Long-term Effects of Breast Cancer Treatment

March 5, 2026 updated by: Norwegian Institute of Public Health

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

4487

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Oslo County
      • Oslo, Oslo County, Norway, 0304
        • Cancer Registry of Norway

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life score
Time Frame: 2006-2017
Quality of life measure from 0 to 100 on a visual analogue scale
2006-2017
QALY (Quality-Adjusted-Life-Year)
Time Frame: 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
2006-2017

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian Institute of Public Health

Collaborators

The Dam Foundation

Investigators

  • Principal Investigator: Solveig Hofvind, PhD, Norwegian Institute of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2019

Primary Completion (Actual)

November 13, 2024

Study Completion (Actual)

December 15, 2025

Study Registration Dates

First Submitted

March 14, 2019

First Submitted That Met QC Criteria

March 14, 2019

First Posted (Actual)

March 15, 2019

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/FO244363

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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