Breast CancerNCT03877029
Long-term Effects of Breast Cancer Treatment
An observational study of Breast Cancer, run by Norwegian Institute of Public Health at 1 site in Norway.
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… Read more about this study
- Who is it for?
- Ages 50 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- How many people
- 4,487 participants
- Where
- 1 siteNorway
- Study dates
- 23 Nov 2019to 15 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
- 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
Who cannot join
- Death after recruitment
- Study III
- Death after recruitment
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- 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
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Quality of life score
Quality of life measure from 0 to 100 on a visual analogue scale
Measured: 2006-2017
QALY (Quality-Adjusted-Life-Year)
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
Measured: 2006-2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start23 Nov 2019
- Primary completion13 Nov 2024
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,487 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian Institute of Public Health
- Sponsor type
- Other government
- Collaborators
- The Dam Foundation
- Responsible party
- Sponsor
- Investigators
- Solveig Hofvind, PhD, Principal investigator, Norwegian Institute of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877029
- Sponsor's protocol ID
- 2019/FO244363
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2019
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moshina N, Falk RS, Botteri E, Larsen M, Akslen LA, Ursin G, Cairns JA, Hofvind S. Long-term quality of life and quality adjusted life years after breast cancer: Impact of detection mode, tumor characteristics and treatment. J Cancer Policy. 2025 Sep;45:100631. doi: 10.1016/j.jcpo.2025.100631. Epub 2025 Aug 5.
PubMed 40774379Moshina N, Falk RS, Botteri E, Larsen M, Akslen LA, Cairns JA, Hofvind S. Quality of life among women with symptomatic, screen-detected, and interval breast cancer, and for women without breast cancer: a retrospective cross-sectional study from Norway. Qual Life Res. 2022 Apr;31(4):1057-1068. doi: 10.1007/s11136-021-03017-7. Epub 2021 Oct 26.
PubMed 34698976Moshina 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.
PubMed 34560477
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effects Following Treatment of Women With Screen-detected Versus Symptomatic Breast Cancer
- ClinicalTrials.gov ID
- NCT03877029
- Acronym / sponsor ID
- 2019/FO244363
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,487 participants (actual)
- Lead sponsor
- Norwegian Institute of Public HealthOther government
- Collaborators
- The Dam Foundation
- Study start
- 23 Nov 2019 (actual)
- Primary completion
- 13 Nov 2024 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 15 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
- Screened in BreastScreen Norway and diagnosed with breast cancer between 2006 and 2017
Key exclusion criteria (3 listed)
- Death after recruitment
- Study III
- Death after recruitment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of life score
Time frame: 2006-2017
Quality of life measure from 0 to 100 on a visual analogue scale
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Results publication: PubMed 40774379Moshina N, Falk RS, Botteri E, Larsen M, Akslen LA, Ursin G, Cairns JA, Hofvind S. Long-term quality of life and quality adjusted life years after breast cancer: Impact of detection mode, tumor characteristics and treatment. J Cancer Policy. 2025 Sep;45:100631. doi: 10.1016/j.jcpo.2025.100631. Epub 2025 Aug 5.
- Results publication: PubMed 34698976Moshina N, Falk RS, Botteri E, Larsen M, Akslen LA, Cairns JA, Hofvind S. Quality of life among women with symptomatic, screen-detected, and interval breast cancer, and for women without breast cancer: a retrospective cross-sectional study from Norway. Qual Life Res. 2022 Apr;31(4):1057-1068. doi: 10.1007/s11136-021-03017-7. Epub 2021 Oct 26.
- Results publication: PubMed 34560477Moshina 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Solveig Hofvind, PhD principal investigator
Norwegian Institute of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Norwegian Institute of Public Health at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life score (time frame: 2006-2017). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03877029, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.