Clinical Trial: Examination of the Utility of a Dialogue-Based Nursing Practice Model (Ver.2) for Sharing Meaningful Way of Living among Patients with Treatment-Resistant Illness (Japan)

Tokyo, Feb. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060749) titled 'Examination of the Utility of a Dialogue-Based Nursing Practice Model (Ver.2) for Sharing Meaningful Way of Living among Patients with Treatment-Resistant Illness' on Feb. 25.

Study Type: Interventional

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

Primary Sponsor: Institute - Chiba University

Condition: Condition - Treatment-resistant illness (including cancer and non-cancer) Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To examine the effectiveness of implementing a Dialogue-Based Nursing Practice Model (Ver.2) for sharing meaningful way of living among patients with treatment-resistant illness, focusing on improving patient satisfaction and enhancing general nurses' communication skills. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - General nurses conduct dialogues with patients with treatment-resistant illness using the Dialogue-Based Nursing Practice Model (Ver.2). The dialogues are conducted multiple times during hospitalization (approximately 3 times as a guide), through a process of attentively receiving and clarifying the patient's meaningful way of living, and sharing it between the patient and healthcare providers.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - [Patients] 1) Aged 20 years or older and capable of communicating their own wishes; 2) In a physical and mental condition that allows dialogues of approximately 30 minutes; 3) Diagnosed with treatment-resistant illness and having received explanations from a physician regarding their condition, current treatment, and treatment goals; 4) For cancer patients: judged by a physician as relapsed/refractory, undergoing 3 or more lines of treatment regimens, or hospitalized due to poorly controlled complications; for non-cancer patients: judged by a physician as relapsed/refractory or repeatedly hospitalized in a declining phase. [Nurses] 1) Ward nurses with at least 2 full years of experience in the same ward and at least 3 years of overall nursing experience; 2) Having attained Japanese Nursing Association Clinical Ladder (2023 revised edition) Level I or above. Key exclusion criteria - [Patients] 1) Unable to communicate their own wishes due to impaired consciousness or cognitive decline; 2) In a physical or mental condition that makes 30-minute dialogues difficult; 3) Those whose attending physician judges participation to be inappropriate based on the patient's understanding of their medical condition; 4) Those who do not provide informed consent for participation; 5) Those judged by the researcher or attending nurse as unsuitable for participation. [Nurses] 1) Those who do not provide informed consent for participation. Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 09 Month 16 Day Date of IRB - 2025 Year 11 Month 18 Day Anticipated trial start date - 2026 Year 02 Month 04 Day Last follow-up date - 2026 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069514

Disclaimer: Curated by HT Syndication.