Breast CancerNCT00582803
Adherence to Intensive Surveillance for Hereditary Breast Cancer
An observational study of Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
Women with strong family histories of breast cancer are at increased risk to have breast cancer. Women whose close relatives have had breast cancer often have more breast cancer screening than other women their age. Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to Mar 2009
- 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 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: unaffected women over age 25 who are at elevated risk for breast cancer by virtue by a hereditary predisposition
Who may be able to join
- Female
- Age 25 years or greater
- Genetic predisposition as defined by one of the following:
- Known BRCA1 or BRCA2 mutation (deleterious or uncertain significance) OR
- Untested first-degree relative of an individual with a known deleterious BRCA mutation OR
- Unaffected first-degree relative of an affected individual within a hereditary breast-ovarian kindred in which no testing has been performed or testing is negative, defined as: 3 or more women in 2 generations affected with breast or ovarian cancer. Women with bilateral breast cancer and woman with both breast and ovarian cancer count as single individual AND 1 woman must be first-degree relative of the other two, or related to the other two through a male AND At least 1 woman affected with breast cancer before age 50 or ovarian cancer at any age
Show all 9Show fewer
- Able to understand and complete English-language questionnaires
- Intend to receive clinical and radiographic follow-up at MSKCC
- Women will not be excluded if they have previously received clinical and radiographic follow-up at either MSKCC or another institution.
Who cannot join
- Prior history of breast or ovarian cancer
- Contraindication to breast MRI examination (e.g. aneurysm clips, pacemaker, cochlear implant, severe claustrophobia, weight over 300 pounds) or to paramagnetic contrast (prior IgE-type allergic reaction, sickle cell anemia, renal failure)
- Pregnant or planning to begin attempts at conception within 1 year of enrollment. A negative serum β-hCG will not be required for study entry, nor for radiographic examination, as this test is not routinely performed before clinically indicated radiographic study.
- Unable for physical, psychological, or financial reasons to receive clinical and radiographic follow-up at MSKCC
- Concurrent medical or psychological conditions that, in the opinion of the attending physician or Principal Investigator, would place the subject at risk were she to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
Women with strong family histories of breast cancer are at increased risk to have breast cancer. Women whose close relatives have had breast cancer often have more breast cancer screening than other women their age. To increase the chance that any breast cancer will be caught early, women at risk often take part in special screening programs. These programs involve more frequent visits to the doctor for breast exams, yearly mammography, and new types of exam like breast Magnetic Resonance Imaging (MRI). Studies are going on to find out whether these programs are better than standard screening. The purpose of this study is to find out how these programs impact women's quality of life. The study will also try to learn what factors make it hard to take part in the programs. We hope to be able to design new programs that are easier to follow.
Read the detailed description
Women at risk for hereditary breast cancer are recommended to undergo intensive surveillance to maximize the likelihood of detecting the disease at an early, more curable, stage (Burke et al. 1997, Eisenger et al. 1998, Moller et al. 1999). Although the particular recommendations of different groups have varied, all suggest programs that incorporate clinical and radiographic screening performed more frequently than in the general population, beginning at a considerably younger age. Recent studies demonstrating the sensitivity of breast MRI have led several groups to incorporate this technology as an incremental (not replacement) modality, further increasing the intensity of the surveillance regimen. While data are beginning to accumulate regarding the effectiveness of aggressive surveillance, little is known about the ability and willingness of women to adhere to these rigorous schedules, nor about the psychosocial and economic costs of the programs. Based upon the Cognitive-Social Health Information Processing (C-SHIP)model (Miller, Shoda, Hurley 1996), we hypothesize that the ability to adhere to a proposed screening regimen will result from a complex and dynamic interaction between the nature of that regimen, events that can be expected to occur in the course of screening (such as abnormal results and practical barriers) and key psychological factors such as the individual's attentional style, affective state, perceived risk of cancer, cancer-specific worries, and beliefs regarding the effectiveness of screening. To test the hypothesis, we propose to prospectively study women with a hereditary risk for breast cancer participating in a structured surveillance program of monthly breast self-examination, semi-annual clinical examination and annual mammography, augmented by annual interval breast MRI.
