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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA251754 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The purpose of this research study was to determine the potential benefits of adding information on patients' breast arterial calcification (BAC) results to the standard results letter women receive after mammography. In addition to looking for potential breast cancer, research shows that mammograms can also detect the presence of calcifications within the breast arteries. Those calcifications can be associated with coronary artery disease. Women are not currently routinely told whether or not they have BAC; that is, it's not part of standard national practice to communicate that information to patients. However, previous research has suggested that patients would like to be informed about the BAC status more often. In this study, the team had two goals. First, the team wanted to measure the rates of BAC in a large, representative sample of 5492 women.
Second, the study team wanted to understand the effects of providing women with the BAC results as part of the standard post-mammography letter. Specifically, the study team wants to see how sharing BAC information might affect women's healthcare choices and lifestyle. The research includes 527 randomized women in this second part of the study, which is the first in the literature to explore women's reactions to the BAC results. If research shows that women find the information useful, BAC information may be given to women regularly in the future.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAC-enhanced group | Experimental | Participants will receive a post-mammography results letter which includes information on their BAC results. |
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| Waitlist control group | Other | Participants will receive a post-mammography results letter without BAC information, which is the current standard of care. These patients will receive BAC information following study completion (approximately 6 months after mammography). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAC-Enhanced Letter | Behavioral | The BAC-Enhanced Letter intervention includes enhancing the standard mammography results letter with a few additional lines of text informing patients of their personal BAC status. |
| Measure | Description | Time Frame |
|---|---|---|
| Attendance at a cardiovascular appointment | Patients will be asked a YES/NO question asking them to report whether they have seen a healthcare provider to talk about their heart or coronary artery disease in the last six months. Patient's self-report responses will be confirmed via medical record review. | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Healthy Heart Score | The Healthy Heart Score is a survey to assess patients' heart healthy behaviors. It assesses age, smoking, body mass index, exercise, alcohol, and a composite diet score. A higher score indicates a greater risk of cardiovascular disease. Score has gender-specific algorithm that estimates 20-year CVD risk (https://healthyheartscore.sph.harvard.edu/) (DOI: 10.1161/JAHA.114.000954): 20-yr CVD risk (%) "Healthy Heart Score" = [1 - 0. 9660 (exp [W- 6.57301)] × 100% where W= 0.10820 x age + 0.15285 (if past smoker) + 0.90138 (if current smoker) + 0.04676 × BMI - 0.01923 × g/d of alcohol + 0.0004 × (g/d of alcohol)2- 0.029251 × hrs/wk of physical activity - 0.05113 × diet score* 20-yr CVD risk (%) "Healthy Heart Score" = [1 - 0. 96368 (exp [W-7.2437)] × 100% where W= 0.13580 x age- 0.0005 x (age)2 + 0.06979 (if past smoker) + 0.42305 (if current smoker) +0.07424 × BMI - 0.00898 × g/d of alcohol + 0.0001 × (g/d of alcohol)2- 0.01755 × hrs/wk of physical activity - 0.06691 × diet score](streamdown:incomplete-link) |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guy H. Montgomery, Ph.D. | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai | New York | New York | 10029 | United States |
There currently isn't a plan to share individual participant data (IPD) with other researchers as this is a single-center trial and all study investigators and personnel are affiliated with Mount Sinai.
