Decisions About Cancer Screening in Alzheimer's Disease

NCT ID: NCT03282097

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 442 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2024-07-01

Brief 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).

Detailed 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.

Conditions

Cancer, Breast; Alzheimer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Mammogram decision aid

Family caregivers and patients with dementia will be mailed the DECAD decision aid about mammography and breast cancer screening before the patients next PCP visit to test if the aid improves decision making about breast cancer screening in older women with dementia.

Group Type: EXPERIMENTAL

DECAD decision aid

Intervention Type: BEHAVIORAL

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.

Home safety guide

Family caregivers and patients with dementia will be mailed a home safety guide, which 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 about mammography.

Group Type: ACTIVE_COMPARATOR

Home safety guide

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Other Intervention Names

control group

Eligibility Criteria

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

• 18 years or older
• Primary family caregiver of the patient*
• Must have a telephone
• Ability to provide informed consent
• Ability to communicate in English

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 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

• Minimum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Nicole R. Fowler, PhD

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicole Fowler, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Parkview Health

Fort Wayne, Indiana, United States

Alzheimer's Association

Indianapolis, Indiana, United States

Eskenazi Health

Indianapolis, Indiana, United States

IU Health

Indianapolis, Indiana, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

References

Fowler NR, Schonberg MA, Sachs GA, Schwartz PH, Gao S, Lane KA, Inger L, Torke AM. Supporting breast cancer screening decisions for caregivers of older women with dementia: study protocol for a randomized controlled trial. Trials. 2018 Dec 12;19(1):678. doi: 10.1186/s13063-018-3039-z.

Reference Type: DERIVED

PMID: 30541634 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5R01AG055424

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1501278953

Identifier Type: -

Identifier Source: org_study_id