Long-term Effects of Breast Cancer Treatment
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|ClinicalTrials.gov Identifier: NCT03877029|
Recruitment Status : Not yet recruiting
First Posted : March 15, 2019
Last Update Posted : March 15, 2019
|Condition or disease|
The project will include a retrospective information which we will collect 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, we will only include studies reporting from women who have received treatment in 1995 or later. Only 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.
In Study IV, we will 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).
|Study Type :||Observational|
|Estimated Enrollment :||4000 participants|
|Official Title:||Long-term Effects Following Treatment of Women With Screen-detected Versus Symptomatic Breast Cancer|
|Estimated Study Start Date :||July 1, 2019|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||June 30, 2022|
Both groups of women will receive the questionnaire.
- QALY (Quality-Adjusted-Life-Year) [ Time Frame: 1996-2016 ]QALY is defined as one year of life in perfect health and 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03877029
|Contact: Solveig Hofvind, PhDfirstname.lastname@example.org|
|Principal Investigator:||Solveig Hofvind, PhD||Cancer Registry of Norway|