Long-term Effects of Breast Cancer Treatment

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03877029
• Other study ID #: 2019/FO244363
• Status: Not yet recruiting
• Start date: July 1, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: January 2019
• Source: Cancer Registry of Norway
• Contact: Solveig Hofvind, PhD
• Phone: +4722928828
• Email: solveig.hofvind[@]kreftregisteret.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4000
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 69 Years

Eligibility

Study II

Inclusion Criteria:

• Screened in BreastScreen Norway and diagnosed with breast cancer between 1996 and 2016

• Diagnosed with symptomatic breast cancer between 1996 and 2016 and never attended screening

Exclusion Criteria:

• Death after recruitment

Study III

Inclusion Criteria:

• Screened in BreastScreen Norway and diagnosed with breast cancer between 1996 and 2016

• Screened in BreastScreen Norway and diagnosed with interval breast cancer between 1996 and 2016

• Diagnosed with symptomatic breast cancer between 1996 and 2016 and never attended screening

• Screened in BreastScreen Norway between 1996 and 2016 and have never been diagnosed with breast cancer

Exclusion Criteria:

• Death after recruitment

Study IV

Inclusion Criteria:

• Screened in BreastScreen Norway and diagnosed with breast cancer between 1996 and 2016

• Screened in BreastScreen Norway and diagnosed with interval breast cancer between 1996 and 2016

• Diagnosed with symptomatic breast cancer between 1996 and 2016 and have never attended screening

Exclusion Criteria:

• Death after recruitment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Cancer Registry of Norway	Extrastiftelsen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QALY (Quality-Adjusted-Life-Year)	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	1996-2016