- Conditions
- Breast Cancer
- Keywords
- breast cancer, germline mutation, BRCA1, BRCA2, family history, genetic testing, unaffected women over age 25 who are at elevated risk for, breast cancer by virtue by a hereditary predisposition
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive-affective mediating units that are likely to be involved in health information processing and the execution of health-protective behavior
Measured: 5 years 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2007 (estimated)
- Study startMay 2003
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Investigators
- Mark Robson, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00582803
- Sponsor's protocol ID
- 03-059
- Status last verified
- Jul 2009
- First submitted
- 21 Dec 2007
- Last updated
- 10 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Intensive Surveillance for Hereditary Breast Cancer
- ClinicalTrials.gov ID
- NCT00582803
- Acronym / sponsor ID
- 03-059
- Conditions
- Breast Cancer
- Keywords
- breast cancer, germline mutation, BRCA1, BRCA2, family history, genetic testing, unaffected women over age 25 who are at elevated risk for, breast cancer by virtue by a hereditary predisposition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- May 2003
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 28 Dec 2007 (estimated)
- 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.
Women with strong family histories of breast cancer are at increased risk to have breast cancer. Women whose close relatives have had breast cancer often have more breast cancer screening than other women their age. To increase the chance that any breast cancer will be caught early, women at risk often take part in special screening programs. These programs involve more frequent visits to the doctor for breast exams, yearly mammography, and new types of exam like breast Magnetic Resonance Imaging (MRI). Studies are going on to find out whether these programs are better than standard screening. The purpose of this study is to find out how these programs impact women's quality of life. The study will also try to learn what factors make it hard to take part in the programs. We hope to be able to design new programs that are easier to follow.
Detailed description
Women at risk for hereditary breast cancer are recommended to undergo intensive surveillance to maximize the likelihood of detecting the disease at an early, more curable, stage (Burke et al. 1997, Eisenger et al. 1998, Moller et al. 1999). Although the particular recommendations of different groups have varied, all suggest programs that incorporate clinical and radiographic screening performed more frequently than in the general population, beginning at a considerably younger age. Recent studies demonstrating the sensitivity of breast MRI have led several groups to incorporate this technology as an incremental (not replacement) modality, further increasing the intensity of the surveillance regimen. While data are beginning to accumulate regarding the effectiveness of aggressive surveillance, little is known about the ability and willingness of women to adhere to these rigorous schedules, nor about the psychosocial and economic costs of the programs. Based upon the Cognitive-Social Health Information Processing (C-SHIP)model (Miller, Shoda, Hurley 1996), we hypothesize that the ability to adhere to a proposed screening regimen will result from a complex and dynamic interaction between the nature of that regimen, events that can be expected to occur in the course of screening (such as abnormal results and practical barriers) and key psychological factors such as the individual's attentional style, affective state, perceived risk of cancer, cancer-specific worries, and beliefs regarding the effectiveness of screening. To test the hypothesis, we propose to prospectively study women with a hereditary risk for breast cancer participating in a structured surveillance program of monthly breast self-examination, semi-annual clinical examination and annual mammography, augmented by annual interval breast MRI.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- unaffected women over age 25 who are at elevated risk for breast cancer by virtue by a hereditary predisposition
Key inclusion criteria (9 listed)
- Female
- Age 25 years or greater
- Genetic predisposition as defined by one of the following:
- Able to understand and complete English-language questionnaires
- Intend to receive clinical and radiographic follow-up at MSKCC
Key exclusion criteria (5 listed)
- Prior history of breast or ovarian cancer
- Contraindication to breast MRI examination (e.g. aneurysm clips, pacemaker, cochlear implant, severe claustrophobia, weight over 300 pounds) or to paramagnetic contrast (prior IgE-type allergic reaction, sickle cell anemia, renal failure)
- Pregnant or planning to begin attempts at conception within 1 year of enrollment. A negative serum β-hCG will not be required for study entry, nor for radiographic examination, as this test is not routinely performed before clinically indicated radiographic study.
- Unable for physical, psychological, or financial reasons to receive clinical and radiographic follow-up at MSKCC
- Concurrent medical or psychological conditions that, in the opinion of the attending physician or Principal Investigator, would place the subject at risk were she to participate
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
cognitive-affective mediating units that are likely to be involved in health information processing and the execution of health-protective behavior
Time frame: 5 years 7 months
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 10 Jul 2009.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Mark Robson, MD principal investigator
Memorial Sloan Kettering Cancer Center
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 Memorial Sloan Kettering Cancer Center at 1 site in United States.
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 9 inclusion and 5 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 10 Jul 2009. 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 United States. 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?
cognitive-affective mediating units that are likely to be involved in health information processing and the execution of health-protective behavior (time frame: 5 years 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2009.