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Completed

NCT Number: NCT06204289

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

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.

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Key information

Conditions

Nurse-led Supportive Care Behavior Behavioral Symptoms Caregiver Burden Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Stress, Psychological Thoracic Neoplasms

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)

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Izmir Bakircay University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 12, 2024
Registry last updated
Aug 6, 2024

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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