Decisions About Cancer Screening in Alzheimer's Disease

Study Overview
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Brief Summary
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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.

Official Title
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Decisions About Cancer Screening in Alzheimer's Disease

Conditions
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Cancer, Breast

Intervention / Treatment
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* Behavioral: DECAD decision aid
* Other: Home safety guide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mammogram decision aid<br>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<br>* A mammography decision aid that will help caregivers of patients with Alzheimer's make decisions about stopping or continuing breast cancer screening.<br>|
| Active Comparator: Home safety guide<br>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<br>* 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.<br>* Other names: control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional conflict Scale | 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 | 0-5 days after the POST-Index PCP visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Decision-making self-efficacy | 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. | Baseline and 0-5 days after the POST-Index post PCP visit | 
| Caregiver Role in decision making | 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. | 0-5 days after the PCP Index visit | 
| Patient Role in decision making | 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. | 0-5 days after the PCP Index visit | 
| Record of mammogram | 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. | 15 month followup, 24 month EMR data |