Clinical trial NCT03282097: Decisions About Cancer Screening in Alzheimer's Disease
Official title: Decisions About Cancer Screening in Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer, Breast
Alzheimer Disease
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Aging (NIA)
First posted: 2017-09-13
Enrollment: 442
Sex: FEMALE
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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 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

Primary outcomes:
measure: Decisional Conflict Scale
timeFrame: 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 outcomes:
measure: Change in Decision-making Self-efficacy
timeFrame: Baseline and 0-5 days after the POST-Index post PCP visit
measure: Caregiver Role in Decision Making
timeFrame: 0-5 days after the PCP Index visit
measure: Patient Role in Decision Making
timeFrame: 0-5 days after the PCP Index visit
measure: Record of Mammogram
timeFrame: 15 month followup, 24 month EMR data
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: Parkview Health
state: Indiana
city: Indianapolis
country: United States
facility: Alzheimer's Association
state: Indiana
city: Indianapolis
country: United States
facility: Eskenazi Health
state: Indiana
city: Indianapolis
country: United States
facility: IU Health
state: Indiana
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Indiana University
name: Nicole Fowler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.