Clinical Trial: Women Informed to Screen Depending on Measures of Risk
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Enabling a Paradigm Shift: A Preference-Tolerant RCT of Personalized vs. Annual Screening for Breast Cancer
Brief Summary:
Most physicians still use a one-size-fits-all approach to breast screening in which all women, regardless of their personal history, family history or genetics (except BRCA carriers) are recommended to have annual mammograms starting at age 40. Mammograms benefit women by detecting cancers early when they are easier to treat, but they are not perfect. Recent news stories have discussed some of the potential harms: large numbers of positive results that cause stressful recalls for additional mammograms and biopsies. With the current screening approach, half of the women who undergo annual screening for ten years will have at least one false positive biopsy. Potentially more important are cancer diagnoses for growths that might never come to clinical attention if left alone (called "overdiagnosis"). This can lead to unnecessary treatment. Even more concerning is evidence that up to 20% of breast cancers detected today may fall into the category of "overdiagnosis."
This proposal compares annual screening with a risk-based breast cancer screening schedule, based upon each woman's personal risk of breast cancer. The investigators have designed the study to be inclusive of all, so that even women who might be nervous about being randomly assigned to receive a particular type of care (a procedure that is typical in clinical studies) will still be able to participate by choosing the type of care they receive.
For participants in the risk-based screening arm, each woman will receive a personal risk assessment that includes her family and medical history, breast density measurement and tests for genes (mutations and variations) linked to the development of breast cancer. Women who have the highest personal risk of developing breast cancer will receive more frequent screening, while women with a lower personal ris
Detailed Summary:
For almost 30 years, annual mammograms for women over 40 have been a cornerstone of the US strategy to reduce mortality from breast cancer. A number of advances in the understanding of breast cancer biology, and screening in general, have led to calls to revise and improve national screening strategies (Esserman et al., 2014). In 2009, the US Preventive Services Task Force (USPSTF) introduced changes to screening guidelines, recommending that annual mammograms for all women 40-75 be replaced by biennial screening for women ages 50-75, and that screening in the 40's should be individualized by taking patient context into account, including the patient's values regarding specific benefits and harms. Despite being based on a thorough review of the scientific literature, these recommendations continue to spark debate and scientific opinion on the effectiveness of annual screening is greatly divided. On one hand the radiology and obstetrics/gynecology community argues that annual mammograms starting at 40 reduce the rate of interval cancers. On the other hand, primary care physicians and other specialists believe that annual screening results in more false-positives and unnecessary treatment and that a more targeted approach could result in fewer false-positives and less over-diagnosis without increasing the number of interval cancers. In fact it has been estimated that half of women will receive a false-positive recall over 10 years of annual screening and that as many as 20% of all breast cancers might be overdiagnosed. Since 2009 this debate has intensified, paralyzing the system and thwarting any efforts to change or improve screening. The end result is that women are frustrated and confused, and some have stopped screening altogether.
Despite a vastly improved understanding of breast cancer risk, the only criteria used to establish a woman's screening recommendations is h
Sponsor: University of California, San Francisco
Current Primary Outcome:
- Late-stage cancer [ Time Frame: 5 years ]Proportion of cancers diagnosed at Stage IIB or higher
- Biopsy rate [ Time Frame: 5 years ]Rate of biopsies performed
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Late-stage cancers rate [ Time Frame: 5 years ]Rate of Stage IIB or higher cancers
- Interval cancers rate [ Time Frame: 5 years ]Rate of interval (detected within 12-24 months of a normal screen) cancers
- Rate of systemic therapy [ Time Frame: 5 years ]Rate of systemic therapy as measure of morbidity
- Mammogram recall rate [ Time Frame: 5 years ]Mammogram recall rate as measure of morbidity
- Breast biopsy rate [ Time Frame: 5 years ]Breast biopsy rate as measure of morbidity
- DCIS rate [ Time Frame: 5 years ]Rate of ductal carcinoma in situ (DCIS) as a measure of morbidity, stratified by biologic type
- Chemoprevention uptake rate [ Time Frame: 5 years ]Rate of uptake of endocrine prevention interventions
- Choice of risk-based versus annual screening in self-assigned cohort [ Time Frame: 5 years ]Proportion of participants who choose risk-based versus annual screening in the self-assigned cohort as a measure of acceptability
- Adherence to assigned screening schedule [ Time Frame: 5 years ]Proportion of participants who adhere to their assigned screening schedules as a measure of acceptability
- Breast-cancer anxiety [ Time Frame: 5 years ]Breast cancer anxiety (as measured with the PROMIS anxiety scale) as a measure of acceptability
- Decisional regret [ Time Frame: 5 years ]Decisional regret (as measured with the Decision Regret Scale, a 5-item Likert scale) as a measure of acceptability
- Ultra-low risk cancer rate [ Time Frame: 5 years ]Rates of ultra-low risk cancer
Original Secondary Outcome: Same as current
Information By: University of California, San Francisco
Dates:
Date Received: December 1, 2015
Date Started: August 31, 2016
Date Completion: December 2020
Last Updated: April 25, 2017
Last Verified: April 2017
