Breast Cancer Clinical Trial
Official title:
Long-term Effects Following Treatment of Women With Screen-detected Versus Symptomatic Breast Cancer
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.
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, III and IV, 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.
In Study II, quality of life will be compared between 1000 women treated for screen-detected
and 1000 women treated for symptomatic breast cancer. The main hypothesis is that women with
screen-detected breast cancer have a higher quality of life than women diagnosed with
symptomatic breast cancer.
Study III will be a continuation of Study II, where quality of life among women with
screen-detected breast cancer, interval breast cancer, breast cancer diagnosed outside the
screening program and women without any diagnosis of breast cancer will be analyzed. The main
hypothesis is that women with no history of breast cancer and those with a screen-detected
breast cancer have a higher quality of life than those diagnosed with an interval breast
cancer or breast cancer detected outside the screening program.
The aim of Study IV is to investigate the impact of detection mode versus tumor
characteristics as the main predictor of long-term quality of life among women diagnosed and
treated for breast cancer among the two groups of women treated for breast cancer (diagnosed
with sceen-detected breast cancer, diagnosed with interval breast cancer, and diagnosed with
symptomatic breast cancer).
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