Alzheimer Disease, Cancer, Breast
Conditions
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.
Interventions
BEHAVIORALDECAD 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.
OTHERHome 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.
Sponsors
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
75 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decisional Conflict Scale | Change in DCS score from Baseline to post-PCP Index Visit. Post-PCP Index visit routinely occurs 0-5 days after the patient's index visit with their PCP. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Decision-making Self-efficacy Scale Score | Change in Decision Self-Efficacy score from Baseline to post-PCP Index Visit. Post-PCP Index visit routinely occurs 0-5 days after the patient's index visit with their PCP. | 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 on a 0-4 Likert scale (not at all confident, somewhat confident, neither confident nor not confident, confident, and very confident) to measure caregiver decision-making self-efficacy for mammography decisions for their relative with Alzheimer's Disease and related dementias. To score the sum of all items are divided by 11 and multiplied by 25. Scores range from 0 (Extremely low self-efficacy) to 100 (Extremely high self-efficacy). To measure the change in self-efficacy over time in both groups, we will measure it at two time points. |
| Caregiver Role in Decision Making | The above values represent the number of caregivers that completed the assessment at post-PCP Index Visit. Post-PCP Index visit routinely occurs 0-5 days after the patient's index visit with their PCP. | On a scale from 1 to 10, caregivers assessed the role that they have in decision making for the patient. The scale is 1 to 10 where 1 means the patient makes all the medical decisions on her own, 5 means that the patient and caregiver equally share the medical decisions, and 10 means that the caregiver makes all medical decisions for the patient. |
| Receipt of Mammogram Screening | 15 month post intervention | Receipt of mammograms was assessed 15 months post intervention. |
| Change in Caregiver Knowledge About Mammograms in Older Women With ADRD | Change in Caregiver knowledge from Baseline to post-PCP Index Visit. Post-PCP Index visit routinely occurs 0-5 days after the patient's index visit with their PCP. | Knowledge about mammograms for older women with Alzheimer's Disease and Related Dementias will be measured with a 16-item measure (6 multiple choice and 10 true/false) mapped directly from the information presented in the decision aid. Scoring for this study created measure is the sum of the correct responses. |
| Caregiver Intention for the Patient to Receive Mammogram Screening in the Future | Post-PCP Index visit routinely occurs 0-5 days after the patient's index visit with their PCP. | Caregivers were asked when they believed the patient would receive their next mammogram. Never responses were labeled as no, and responses that indicated an intention to be screened in the future were labeled as yes. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from primary care clinics in central Indiana and Boston, MA between November 2017 and August 2022. The first participant was enrolled on December 1, 2017 and the last participant was enrolled on August 29, 2022.
Pre-assignment details
Of the 442 enrolled dyads, 429 were randomized to receive the mammogram decision aid or home safety pamphlet, 427 dyads met inclusion criteria to proceed with the study.
Participants by arm
| Arm | Count |
|---|---|
| Mammogram Decision Aid - Caregivers Will be mailed the DECAD decision aid before their next PCP visit in order to better inform their decision to continue or stop mammography.
DECAD decision aid: A mammography decision aid that will help caregivers of patients with Alzheimer's make decisions about stopping or continuing breast cancer screening. | 213 |
| Mammogram Decision Aid - Patient Will be mailed the DECAD decision aid before their next PCP visit in order to better inform their decision to continue or stop mammography.
DECAD decision aid: A mammography decision aid that will help caregivers of patients with Alzheimer's make decisions about stopping or continuing breast cancer screening. | 213 |
| Home Safety Guide - Caregivers 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.
Home safety guide: 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. | 214 |
| Home Safety Guide - Patient 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.
Home safety guide: 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. | 214 |
| Total | 854 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 15 Month Follow-up Complete | Lost to Follow-up | 6 | 8 |
| 15 Month Follow-up Complete | Withdrawal by Subject | 0 | 1 |
| Intervention Visit Complete | Became Ineligible before PCP Index visit | 12 | 21 |
| Intervention Visit Complete | Caregiver Death | 0 | 3 |
| Intervention Visit Complete | Patient Death | 13 | 15 |
| Intervention Visit Complete | PCP Index Visit Not Completed | 3 | 7 |
| Intervention Visit Complete | Withdrawal by Subject | 14 | 13 |
| Primary Outcome Data Collection Complete | Missing | 2 | 3 |
| Primary Outcome Data Collection Complete | Withdrawal by Subject | 1 | 0 |
| Randomized and Completed Baseline | Randomized no Baseline | 1 | 1 |
Baseline characteristics
| Characteristic | Mammogram Decision Aid - Caregivers | Mammogram Decision Aid - Patient | Home Safety Guide - Caregivers | Home Safety Guide - Patient | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 65 Participants | 213 Participants | 73 Participants | 214 Participants | 565 Participants |
| Age, Categorical Between 18 and 65 years | 146 Participants | 0 Participants | 139 Participants | 0 Participants | 285 Participants |
| Race/Ethnicity, Customized African American | 57 Participants | 55 Participants | 51 Participants | 53 Participants | 216 Participants |
| Race/Ethnicity, Customized No response provided | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 9 Participants | 7 Participants | 4 Participants | 2 Participants | 22 Participants |
| Race/Ethnicity, Customized White | 147 Participants | 150 Participants | 159 Participants | 159 Participants | 615 Participants |
| Region of Enrollment United States | 213 participants | 213 participants | 214 participants | 214 participants | 854 participants |
| Sex/Gender, Customized Female | 133 Participants | 213 Participants | 131 Participants | 214 Participants | 691 Participants |
| Sex/Gender, Customized Male | 80 Participants | 0 Participants | 82 Participants | 0 Participants | 162 Participants |
| Sex/Gender, Customized Other | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 37 / 213 | 0 / 213 | 30 / 214 | 3 / 214 |
| other Total, other adverse events | 4 / 213 | 0 / 0 | 4 / 214 | 0 / 0 |
| serious Total, serious adverse events | 1 / 213 | 0 / 0 | 2 / 214 | 0 / 0 |
Outcome results
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.
