Trial of a Mammography Decision Aid for Women Aged 75 and Older

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.

Inclusion Criteria:

- English-speaking women

- Aged 75 to 89 years

- Scheduled for a routine visit or physical with their PCP in the next 4-12 weeks

- Women who have not had a mammogram in 6 months but have had one in 2 years.

Exclusion Criteria:

- Women who have it documented in their screening sheet that they have chosen to stop
screening

- Women with a history of atypical ductal hyperplasia (ADH) or non-invasive or invasive
breast cancer

- Women with dementia (on problem list/reported by PCP).

- Women without capacity for informed consent.

- Women that report <7th grade education (the reading level of study materials)

- Patients from PCPs that participated in the pilot or are study investigators.

- Women whose PCPs already had 25 patients participate in the study (the cap per PCP)