Long-term Effects of Breast Cancer Treatment

NCT03877029 | Completed

• 1 other identifier: 2019/FO244363
• Study Type: observational
• Target: 4,487
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Quality of life score

  Quality of life measure from 0 to 100 on a visual analogue scale

  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

  2006-2017

Study Arms (2)

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

Eligibility Criteria

• Age: 50 Years - 69 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Death after recruitment
• Study III
• 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
• Death after recruitment

Sponsors & Collaborators

• Norwegian Institute of Public Health: lead
• The Dam Foundation: collaborator

Study Sites (1)

Cancer Registry of Norway

Oslo, Oslo County, 0304, Norway

Location

Related Publications (3)

• 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.

  PMID: 40774379 RESULT

• Moshina 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.

  PMID: 34698976 RESULT

• 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.

  PMID: 34560477 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Solveig Hofvind, PhD

  Norwegian Institute of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 15, 2019
• Study Start: November 23, 2019
• Primary Completion: November 13, 2024
• Study Completion: December 15, 2025
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)