face clinic interviews. It took an average of 30 minutes to interview with primary caregivers at the clinic.
No Intervention: Control Group; The control group received only usual care. They did not receive any intervention during the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Zarit Burden Interview (ZBI)	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	Change from baseline Zarit Burden Interview score at 9th weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver Well-Being Scale	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.	Change from baseline Caregiver Well-Being Scale score at 9th weeks.

Collaborators and Investigators

• Sponsor: Izmir Bakircay University
• Investigators: Principal Investigator: Pinar Zorba Bahceli, PhD, Izmir Bakircay University Faculty of Health Sciences Izmir, Turkey, 35560

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2022
• Primary Completion (Actual): December 24, 2022
• Study Completion (Actual): January 13, 2023

Study Registration Dates

• First Submitted: July 19, 2022
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (Actual): July 22, 2022

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 16, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Breast cancer; Caregiver burden; Well-being; Nurse-led care
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Caregiver Burden
• Other Study ID Numbers: 2019/639

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No