Technology-Enabled Platform for Managing Depression in Cancer Patients in India (Pilot)
- Conditions
- Health Condition 1: C50- Malignant neoplasm of breastHealth Condition 2: C34- Malignant neoplasm of bronchus andlungHealth Condition 3: C539- Malignant neoplasm of cervix uteri, unspecifiedHealth Condition 4: C189- Malignant neoplasm of colon, unspecifiedHealth Condition 5: C760- Malignant neoplasm of head, face and neckHealth Condition 6: C61- Malignant neoplasm of prostateHealth Condition 7: C569- Malignant neoplasm of unspecifiedovaryHealth Condition 8: F30-F39- Mood [affective] disorders
- Registration Number
- CTRI/2024/08/072398
- Lead Sponsor
- The George Institute for Global Health, India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Consenting adult patients (18 years and above) suffering from breast, cervix, ovarian, lung, prostrate, colon, head, and neck cancer with comorbid depression as per screen positive cut-off score on PHQ9/GAD7 attending the relevant departments of the 3 hospitals;
2. Newly diagnosed patients will be recruited from both inpatient and outpatients.
1. Patients at imminent risk of suicide based on clinical assessment, or showing aggressive behavior, or lacking insight due to psychotic features;
2. Patients who score 2 or more on the Eastern Cooperative Oncology Group Performance Status (ECOG-PS);
3. Patients and caregivers are unable to read Hindi/English/Punjabi/Kannada/Telegu (that would prevent them from responding to the self-monitoring questions).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A. Change in PHQ-9 depression scores in both the intervention arms compared to the control arm. <br/ ><br>B. Change in WHO-5 wellbeing scores in both the intervention arms compared to control arm.Timepoint: A. Baseline (just before randomization) and at 3 months since randomization. <br/ ><br>B. Baseline (just before randomization) and at 3 months since randomization.
- Secondary Outcome Measures
Name Time Method A. Changes in PHQ-9 depression scores. <br/ ><br>B. Quality of life using WHOQol-Bref.Timepoint: A. Baseline (just before randomization) & at 6 & 9 months after randomization. <br/ ><br>B. Baseline (just before randomization) & at 9 months after randomization.