N/A
N=429
Decisions About Cancer Screening in Alzheimer's Disease
Cancer, Breast · Alzheimer Disease
Bottom Line
View on ClinicalTrials.gov: NCT03282097 ↗Enrolled (actual)
429
Serious AEs
0.7%
Results posted
Jun 2024
Primary outcome: Primary: Decisional Conflict Scale — -1.9; -0.8 Units on DCS scale — p=0.4393
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- DECAD decision aid (Behavioral); Home safety guide (Other)
- Age
- Older Adult · 75+ yrs
- Sex
- Female
- Sponsor
- Indiana University
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Decisional Conflict Scale |
-1.9; -0.8 | 0.4393 |
| SECONDARY Change in Decision-making Self-efficacy Scale Score |
-1.7; 0.0 | .2262 |
| SECONDARY Caregiver Role in Decision Making |
5.7; 5.2 | 0.0023 sig |
| SECONDARY Receipt of Mammogram Screening |
32; 33; 139; 122 | 0.6075 |
| SECONDARY Change in Caregiver Knowledge About Mammograms in Older Women With ADRD |
1.4; 0.1 | <.0001 sig |
| SECONDARY Caregiver Intention for the Patient to Receive Mammogram Screening in the Future |
73; 104; 86; 37 | <0.0001 sig |
Summary
The Decisions about Cancer screening in Alzheimer's Disease (DECAD) study tests if an evidence-based decision aid for dementia caregivers can support decision-making about mammography and improve the quality of medical decision-making about breast cancer screening. This large randomized controlled trial will recruit up to 450 dyads (900 individual participants) of older women with dementia and a family caregiver, for a goal of 426 dyad baselines (852 individual participants).
Eligibility Criteria
Patient Inclusion Criteria:
- Female and 75 years or older
- At least one mammogram in the past five years
- Primary care visit scheduled in the next 12 months
- Diagnosis of Alzheimer's disease or related dementia as determined by ICD-10 code
- Ability to provide informed consent or assent
- Ability to communicate in English
Patient Exclusion Criteria:
- Permanent resident of a nursing facility
- Had a mammogram in the past 6 months
- Primary care visit scheduled is the first visit with the PCP
- Made a decision to stop getting mammograms
- History of Atypical Ductal Hyperplasia, lobular carcinoma in situ, ductal carcinoma in situ, or non-invasive breast cancer
- Has mild cognitive impairment, serious mental illness such as bipolar or schizophrenia as determined by ICD-10 code
Caregiver Inclusion Criteria:
- 18 years or older
- Primary family caregiver of the patient*
- Must have a telephone
- Ability to provide informed consent
- Ability to communicate in English
Caregiver Exclusion Criteria:
- Caregiver is a non-family member who is not a legal Healthcare Power of Attorney
- Less than a 7th grade education**
- Made a decision that the patient will stop getting mammograms
- Has a diagnosis of AD or has a serious mental illness such as bipolar or schizophrenia as determined by ICD-10 code
Data sourced from ClinicalTrials.gov (NCT03282097). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.