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临床试验/CTRI/2024/11/076743
CTRI/2024/11/076743招募中不适用

Young Women with Breast Cancer: Assessing the Unmet needs Longitudinally

Tata Memorial Centre1 个研究点 分布在 1 个国家目标入组 657 人开始时间: 2024年12月2日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
657
试验地点
1
主要终点
To assess the temporal trends in the psychosocial domain of QoL based on FACT-B questionnaire during various phases of therapy and at first follow up compared to baseline

研究概览

简要总结

Breast cancer is the most commonly diagnosed cancer among women globally, with 2.3 million new cases in 2020, accounting for 24.2 percent of all female cancer diagnoses. In India, it has surpassed cervical cancer as the leading cancer among women, marking a significant demographic shift. While breast cancer primarily affects older women, younger women under 40 years constitute a notable proportion of cases. Globally, this age group accounts for approximately 7 percent of cases, but in India, the rate is higher, ranging from 9.77 percent to 15–20 percent.

For young breast cancer patients, diagnosis and treatment often disrupt key life stages such as education, career, family planning, and social roles. These patients face unique challenges, including chemotherapy-induced menopause, fertility concerns, body image issues, and balancing personal and professional responsibilities. Their quality of life (QoL) is impacted across physical, psychological, social, and environmental dimensions.

This study aims to evaluate QoL in young breast cancer patients, focusing on unmet needs related to premature ovarian failure and psychosocial concerns. QoL will be assessed at five key time points: baseline (post-diagnosis, pre-treatment), post-chemotherapy, post-surgery, post-radiotherapy, and six months after treatment. Demographic, clinical, and treatment data will be collected using validated tools in English, Hindi, and Marathi to ensure cultural relevance.

The study will employ tools such as FACT-B and FACIT-Sp to assess physical, social, emotional, functional, and spiritual well-being; the Body Image Scale to evaluate body image concerns; the Hospital Anxiety and Depression Scale for anxiety and depression; FertiQOL for fertility-related concerns; and the Menopausal Rating Scale for menopausal symptoms, including chemotherapy-induced amenorrhea.

Conducted over three years with an enrollment target of 657 patients, this study will provide a comprehensive assessment of QoL among young breast cancer patients in India. By addressing physical and psychosocial challenges, it aims to improve survivorship care and address gaps in understanding the unique experiences of this population.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • To study young patients with breast cancer.

排除标准

  • Not willing to participate.
  • Unable to comprehend questions.

结局指标

主要结局

To assess the temporal trends in the psychosocial domain of QoL based on FACT-B questionnaire during various phases of therapy and at first follow up compared to baseline

时间窗: At Baseline, After Surgery, After Chemotherapy, Afer Radiotherapy, 1st Follow-up

次要结局

  • 1. To collect longitudinal data about quality of life in young breast cancer patients; 2. To identify unmet needs in patient using the unmet needs inventory (YBC-UNI); 3. To evaluate the fertility related concerns in patients using FertiQOL; 4. To assess the impact of premature ovarian suppression on quality of life using MRS(3 years)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Tabassum Wadasadawala

Tata Memorial Centre

研究点 (1)

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