Breast CancerNCT00416975
Individualized Risk-Based Education in Promoting Breast Cancer Screening in Healthy Women
A study testing counseling intervention, educational intervention and evaluation of cancer risk factors in people with Breast Cancer, run by Virginia Commonwealth University.
Trial summary
RATIONALE: Education, based on a patient's risk factors, may help promote breast cancer screening in healthy women. PURPOSE: This randomized clinical trial is studying individualized risk-based education to see how well it promotes breast cancer screening in healthy women compared to standard education. Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- counseling intervention, educational intervention and evaluation of cancer risk factors
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 899 participants
- Where
- No sites listed yet
- Study dates
- May 2000to Feb 2013
- Phase
- Interventional
- 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 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Receiving care at the Women's Health Center gynecology clinic in downtown Richmond, VA or at either the satellite Stony Point or Hayes Willis clinics
- No history of breast cancer, including in situ lesions
- At least 7 years old at first menarche
- No prior genetic counseling or genetic testing for breast cancer
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Female
- Menopausal status not specified
- Not pregnant
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Breast Cancer Risk-Tailored Messages for More Women
RATIONALE: Education, based on a patient's risk factors, may help promote breast cancer screening in healthy women.
PURPOSE: This randomized clinical trial is studying individualized risk-based education to see how well it promotes breast cancer screening in healthy women compared to standard education.
Read the detailed description
OBJECTIVES:
Primary
- Compare the impact of risk-tailored messages vs standard health information on the outcome of mammography in healthy women.
Secondary
- Compare the effect of these interventions on breast self-examination, clinical breast exam, risk perceptions, and breast cancer worry.
- Compare the mechanism of action of these interventions on participants by assessing the impact of covariants (coping mechanisms, expanded Health Belief Model variables, breast cancer worry, breast cancer risk factors including family history, risk perceptions, discussion of breast cancer with relatives, previous screening practices, intentions to screen, and various demographic variables-age, race, and education) on breast cancer screening.
OUTLINE: This is a randomized study.
Participants are approached to complete a baseline survey while they are waiting for their clinic visits. Baseline surveys measure breast cancer risk factors, current breast cancer screening practices, intentions to screen, risk perceptions, breast cancer worry, coping mechanisms, and discussion of breast cancer with relatives. After completion of the baseline surveys, participants are then randomized to 1 of 2 education arms.
- Arm I (intervention group): Participants undergo a computerized risk assessment followed by personalized risk-tailored health messages. Health messages are based on principles of the expanded Health Belief Model (HBM). These messages include screening and lifestyle recommendations, information on the seriousness of breast cancer, instructions on how to arrange a mammography appointment, and contact information for genetic and psychosocial counseling.
- Arm II (control group): Participants receive generalized breast health information sheets that contain appropriate screening and lifestyle recommendations for the general public and contact information for genetic and psychosocial counseling.
All participants undergo follow-up assessment by telephone (or by mail if unreachable by phone) at 1, 6, and 18 months after the initial intervention. Self-reported mammography use, additional breast health monitoring practices, risk perception, breast cancer worry, coping mechanisms, HBM-related beliefs, and family communication are measured.
PROJECTED ACCRUAL: A total of 900 participants will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- counseling intervention, educational intervention, evaluation of cancer risk factors
- Keywords
- breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
counseling interventionOther
Women in the intervention group will be offered breast cancer risk assessment at baseline. Computerized risk assessment is followed by personalized risk tailored health messages. The health messages will also include appropriate recommendations for genetic and psychosocial counseling. Baseline measurements from a questionnaire given prior to the intervention will capture current breast cancer screening practices (mammography, clinical breast exam and self exam), intentions to get mammograms, family discussion of breast cancer, risk perceptions, and breast cancer worry. Important demographic variables and breast cancer risk factors will also be measured. Participants will receive follow up telephone interviews at 1, 6, and 18 months to assess mammography use.
educational interventionOther
Women in the intervention group will be offered breast cancer risk assessment at baseline. Computerized risk assessment is followed by personalized risk tailored health messages. The health messages will also include appropriate recommendations for genetic and psychosocial counseling. Baseline measurements from a questionnaire given prior to the intervention will capture current breast cancer screening practices (mammography, clinical breast exam and self exam), intentions to get mammograms, family discussion of breast cancer, risk perceptions, and breast cancer worry. Important demographic variables and breast cancer risk factors will also be measured. Participants will receive follow up telephone interviews at 1, 6, and 18 months to assess mammography use.
evaluation of cancer risk factorsProcedure or surgery
Women in the intervention group will be offered breast cancer risk assessment at baseline. Computerized risk assessment is followed by personalized risk tailored health messages. The health messages will also include appropriate recommendations for genetic and psychosocial counseling. Baseline measurements from a questionnaire given prior to the intervention will capture current breast cancer screening practices (mammography, clinical breast exam and self exam), intentions to get mammograms, family discussion of breast cancer, risk perceptions, and breast cancer worry. Important demographic variables and breast cancer risk factors will also be measured. Participants will receive follow up telephone interviews at 1, 6, and 18 months to assess mammography use.
