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

NCT06204289 | Completed

• 1 other identifier: 2022/754
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nurse-led Supportive Care

Keywords

Lung cancer; Family caregivers; Caregiver burden; Resilience

Outcome Measures

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.

  The scale was filled in the baseline (before the beginning of the nurse-led supportive care), 8th and 12th weeks.

Secondary Outcomes (1)

• Connor-Davidson Resilience Scale Short Form (CDRSSF)

  The scale was filled in the baseline (before the beginning of the nurse-led supportive care), 8th and 12th weeks.

Study Arms (2)

Nurse-led Supportive Care Group

EXPERIMENTAL

Nurse-led supportive care was given to family caregivers of patients with lung cancer.

Behavioral: Nurse-led Supportive Care Programme

Control Group

NO INTERVENTION

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

Interventions

Nurse-led Supportive Care Programme BEHAVIORAL

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.

Nurse-led Supportive Care Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Izmir Bakircay University: lead

Study Sites (1)

Izmir Bakircay University Faculty of Health Sciences

Izmir, 35560, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lung Neoplasms; Caregiver Burden

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Pinar Zorba Bahceli, PhD

  Izmir Bakircay University Faculty of Health Sciences Izmir, Turkey, 35560

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 12, 2024
• Study Start: July 31, 2023
• Primary Completion: January 22, 2024
• Study Completion: February 29, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)