Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2018 Dec 12;19(1):678.
doi: 10.1186/s13063-018-3039-z.

Supporting breast cancer screening decisions for caregivers of older women with dementia: study protocol for a randomized controlled trial

Nicole R Fowler  1   2   3   4 , Mara A Schonberg  5 , Greg A Sachs  6   7   8   9 , Peter H Schwartz  6   7   5 , Sujuan Gao  6   10 , Kathleen A Lane  6   10 , Lev Inger  8 , Alexia M Torke  6   7   8   11
Affiliations

Supporting breast cancer screening decisions for caregivers of older women with dementia: study protocol for a randomized controlled trial

Nicole R Fowler et al. Trials. .

Abstract

Background: 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.

Methods/design: 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 in Indiana 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). A third follow-up at 24 months will extract EMR data on mammogram orders, occurrences, results, and the burden of mammograms.

Discussion: 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.

Trial registration: Clinical Trials Register, NCT03282097 . Registered on 13 September 2017.

Keywords: Alzheimer’s disease; breast cancer; dementia; mammography; screening.

PubMed Disclaimer

Conflict of interest statement

Ethics approval and consent to participate

All participants will provide informed consent before beginning the study. All team members have been trained to introduce, show, and take questions about the informed consent, the assessments, and any discomfort associated with the interventions before the patients sign the informed consent. The study protocol has been approved by Indiana University’s institutional review board (1501278953A022) and will be conducted according to the principles of the Declaration of Helsinki and in compliance with the National Institutes of Health policy and data safety monitoring guidelines.

Competing Interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flowchart of study participation and intervention
Fig. 2
Fig. 2
Schedule of enrollment, interventions, and assessments
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Data on Seer (Surveillance, Epidemiology and End Results) cancer statistics. Available from: https://seer.cancer.gov/. Acccessed 13 Dec 2016.
    1. Alzheimer's disease facts and figures. Alzheimers Dement. 2016;12(4):459–509. - PubMed
    1. Fowler NR, Barnato AE, Schonberg MA, Torke AM. Cancer screening in adults with cognitive impairment. J Am Geriatr Soc. 2014;62(s1):S131.
    1. Torke AM, Schwartz PH, Holtz LR, Montz K, Sachs GA. Caregiver perspectives on cancer screening for persons with dementia: "why put them through it?". J Am Geriatr Soc. 2013;61(8):1309–1314. doi: 10.1111/jgs.12359. - DOI - PMC - PubMed
    1. Choosing Wisely: An initiative of the ABIM Foundation [online]. Available at www.choosingwisly.org. Accessed 20 Dec 2017.

Publication types

MeSH terms

Associated data