Effect of Nurse-led Supportive Care on Caregiver Burden and Well-being
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 18, 2022
CompletedFirst Submitted
Initial submission to the registry
July 19, 2022
CompletedFirst Posted
Study publicly available on registry
July 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 24, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 13, 2023
CompletedJanuary 18, 2023
January 1, 2023
8 months
July 19, 2022
January 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Caregiver Well-Being Scale
Change from baseline Caregiver Well-Being Scale score at 9th weeks.
Study Arms (2)
Nurse-led Supportive Care Group
EXPERIMENTALControl Group
NO INTERVENTIONThe control group received only usual care. They did not receive any intervention during the study period.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Being the primary caregiver of breast cancer patients
- Literate
- Able to understand and complete the questionnaires
- Willingness to participate in the study
You may not qualify if:
- Having communication problems
- Having psychological diseases
- Receiving any supportive care
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Izmir Bakircay University Faculty of Health Sciences
Izmir, 35560, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pinar Zorba Bahceli, PhD
Izmir Bakircay University Faculty of Health Sciences Izmir, Turkey, 35560
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
July 19, 2022
First Posted
July 22, 2022
Study Start
April 18, 2022
Primary Completion
December 24, 2022
Study Completion
January 13, 2023
Last Updated
January 18, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share