Long-term Effects of Breast Cancer Treatment

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: Unknown
• Conditions: 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, III and IV, 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 1000 women treated for screen-detected and 1000 women treated for symptomatic 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, where quality of life among women with screen-detected breast cancer, interval breast cancer, breast cancer diagnosed outside the screening program and women without any diagnosis of breast cancer will be analyzed. The main hypothesis is that women with no history of breast cancer and those with a screen-detected breast cancer have a higher quality of life than those diagnosed with an interval breast cancer or breast cancer detected outside the screening program.

The aim of Study IV is to investigate the impact of detection mode versus tumor characteristics as the main predictor of long-term quality of life among women diagnosed and treated for breast cancer among the two groups of women treated for breast cancer (diagnosed with sceen-detected breast cancer, diagnosed with interval breast cancer, and diagnosed with symptomatic breast cancer).

• Study Type: Observational
• Enrollment (Anticipated): 4000

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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 and were not diagnosed with breast cancer, 1996-2016, 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 year of diagnosis, age and residing county. Additionally, women who have never had a diagnosis of breast cancer will be randomly selected from the target population of BreastScreen Norway. The women will be matched by age and residing county.

Description

Study II

Inclusion Criteria:

• Screened in BreastScreen Norway and diagnosed with breast cancer between 1996 and 2016
• Diagnosed with symptomatic breast cancer between 1996 and 2016 and never attended screening

Exclusion Criteria:

• Death after recruitment

Study III

Inclusion Criteria:

• Screened in BreastScreen Norway and diagnosed with breast cancer between 1996 and 2016
• Screened in BreastScreen Norway and diagnosed with interval breast cancer between 1996 and 2016
• Diagnosed with symptomatic breast cancer between 1996 and 2016 and never attended screening
• Screened in BreastScreen Norway between 1996 and 2016 and have never been diagnosed with breast cancer

Exclusion Criteria:

• Death after recruitment

Study IV

Inclusion Criteria:

• Screened in BreastScreen Norway and diagnosed with breast cancer between 1996 and 2016
• Screened in BreastScreen Norway and diagnosed with interval breast cancer between 1996 and 2016
• Diagnosed with symptomatic breast cancer between 1996 and 2016 and have never attended screening

Exclusion Criteria:

• Death after recruitment

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Study II; Women with a screen-detected breast cancer after attending BreastScreen Norway; Women who have never attended BreastScreen Norway despite of several invitation, and who are diagnosed with symtomatic breast cancer. Both groups of women will receive the questionnaire.
Study III; Women with a screen-detected breast cancer after attending BreastScreen Norway; Women with interval breast cancer after attending BreastScreen Norway; Women with symptomatic breast cancer, who have never been screened in BreastScreen Norway; Women free from breast cancer
Study IV; Women with a screen-detected breast cancer after attending BreastScreen Norway; Women with interval breast cancer after attending BreastScreen Norway; 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
QALY (Quality-Adjusted-Life-Year)	QALY is defined as one year of life in perfect health and 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	1996-2016

Collaborators and Investigators

• Sponsor: Cancer Registry of Norway
• Collaborators: Extrastiftelsen

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2019
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): June 30, 2022

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 26, 2019
• Last Update Submitted That Met QC Criteria: March 25, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Mammography; Health related quality of life; Breast cancer screening; Long-term effects of breast cancer treatment; Screen-detected breast cancer; Symptomatic breast cancer; Tumor characteristics; Interval breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• 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