Tokyo, June 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061852) titled 'A Study of Video-Based Education for Safe Handling of Oral Anticancer Drugs at Home' on June 15.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Condition:
Condition - Gastrointestinal cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to evaluate the usefulness of video-based patient education on safe handling of oral anticancer agents at home by assessing adherence to safe handling practices after the intervention and changes in knowledge and self-efficacy before and after video-based education.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Participants will view a standardized educational video on safe handling of oral anticancer agents at home, followed by pharmacist-led question-and-answer counseling and teach-back. Knowledge and self-efficacy will be assessed before the intervention, and video evaluation and psychological impact will be assessed after viewing. At the second treatment cycle after discharge, safe handling practices at home, knowledge, and self-efficacy will be reassessed.
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Patients with gastrointestinal cancer who are chemotherapy-naive and newly start a regimen including oral anticancer agents during hospitalization. 2. Patients who provide written informed consent to participate in the study. 3. Patients aged 18 years or older on the date of registration.
Key exclusion criteria - 1. Patients who have previously received education on exposure prevention for anticancer agents. 2. Patients who have difficulty viewing the video because of visual impairment, hearing impairment, or other reasons. 3. Patients with cognitive impairment. 4. Patients who do not provide informed consent. 5. Patients judged to have difficulty participating in the study because of clinically significant psychiatric or neurological symptoms. 6. Patients judged by the physician to be unsuitable for enrollment.
Target Size - 56
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 05 Month 21 Day
Date of IRB - 2026 Year 05 Month 28 Day
Anticipated trial start date - 2026 Year 06 Month 15 Day
Last follow-up date - 2027 Year 11 Month 14 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070758
Disclaimer: Curated by HT Syndication.