跳至主要内容
临床试验/CTRI/2025/02/081037
CTRI/2025/02/081037招募中不适用

Time toxicity of patients with advanced malignancies receiving palliative intravenous systemic therapy - a multicenter observational study (GiveMeTIME)

Indian Council of Medical Research2 个研究点 分布在 1 个国家目标入组 224 人开始时间: 2025年3月5日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
224
试验地点
2
主要终点
Time toxicity index

研究概览

简要总结

The concept of time toxicity in cancer care is an often-neglected aspect of the significant time commitment demanded of patients undergoing treatment. While advancements in survival outcomes are pivotal, comprehending and quantifying the repercussions of time invested in cancer care are significant to patients with limited life-expectancy. “Time toxicity” includes diverse elements, including coordinating care, frequent visits to healthcare facilities (involving travel and wait times), and addressing side effects through urgent or emergent care, hospitalizations, and follow-up tests. These components collectively contribute to the overall burden of time devoted to pursuing cancer-directed therapy. Also, it is critical that the time spent on these activities can be substantial and, in certain instances, might outweigh the modest gains in survival offered by specific treatments. In addition to the medical and time-related considerations in cancer care, the financial aspect also plays a significant role in the overall impact of treatments on patients. While the providers commonly discuss side effects and medical costs associated with cancer therapy, the financial burden extends beyond direct medical expenses. It includes indirect costs that contribute to the overall financial toxicity. Patients and their families often face considerable financial challenges related to their cancer treatment, such as high out-of-pocket expenses for medications, co-pays for medical visits, and costs associated with supportive care and managing treatment-related side effects. Additionally, the indirect costs, including lost wages due to time away from work, transportation expenses for frequent visits to healthcare facilities, and the potential need for additional caregiving support, further contribute to the financial strain experienced by patients and their families. The time toxicity and financial toxicity associated with cancer care can have profound consequences on a patient’s quality of life, affecting their ability to meet basic needs, adhere to treatment plans, and maintain overall well-being. It may even influence treatment decisions also. Understanding the attitudes of oncologists, patients and caregivers regarding the relation of time toxicity to the relative gain in QoL and survival time is also important to understand different priorities. To address the financial and time-related aspects of cancer care, it is essential to integrate a comprehensive approach that considers both the direct and indirect implications on patients.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients with advanced cancer 2) Expected survival of less than 1 year 3) Planned for palliative chemotherapy/systemic therapy.

排除标准

  • Patients already on palliative IV chemotherapy/ immunotherapy for more than one month 2) Patients unable to provide informed consent or complete study procedures including questionnaire 3) Patients with Eastern Cooperative Oncology Group performance status (ECOG PS) 3 4) Terminally ill patients who are planned only for best supportive care 5) Patients less than 18 years 6) Patients planned for only oral therapy 7) Patients with hematological malignancies.

结局指标

主要结局

Time toxicity index

时间窗: 3 months

次要结局

  • Correlation of Tt with QoL, financial toxicity and survival and develop a metric for incremental time toxicity(3 months for all parameters except survival which will be updated at 6 months, 9 months and 12 months)

研究者

申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Sharada Mailankody

Kasturba Medical College, Manipal

研究点 (2)

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