Decisions About Cancer Screening in Alzheimer's Disease (DECAD)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03282097 |
Recruitment Status :
Recruiting
First Posted : September 13, 2017
Last Update Posted : February 26, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cancer, Breast | Behavioral: DECAD decision aid Other: Home safety guide | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 426 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Decisions About Cancer Screening in Alzheimer's Disease |
Actual Study Start Date : | November 17, 2017 |
Estimated Primary Completion Date : | October 2021 |
Estimated Study Completion Date : | October 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Mammogram decision aid
Will be mailed the DECAD decision aid before their next PCP visit in order to better inform their decision to continue or stop mammography.
|
Behavioral: DECAD decision aid
A mammography decision aid that will help caregivers of patients with Alzheimer's make decisions about stopping or continuing breast cancer screening. |
Active Comparator: Home safety guide
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.
|
Other: Home safety guide
The home safety guide 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.
Other Name: control group |
- Decisional conflict Scale [ Time Frame: 0-5 days after the POST-Index PCP visit ]The DCS includes 16 questions regarding a medical decision that they have made or that they are about to make. 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
- Change in Decision-making self-efficacy [ Time Frame: Baseline and 0-5 days after the POST-Index post PCP visit ]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 ("not at all confident" to "very confident") to measure caregiver decision-making self-efficacy for mammography decisions for their relative with AD.
- Record of mammogram [ Time Frame: 15 month followup ]We will review the patient's EMR to assess primary care notes, radiology records, and other documentation of a mammogram outside of the INPC. We will also ask caregivers at the 15 months post-intervention follow-up, via phone-administered questionnaire, if the patient received a mammogram at any time since intervention date and any burdens of the procedure for the patient or for them.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 75 Years and older (Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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 AD 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 9 months
- Primary care visit scheduled is not 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
- Two or more first degree relatives with 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*
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03282097
Contact: Karolina Puchalski | 317-274-9492 | kapuch@iu.edu | |
Contact: Shelley Suarez | 317-274-9509 | sdsuarez@regenstrief.org |
United States, Indiana | |
Parkview Health | Recruiting |
Fort Wayne, Indiana, United States, 46805 | |
Contact: Kala Smith | |
Alzheimer's Association | Recruiting |
Indianapolis, Indiana, United States, 46220 | |
Contact: Nicole Fowler 317-274-9123 | |
Eskenazi Health | Recruiting |
Indianapolis, Indiana, United States, 46220 | |
Contact: Nicole Fowler 317-274-9123 | |
IU Health | Recruiting |
Indianapolis, Indiana, United States, 46220 | |
Contact: Nicole Fowler 317-274-9123 | |
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: Mara Schonberg |
Principal Investigator: | Nicole Fowler | Indiana University |
Responsible Party: | Nicole R. Fowler, PhD, Assistant Professor of Medicine, Indiana University |
ClinicalTrials.gov Identifier: | NCT03282097 |
Other Study ID Numbers: |
1501278953 |
First Posted: | September 13, 2017 Key Record Dates |
Last Update Posted: | February 26, 2020 |
Last Verified: | February 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Breast Neoplasms Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies |
Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |