Patient Reported Scale vs CTCAE Grading: A Prospective Comparator Study

NCT05158907 | Suspended

• 1 other identifier: 2021/TMC/239/IRB50
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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

Gastrointestinal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Patient Compliance to filling the patient reported AE scale.

  1 year

• Early intervention using patient reported AE scale and preventing severity of AE in the subsequent chemotherapy cycles.

  1 year

• Timely chemotherapy dose adjustments using patient reported adverse effect scale

  1 year

• Reduction in cost of cancer care using patient reported AE scale.

  1 year

Interventions

Patient reported Adverse event scale OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tata Medical Center: lead

Study Sites (1)

Tata Medical Center

Kolkata, West Bengal, 700160, India

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Tanuj Chawla, MD

  Tata Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: The clinician will not get the opportunity to see the patient reported scale until the end of patient's participation in the study.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patient reported adverse event scale will be given to study participants

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: December 15, 2021
• Study Start: November 23, 2021
• Primary Completion: December 31, 2023
• Study Completion: February 28, 2024
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)