Decisions About Cancer Screening in Alzheimer's Disease
DECAD
2 other identifiers
interventional
442
1 country
5
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2017
Longer than P75 for not_applicable
5 active sites
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
September 11, 2017
CompletedFirst Posted
Study publicly available on registry
September 13, 2017
CompletedStudy Start
First participant enrolled
December 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 6, 2023
CompletedResults Posted
Study results publicly available
June 7, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2024
CompletedAugust 11, 2025
August 1, 2025
5.3 years
September 11, 2017
April 8, 2024
August 5, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Decisional Conflict Scale
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 Post-Index PCP visit.
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.
Secondary Outcomes (5)
Change in Decision-making Self-efficacy Scale Score
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.
Caregiver Role in Decision Making
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.
Receipt of Mammogram Screening
15 month post intervention
Change in Caregiver Knowledge About Mammograms in Older Women With ADRD
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.
Caregiver Intention for the Patient to Receive Mammogram Screening in the Future
Post-PCP Index visit routinely occurs 0-5 days after the patient's index visit with their PCP.
Study Arms (2)
Mammogram decision aid
EXPERIMENTALFamily caregivers and patients with dementia will be mailed the DECAD decision aid about mammography and breast cancer screening before the patients next PCP visit to test if the aid improves decision making about breast cancer screening in older women with dementia.
Home safety guide
ACTIVE COMPARATORFamily caregivers and patients with dementia will be mailed a home safety guide, which is a two-page paper pamphlet developed by the American Geriatrics Society Foundation for Health in Aging. It provides tips about important actions older adults can take to prevent falls, poisoning, and bathroom hazards and protection against abuse, fire and other related hazards. We selected the home safety guide to account for the attention given to the intervention group but not to provide information that would bias the control group about mammography.
Interventions
A mammography decision aid directed toward family caregivers of older women with Alzheimer's disease and other dementias to assist with decisions about breast cancer screening.
The home safety guide to provide tips about important actions older adults can take to prevent falls, poisoning, and bathroom hazards and protection against abuse, fire and other related hazards.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- years or older
- Primary family caregiver of the patient\*
- Must have a telephone
- Ability to provide informed consent
- Ability to communicate in English
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indiana Universitylead
- National Institutes of Health (NIH)collaborator
- National Institute on Aging (NIA)collaborator
Study Sites (5)
Parkview Health
Fort Wayne, Indiana, 46805, United States
Alzheimer's Association
Indianapolis, Indiana, 46220, United States
Eskenazi Health
Indianapolis, Indiana, 46220, United States
IU Health
Indianapolis, Indiana, 46220, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Related Publications (1)
Fowler NR, Schonberg MA, Sachs GA, Schwartz PH, Gao S, Lane KA, Inger L, Torke AM. Supporting breast cancer screening decisions for caregivers of older women with dementia: study protocol for a randomized controlled trial. Trials. 2018 Dec 12;19(1):678. doi: 10.1186/s13063-018-3039-z.
PMID: 30541634DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Nicole R. Fowler, PhD, MHSA; Associate Professor of Medicine
- Organization
- Indiana University School of Medicine; Indiana University Center for Aging Research; Regenstrief Institute, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Nicole Fowler, PhD
Indiana University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
September 11, 2017
First Posted
September 13, 2017
Study Start
December 1, 2017
Primary Completion
April 6, 2023
Study Completion
July 1, 2024
Last Updated
August 11, 2025
Results First Posted
June 7, 2024
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share