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临床试验/NCT03877029
NCT03877029已完成不适用

Long-term Effects Following Treatment of Women With Screen-detected Versus Symptomatic Breast Cancer

Norwegian Institute of Public Health1 个研究点 分布在 1 个国家目标入组 4,487 人开始时间: 2019年11月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
4,487
试验地点
1
主要终点
Quality of life score

研究概览

简要总结

The objective of this project is to generate evidence about quality of life related to side effects of treatment of women with screen-detected versus symptomatic breast cancer. The project will investigate the impact of detection mode (by screening or by symptoms) versus tumor characteristics as a predictor of quality of life among breast cancer survivors. The burden of long-term effects, measured as quality of life at specific points after diagnosis, will be compared between these groups. The results will also be compared with a control group of women, who have attended screening, but never been diagnosed with breast cancer.

详细描述

The project will include a retrospective information which will be collected by using a self-administered questionnaire about the treatment women received and their quality of life at certain time points after a breast cancer diagnosis. Women aged 50-69 years at the time of diagnosis are the target group of BreastScreen Norway and also for this project.

The women will be identified from the Cancer Registry databases. The questionnaire will be based on EQ-5D-5L and will be developed in close collaboration with breast cancer survivors who have personally experienced the long-term effects of breast cancer treatment, whether resulting from screen-detected or symptomatic breast cancer.

The questionnaire will cover topics related to demographics, treatment, and information required to estimate health related quality of life (HRQoL) and quality-adjusted life years (QALY). Information about detection mode and disease stage at diagnosis will be extracted from the Cancer Registry.

Study I - a review of the literature in a paper describing and analyzing the current evidence on quality of life among women diagnosed with breast cancer and treated for this disease, with a focus on disease stage at diagnosis. Due to substantial changes in treatment during the last decades, only studies reporting on women who have received treatment in 1995 or later will be included. Solely studies written in English will be included.

For studies II and III, data collected from the self-administered questionnaire will be used. In addition, information about screening history and tumor characteristics will be obtained from the Cancer Registry of Norway.

研究设计

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

入排标准

年龄范围
50 Years 至 69 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Inclusion Criteria:
  • Screened in BreastScreen Norway and diagnosed with breast cancer between 2006 and 2017
  • Diagnosed with symptomatic breast cancer between 2006 and 2017 and never attended screening
  • Screened in BreastScreen Norway and diagnosed with interval breast cancer between 2006 and 2017
  • Screened in BreastScreen Norway and have never been diagnosed with breast cancer

排除标准

  • Death after recruitment
  • Inclusion Criteria:
  • Screened in BreastScreen Norway and diagnosed with breast cancer between 2006 and 2017
  • Screened in BreastScreen Norway and diagnosed with interval breast cancer between 2006 and 2017
  • Diagnosed with symptomatic breast cancer between 2006 and 2017 and never attended screening
  • Exclusion Criteria:
  • Death after recruitment

研究组 & 干预措施

Study II

  • Women with a screen-detected breast cancer after attending BreastScreen Norway
  • Women with symptomatic breast cancer, who have never been screened in BreastScreen Norway
  • Women with interval breast cancer after attending BreastScreen Norway
  • Women free from breast cancer

Study III

  • Women with a screen-detected breast cancer after attending BreastScreen Norway
  • Women with interval breast cancer after attending BreastScreen Norway and women with symptomatic breast cancer, who have never been screened in BreastScreen Norway

结局指标

主要结局

Quality of life score

时间窗: 2006-2017

Quality of life measure from 0 to 100 on a visual analogue scale

QALY (Quality-Adjusted-Life-Year)

时间窗: 2006-2017

QALY is calculated by estimating the years of life remaining for a woman following a particular treatment or intervention and weighting each year with her corresponding health related quality of life score

次要结局

未报告次要终点

研究者

发起方
Norwegian Institute of Public Health
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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