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer Risk Assessment Screening | Other | Counseling Intervention and Eduation Intervention Receives: Other: counseling intervention; Other: educational intervention; Procedure: evaluation of cancer risk factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
To reduce the impact of breast cancer by promoting screening, increasing breast health awareness, and providing supportive resources to women who want them;
Measured: 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2006 (estimated)
- Study startMay 2000
- Primary completionDec 2005
- Study completionFeb 2013
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 Virginia Commonwealth UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 899 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Joann N. Bodurtha, MD, MPH, Principal investigator, Massey Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00416975
- Sponsor's protocol ID
- MCC-00036
- Other IDs
- P30CA016059, MCC-00036
- Status last verified
- Apr 2013
- First submitted
- 27 Dec 2006
- Last updated
- 24 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer Risk-Tailored Messages for More Women
- ClinicalTrials.gov ID
- NCT00416975
- Acronym / sponsor ID
- MCC-00036
- Conditions
- Breast Cancer
- Keywords
- breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 899 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2000
- Primary completion
- Dec 2005 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 28 Dec 2006 (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.
RATIONALE: Education, based on a patient's risk factors, may help promote breast cancer screening in healthy women.
PURPOSE: This randomized clinical trial is studying individualized risk-based education to see how well it promotes breast cancer screening in healthy women compared to standard education.
Detailed description
OBJECTIVES:
Primary
- Compare the impact of risk-tailored messages vs standard health information on the outcome of mammography in healthy women.
Secondary
- Compare the effect of these interventions on breast self-examination, clinical breast exam, risk perceptions, and breast cancer worry.
- Compare the mechanism of action of these interventions on participants by assessing the impact of covariants (coping mechanisms, expanded Health Belief Model variables, breast cancer worry, breast cancer risk factors including family history, risk perceptions, discussion of breast cancer with relatives, previous screening practices, intentions to screen, and various demographic variables-age, race, and education) on breast cancer screening.
OUTLINE: This is a randomized study.
Participants are approached to complete a baseline survey while they are waiting for their clinic visits. Baseline surveys measure breast cancer risk factors, current breast cancer screening practices, intentions to screen, risk perceptions, breast cancer worry, coping mechanisms, and discussion of breast cancer with relatives. After completion of the baseline surveys, participants are then randomized to 1 of 2 education arms.
- Arm I (intervention group): Participants undergo a computerized risk assessment followed by personalized risk-tailored health messages. Health messages are based on principles of the expanded Health Belief Model (HBM). These messages include screening and lifestyle recommendations, information on the seriousness of breast cancer, instructions on how to arrange a mammography appointment, and contact information for genetic and psychosocial counseling.
- Arm II (control group): Participants receive generalized breast health information sheets that contain appropriate screening and lifestyle recommendations for the general public and contact information for genetic and psychosocial counseling.
All participants undergo follow-up assessment by telephone (or by mail if unreachable by phone) at 1, 6, and 18 months after the initial intervention. Self-reported mammography use, additional breast health monitoring practices, risk perception, breast cancer worry, coping mechanisms, HBM-related beliefs, and family communication are measured.
PROJECTED ACCRUAL: A total of 900 participants will be accrued for this study.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Risk Assessment Screening | Other | Other: counseling intervention, Other: educational intervention, Procedure: evaluation of cancer risk factorsCounseling Intervention and Eduation Intervention |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| counseling interventionWomen in the intervention group will be offered breast cancer risk assessment at baseline. Computerized risk assessment is followed by personalized risk tailored health messages. The health messages will also include appropriate recommendations for genetic and psychosocial counseling. Baseline measurements from a questionnaire given prior to the intervention will capture current breast cancer screening practices (mammography, clinical breast exam and self exam), intentions to get mammograms, family discussion of breast cancer, risk perceptions, and breast cancer worry. Important demographic variables and breast cancer risk factors will also be measured. Participants will receive follow up telephone interviews at 1, 6, and 18 months to assess mammography use. | Other | Breast Cancer Risk Assessment Screening |
| educational interventionWomen in the intervention group will be offered breast cancer risk assessment at baseline. Computerized risk assessment is followed by personalized risk tailored health messages. The health messages will also include appropriate recommendations for genetic and psychosocial counseling. Baseline measurements from a questionnaire given prior to the intervention will capture current breast cancer screening practices (mammography, clinical breast exam and self exam), intentions to get mammograms, family discussion of breast cancer, risk perceptions, and breast cancer worry. Important demographic variables and breast cancer risk factors will also be measured. Participants will receive follow up telephone interviews at 1, 6, and 18 months to assess mammography use. | Other | Breast Cancer Risk Assessment Screening |
| evaluation of cancer risk factorsWomen in the intervention group will be offered breast cancer risk assessment at baseline. Computerized risk assessment is followed by personalized risk tailored health messages. The health messages will also include appropriate recommendations for genetic and psychosocial counseling. Baseline measurements from a questionnaire given prior to the intervention will capture current breast cancer screening practices (mammography, clinical breast exam and self exam), intentions to get mammograms, family discussion of breast cancer, risk perceptions, and breast cancer worry. Important demographic variables and breast cancer risk factors will also be measured. Participants will receive follow up telephone interviews at 1, 6, and 18 months to assess mammography use. | Procedure or surgery | Breast Cancer Risk Assessment Screening |
Primary outcome
To reduce the impact of breast cancer by promoting screening, increasing breast health awareness, and providing supportive resources to women who want them;
Time frame: 12 years
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 24 Apr 2013.
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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.
Joann N. Bodurtha, MD, MPH principal investigator
Massey Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing counseling intervention, educational intervention and evaluation of cancer risk factors in people with Breast Cancer, run by Virginia Commonwealth University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 24 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
To reduce the impact of breast cancer by promoting screening, increasing breast health awareness, and providing supportive resources to women who want them; (time frame: 12 years). 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 24 Apr 2013; AzTrials last refreshed its copy on 6 Nov 2026.