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| ID | Term |
|---|---|
| D061205 | Vascular Calcification |
| ID | Term |
|---|---|
| D002114 | Calcinosis |
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Waitlist Control | Behavioral | Patients randomized to this group will receive a standard post-mammography results letter which does not include any information about their personal BAC status. However, participants randomized to this group will be informed of their personal BAC findings at the end of their study participation (approximately 6 months after mammography). |
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| Baseline |
| Healthy Heart Score | The Healthy Heart Score is a survey to assess patients' heart healthy behaviors. It assesses age, smoking, body mass index, exercise, alcohol, and a composite diet score. A higher score indicates a greater risk of cardiovascular disease. Score has gender-specific algorithm that estimates 20-year CVD risk (https://healthyheartscore.sph.harvard.edu/) (DOI: 10.1161/JAHA.114.000954): 20-yr CVD risk (%) "Healthy Heart Score" = [1 - 0. 9660 (exp [W- 6.57301)] × 100% where W= 0.10820 x age + 0.15285 (if past smoker) + 0.90138 (if current smoker) + 0.04676 × BMI - 0.01923 × g/d of alcohol + 0.0004 × (g/d of alcohol)2- 0.029251 × hrs/wk of physical activity - 0.05113 × diet score* 20-yr CVD risk (%) "Healthy Heart Score" = [1 - 0. 96368 (exp [W-7.2437)] × 100% where W= 0.13580 x age- 0.0005 x (age)2 + 0.06979 (if past smoker) + 0.42305 (if current smoker) +0.07424 × BMI - 0.00898 × g/d of alcohol + 0.0001 × (g/d of alcohol)2- 0.01755 × hrs/wk of physical activity - 0.06691 × diet score](streamdown:incomplete-link) | Week 1 |
| Healthy Heart Score | The Healthy Heart Score is a survey to assess patients' heart healthy behaviors. It assesses age, smoking, body mass index, exercise, alcohol, and a composite diet score. A higher score indicates a greater risk of cardiovascular disease. Score has gender-specific algorithm that estimates 20-year CVD risk (https://healthyheartscore.sph.harvard.edu/) (DOI: 10.1161/JAHA.114.000954): 20-yr CVD risk (%) "Healthy Heart Score" = [1 - 0. 9660 (exp [W- 6.57301)] × 100% where W= 0.10820 x age + 0.15285 (if past smoker) + 0.90138 (if current smoker) + 0.04676 × BMI - 0.01923 × g/d of alcohol + 0.0004 × (g/d of alcohol)2- 0.029251 × hrs/wk of physical activity - 0.05113 × diet score* 20-yr CVD risk (%) "Healthy Heart Score" = [1 - 0. 96368 (exp [W-7.2437)] × 100% where W= 0.13580 x age- 0.0005 x (age)2 + 0.06979 (if past smoker) + 0.42305 (if current smoker) +0.07424 × BMI - 0.00898 × g/d of alcohol + 0.0001 × (g/d of alcohol)2- 0.01755 × hrs/wk of physical activity - 0.06691 × diet score](streamdown:incomplete-link) | Month 6 |
| Detection of coronary artery disease (CAD) | Participants will respond to a single, self-report item (adapted from the 2019 NHIS survey item) which will ask if they have been told by a doctor or other health professional that they had coronary artery disease in the last 6 months. The item will be rated as, "yes, no, or don't know." Self-reported diagnosis will be confirmed via medical record review. | Month 6 |
| Revised Illness Perception Questionnaire (IPQ-R) | Illness representations will be assessed using the IPQ-R which have been adapted to include an addendum of Cardiovascular-Disease Related Worry Scale questions. Participants will be asked to rate items related to personal beliefs about CAD with regard to causal beliefs and on 8 subscales: identity (scale 0-13); timeline (scale 6-30); consequences (scale 6-30); personal control (scale 6-30); treatment control (scale 5-25); illness coherence (scale5-25); timeline cyclical (scale 4-20); and emotional representations (scale 6-30); and CVD related worry scale (scale3-13). Full scale from 41-216, higher scores represent a higher number of symptoms related to CAD, more positive beliefs about the controllability of disease, and a greater personal understanding of the condition. | Week 1 |
| Revised Illness Perception Questionnaire (IPQ-R) | Illness representations will be assessed using the IPQ-R which have been adapted to include an addendum of Cardiovascular-Disease Related Worry Scale questions. Participants will be asked to rate items related to personal beliefs about CAD with regard to causal beliefs and on 8 subscales: identity (scale 0-13); timeline (scale 6-30); consequences (scale 6-30); personal control (scale 6-30); treatment control (scale 5-25); illness coherence (scale5-25); timeline cyclical (scale 4-20); and emotional representations (scale 6-30); and CVD related worry scale (scale3-13). Full scale from 41-216, higher scores represent a higher number of symptoms related to CAD, more positive beliefs about the controllability of disease, and a greater personal understanding of the condition. | Month 6 |