Distress screening in Head and Neck Cancer patients before and after undergoing treatment.
- Conditions
- Health Condition 1: null- Head and neck cancer patients with histological confirmation
- Registration Number
- CTRI/2016/01/006549
- Lead Sponsor
- Tata Memorial Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 812
Part A:
1)Head and neck cancer patients with histological confirmation.
2)Planned to receive curative active cancer directed treatment.
3)Aware of their diagnosis and treatment plan.
4)Willingness to participate in study and sign ICF.
5)Age >18 years.
6)ECOG 2 or less
Part B :
1) Patients who score 4 or above on Distress Thermometer.
2) Willingness to participate in study
3) Reliable to complete the stipulated follow up.
Part A:
1)Prior history of treatment â?? radiotherapy / chemotherapy.
Part B:
1)Pre-existent diagnosed psychiatric disorder.
2)Patients on antidepressants, anti-psychotics for a pre-existent diagnosed psychiatric disorder.
3)Poorly controlled co-morbid conditions requiring intensive medical management.
Suicidal tendencies
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PART A <br/ ><br>â?¢Frequency and percentage of patients having clinically significant distress (Score of 4 and above on Distress Thermometer) <br/ ><br> <br/ ><br>PART B <br/ ><br>â?¢Change in distress scores on DT at baseline and 6 months in both groupsTimepoint: Proportion of Clinically significant distress at base line, first follow-up.
- Secondary Outcome Measures
Name Time Method Change in NCCN Problem checklist & ESAS Scores & QOL C30 & HN 35 <br/ ><br>â?¢Correlation of presence and absence of clinically significant distress with loco regional control of diseaseTimepoint: Proportion of Clinically significant distress at base line, first follow-up.