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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03282097
Recruitment Status : Active, not recruiting
First Posted : September 13, 2017
Last Update Posted : January 19, 2023
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Nicole R. Fowler, PhD, Indiana University

Study Description
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Brief Summary:
The Decisions about Cancer screening in Alzheimer's Disease (DECAD) study is the first study to test if an evidence-based decision aid for AD 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 AD and a family caregiver, for a goal of 426 dyad baselines (852 individual participants), from 24 primary care practices in central Indiana to test this decision aid.

Condition or disease Intervention/treatment Phase
Cancer, Breast Behavioral: DECAD decision aid Other: Home safety guide Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 427 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 : April 30, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. Caregiver Role in decision making [ Time Frame: 0-5 days after the PCP Index visit ]
    Adapted from the Control Preferences Scale, this is a 4-item instrument to assess preferences for and involvement in making decisions on their own or sharing responsibility with the patient or doctor.

  3. Patient Role in decision making [ Time Frame: 0-5 days after the PCP Index visit ]
    Adapted from the Control Preferences Scale, this is a 2-item instrument to assess involvement in making decisions on their own or sharing responsibility with their family or doctor.

  4. Record of mammogram [ Time Frame: 15 month followup, 24 month EMR data ]
    We will 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. We will also review the patient's EMR to assess primary care notes, radiology records, and other documentation of a mammogram outside of the INPC at the 24 months post-intervention follow-up.


Eligibility Criteria
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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Indiana
Parkview Health
Fort Wayne, Indiana, United States, 46805
Alzheimer's Association
Indianapolis, Indiana, United States, 46220
Eskenazi Health
Indianapolis, Indiana, United States, 46220
IU Health
Indianapolis, Indiana, United States, 46220
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Indiana University
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Nicole Fowler, PhD Indiana University
  Study Documents (Full-Text)

Documents provided by Nicole R. Fowler, PhD, Indiana University:
Informed Consent Form  [PDF] April 28, 2022

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Nicole R. Fowler, PhD, Assistant Professor of Medicine, Indiana University
ClinicalTrials.gov Identifier: NCT03282097    
Other Study ID Numbers: 1501278953
5R01AG055424-05 ( U.S. NIH Grant/Contract )
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: January 19, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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