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Long-term Effects of Breast Cancer Treatment

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ClinicalTrials.gov Identifier: NCT03877029
Recruitment Status : Not yet recruiting
First Posted : March 15, 2019
Last Update Posted : March 26, 2019
Sponsor:
Collaborator:
Extrastiftelsen
Information provided by (Responsible Party):
Cancer Registry of Norway

Study Description
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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.

Condition or disease
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 Design
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Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Long-term Effects Following Treatment of Women With Screen-detected Versus Symptomatic Breast Cancer
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. QALY (Quality-Adjusted-Life-Year) [ Time Frame: 1996-2016 ]
    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


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
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 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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03877029


Contacts
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Contact: Solveig Hofvind, PhD +4722928828 solveig.hofvind@kreftregisteret.no

Sponsors and Collaborators
Cancer Registry of Norway
Extrastiftelsen
Investigators
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Principal Investigator: Solveig Hofvind, PhD Cancer Registry of Norway
More Information
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Responsible Party: Cancer Registry of Norway
ClinicalTrials.gov Identifier: NCT03877029    
Other Study ID Numbers: 2019/FO244363
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cancer Registry of Norway:
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
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases