Long-term Effects of Breast Cancer Treatment

NCT ID: NCT03877029

Last Updated: 2024-10-31

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 4487 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-23
• Study Completion Date: 2025-05-31

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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

• 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 III

• Death after recruitment

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The Dam Foundation

OTHER

Sponsor Role: collaborator

Norwegian Institute of Public Health

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Solveig Hofvind, PhD

Role: PRINCIPAL_INVESTIGATOR

Norwegian Institute of Public Health

Locations

Cancer Registry of Norway

Oslo, , Norway

Countries

Norway

References

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.

Reference Type: RESULT

PMID: 34560477 (View on PubMed)

Other Identifiers

2019/FO244363

Identifier Type: -

Identifier Source: org_study_id