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

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ClinicalTrials.gov Identifier: NCT03282097
Recruitment Status : Recruiting
First Posted : September 13, 2017
Last Update Posted : February 26, 2020
Sponsor:
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 426 dyads of older women with AD and a family caregiver 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)
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

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. 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.


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 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
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


Contacts
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Contact: Karolina Puchalski 317-274-9492 kapuch@iu.edu
Contact: Shelley Suarez 317-274-9509 sdsuarez@regenstrief.org

Locations
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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         
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Nicole Fowler Indiana University
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
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

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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