Decisions About Cancer Screening in Alzheimer's Disease

Alzheimer Disease Clinical Trial

— DECAD  

Official title:

Decisions About Cancer Screening in Alzheimer's Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03282097
• Other study ID #: 1501278953
• Secondary ID: 5R01AG055424
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 442
• 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

Related Conditions & MeSH terms

• Alzheimer Disease
• Breast Neoplasms
• Cancer, Breast

Intervention

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.

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.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Indiana University	National Institute on Aging (NIA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decisional Conflict Scale	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 Primary Outcome Data. DCS is collected at baseline and during the Post-PCP Index visit, that occurs 0-5 days after the patient's index visit with their PCP.
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