Clinical Trial: A before-and-after controlled trial evaluating the effectiveness of patient-reported outcomes in outpatient cancer chemotherapy (Japan)

Tokyo, April 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061122) titled 'A before-and-after controlled trial evaluating the effectiveness of patient-reported outcomes in outpatient cancer chemotherapy' on April 1.

Study Type: Interventional

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

Primary Sponsor: Institute - Tohoku University Graduate School

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

Objective: Narrative objectives1 - As a pilot study to evaluate the effectiveness of electronic patient-reported outcomes (PROs) for patients undergoing outpatient chemotherapy, we will evaluate the feasibility of PRO-CTCAE, patient-provider communication, and questionnaire responses to measure quality of life after cancer treatment. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - A system created by 3H MediSolutions, Inc. is downloaded onto the research participant's smartphone, and a membership number is registered without entering the research participant's name. Pro-CTCAE is entered into the system once a week. If participants are unable to enter it themselves, a family member or medical professional will enter it.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - (1) Patients diagnosed with cancer, including solid tumors and hematologic cancers (2) Cancer patients with recurrence or metastasis (3) Patients starting a new cancer chemotherapy regimen (second-line or third-line treatment) in the outpatient chemotherapy room of the target facility (4) Able to independently complete ePRO using a smartphone Key exclusion criteria - (1) Those whose life expectancy is expected to be within three months (2) Those deemed inappropriate by a doctor Target Size - 60

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 06 Day Anticipated trial start date - 2026 Year 05 Month 01 Day Last follow-up date - 2026 Year 07 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069624

Disclaimer: Curated by HT Syndication.