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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05470543
Enrollment
60
Registered
2022-07-22
Start date
2022-04-18
Completion date
2023-01-13
Last updated
2023-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nurse-led Supportive Care

Keywords

Breast cancer, Caregiver burden, Well-being, Nurse-led care

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.

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.

Sponsors

Izmir Bakircay University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
Caregiver Well-Being ScaleChange 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026