Decisions About Cancer Screening in Alzheimer's Disease (DECAD)

August 5, 2025 updated by: Nicole R. Fowler, PhD, Indiana University
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Alzheimer's disease and related dementias (ADRD) impact a woman's life expectancy and her ability to participate in medical decision-making about breast cancer screening, necessitating the involvement of family caregivers. Making decisions about mammography screening for women with ADRD is stressful. There are no data that suggest that breast cancer screening helps women with ADRD live longer or better. Decision aids may improve the quality of decision-making about mammography for ADRD patients and may inform family caregivers about the risks, benefits, and need for decision-making around mammography screening.

The Decisions about Cancer Screening in Alzheimer's Disease (DECAD) trial, a randomized controlled clinical trial, will enroll 426 dyads of older women with ADRD (≥75 years) and a family caregiver from clinics and primary-care practices to test a novel, evidence-based decision aid. This decision aid includes information about the impact of ADRD on life expectancy, the benefit of mammograms, and the impact on the quality of life for older women with ADRD. Dyads will be randomized to receive the decision aid or active control information about home safety. This trial will examine the effect on the caregiver's decisional conflict (primary outcome) and the caregiver's decision-making self-efficacy (secondary outcome). A second follow-up at 15 months will include a brief, semi-structured interview with the caregiver regarding the patient's experience with mammograms and decision-making about mammograms. At the same time, a review of the patient's electronic medical record (EMR) will look at discussions about mammography with their primary-care physician and mammogram orders, receipt, results, and burden (e.g., additional diagnostic procedures due to false-positive results, identification of an abnormality on the screening exam but further work-up declined, and identification of a clinically unimportant cancer).

We hypothesize that caregivers who receive the decision aid will have lower levels of decisional conflict and higher levels of decision-making self-efficacy compared to the control group. We also hypothesize that the DECAD decision aid will reduce mammography use among older women with ADRD.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
442

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Fort Wayne, Indiana, United States, 46805
        • Parkview Health
      • Indianapolis, Indiana, United States, 46220
        • Alzheimer's Association
      • Indianapolis, Indiana, United States, 46220
        • Eskenazi Health
      • Indianapolis, Indiana, United States, 46220
        • IU Health
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mammogram decision aid
Family 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.
Behavioral: DECAD decision aid
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.
Active Comparator: Home safety guide
Family 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.
Other: Home safety guide
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.
Other Names:
  • control group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Decisional Conflict Scale
Time Frame: 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 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Decision-making Self-efficacy Scale Score
Time Frame: 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 the sum of all items are divided by 11 and multiplied by 25. Scores range from 0 (Extremely low self-efficacy) to 100 (Extremely high self-efficacy). To measure the change in self-efficacy over time in both groups, we will measure it at two time points.
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
Time Frame: 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.
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
Time Frame: 15 month post intervention
Receipt of mammograms was assessed 15 months post intervention.
15 month post intervention
Change in Caregiver Knowledge About Mammograms in Older Women With ADRD
Time Frame: 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.
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
Time Frame: 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.
Post-PCP Index visit routinely occurs 0-5 days after the patient's index visit with their PCP.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indiana University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institutes of Health (NIH)
National Institute on Aging (NIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nicole Fowler, PhD, Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 6, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1501278953
  • 5R01AG055424 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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