Clinical trial NCT02198690: Trial of a Mammography Decision Aid for Women Aged 75 and Older
Official title: Randomized Trial of a Mammography Decision Aid for Women Aged 75 and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Screening
Keywords: Mammography, Older women, decision making
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-07-24
Enrollment: 541
Sex: FEMALE
Minimum age (years): 75
Maximum age (years): 89
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Receipt of mammography screening
timeFrame: 18 months
Secondary outcomes:
measure: Screening intentions
timeFrame: follow-up interview within 1 week
measure: Knowledge of the pros and cons of mammography screening
timeFrame: follow-up interview within 1 week
measure: Decisional Conflict Scale (DCS)
timeFrame: Follow-up interview within 1 week
measure: Decision-making role
timeFrame: Follow-up interview within 1 week
measure: Preparation for Decision-Making
timeFrame: Follow-up interview within 1 week
measure: Acceptability
timeFrame: Follow-up interview within 1 week
measure: Anxiety
timeFrame: Follow-up interview within 1 week
measure: Home safety
timeFrame: Follow-up interview within 1 week
measure: Screening discussions
timeFrame: 18 months
measure: Home safety discussions
timeFrame: 18 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Affiliated Physicians Group
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Harvard Vanguard Medical Associates
state: Massachusetts
city: Chapel Hill
country: United States
facility: University of North Carolina Medical Center
state: North Carolina
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Mara A Schonberg, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schonberg MA, Kistler CE, Pinheiro A, Jacobson AR, Aliberti GM, Karamourtopoulos M, Hayes M, Neville BA, Lewis CL, Wee CC, Fagerlin A, Nekhlyudov L, Marcantonio ER, Hamel MB, Davis RB. Effect of a Mammography Screening Decision Aid for Women 75 Years and Older: A Cluster Randomized Clinical Trial. JAMA Intern Med. 2020 Jun 1;180(6):831-842. doi: 10.1001/jamainternmed.2020.0440.