75 and older, female only, with Cancer, Breast or Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Decisional Conflict ScalePrimary· Change in DCS score from Baseline to post-PCP Index Visit. Post-PCP Index visit routinely occurs 0-5 days after the patient's index visit with their PCP.
The Decisional Conflict Scale (DCS) includes 16-items on a 1-5 Likert scale. Questions are regarding a medical decision that participants have made or that they are about to make; it measures uncertainty around a decision, whether one feels informed, clear about their personal values, and supported in their decision-making It is a validated and widely accepted measure of decision quality that has been used in previous studies of decision aids intended for AD caregivers. Scores can range from 0-100, with lower scores indicating less conflict. This survey is completed during the baseline and Pos
Group
Value
95% CI
Mammogram Decision Aid
-1.9
± 16.1
Home Safety Guide
-0.8
± 12.0
Change in Decision-making Self-efficacy Scale ScoreSecondary· Change in Decision Self-Efficacy score from Baseline to post-PCP Index Visit. Post-PCP Index visit routinely occurs 0-5 days after the patient's index visit with their PCP.
To measure decision-making self-efficacy, we will use the Decision Self-Efficacy Scale (DSE). The DSE is a validated, 11-item instrument that measures how confident the respondent is in their ability to make an informed medical decision, including SDM. We will adapt the DSE with five response categories on a 0-4 Likert scale ("not at all confident", "somewhat confident", "neither confident nor not confident", "confident", and "very confident") to measure caregiver decision-making self-efficacy for mammography decisions for their relative with Alzheimer's Disease and related dementias. To score
Group
Value
95% CI
Mammogram Decision Aid-Family Member
-1.7
± 14.6
Home Safety Guide-Family Member
0.0
± 11.4
Caregiver Role in Decision MakingSecondary· The above values represent the number of caregivers that completed the assessment at post-PCP Index Visit. Post-PCP Index visit routinely occurs 0-5 days after the patient's index visit with their PCP.
On a scale from 1 to 10, caregivers assessed the role that they have in decision making for the patient. The scale is 1 to 10 where 1 means the patient makes all the medical decisions on her own, 5 means that the patient and caregiver equally share the medical decisions, and 10 means that the caregiver makes all medical decisions for the patient.
Group
Value
95% CI
Mammogram Decision Aid-Caregiver
5.7
± 1.6
Home Safety Guide-Caregiver
5.2
± 1.4
Receipt of Mammogram ScreeningSecondary· 15 month post intervention
Receipt of mammograms was assessed 15 months post intervention.
Group
Value
95% CI
Mammogram Decision Aid-Patient
32
Home Safety Guide-Patient
33
Mammogram Decision Aid-Patient
139
Home Safety Guide-Patient
122
Change in Caregiver Knowledge About Mammograms in Older Women With ADRDSecondary· Change in Caregiver knowledge from Baseline to post-PCP Index Visit. Post-PCP Index visit routinely occurs 0-5 days after the patient's index visit with their PCP.
Knowledge about mammograms for older women with Alzheimer's Disease and Related Dementias will be measured with a 16-item measure (6 multiple choice and 10 true/false) mapped directly from the information presented in the decision aid. Scoring for this study created measure is the sum of the correct responses.
Group
Value
95% CI
Mammogram Decision Aid-Caregiver
1.4
± 2.4
Home Safety Guide-Caregiver
0.1
± 1.9
Caregiver Intention for the Patient to Receive Mammogram Screening in the FutureSecondary· Post-PCP Index visit routinely occurs 0-5 days after the patient's index visit with their PCP.
Caregivers were asked when they believed the patient would receive their next mammogram. Never responses were labeled as no, and responses that indicated an intention to be screened in the future were labeled as yes.
Group
Value
95% CI
Mammogram Decision Aid-Caregiver
73
Home Safety Guide-Caregiver
104
Mammogram Decision Aid-Caregiver
86
Home Safety Guide-Caregiver
37
Adverse events — posted to ClinicalTrials.gov
Time frame: All adverse events, unanticipated problems and potential risks will be monitored and collected ongoing and throughout the study by the DECAD research staff and coordinators. For all patients, adverse events will be collected starting at enrollment and continue until after the patient has completed the study either by completing the 15-month follow up or 24-months post-Primary Outcome Data Collection..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Mammogram Decision Aid - Patient
Serious: 1/213 (0%)
Deaths: 37/213
Mammogram Decision Aid - Caregiver
Serious: 0
Deaths: 0/213
Home Safety Guide - Patient
Serious: 2/214 (1%)
Deaths: 30/214
Home Safety Guide - Caregiver
Serious: 0
Deaths: 3/214
Serious adverse events (1 terms)
Reaction
System
Mammogram Decision Aid - P…
Mammogram Decision Aid - C…
Home Safety Guide - Patient
Home Safety Guide - Caregi…
New Breast Cancer Diagnosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
—
Other adverse events (1 terms — click to expand)
Reaction
System
Mammogram Decision Aid - P…
Mammogram Decision Aid - C…
Home Safety Guide - Patient
Home Safety Guide - Caregi…
Complications and distress of receiving a mammogram
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Indiana University
Last refreshed: 11 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03282097.