CognIFied Trial

MAPLE2 is a multicentre, open-label, parallel-group pilot RCT conducted at two academic hospitals in Tokyo, Japan. The trial compares adapted CCT with Enhanced Recreational Therapy as an active control condition. Participants are randomised 1:1 to enhanced usual care only or enhanced usual care plus vSH+. The target enrolment of 40 participants is consistent with the CONSORT 2010 pilot extension recommendation of approximately 10% of the anticipated definitive trial size. The trial is primarily intended to inform a future definitive trial rather than establish clinical effectiveness. The protocol was co-designed with a cancer survivor and a family member of a patient with pancreatic cancer, and reviewed by patient and public involvement representatives. Randomisation uses stratified block design with allocation balanced by study site, cancer type, treatment goal, and line of treatment. Blinding of participants and oncologists is not possible given the nature of the digital intervention. Quality of life is assessed using the EORTC QLQ-C30, a 30-item instrument covering five functional domains, a global health status scale, nine symptom scales, and a financial difficulties item. Cog…