Cancer, BreastDECADNCT03282097
Decisions About Cancer Screening in Alzheimer's Disease
A study testing DECAD decision aid and Home safety guide in people with Cancer, Breast and Alzheimer Disease, run by Indiana University at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 75 years and older, women only
- Conditions the study is for
- Cancer, Breast, Alzheimer Disease
- What is being tested?
- DECAD decision aid and Home safety guide
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 442 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Dec 2017to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- Women only
- No healthy volunteers
- Older adult
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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Parkview Health
Fort Wayne, Indiana, 46805
Alzheimer's Association
Indianapolis, Indiana, 46220
Eskenazi Health
Indianapolis, Indiana, 46220
IU Health
Indianapolis, Indiana, 46220
About this study
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).
Read the 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
- Being tested
- DECAD decision aid, Home safety guide
- Medical subject headings
- Breast Neoplasms, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DECAD decision aidBehavioural
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 guideOther
Also called control group
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.
| Study group | Role | What they receive |
|---|---|---|
| Mammogram decision aid | Experimental | 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. Receives: Behavioral: DECAD decision aid |
| Home safety guide | Active comparator | 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. Receives: Other: Home safety guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Secondary outcomes (5)
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.
Measured: 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.
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.
Measured: 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.
Receipt of Mammogram Screening
Receipt of mammograms was assessed 15 months post intervention.
Measured: 15 month post intervention
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.
Measured: 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.
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.
Measured: Post-PCP Index visit routinely occurs 0-5 days after the patient's index visit with their PCP.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start1 Dec 2017
- Primary completion6 Apr 2023
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer, BreastStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 442 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Nicole R. Fowler, PhD, Indiana University
- Investigators
- Nicole Fowler, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03282097
- Sponsor's protocol ID
- 1501278953
- Other IDs
- 5R01AG055424
- Acronym
- DECAD
- Status last verified
- Aug 2025
- First submitted
- 11 Sep 2017
- Last updated
- 11 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30541634
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decisions About Cancer Screening in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03282097
- Acronym / sponsor ID
- DECAD / 1501278953
- Conditions
- Cancer, Breast, Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 442 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 6 Apr 2023 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 13 Sep 2017 (actual)
- Results
- Posted 7 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mammogram decision aid | Experimental | Behavioral: DECAD decision aidFamily 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. |
| Home safety guide | Active comparator | Other: Home safety guideFamily 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. |
Who may qualify
- Ages
- 75 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DECAD decision aidA 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. | Behavioural | Mammogram decision aid |
| Home safety guideAlso: control groupThe 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. | Other | Home safety guide |
Primary outcome
Decisional Conflict Scale
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.
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.
5 secondary outcomes
Change in Decision-making Self-efficacy Scale Score
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.
Caregiver Role in Decision Making
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.
Receipt of Mammogram Screening
Time frame: 15 month post intervention
Change in Caregiver Knowledge About Mammograms in Older Women With ADRD
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.
Caregiver Intention for the Patient to Receive Mammogram Screening in the Future
Time frame: Post-PCP Index visit routinely occurs 0-5 days after the patient's index visit with their PCP.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30541634Fowler 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Fowler, PhD principal investigator
Indiana University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DECAD decision aid and Home safety guide in people with Cancer, Breast and Alzheimer Disease, run by Indiana University at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional Conflict Scale (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03282097, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.