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NCT Number: NCT05470543

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

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.

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Key information

Conditions

Nurse-led Supportive Care Behavior Behavioral Symptoms Breast Diseases Breast Neoplasms Caregiver Burden Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Izmir Bakircay University Faculty of Health Sciences

Izmir, 35560, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nurse-led Supportive Care

Behavioral

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 outcomes

  1. Zarit Burden Interview (ZBI)

    Time frame: 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 outcomes

  1. Caregiver Well-Being Scale

    Time frame: Change 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.

Sponsors and collaborators

Lead sponsor

Izmir Bakircay University

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jul 22, 2022
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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