Effectiveness of a perioperative support programme to reduce psychological distress for family caregivers of patients with early-stage lung cancer: study protocol for a randomised controlled trial.

Introduction: Family caregivers play a key role in providing ongoing long-term care and assistance to their loved ones during cancer treatment. However, family caregivers of patients with lung cancer are frequently unprepared for their roles and they may undergo psychological distress, thus reducing their own quality of life while affecting patients' health outcomes. Interventions that specifically target this population are lacking. This study aims to evaluate the effectiveness of a perioperative support programme on family caregivers of patients with early-stage lung cancer.

Methods And Analysis: This study is guided by the Stress-Coping Model. Family caregivers of patients diagnosed with early-stage lung cancer and those who are scheduled for lung resection treatment will be invited to participate. Participants will be randomised to groups that either receive the perioperative support programme or usual care. The intervention consists of four face-to-face intervention sessions during the hospital stay and two weekly telephone follow-up sessions after discharge. Primary and secondary outcomes will be assessed at baseline and at 4 and 12 weeks after the intervention. Primary outcomes will include psychological distress and secondary outcomes will include caregiving burden, quality of life, coping style and social support. Generalised estimation equation model will be used to analyse the intervention effects.

Ethics And Dissemination: The study was approved by the Ethics Committee of the Second Xiangya Hospital of Central South University (LYG2022003). The authors will disseminate the study's findings by publishing them in international scientific journals.

Trial Registration Number: ChiCTR2200058280.