Palliative Care in blood cancers undergoing CAR-T Cell therapy : A pilot single-arm single-center prospective observational study

Not yet recruiting

Conditions: Malignant neoplasm of lymphoid, hematopoietic and related tissue, unspecified, (2) ICD-10 Condition: C81-C96||Malignant neoplasms of lymphoid, hematopoietic and related tissue,

Registration Number: CTRI/2025/05/086476

Brief Summary: Blood cancers such as leukemia and lymphoma are aggressive and have high relapse rates, posing significant challenges for treatment. Chimeric Antigen Receptors (CAR)-T cell therapy, an innovative approach that modifies a patient’s T cells to target cancer cells, has shown promise for relapsed or refractory cases. However, patients undergoing CAR-T therapy often experience severe symptoms and reduced quality of life. Specialized palliative care ( SPC) can address these issues by providing holistic support to improve physical, psychological, and emotional well-being. This study aims to improve the quality of life for patients with relapsed or refractory blood cancers undergoing CAR- T Cell therapy. We will assess the feasibility and effectiveness of SPC into their treatment. SPC focuses on managing symptoms, pain, and stress to improve overall well-being. Our goal is to determine if SPC can enhance patients’ quality of life and reduce symptoms during CAR-T cell therapy. Patients will receive comprehensive care addressing physical, psychological, nursing, and social needs. It is a pilot single-arm single-center prospective observational study with duration of 4 months and study population includes adults aged more than 18 with relapsed / refractory blood cancers eligible for CAR-T therapy. We will assess quality of life and symptom burden at three time points: before CAR-T cell therapy, 1 day before initiating therapy, and 28 days after therapy. This study will provide valuable insights into improving care for blood cancer patients undergoing CAR-T cell therapy. Findings may advance future clinical practices and promote patient-centered care.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

Adult patients of age more than and equal to 18 years Relapsed or Refractory hematologic malignancies Patients planned for CAR-T Cell Therapy Patient has been informed of the diagnosis treatment and prognosis of disease Able to communicate in English Marathi Hindi Bengali Capable of giving a written informed consent.

Exclusion Criteria

Patients planned for best supportive care alone Patients should not have cognitive impairment preventing patients from comprehending questionnaire.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of the study will be assessed by the proportion of patients who complete the questionnaire	Baseline (T0) \| 1 Day prior to initiating CAR-T cell therapy (T1) \| Day 28 after CAR-T cell therapy (T2)

Secondary Outcome Measures

Name	Time	Method
1)Change in FACT-Leu & FACT-Lym score at T0,T1,T2	2)Symptom profile in this population using Edmonton Symptom Assessment System ESAS r CS at T0 T1 & T2

Trial Locations

Locations (1): Tata Memorial Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Tata Memorial Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Dr Jayita Deodhar
Principal investigator
9892358023
jukd2000@yahoo.co.uk