Study to find the distress, expectations, preferences and QOL in patients treated with palliative chemotherapy in Head and neck cancers

Active, not recruiting

• Conditions: patients must have histologically confirmed squamous cell cancers of the Head and neck region warranting palliative chemotherapy

• Registration Number: CTRI/2015/11/006392
• Lead Sponsor: Tata Memorial Centre

Brief Summary

This is a prospective observational single arm study in 200 patients,  newly started on palliative chemotherapy in Head and neck cancers.  These patients would be administered three short questionnaires; NCCN distress thermometer, Chemotherapy expectations and preference questionnaire  and FACT H&N questionnaire at baseline. The first 2 proformas would be filled by the interviewer while the 3rd proforma (FACT) will be self administered by the patient. These patients would receive there palliative chemotherapy according to institutional guidelines. Then again at 2 monthly intervals for 6 months  FACT H&N  questionnaire would be administered. The primary expectation of patients for chemotherapy, their preferences for it , the baseline distress levels, the compliance for the 3 questionnaires and the improvement in QOL at 2 months would be studied.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-30
• Last Update Posted: 2016-06-14

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 1.Participants must have histologically confirmed squamous cell cancers of the Head and neck region warranting palliative chemotherapy 2.Age : Any age above 18 years.
• No maximum age.
• 3.ECOG performance status ≤2 4.Life expectancy of less than 12 months with standard palliative treatments.
• 5.Participants must have normal organ and marrow function as defined below: a.Leukocytes≥3,000/mcL b.Platelets≥100,000/mcL c.Total bilirubin< 1.5 times normal d.AST(SGOT)/ALT(SGPT)≤2.5 × institutional upper limit of normal e.Calculated Creatinine clearance > 30 ml/min 6.Both men and women of all races and ethnic groups are eligible for this trial 7.Ability to understand Hindi, Marathi or English language 8.Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

• 1.Uncontrolled intercurrent illness including, but not limited to, hypertension, tuberculosis, diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, renal failure (on dialysis) or psychiatric illness/social situations that would limit compliance with study requirements.
• Patients should be considered physiologically fit to withstand major cancer surgery.
• 2.Pregnant women and breastfeeding women are excluded from this study 3.HIV-positive, Hepatitis B and C seropositive patients are excluded from this study.
• 4.Patients with previous history of other cancers.
• 5.Patients who have been started on palliative chemotherapy regimen.
• ( Patients who have received previous palliative chemotherapy and awaiting start of second line chemotherapy are not excluded) ECOG PS 0-2.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The percentage of patients opting for increase in survival as the primary expectation from chemotherapy	Day 1

Secondary Outcome Measures

Name	Time	Method
1.The preferences for chemotherapy	2.Identify patients having high distress scores ( score 4 or more) and factors associated with it

Trial Locations

Locations (1)

Tata MemorialHospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Tata MemorialHospital

🇮🇳Mumbai, MAHARASHTRA, India

Dr Vijay Patil

Principal investigator

02224176314

vijaypgi@gmail.com