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CompletedNCT05470543Updated Jan 18, 2023

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

An interventional study of Nurse-led supportive care in Nurse-led Supportive Care, sponsored by Izmir Bakircay University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-18.

Sponsored by Izmir Bakircay University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Apr 2022, registered Jul 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Nurse-led Supportive Care

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Keywords

  • Breast cancer
  • Caregiver burden
  • Well-being
  • Nurse-led care
03

In context

Caregiver Burden

422 studies on the registry are indexed under Caregiver Burden; 151 are open to participants now.

This study's enrollment of 60 is below the median of 73 across 330 interventional studies indexed under Caregiver Burden.

Browse Caregiver Burden studies →

Lead sponsor

Izmir Bakircay University is the lead sponsor of 73 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Having communication problems
  • Having psychological diseases
  • Receiving any supportive care
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Nurse-led Supportive Care Group

    Behavioral: Nurse-led supportive care

  • No intervention
    Control Group

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

Interventions

  • BehavioralNurse-led supportive care

    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.

06

What researchers measure

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

    Time frame: Change from baseline Zarit Burden Interview score at 9th weeks.

Secondary outcomes

  1. 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.

    Time frame: Change from baseline Caregiver Well-Being Scale score at 9th weeks.

07

Study locations

1 site
  • Izmir Bakircay University Faculty of Health Sciences
    Izmir, 35560, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05470543
Lead sponsor
Izmir Bakircay University
Responsible party
Pinar Zorba Bahceli, PhD RN (Assistant Professor, Izmir Bakircay University) — Principal investigator
First posted
Jul 22, 2022
Start date
Apr 18, 2022
Primary completion
Dec 24, 2022
Completion
Jan 13, 2023
Last update
Jan 18, 2023

Study contacts

Pinar Zorba Bahceli, PhD
principal investigator · Izmir Bakircay University Faculty of Health Sciences Izmir, Turkey, 35560

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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