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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Nurse-led Supportive Care

Intervention / Treatment
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* Behavioral: Nurse-led supportive care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nurse-led Supportive Care Group<br> | Behavioral: Nurse-led supportive care<br>* 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.<br>|
| No Intervention: Control Group<br>The control group received only usual care. They did not receive any intervention during the study period. | |

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Caregiver burden, Well-being, Nurse-led care