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

NCT ID: NCT02198690

Last Updated: 2023-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 541 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2020-04-01

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.

Conditions

Breast Cancer Screening

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Mammography Decision Aid

Development and pilot testing of the decision aid (DA) has been described previously. In brief, the DA is written at a 6th grade reading level and includes information on 1) breast cancer risk factors for women \>75 years; 2) health/life expectancy; 3) likely outcomes if screened and not screened with mammography; 4) competing mortality risks; 5) breast cancer treatments; and 6) a values clarification exercise. The last page asks users their intentions of being screened on a 15-point validated scale and invites users to share this information with their clinician. PCPs whose patients are randomized to receive the DA will be sent a copy of the DA via email and a link to an optional training on using the DA (5 informational slides and a 3-minute video).

Group Type: EXPERIMENTAL

Mammography decision aid

Intervention Type: OTHER

Home safety pamphlet

To reduce response bias and to compensate for the time and attention required by the intervention group to read the DA, patients in the control arm will be provided a two page pamphlet on home safety for older adults developed by the American Geriatrics Society (AGS) Foundation for Health in Aging. PCPs whose patients are randomized to the receive the home safety pamphlet, will be sent an email informing them that their patient will be coming in early to read health educational materials for older adults as part of a study. We otherwise do not plan any intervention for control group PCPs because we do not want to change their usual behavior. However, if PCPs in the control arm request a copy of the educational materials then we will email them a copy of the home safety pamphlet.

Group Type: PLACEBO_COMPARATOR

Home safety pamphlet

Intervention Type: OTHER

Interventions

Mammography decision aid

Intervention Type: OTHER

Home safety pamphlet

Intervention Type: OTHER

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)

• Minimum Eligible Age: 75 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Mara Schonberg

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mara A Schonberg, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Affiliated Physicians Group

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Harvard Vanguard Medical Associates

Boston, Massachusetts, United States

University of North Carolina Medical Center

Chapel Hill, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32310288 (View on PubMed)

Other Identifiers

R01CA181357

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2014P000108

Identifier Type: -

Identifier Source: org_study_id