Clinical trial · Interventional
Trial of a Mammography Decision Aid for Women Aged 75 and Older
Randomized Trial of a Mammography Decision Aid for Women Aged 75 and Older
NCT02198690CI-TRIAL-00071327completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Screening | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Home safety pamphlet | Other | — | UNRESOLVED |
| Mammography decision aid | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Mammography Decision Aid
- description
- 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).
- interventionNames
- Other: Mammography decision aid
- type
- PLACEBO_COMPARATOR
- label
- Home safety pamphlet
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 75 Years
- Maximum age
- 89 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDSchonberg 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 32310288