Gastrointestinal Cancer clinical trials

Patient Reported Scale vs CTCAE Grading: A Prospective Comparator Study

Over a million new cancer cases are diagnosed in India each year. This huge burden coupled with inadequate infrastructural facilities is adversely affecting the quality of patient care. As a side effect it is adding to cost of health care which patient is paying from his/her own pocket. Total care of cancer patients taking chemotherapy is interrupted by several obstacles some of which can be prevented or detected early and treated. Most of the patients experience toxicity during cancer chemotherapy but the reporting remains inadequate as patients are not aware how to report or the physicians, many a times, are extremely busy to record and act on them early. We assume that using patient reported adverse event (AE) scale is more practical and easier to use for reporting AEs. This intervention, we feel, can pick more AEs which can lead to early intervention by the physician and ultimately reducing the cost of treatment to patients. We plan to include adult patients (>18years) having Gastro-intestinal cancers (both colorectal and non-colorectal cancers) who are scheduled to receive combination chemotherapy medicines with both curative and non-curative intent (in patients with advanced cancers). Patients will be given an AE scale and will be asked to fill it at home during each chemotherapy cycle, for upto 4 cycles. The physician will also ask them about the AE during the next clinic visit and record the AEs as per the widely accepted AE scale (Common Terminology Criteria for Adverse Events-CTCAE) for reporting. The patient reported AE scale will then be compared and analyzed with standard CTCAE using relevant statistical methods.