Health Condition 1: null- Head and neck cancer patients with histological confirmation
Conditions
Interventions
Intervention1: NIL: NIL
Sponsors
Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PART A â?¢Frequency and percentage of patients having clinically significant distress (Score of 4 and above on Distress Thermometer) PART B 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
| Measure | Time frame |
|---|---|
| Change in NCCN Problem checklist & ESAS Scores & QOL C30 & HN 35 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. | — |
Countries
India
Contacts
Public ContactDr J P Agarwal
Tata Memorial Centre
Outcome results
None listed