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

Primary Purpose

Nurse-led Supportive Care

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Nurse-led supportive care
Sponsored by
Izmir Bakircay University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nurse-led Supportive Care focused on measuring Breast cancer, Caregiver burden, Well-being, Nurse-led care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Izmir Bakircay University Faculty of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Nurse-led Supportive Care Group

Control Group

Arm Description

The control group received only usual care. They did not receive any intervention during the study period.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
July 19, 2022
Last Updated
January 16, 2023
Sponsor
Izmir Bakircay University
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1. Study Identification

Unique Protocol Identification Number
NCT05470543
Brief Title
Effect of Nurse-led Supportive Care on Caregiver Burden and Well-being
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
April 18, 2022 (Actual)
Primary Completion Date
December 24, 2022 (Actual)
Study Completion Date
January 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Izmir Bakircay University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nurse-led Supportive Care
Keywords
Breast cancer, Caregiver burden, Well-being, Nurse-led care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nurse-led Supportive Care Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group received only usual care. They did not receive any intervention during the study period.
Intervention Type
Behavioral
Intervention Name(s)
Nurse-led supportive care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Zarit Burden Interview (ZBI)
Description
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
Time Frame
Change from baseline Zarit Burden Interview score at 9th weeks.
Secondary Outcome Measure Information:
Title
Caregiver Well-Being Scale
Description
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.
Time Frame
Change from baseline Caregiver Well-Being Scale score at 9th weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pinar Zorba Bahceli, PhD
Organizational Affiliation
Izmir Bakircay University Faculty of Health Sciences Izmir, Turkey, 35560
Official's Role
Principal Investigator
Facility Information:
Facility Name
Izmir Bakircay University Faculty of Health Sciences
City
Izmir
ZIP/Postal Code
35560
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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