NCT02198690

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
541

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 24, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

4.9 years

First QC Date

July 16, 2014

Last Update Submit

November 10, 2023

Conditions

Breast Cancer Screening

Keywords

Mammography, Older women, decision making

Outcome Measures

Primary Outcomes (1)

  • Receipt of mammography screening

    The investigators chose receipt of screening as the primary outcome since they anticipate that implementation of the DA will require that the DA impacts mammography use, especially for women with short life expectancy. The investigators will follow women for 15 months to guarantee at least two years of data since their last mammogram (the upper bound of the recommended screening interval). Research staff will review primary care notes, radiology records, and screening sheets (mammograms performed outside the medical system are manually entered on screening sheets). Research staff will contact patients or an alternate if follow-up is not complete in the medical records.

    18 months

Secondary Outcomes (10)

  • Screening intentions

    follow-up interview within 1 week

  • Knowledge of the pros and cons of mammography screening

    follow-up interview within 1 week

  • Decisional Conflict Scale (DCS)

    Follow-up interview within 1 week

  • Decision-making role

    Follow-up interview within 1 week

  • Preparation for Decision-Making

    Follow-up interview within 1 week

  • +5 more secondary outcomes

Study Arms (2)

Mammography Decision Aid

EXPERIMENTAL

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).

Other: Mammography decision aid

Home safety pamphlet

PLACEBO COMPARATOR

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.

Other: Home safety pamphlet

Interventions

Mammography decision aidOTHER
Mammography Decision Aid
Home safety pamphletOTHER
Home safety pamphlet

Eligibility Criteria

Age75 Years - 89 Years
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Affiliated Physicians Group

Boston, Massachusetts, 02215, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Harvard Vanguard Medical Associates

Boston, Massachusetts, 02215, United States

Location

University of North Carolina Medical Center

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (1)

  • 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.

    PMID: 32310288DERIVED

Study Officials

  • Mara A Schonberg, MD, MPH

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

July 16, 2014

First Posted

July 24, 2014

Study Start

September 1, 2014

Primary Completion

August 1, 2019

Study Completion

April 1, 2020

Last Updated

November 14, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(4)