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Technology-Enabled Platform for Managing Depression in Cancer Patients in India (Pilot)

A randomized controlled trial to evaluate a technology-enabled platform to manage depreSsion with or without beHavioural actiVation In patieNtS with cancer in India (Pilot) - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/072398
Enrollment
90
Registered
2024-08-12
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C50- Malignant neoplasm of breast Health Condition 2: C569- Malignant neoplasm of unspecifiedovary Health Condition 3: C34- Malignant neoplasm of bronchus andlung Health Condition 4: C61- Malignant neoplasm of prostate Health Condition 5: C189- Malignant neoplasm of colon, unspecified Health Condition 6: C760- Malignant neoplasm of head, face and neck Health Condition 7: C539- Malignant neoplasm of cervix uteri, unspecified Health Condition 8: F30-F39- Mood [affective] disord

Interventions

Intervention1: Self-monitoring and integrated referral system.: An internet (web-based) and mobile-technology based system to self-monitor their symptoms of depression. An Electronic Decision Support
8 modules, each lasting 1 hour delivered over 8-10 weeks using a mix of in-person and online modes. The modules will include elements related to treatment pattern and objectives, realization of emotio
8 modules, each lasting 1 hour delivered over 8-10 weeks using a mix of in-person and online modes. The modules will include elements related to treatment pattern and objectives, realization of emotio
Behavioral activa

Sponsors

The George Institute for Global Health, India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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 (clinically or confirmed by radiological/pathological reports) patients (within 3 months, which includes patients with recurring/ secondary cancer) will be recruited from both inpatient and outpatients.

Exclusion criteria

Exclusion criteria: 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 who are unable to read Hindi/ English/ Punjabi/ Kannada/ Telegu (that would prevent them from responding to the self-monitoring questions). 4. Patients who are unable to speak and communicate because of the disease and treatment which hinders their participation.

Design outcomes

Primary

MeasureTime frame
A. Change in PHQ-9 depression scores in both the intervention arms compared to the control arm. B. Change in WHO-5 wellbeing scores in both the intervention arms compared to control arm.Timepoint: A. Baseline (just before randomization) and at 6 months since randomization. B. Baseline (just before randomization) and at 6 months since randomization.

Secondary

MeasureTime frame
A. Changes in PHQ-9 depression scores. B. Changes in Quality of life WHOQol-Bref scores.Timepoint: A. Baseline (just before randomization) & at 9 months after randomization. B. Baseline (just before randomization) & at 9 months after randomization.

Countries

India

Contacts

Public ContactDr Mercian Daniel

George Institute for Global Health

pmaulik@georgeinstitute.org.in8800493204

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026