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

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ClinicalTrials.gov Identifier: NCT03282097
Recruitment Status : Recruiting
First Posted : September 13, 2017
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
Nicole R. Fowler, PhD, Indiana University

Tracking Information
First Submitted Date  ICMJE September 11, 2017
First Posted Date  ICMJE September 13, 2017
Last Update Posted Date February 26, 2020
Actual Study Start Date  ICMJE November 17, 2017
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2019)
Decisional conflict Scale [ Time Frame: 0-5 days after the POST-Index PCP visit ]
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
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2017)
Decisional conflict Scale [ Time Frame: 0-2 days after the POST-Index PCP visit ]
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2019)
  • Change in Decision-making self-efficacy [ Time Frame: Baseline and 0-5 days after the POST-Index post PCP visit ]
    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.
  • Record of mammogram [ Time Frame: 15 month followup ]
    We will review the patient's EMR to assess primary care notes, radiology records, and other documentation of a mammogram outside of the INPC. We will also 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2017)
  • Change in Decision-making self-efficacy [ Time Frame: Baseline and 0-2 days after the POST-Index post PCP visit ]
    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.
  • Record of mammogram [ Time Frame: 15 month followup ]
    We will review the patient's EMR to assess primary care notes, radiology records, and other documentation of a mammogram outside of the INPC. We will also 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Decisions About Cancer Screening in Alzheimer's Disease
Official Title  ICMJE Decisions About Cancer Screening in Alzheimer's Disease
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 426 dyads of older women with AD and a family caregiver from 24 primary care practices in central Indiana to test this decision aid
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Cancer, Breast
Intervention  ICMJE
  • Behavioral: 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.
  • Other: 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.
    Other Name: control group
Study Arms  ICMJE
  • Experimental: Mammogram decision aid
    Will be mailed the DECAD decision aid before their next PCP visit in order to better inform their decision to continue or stop mammography.
    Intervention: Behavioral: DECAD decision aid
  • Active Comparator: Home safety guide
    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: Other: Home safety guide
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 12, 2017)
426
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2022
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 AD 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 9 months
  • Primary care visit scheduled is not 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
  • Two or more first degree relatives with 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*
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 75 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Karolina Puchalski 317-274-9492 kapuch@iu.edu
Contact: Shelley Suarez 317-274-9509 sdsuarez@regenstrief.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03282097
Other Study ID Numbers  ICMJE 1501278953
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nicole R. Fowler, PhD, Indiana University
Study Sponsor  ICMJE Indiana University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nicole Fowler Indiana University
PRS Account Indiana University
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP