Patient Reported Scale vs CTCAE Grading for Reporting Chemotherapy Related Adverse Effects: A Prospective Comparator Study

Population and setting: This study will be conducted at Tata Medical Center (TMC), Kolkata. Patients in TMC are managed using evidence-based treatment protocols and through multidisciplinary teams. Patients in this study will be drawn from those attending the cancer clinics. Adult patients (>18years age) receiving combination anti-cancer chemotherapy for gastro-intestinal cancers (colorectal and non-colorectal) will be enrolled.

Trial design: This is a single centre prospective study. Patients who provide written consent for the study will be enrolled. Most commonly used standard combination chemotherapy regimens used in our clinic will be taken in this study i.e., weekly (e.g., Paclitaxel-Carboplatin, Gemcitabine-Cisplatin), biweekly (e.g. FOLFOX/FOLFIRI/ FOLFOXIRI/FLOT/DCF/GEMOX), once every three weeks (e.g. Capox/CapIri/mDCF) or once every 4 weeks (e.g. ETOCIS/Capecitabine-Temozolomide) with or without Targeted therapy (e.g. Bevacizumab/Cetuximab/Panitumumab) and/or Immunotherapy (e.g. Pembrolizumab/ Nivolumab/Atezolizumab/Ipilimumab). No single agent chemotherapy will be considered. Patients will be stratified to type of combination chemotherapy with high and low probability of causing severe toxicities. This will be based on our experience in clinical practice. Chemotherapy combinations with high probability are FOLFOXIRI, FLOT, Capiri (Xeliri), mDCF and with low probability are FOLFOX, FOLFIRI, GEMOX, Gemcitabine-Cisplatin, Paclitaxel-Carboplatin, CapOx, ETOCIS, Capecitabine-Temozolomide.

Intervention: Consenting patients will be given a patient reported AE (PRAE) scale with numbers from 0 (Nil) to 10 (most severe) before start of each chemotherapy cycle. This AE scale will have pre-defined symptom related AEs with the provision of adding some more by the patient if they have those symptoms. The PRAE scale will be like a Visual Analogue Scale (VAS) and the patients will be given instructions how to record AEs that they experience after each chemotherapy cycle, until the first radiological assessment is done (palliative settings) or after 4 cycles of chemotherapy in adjuvant settings. They will be asked to take the scale home to record the adverse effects and give it a number (as per VAS), depending on the severity. They will be told to record all the AEs (whenever they experience), even if same AE happens more than once during a particular chemotherapy. Only the most severe one will be analysed. When patient reports for the next cycle of chemotherapy he/she will be asked to deposit the PRAE scale with the study co-ordinator before meeting the treating physician and a new copy of a blank scale will be given to him/her for the next cycle. In the clinic, as a standard practice, the doctor will ask the patient about the AEs experienced with the previous chemotherapy and record them as per the CTCAE, grade, version 5. The clinician will not get the opportunity to see the patient reported scale until the end of patient's participation in the study. All the study participants, at the start of chemotherapy and before each chemotherapy cycle, will be informed, as a standard practice, to report to the emergency or contact nearest local clinic/hospital if the AE is severe or can't be managed at home. The response by patients will be analysed for the pre-defined outcomes. The management of side effects is beyond the scope of this study and will be managed as per the standard clinical practice in TMC. The cost of which will be borne by the patient or his/her insurance company.