A clinical trial to study the effect of starting early palliative care with chemotherapy at diagnosis of advanced sarcoma compared to chemotherapy alone.

Early integrated palliative care versus routine oncological care for advanced adult sarcoma patients in tertiary care center in India: a randomised phase II trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/05/019367

Enrollment

Registered

2019-05-27

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: C419- Malignant neoplasm of bone and articular cartilage, unspecified Health Condition 2: C410- Malignant neoplasm of bones of skull and face Health Condition 3: C494- Malignant neoplasm of connective and soft tissue of abdomen Health Condition 4: C490- Malignant neoplasm of connective and soft tissue of head, face and neck Health Condition 5: C492- Malignant neoplasm of connective and soft tissue of lower limb, including hip Health Condition 6: C495- Malignant neoplasm of co

Interventions

Intervention1: Early integrated palliative care: Patient in intervention group (Group B) â?¢ Patient will be required to meet the palliative care team within 4 weeks of randomisation (next medical on

more often coinciding with chemotherapy or radiation schedule Study Instruments QOL-Patient: To assess quality of life over time in study patients, we will use the Functional Assessment of Cancer Th

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects with histologically confirmed diagnosis of advanced sarcoma not being treated with curative intent. 2. Diagnosed within the previous 8 weeks. 3. No prior therapy for metastatic disease. 4. Subjects who are willing to provide written informed consent. 5. Ability to understand questions in Hindi or English. 6. Male or female subjects, 18 years of age and older.

Exclusion criteria

Exclusion criteria: 1. Subjects who are already receiving palliative care. 2. Subjects requiring immediate referral to hospice. 3. Subjects with any communication disability, history of or current neurological or psychiatric impairment, or cognitive dysfunction, active brain metastases.

Design outcomes

Primary

Measure	Time frame
Determine the effects of early integrated palliative care on overall QOL (FACT-G total score) at 12 weeksTimepoint: 12 weeks	—

Secondary

Measure	Time frame
Determine associations between blood biomarkers at baseline, other possible prognostic and predictive factors, and clinical outcomes.Timepoint: Baseline;Determine the effects of early integrated palliative care on anxiety and depression (HADS & PHQ) at 12 and 24 weeksTimepoint: 12 and 24 weeks;Determine the effects of early integrated palliative care on caregiver burden (Zarit Burden Index) at 12 and 24 weeksTimepoint: 12 and 24 weeks;Determine the effects of early integrated palliative care on emotional, physical, social/family, and functional well-being (FACT-G scales) at 12 and 24 weeksTimepoint: 12 and 24 weeks;Determine the effects of early integrated palliative care on number of emergency visits and days of hospitalisation at 12 and 24 weeksTimepoint: 12 and 24 weeks;Determine the effects of early integrated palliative care on nutrition status (PG-SGA) at 12 and 24 weeksTimepoint: 12 and 24 weeks;Determine the effects of early integrated palliative care on overall QOL (FACT-G total score) at 24 weeksTimepoint: 24 weeks;Determine the effects of early integrated palliative care on symptom burden (ESAS) at 12 and 24 weeksTimepoint: 12 and 24 weeks	—

Measure

Time frame

Determine associations between blood biomarkers at baseline, other possible prognostic and predictive factors, and clinical outcomes.Timepoint: Baseline;Determine the effects of early integrated palliative care on anxiety and depression (HADS & PHQ) at 12 and 24 weeksTimepoint: 12 and 24 weeks;Determine the effects of early integrated palliative care on caregiver burden (Zarit Burden Index) at 12 and 24 weeksTimepoint: 12 and 24 weeks;Determine the effects of early integrated palliative care on emotional, physical, social/family, and functional well-being (FACT-G scales) at 12 and 24 weeksTimepoint: 12 and 24 weeks;Determine the effects of early integrated palliative care on number of emergency visits and days of hospitalisation at 12 and 24 weeksTimepoint: 12 and 24 weeks;Determine the effects of early integrated palliative care on nutrition status (PG-SGA) at 12 and 24 weeksTimepoint: 12 and 24 weeks;Determine the effects of early integrated palliative care on overall QOL (FACT-G total score) at 24 weeksTimepoint: 24 weeks;Determine the effects of early integrated palliative care on symptom burden (ESAS) at 12 and 24 weeksTimepoint: 12 and 24 weeks

—

Countries

India

Contacts

Public ContactVIKAS GARG

DR BRAIRCH, AIIMS, NEW DELHI

samdoc_mamc@yahoo.com9013231857

Outcome results

None listed

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