Patient Reported Scale vs CTCAE Grading: A Prospective Comparator Study (PROSE)

Patient Reported Scale vs CTCAE Grading for Reporting Chemotherapy Related Adverse Effects: 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.

Study Overview

• Status: Suspended
• Conditions: Gastrointestinal Cancer
• Intervention / Treatment: Other: Patient reported Adverse event scale

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • West Bengal
    • Kolkata, West Bengal, India, 700160
      • Tata Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female with more than 18years of age.
• Provide written informed consent
• Diagnosed with Gastrointestinal cancer (both colorectal and non-colorectal cancer of all histological types) and are planned for adjuvant or palliative combination chemotherapy with or without Targeted therapy and Immunotherapy.
• Patients who have been fully recovered from cancer surgery, if any.
• Residing within 50km radius of TMC.
• Patient or their family member who can read, write and comprehend Bangla, Hindi or English language.

Exclusion Criteria:

• Patients not residing in India e.g. patients from neighbouring countries like Bangladesh, Nepal, Bhutan.
• Patients whose comorbid conditions like diabetes, hypertension, hypo/hyperthyroidism, heart ailment are not under control.
• Patient who is not willing to start or continue the medicines for their comorbid conditions.
• Patients with psychomotor comorbid conditions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in detection rate of adverse effects of patient reported adverse effect (AE) scale versus the standard CTCAE grading by a physician.	Proposed AE scale will be compared with standard CTCAE scale	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Compliance to filling the patient reported AE scale.	Will see how many patients will be able to fill the new scale	1 year
Early intervention using patient reported AE scale and preventing severity of AE in the subsequent chemotherapy cycles.	Whether AE scale can prevent severity of adverse events	1 year
Timely chemotherapy dose adjustments using patient reported adverse effect scale	Chemotherapy doses can be adjusted if early adverse effects can be picked using AE scale.	1 year
Reduction in cost of cancer care using patient reported AE scale.	Whether cost of cancer can be reduced using the proposed scale	1 year

Collaborators and Investigators

• Sponsor: Tata Medical Center
• Investigators: Principal Investigator: Tanuj Chawla, MD, Tata Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): February 28, 2024

Study Registration Dates

• First Submitted: December 2, 2021
• First Submitted That Met QC Criteria: December 2, 2021
• First Posted (Actual): December 15, 2021

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Gastrointestinal Neoplasms
• Other Study ID Numbers: 2021/TMC/239/IRB50

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No