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Decisions About Cancer Screening in Alzheimer's Disease (DECAD)

Primary Purpose

Cancer, Breast

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DECAD decision aid
Home safety guide
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer, Breast

Eligibility Criteria

75 Years - undefined (Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Parkview Health
  • Alzheimer's Association
  • Eskenazi Health
  • IU Health
  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mammogram decision aid

Home safety guide

Arm Description

Will be mailed the DECAD decision aid before their next PCP visit in order to better inform their decision to continue or stop mammography.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
September 11, 2017
Last Updated
May 15, 2023
Sponsor
Indiana University
Collaborators
National Institutes of Health (NIH), National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT03282097
Brief Title
Decisions About Cancer Screening in Alzheimer's Disease
Acronym
DECAD
Official Title
Decisions About Cancer Screening in Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 17, 2017 (Actual)
Primary Completion Date
April 6, 2023 (Actual)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
National Institutes of Health (NIH), National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Breast

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
427 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mammogram decision aid
Arm Type
Experimental
Arm Description
Will be mailed the DECAD decision aid before their next PCP visit in order to better inform their decision to continue or stop mammography.
Arm Title
Home safety guide
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
DECAD decision aid
Intervention Description
A mammography decision aid that will help caregivers of patients with Alzheimer's make decisions about stopping or continuing breast cancer screening.
Intervention Type
Other
Intervention Name(s)
Home safety guide
Other Intervention Name(s)
control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Decisional conflict Scale
Description
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
Time Frame
0-5 days after the POST-Index PCP visit
Secondary Outcome Measure Information:
Title
Change in Decision-making self-efficacy
Description
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.
Time Frame
Baseline and 0-5 days after the POST-Index post PCP visit
Title
Caregiver Role in decision making
Description
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.
Time Frame
0-5 days after the PCP Index visit
Title
Patient Role in decision making
Description
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.
Time Frame
0-5 days after the PCP Index visit
Title
Record of mammogram
Description
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.
Time Frame
15 month followup, 24 month EMR data

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Fowler, PhD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parkview Health
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46805
Country
United States
Facility Name
Alzheimer's Association
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46220
Country
United States
Facility Name
Eskenazi Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46220
Country
United States
Facility Name
IU Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46220
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30541634
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.
Results Reference
derived

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Decisions About Cancer Screening in Alzheimer's Disease

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