Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058887) titled 'Mobile application for geriatric assessment and communication support to facilitate personalized multidisciplinary care in older adults with cancer (MAPLE2 pilot)' on Sept. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - National Cancer Center

Condition: Condition - Solid tumor or lymphoma Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - Our previous study (the MAPLE study) demonstrated that integrating geriatric assessment (GA) with structured communication support using a question prompt list (QPL) significantly facilitated discussion about aging-related concerns, leading to higher implementation of GA-guided management (GAM) recommendations and improved health outcomes among older adults with cancer. The MAPLE2 pilot study aims to evaluate the feasibility of a newly developed mobile application-based GA and QPL intervention among older adults with cancer aged 70 years or older who are initiating or changing systemic anticancer therapy. Basic objectives2 - Others

Intervention: Interventions/Control_1 - The intervention will, in principle, be conducted by patients themselves using the mobile application, with investigators assisting them as needed. 1. GA: Patients will complete the GA on the mobile application during waiting time before consultation. Based on the GA results, predefined management recommendations for identified vulnerable domains will be automatically generated. 2. QPL: According to the GA results, a tailored QPL will be generated and displayed in the application. Patients will identify their aging-related concerns and express their preferences regarding treatment and care by responding to the questions. 3. Care Plan Sharing: A tailored care plan will be created within the application, based on GA results and selected QPL items. The generated care plan will be shared between patients and physicians at the first outpatient visit following the intervention. Interventions/Control_2 - Usual care

Eligibility: Age-lower limit - 70 years-old =70 years 3. Scheduled to initiate or change the line of systemic anticancer therapy (chemotherapy, molecularly targeted therapy, or immunotherapy) 4. ECOG Performance Status of 0-2 5. Ability to read, write, and understand Japanese 6. Provision of written informed consent 7. Presence of at least one impaired GA domain at the time of registration Key exclusion criteria - 1. Participation or planned participation in other interventional studies that may interfere with this study (e.g., other psychological or communication support studies, or therapeutic clinical trials) 2. Judged by their attending oncologists to be unsuitable for participation 3. Presence of severe cognitive impairment without a proxy or legal representative Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 08 Month 05 Day Anticipated trial start date - 2025 Year 09 Month 08 Day Last follow-up date - 2030 Year 08 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067348

Disclaimer: Curated by HT Syndication.