Clinical trial NCT03877029: Long-term Effects of Breast Cancer Treatment
Official title: Long-term Effects Following Treatment of Women With Screen-detected Versus Symptomatic Breast Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Keywords: Mammography
Breast cancer screening
Health related quality of life
Long-term effects of breast cancer treatment
Screen-detected breast cancer
Symptomatic breast cancer
Tumor characteristics
Interval breast cancer
Lead sponsor: Norwegian Institute of Public Health
Sponsor class: OTHER_GOV
Collaborators: name: The Dam Foundation
First posted: 2019-03-15
Enrollment: 4487
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include women residing in Norway, who are currently alive and were invited and attended, and were invited but did not attend the screening program. Among the attending and not attending women, women who were diagnosed with breast cancer 2006-2017 will be randomly selected. The women diagnosed with breast cancer will be stratified by detection mode (screen-detected versus symptomatic breast cancer). The women within each group will be matched by age. Additionally, women who have never had a diagnosis of breast cancer will be randomly selected from the target population of BreastScreen Norway.

Brief 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.

Detailed 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 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.

In Study II, quality of life will be compared between about 1000 women treated for screen-detected, about 1000 women treated for symptomatic, about 1000 women treated for interval cancer and about 1000 women without any diagnosis of 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, and will aim to investigate the impact of detection mode versus tumor characteristics and treatment types as the main predictor of long-term quality of life among women diagnosed and treated for breast cancer among the two groups of women, those diagnosed with screen-detected breast cancer versus those diagnosed with interval breast and symptomatic breast cancer.

Eligibility criteria: Study II

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

Exclusion Criteria:

* Death after recruitment

Study III

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

Primary outcomes:
measure: Quality of life score
timeFrame: 2006-2017
measure: QALY (Quality-Adjusted-Life-Year)
timeFrame: 2006-2017
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Cancer Registry of Norway
Study officials:
affiliation: Norwegian Institute of Public Health
name: Solveig Hofvind, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moshina N, Falk RS, Hofvind S. Long-term quality of life among breast cancer survivors eligible for screening at diagnosis: a systematic review and meta-analysis. Public Health. 2021 Oct;199:65-76. doi: 10.1016/j.puhe.2021.08.008. Epub 2021 Sep 21.