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Patient Reported Scale vs CTCAE Grading: A Prospective Comparator Study

NCT05158907 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2023-04-19

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Patient reported Adverse event scale

Participants will be given a patient reported AE scale with numbers from 0 to 10 before start of each chemotherapy cycle. The PRAE scale will be like a Visual Analogue Scale 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. Participants will take scale home to record the adverse effects and give it a number. Only the most severe will be analyzed. When patient reports for the next cycle of chemotherapy they will be asked to deposit the scale before meeting the physician. The physician will ask patient about the AEs experienced with the chemotherapy and record them using CTCAE grade. The study participants, at the start of 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.

Sponsors & Collaborators

  • Tata Medical Center

    lead OTHER

Principal Investigators

  • Tanuj Chawla, MD · Tata Medical Center

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-23
Primary Completion
2023-12-31
Completion
2024-02-28

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05158907 on ClinicalTrials.gov