Tokyo, Aug. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062532) titled 'Support for Cancer patients receiving genomics testing and Advanced Therapeutics: A Feasibility Study' on Aug. 10.

Study Type: Interventional

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

Primary Sponsor: Institute - National Cancer Center

Condition: Condition - Advanced cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - This feasibility study aims to evaluate the feasibility of implementing, in clinical practice, a support program designed to alleviate distress among patients undergoing comprehensive genomic profiling testing. The program consists of follow-up provided by an interventionist using a checklist after the consultation in which the test results are explained. Basic objectives2 - Others

Intervention: Interventions/Control_1 - All registered patients will receive a single session support program using a checklist after the consultation in which the results of comprehensive genomic profiling testing are explained. After the results disclosure consultation, each patient will complete the checklist. The interventionist will review the responses to assess the patient's understanding, questions, concerns, and need for support. When necessary, the interventionist will provide follow up tailored to the identified needs, including supplementary explanations, responses to questions, confirmation of understanding, and referral or guidance to appropriate consultation and support services. The intervention will be considered complete when the checklist has been completed and collected and, for patients identified as requiring support, the specified follow-up response has been completed.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients receiving outpatient care at the National Cancer Center Hospital. 2. Patients who have been informed of their cancer diagnosis. 3. Patients with a solid tumor who have agreed to undergo comprehensive genomic profiling (CGP) testing. 4. Patients who are able to provide informed consent to participate in the study. 5. Patients aged 18 years or older who are able to read and understand the Japanese-language information sheet and questionnaires and complete the questionnaires independently. Key exclusion criteria - 1. Patients referred from a medical institution other than the National Cancer Center Hospital for the purpose of undergoing CGP testing. 2. Patients undergoing CGP testing for a hematologic malignancy. 3. Patients undergoing CGP testing under the Advanced Medical Care A framework. 4. Patients who are participating or planning to participate during the study period in another interventional study, including a psychological support study, communication intervention study, or clinical trial. 5. Patients who are considered by the attending physician to be unable to participate in the study. Target Size - 40

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 07 Month 20 Day Date of IRB - 2026 Year 07 Month 27 Day Anticipated trial start date - 2026 Year 08 Month 12 Day Last follow-up date - 2027 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071493

Disclaimer: Curated by HT Syndication.