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DECAD Decision Aid for Breast Cancer Screening in Alzheimer's Disease (DECAD Trial)
N/A
Waitlist Available
Led By Nicole Fowler
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female and 75 years or older
Diagnosis of Alzheimer's disease or related dementia as determined by ICD-10 code
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 month followup, 24 month emr data
Awards & highlights
DECAD Trial Summary
This trial will test if an evidence-based decision aid can help caregivers of Alzheimer's patients make better decisions about mammography screening for breast cancer.
Who is the study for?
This trial is for women aged 75 or older with Alzheimer's disease who have had a mammogram in the last five years. They must be able to give consent, speak English, and have a primary care visit scheduled within the next year. It excludes residents of nursing facilities, those with certain mental illnesses or mild cognitive impairment, and individuals with specific breast conditions or recent mammograms.Check my eligibility
What is being tested?
The DECAD study tests an evidence-based decision aid designed to help caregivers of Alzheimer's patients make informed choices about breast cancer screening through mammography. The study involves up to 900 participants (450 patient-caregiver pairs) from Indiana and uses random assignment to compare outcomes.See study design
What are the potential side effects?
Since this trial focuses on decision-making aids rather than medical treatments, there are no direct side effects like you would expect from drugs or surgeries. However, emotional distress due to decisions about cancer screening could occur.
DECAD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman aged 75 or older.
Select...
I have been diagnosed with Alzheimer's disease or a similar type of dementia.
DECAD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 month followup, 24 month emr data
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 month followup, 24 month emr data
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Decisional conflict Scale
Secondary outcome measures
Caregiver Role in decision making
Change in Decision-making self-efficacy
Patient Role in decision making
+1 moreDECAD Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Mammogram decision aidExperimental Treatment1 Intervention
Will be mailed the DECAD decision aid before their next PCP visit in order to better inform their decision to continue or stop mammography.
Group II: Home safety guideActive Control1 Intervention
The home safety guide 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 away from talking about mammography with the patient's PCP.
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Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,161 Total Patients Enrolled
49 Trials studying Breast Cancer
110,358 Patients Enrolled for Breast Cancer
National Institute on Aging (NIA)NIH
1,668 Previous Clinical Trials
28,004,637 Total Patients Enrolled
13 Trials studying Breast Cancer
40,022 Patients Enrolled for Breast Cancer
Indiana UniversityLead Sponsor
980 Previous Clinical Trials
982,734 Total Patients Enrolled
15 Trials studying Breast Cancer
3,143 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman aged 75 or older.You have had a mammogram in the last 6 months.I have a history of early-stage breast cancer or pre-cancerous breast conditions.You have had a mammogram within the last five years.I have been diagnosed with Alzheimer's disease or a similar type of dementia.I have decided to stop having mammograms.I have a primary care appointment within the next year.You have memory problems or a serious mental illness like bipolar disorder or schizophrenia.
Research Study Groups:
This trial has the following groups:- Group 1: Home safety guide
- Group 2: Mammogram decision aid
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this study actively seeking participants at the moment?
"According to clinicaltrials.gov, this research endeavour was initially posted on November 17th 2017 and recently updated in August 15th 2022. It is now seeking enrollees."
Answered by AI
What is the aggregate quantity of people participating in this clinical experiment?
"Affirmative. The clinical trial portal lists this medical study as actively seeking participants. It was initially posted on November 17th 2017, with the most recent edit being made August 15th 2022. This research is looking to recruit a total of 426 patients from three distinct locations."
Answered by AI
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