Cancer, Breast Clinical Trial
— DECADOfficial title:
Decisions About Cancer Screening in Alzheimer's Disease
Verified date | May 2023 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 427 |
Est. completion date | June 30, 2024 |
Est. primary completion date | April 6, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 75 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Parkview Health | Fort Wayne | Indiana |
United States | Alzheimer's Association | Indianapolis | Indiana |
United States | Eskenazi Health | Indianapolis | Indiana |
United States | IU Health | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University | National Institute on Aging (NIA), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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