Effects of Nurse-led Supportive Care Programme on Caregiver Burden and Resilience of Family Caregivers

January 3, 2024 updated by: Pinar Zorba Bahceli, PhD RN, Izmir Bakircay University

Effects of Nurse-led Supportive Care Programme on Caregiver Burden and Resilience of Family Caregivers of Patients With Lung Cancer: A Pragmatic Randomized Controlled Trial

Lung cancer is the leading cause of cancer-related deaths worldwide, with a mortality rate of 18%. The prognosis of lung cancer is progressive and devastating, which may cause patients to experience problems during the treatment and care process. Due to the problems experienced by lung cancer patients, their need for support increases and the care process is provided mostly in the home environment, causing family members to take on important roles as caregivers. Therefore, the resilience of family caregivers decreases and they feel burden.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Izmir, Turkey, 35560
        • Recruiting
        • Izmir Bakircay University Faculty of Health Sciences
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • A family member who has been a primary caregiver for at least one year
  • Literate
  • Willingness to participate in the study

Exclusion Criteria:

  • Have any communication disability
  • Have any diagnosed physical or psychological disorder
  • Receiving any supportive care

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
The control group received only usual care. They did not receive any intervention during the study period.
Experimental: Nurse-led Supportive Care Group
Nurse-led supportive care was given to family caregivers of patients with lung cancer.
Behavioral: Nurse-led Supportive Care Programme
Nurse-led supportive care programme was applied to family caregivers for eight weeks in the form of face-to-face clinic interviews. It took an average of 40 minutes to interview with family caregivers at the clinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Zarit Burden Interview (ZBI)
Time Frame: The scale was filled in the baseline (before the beginning of the nurse-led supportive care), 8th and 12th 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.
The scale was filled in the baseline (before the beginning of the nurse-led supportive care), 8th and 12th weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Connor-Davidson Resilience Scale Short Form (CDRSSF)
Time Frame: The scale was filled in the baseline (before the beginning of the nurse-led supportive care), 8th and 12th weeks.
The CDRSSF was developed to determine the psychological resilience of individuals, which enables them to return to their former state after negative events they have experienced.It is a 5-point Likert-type scale with 10 items.The level of resilience can be ascertained based on the total scale scores, which range from 0 to 40. High scores obtained from the scale are considered as high psychological resilience. The Turkish validity and reliability of the scale was conducted by Kaya and Odacı (2020).
The scale was filled in the baseline (before the beginning of the nurse-led supportive care), 8th and 12th weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir Bakircay University

Investigators

  • Study Director: Pinar Zorba Bahceli, PhD, Izmir Bakircay University Faculty of Health Sciences Izmir, Turkey, 35560

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2023

Primary Completion (Estimated)

January 22, 2024

Study Completion (Estimated)

February 29, 2024

Study Registration Dates

First Submitted

January 3, 2024

First Submitted That Met QC Criteria

January 3, 2024

First Posted (Actual)

January 12, 2024

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/754

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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