跳至主要内容
临床试验/NCT06927102
NCT06927102招募中不适用

A Comprehensive Analysis of Follow-up Outcomes, Continuity and Updated Survivorship in Breast Cancer

Basavatarakam Indo American Cancer Hospital & Research Institute1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2025年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,500
试验地点
1
主要终点
Improvement in follow-up data with proactive outreach

研究概览

简要总结

The goal of this observational study is to determine the proportion of patients who are lost-to-follow-up at five years, identify factors associated with loss of follow-up , and explore patient-reported barriers to follow-up in a public sector cancer care setting.

The main question it aims to answer is : Do proactive outreach programs help in improving follow-up rates among breast cancer patients who are categorized as "lost-to-follow-up." This study will be conducted in a real-world cohort of women with non-metastatic breast cancer treated at a tertiary care centre, between 2017-2018.

详细描述

This is a prospective cohort study involving women diagnosed with non-metastatic breast cancer in the years 2017-2018, who received treatment at our institute. Baseline data collection will include essential demographic information, clinical data including tumor characteristics, stage at presentation and luminal subtype and treatment information including surgical intervention, chemotherapy, radiotherapy, hormonal therapy, and targeted therapy.

The study will be conducted in three phases.

  1. Phase I: Quantitative Follow-Up Analysis Follow-up data will be retrieved from hospital records and electronic medical records (EMR) up to December 2024. Follow-up visits will be documented annually through to the end of 2024.
  2. Phase II: Assessment of Lost to Follow-Up (LTFU) Cases For patients identified as LTFU (definitions provided below), additional variables will be extracted, including geographic distance from the hospital, mode of employment, marital status, and payment method (government scheme, insurance, or self-pay). Proactive outreach efforts will be undertaken via phone calls, messages, or emails using contact information available in hospital records. Informed consent will be obtained in cases where contact has been successfully established - verbally for phone calls and in writing for electronic communication. Patients (or their families) will be queried about current health status, recent diagnostic evaluations, recurrence of disease, or mortality (if applicable). These responses will be documented as valid follow-up entries.
  3. Phase III: Qualitative Analysis of LTFU Reasons During outreach, participants will also be asked to identify reasons for missing follow-up visits. These will be categorized under the following domains: Logistical barriers (e.g., travel, time constraints), financial constraints, availability of alternative/local healthcare facilities, physician recommendations, lack of awareness regarding the importance of follow-up. In addition, participants will be asked about their willingness to maintain hospital contact in the future and their preferred mode of communication (e.g., phone, SMS, email, video call).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients newly diagnosed with non-metastatic breast cancer between 2017-2018
  • •Patients categorized as "lost-to-follow-up", as defined above
  • •Patients willing to participate upon re-engagement

排除标准

  • •Patients with incomplete medical records
  • •Patients who have taken part of the treatment at another hospital/centre
  • •Patients who have relocated permanently out of the study region
  • •Withdrawal Criteria:
  • •1. Patient withdraws consent

结局指标

主要结局

Improvement in follow-up data with proactive outreach

时间窗: 6 months

Follow-up data will be retrieved from hospital records and electronic medical records (EMR) up to December 2024. For patients identified as lost-to-follow-up, proactive outreach efforts will be undertaken via phone calls, messages, or emails. Patients (or their families) will be queried about recurrence of disease, and these responses will be documented as valid follow-up entries.

Updated mortality data

时间窗: 6 months

For patients identified as lost-to-follow-up, proactive outreach efforts will be undertaken via phone calls, messages, or emails. Patients (or their families) will be queried about mortality (if applicable) and these responses will be documented as valid follow-up entries.

次要结局

  • Assessment of willingness for future hospital contact(6 months)
  • 3. Evaluate the reasons for patient disengagement from follow-up care.(6 months)

研究者

发起方
Basavatarakam Indo American Cancer Hospital & Research Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nisha Hariharan

Consultant, Breast Oncosurgeon

Basavatarakam Indo American Cancer Hospital & Research Institute

研究点 (1)

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