Time frame: Change in DCS score from Baseline to post-PCP Index Visit. Post-PCP Index visit routinely occurs 0-5 days after the patient's index visit with their PCP.
Population: The above values represent the number of dyads that completed the Decisional Conflict Scale (DCS) at both baseline and post-PCP Index Visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mammogram Decision Aid | Decisional Conflict Scale | -1.9 Units on DCS scale | Standard Deviation 16.1 |
| Home Safety Guide | Decisional Conflict Scale | -0.8 Units on DCS scale | Standard Deviation 12 |
p-value: 0.4393ANCOVA
Secondary
Caregiver Intention for the Patient to Receive Mammogram Screening in the Future
Caregivers were asked when they believed the patient would receive their next mammogram. Never responses were labeled as no, and responses that indicated an intention to be screened in the future were labeled as yes.
Time frame: Post-PCP Index visit routinely occurs 0-5 days after the patient's index visit with their PCP.
Population: The above values represent the number of caregivers that completed the assessment at post-PCP Index Visit.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mammogram Decision Aid | Caregiver Intention for the Patient to Receive Mammogram Screening in the Future | No | 86 Participants |
| Mammogram Decision Aid | Caregiver Intention for the Patient to Receive Mammogram Screening in the Future | Yes | 73 Participants |
| Home Safety Guide | Caregiver Intention for the Patient to Receive Mammogram Screening in the Future | No | 37 Participants |
| Home Safety Guide | Caregiver Intention for the Patient to Receive Mammogram Screening in the Future | Yes | 104 Participants |
p-value: <0.0001Regression, Logistic
Secondary
Caregiver Role in Decision Making
On a scale from 1 to 10, caregivers assessed the role that they have in decision making for the patient. The scale is 1 to 10 where 1 means the patient makes all the medical decisions on her own, 5 means that the patient and caregiver equally share the medical decisions, and 10 means that the caregiver makes all medical decisions for the patient.
Time frame: The above values represent the number of caregivers that completed the assessment at post-PCP Index Visit. Post-PCP Index visit routinely occurs 0-5 days after the patient's index visit with their PCP.
Population: Caregivers who completed post-PCP Index Visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mammogram Decision Aid | Caregiver Role in Decision Making | 5.7 units on a scale | Standard Deviation 1.6 |
| Home Safety Guide | Caregiver Role in Decision Making | 5.2 units on a scale | Standard Deviation 1.4 |
p-value: 0.0023ANCOVA
Secondary
Change in Caregiver Knowledge About Mammograms in Older Women With ADRD
Knowledge about mammograms for older women with Alzheimer's Disease and Related Dementias will be measured with a 16-item measure (6 multiple choice and 10 true/false) mapped directly from the information presented in the decision aid. Scoring for this study created measure is the sum of the correct responses.
Time frame: Change in Caregiver knowledge from Baseline to post-PCP Index Visit. Post-PCP Index visit routinely occurs 0-5 days after the patient's index visit with their PCP.
Population: The above values represent the number of caregivers that completed the knowledge assessment at both baseline and post-PCP Index Visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mammogram Decision Aid | Change in Caregiver Knowledge About Mammograms in Older Women With ADRD | 1.4 Units on the scale | Standard Deviation 2.4 |
| Home Safety Guide | Change in Caregiver Knowledge About Mammograms in Older Women With ADRD | 0.1 Units on the scale | Standard Deviation 1.9 |
p-value: <0.0001ANCOVA
Secondary
Change in Decision-making Self-efficacy Scale Score
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 on a 0-4 Likert scale (not at all confident, somewhat confident, neither confident nor not confident, confident, and very confident) to measure caregiver decision-making self-efficacy for mammography decisions for their relative with Alzheimer's Disease and related dementias. To score the sum of all items are divided by 11 and multiplied by 25. Scores range from 0 (Extremely low self-efficacy) to 100 (Extremely high self-efficacy). To measure the change in self-efficacy over time in both groups, we will measure it at two time points.
Time frame: Change in Decision Self-Efficacy score from Baseline to post-PCP Index Visit. Post-PCP Index visit routinely occurs 0-5 days after the patient's index visit with their PCP.
Population: The above values represent the number of dyads that completed the Decision Self-Efficacy Scale (DSE) at both baseline and post-PCP Index Visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mammogram Decision Aid | Change in Decision-making Self-efficacy Scale Score | -1.7 Units on the DSE scale | Standard Deviation 14.6 |
| Home Safety Guide | Change in Decision-making Self-efficacy Scale Score | 0.0 Units on the DSE scale | Standard Deviation 11.4 |
p-value: 0.2262ANCOVA
Secondary
Receipt of Mammogram Screening
Receipt of mammograms was assessed 15 months post intervention.
Time frame: 15 month post intervention
Population: All patients who completed an index visit
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mammogram Decision Aid | Receipt of Mammogram Screening | Received mammogram | 32 Participants |
| Mammogram Decision Aid | Receipt of Mammogram Screening | Did not receive mammogram | 139 Participants |
| Home Safety Guide | Receipt of Mammogram Screening | Received mammogram | 33 Participants |
| Home Safety Guide | Receipt of Mammogram Screening | Did not receive mammogram | 122 Participants |
p-value: 0.6075Regression, Logistic