Tokyo, Sept. 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062823) titled 'A Study to Evaluate the Effectiveness of a Decision Support Program Using a Question Prompt List and Nurse-led Navigation for Patients with Hematological Malignancies (MagiQ Study)' on Sept. 8.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Kansai Medical University
Condition:
Condition - Adult patients newly diagnosed with diffuse large B-cell lymphoma, follicular lymphoma, multiple myeloma, or myelodysplastic syndrome who are scheduled to receive first-line treatment
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate whether a decision support program combining a Question Prompt List(QPL) with nurse-led navigation improves patients' satisfaction with decision support compared with usual care among patients with hematological malignancies.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - In addition to receiving the common booklet, participants will receive a single session of a decision support program consisting of nurse-led navigation using a Question Prompt List (QPL) for patients with hematological malignancies before the physician consultation.
Interventions/Control_2 - Participants will receive usual care, including the common booklet provided to both groups.
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Patients who are able to communicate in Japanese.
2. Patients who have received a sufficient explanation of the study, fully understood its content, and provided written informed consent to participate of their own free will.
Key exclusion criteria - 1. Patients with a history of chemotherapy or radiotherapy.
2. Patients whom a physician judges to be unable to participate in the study because of a marked decline in physical functioning or severe distress.
3. Patients with a serious psychiatric disorder or dementia.
Target Size - 292
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 08 Month 17 Day
Date of IRB - 2026 Year 08 Month 17 Day
Anticipated trial start date - 2026 Year 09 Month 28 Day
Last follow-up date - 2028 Year 09 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066184
Disclaimer: Curated by HT Syndication.