Health Condition 1: D899- Disorder involving the immune mechanism, unspecified
Conditions
Interventions
Intervention1: nil: nil
Control Intervention1: nil: nil
Sponsors
Chirag Jain
Eligibility
Inclusion criteria
Inclusion criteria: Demographic: More than 18 years and less than 75 years Able to provide written informed consent Able to understand and communicate in Kannada, English, Hindi, or Malayalam Willing to participate for full study duration 3-6 weeks Medical: Confirmed diagnosis of head and neck cancer any subsite: oral cavity, oropharynx, hypopharynx, larynx, nasopharynx Any cancer stage I to IV Treatment status any of the following Newly diagnosed starting radiotherapy or chemotherapy Currently undergoing radiotherapy and or chemotherapy Pre-operative with neoadjuvant treatment Post-operative undergoing adjuvant therapy Scheduled for minimum 3 weeks of continuous treatment ECOG Performance Status 0 to 2 Life expectancy more than 3 months Baseline distress score more than or equal to 4 on NCCN Distress Thermometer OR HADS anxiety or depression subscale score more than 8 Technical: Able to use smartphone or tablet with assistance No severe hearing impairment preventing headphone use Willing to wear heart rate monitoring device chest strap No known allergy to device materials silicone, fabric, plastic Access to reliable mobile phone for authentication
Exclusion criteria
Exclusion criteria: EXCLUSION CRITERIA: 1 Medical Cardiac conditions: Active arrhythmias requiring medication Recent myocardial infarction less than 3 months Severe heart failure NYHA Class III-IV Implanted cardiac pacemaker or defibrillator Atrial fibrillation affecting HRV measurement 2 Neurological/Psychiatric: Severe cognitive impairment MMSE less than 20 Active psychotic disorder requiring hospitalization Severe depression with suicidal ideation HADS more than 15 Uncontrolled epilepsy 3 Treatment-related: Concurrent enrollment in other interventional trials Palliative care without curative-intent treatment 4 Contraindications to HRV monitoring Conditions causing unreliable heart rate monitoring Pregnancy physiological HRV changes Technical: Severe bilateral hearing loss preventing headphone use Documented allergies to device materials Skin conditions at monitoring site preventing device placement Severe chest wall deformities preventing electrode contact Inability to maintain device connection Logistical Geographic inaccessibility preventing regular visits Planned treatment transfer within study period Inability to attend scheduled assessments Language barriers preventing proper consent Unwillingness to comply with daily sessions 3 times per day
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hospital Anxiety and Depression Scale 14item selfreport questionnaire Two subscales Anxiety 7 items Depression 7 items 4-point Likert scale 0 to -3 per item Score range 0 to 21 per subscale Takes 2 to 3 minutes to complete Available in Kannada English Hindi Malayalam Timepoint: 4 weeks & 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| NCCN Distress Thermometer Single item visual analog scale 0 to 10 39 item problem checklist 5 domains Takes 2 to 3 minutes EORTC QLQ-C30 Quality of Life - Core 30 item cancer specific questionnaire Functional scales symptom scales global health Takes 10 15 minutes EORTC QLQ-H&N35 Head & Neck Module 35 item HNC specific supplement Pain swallowing speech social eating scales Takes 10 minutes Visual Analog Scales Current stress level 0 to 10 Sleep quality 0 to 10 Overall well being 0 to 10 Treatmentrelated anxiety 0 to 10 Patient Satisfaction Questionnaire Custom 10 items 5 point Likert scale Music therapy satisfaction helpfulness comfort Open ended feedback section Timepoint: 4 weeks & 8 weeks | — |
Countries
India
Contacts
Public ContactDr Prabha Adhikari MR
Yenepoya Medical College Hospital
Outcome results
None listed