Trial of a Mammography Decision Aid for Women Aged 75 and Older
Condition: Breast Cancer Screening
Study type: Interventional

Summary: 
      The aim of this study is to test whether an educational pamphlet on mammography designed for
      women aged 75 and older improves older women's decision-making around mammography screening.
      The investigators aim to show that the educational pamphlet improves older women's knowledge
      of the pros and cons or screening and leads to fewer women in poor health with short life
      expectancy being screened.
    

Detailed description: 
      Women aged 75 and older are the fastest growing segment of the US population and breast
      cancer incidence increases with age. However, none of the randomized trials of mammography
      screening included women >74 years and it is not known if mammography helps these women live
      longer. Increasingly, data suggest that women need around 10 year life expectancy to have a
      chance at a mortality benefit from being screened with mammography. Meanwhile, there are
      immediate harms to screening older women including: pain, anxiety, complications from tests
      after a false positive mammogram (e.g., breast biopsy), and overdiagnosis (finding tumors
      that otherwise would never have caused symptoms in one's lifetime). Overdiagnosis is
      particularly concerning since some older women experience significant complications from
      breast cancer treatment. Guidelines state that there is insufficient evidence to recommend
      mammography screening for women aged 75 years or older and encourage clinicians to discuss
      the uncertainty about the balance of benefits and harms with older women. Yet, few older
      women are informed of potential harms of mammography before being screened, likely because
      explaining such uncertainty can be challenging and time consuming.

      To improve older women's understanding of the benefits and risks of mammography screening,
      investigators previously developed and pilot tested a pamphlet decision aid (DA) on
      mammography screening for women aged 75+ years. The pilot pretest/posttest trial of 45 women
      75+ years found that the DA resulted in older women being more knowledgeable about the
      benefits and risks of mammography, clearer in their values, and fewer intended to be
      screened, especially those with <10 year life expectancy.

      Investigators now propose a large cluster randomized controlled trial (RCT) of the DA, using
      primary care physician (PCP) as the unit of randomization, to definitively evaluate the DA's
      efficacy. The investigators aim to recruit 550 women 75-89 years from 100 PCPs who provide
      care at an academic primary care or geriatrics practice in Boston, three community practices
      in the Boston metro area, or at an academic internal medicine or family practice in North
      Carolina. Patient participants will either receive the DA (intervention arm) or an
      educational pamphlet on home safety for older adults (control arm). The investigators chose
      to use PCPs as the unit of randomization rather than individual patients because they
      anticipate that some patients will share the DA with their PCPs. Once PCPs are exposed to the
      DA for one patient they could change their approach to screening which could lead to
      contamination of the control group making it more difficult to show an effect of the DA.

      Aims:

      The investigators will examine and evaluate the impact of providing information on benefits
      and risks of mammography screening to women aged 75 and older on:

        1. receipt of screening;

        2. intentions of being screened;

        3. knowledge of the pros and cons of being screened;

        4. decisional conflict around screening;

        5. preferred decision-making role around mammography (active vs. passive/shared with
           physician);

        6. documented discussions by PCPs of the risks and benefits of mammography screening in
           participants' notes.
    

Intervention name(s): Mammography decision aid; Home safety pamphlet
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Mammography, Older women, decision making