Tokyo, June 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061943) titled 'Pilot Study of Empathic Assessment and Coping Support for Dyspnea in Patients with Advanced Lung Cancer' on June 17.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Gifu University

Condition: Condition - Lung Cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to exploratorily evaluate the feasibility and acceptability of a nurse led nonpharmacological intervention for dyspnea in patients with advanced lung cancer. The intervention includes empathic assessment of symptom experiences, individualized self management support, breathing techniques, and coping strategies provided from hospital discharge through the outpatient period. Outcomes include self efficacy, dyspnea intensity, anxiety and depression, and participants subjective experiences. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Nurse led non pharmacological intervention consisting of empathic assessment of dyspnea experiences, assessment of psychosocial factors, breathing techniques, self management support, and individualized coping strategies. The intervention is delivered at hospital discharge, the first outpatient visit, and the second outpatient visit.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients diagnosed with advanced lung cancer (stage IIIb/IV or recurrent disease) and receiving anticancer drug therapy; patients with subjective dyspnea and a dyspnea score of 2 or higher on the breathlessness item of the questionnaire on ease of daily living at admission; patients scheduled for an outpatient visit approximately 2 weeks after discharge; age 20 years or older; able to provide written informed consent; and able to communicate in Japanese and participate in face to face interviews. Key exclusion criteria - Patients judged to have difficulty expressing their intentions due to cognitive impairment or disturbance of consciousness. Patients judged to have marked difficulty participating in the study because of psychiatric disorders or acute psychological symptoms. Patients with severe comorbidities that are expected to cause acute exacerbation of dyspnea during the study period (e.g., acute exacerbation of interstitial lung disease or severe infection). Patients considered inappropriate for study participation by the attending physician or the principal investigator. Target Size - 10

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 05 Day Date of IRB - 2026 Year 06 Month 15 Day Anticipated trial start date - 2026 Year 08 Month 01 Day Last follow-up date - 2026 Year 10 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070876

Disclaimer: Curated by HT Syndication.