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How much time Cancer Treatment Takes: A Study on the Time Patients with Advanced or Blood Cancers spend on Treatment Care

A prospective observational study to evaluate time toxicity in patients receiving palliative systemic anticancer therapy for haematological and advanced metastatic or recurrent cancers. - NIL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/06/088119
Enrollment
100
Registered
2025-06-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: C00-D49- Neoplasms

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: Nil: Nil Intervention4: Nil: Nil Control Intervention1: Nil: Nil

Sponsors

Tata Memorial Hospital Parel Mumbai
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients with advanced metastatic or recurrent cancers with expected median overall survival (based on the literature) less than 12 months including Elderly acute myeloid leukaemia being treated with hypomethylating agents Advanced biliary tract adenocarcinoma planned for palliative systemic ant-cancer therapy -first or later lines of treatment Advanced hepatocellular carcinoma planned for palliative systemic anti-cancer therapy -first or later lines of treatment Advanced pancreatic adenocarcinoma planned for palliative systemic ant-cancer therapy -first or later lines of treatment Advanced/ metastatic/recurrent oral cavity squamous cancers planned for palliative systemic ant-cancer therapy -first or later lines of treatment Metastatic NSCLC who are on second line systemic anti-cancer therapy 2. Should have histological diagnosis 3. Planned for treatment at the participating centre. 4. Should be greater than 18 years of age.

Exclusion criteria

Exclusion criteria: 1.Inability to understand study-related procedure.

Design outcomes

Primary

MeasureTime frame
To measure the time toxicity as the proportion of days with physical health care system contact. Any hospital visits for blood investigations, outpatient, emergency room, day-care for any duration will be counted as one day of health care system contact. In case of hospitalization, the total number of days of hospitalization will be counted. This will be expressed as the proportion of days with physical health care system contact. The median and range will be calculated for all the patients.Timepoint: During the chemotherapy. 6 months

Secondary

MeasureTime frame
To measure the overall survival for different cancer subtypes - The overall survival will be calculated from the date of start of chemotherapy to death or last follow-up. This will be calculated with Kaplan-Meier methodology and expressed as median and 1-year survival for different cancer subtypes.Timepoint: 1 year;Proportion of days alive that are contact days (contact days divided by overall survival) This will be calculated using the cumulative time spent in the hospital by the individual participants in relation to the overall survival. This will be expressed as median and range for different cancer subtypes and chemotherapy regimens.Timepoint: 6 months;Source of contact days (outpatient planned visits, physical toxicity resulting in hospitalization, physical toxicity resulting in frequent outpatient monitoring and treatment etc.) The number of days spent in contact with health care systems will be categorised and expressed as proportion to overall time spent in the health - care facility.Timepoint: 6 months;Comparing the time toxicity between patients with expected median OS of less than 6 months versus those with more than 6 months.Timepoint: 6 months;Any hospital visits for blood investigations, outpatient, emergency room, day-care for any duration will be counted as one day of health care system contact. In case of hospitalization, the total number of days of hospitalization will be counted. This will be expressed as a cumulative time spent in the hospital per patientTimepoint: 6 months

Countries

India

Contacts

Public ContactDr Manju Sengar

Tata Memorial Hospital

manju.sengar@gmail.com9769690590

Outcome results

None listed

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