Evaluation of a Mammography Screening Decision Aid for Women Aged 75 and Older: Protocol for a Cluster-randomized Controlled Trial

Schonberg, Mara A.; Kistler, Christine E.; Nekhlyudov, Larissa; Fagerlin, Angela; Davis, Roger B.; Wee, Christina C.; Marcantonio, Edward R.; Lewis, Carmen L.; Stanley, Whitney A; Crutchfield, Trisha M.; Hamel, Mary Beth

doi:10.4172/2167-0870.1000191

Cited by 8 publications

(13 citation statements)

References 71 publications

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“…Based on a mammography screening decision aid designed by Dr. Schonberg [47, 48], the investigative team designed a decision aid that is specific for older women with ADRD and their caregivers [28, 32]. The wording, context, and content of the decision aid reflect the literature on the risks and benefits of mammography screening for older women with ADRD [24, 45, 49, 54].…”

Section: Methodsmentioning

confidence: 99%

“…Two items assess propensity to get person with ADRD screened. One item asks how many more mammograms they think the patient will getYes vs. those who are unsure or plan not to be screenedBaseline, follow-upCaregiver reported; patient reportedReceipt of screeningDiscussion with caregiverYes vs. no15-month follow-upCaregiver reportedReview primary-care notes, radiology reports, and documentation on screening and preventive care; caregiver report.Yes vs. no15- and 24-month follow-upsPatient EMRKnowledge16-items (6 multiple choice and 10 true/false) [48]Sum of correct answersBaseline, follow-upCaregiver reportedBurden of screening on patientReview patient’s EMR for additional diagnostic procedures due to false-positive results, identification of an abnormality on screening exam but further work-up declined, identification of a clinically unimportant cancer; documentation of depressive symptoms, anxiety, or pain related to the screening experienceYes or no15- and 24-month follow-upsPatient EMRBurden of screening on caregiverMeasure perceptions about the burden of the mammography for the patient; semi-structured questions about patient’s mammogram experience and perceived burden of screeningDescriptive15-month follow-upCaregiver reported; patient reportedRole in decision-makingAssesses preferences for and involvement in making decisions on their own or sharing responsibility with their family or doctor [71]Active vs. passive/shared with doctor (since aim of decision aids is to help dyads be more active in decision-making)Follow-upCaregiver reported; patient reportedAcceptability of the materialsAssess caregivers’ and patients’ perceptions about the length, clarity, and helpfulness of the decision aid and their willingness to recommend it. The number of times they reviewed it, how many pages they read, how long it took them to read it, how they would prefer to receive it if not part of a studyDescriptiveFollow-upCaregiver reported; patient reported…”

Section: Methodsmentioning

confidence: 99%

“…Intentions to be screened will be examined using one item on a 5-point scale and another categorical item that asks how many more mammograms the patient and caregiver think that the patient will get in her lifetime. We will categorize scores as 1–2 (no), 3 (unsure), or 4–5 (yes) [48, 65]. Knowledge about mammograms for older women with ADRD will be measured with a 16-item measure mapped directly from the information presented in the decision aid [48].…”

Section: Methodsmentioning

confidence: 99%

“…We will categorize scores as 1–2 (no), 3 (unsure), or 4–5 (yes) [48, 65]. Knowledge about mammograms for older women with ADRD will be measured with a 16-item measure mapped directly from the information presented in the decision aid [48]. We also will collect data on the role of the patient and caregiver in the decision about mammography, if a decision occurred, and assess the extent to which each member of the dyad participated in the review of the decision aid through the semi-structured interviews.…”

Section: Methodsmentioning

confidence: 99%

“…To fill the gap in providing ADRD patients and their caregivers with decision support about mammography screening, we created a new decision aid that is written for ADRD caregivers and is specific for older women with ADRD. The design of this decision aid was informed by a decision aid on mammography screening for older women without dementia developed by Dr. Mara Schonberg (co-investigator) [47, 48], our pilot work [28, 32], and critera established for the development and testing of evidence-based decision aids [49]. Our research team is now conducting a randomized controlled trial, Decisions about Cancer Screening in Alzheimer’s Disease (DECAD), to test if this new evidence-based decision aid can improve the quality of decision-making about mammography in older women with ADRD.…”

Section: Introductionmentioning

confidence: 99%

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

Fowler

Schonberg

Sachs

et al. 2018

Trials

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BackgroundAlzheimer’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/designThe 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.DiscussionWe 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 registrationClinical Trials Register, NCT03282097. Registered on 13 September 2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-3039-z) contains supplementary material, which is available to authorized users.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

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

Fowler

Schonberg

Sachs

et al. 2018

Trials

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Effect of a Mammography Screening Decision Aid for Women 75 Years and Older

et al. 2020

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IMPORTANCE Guidelines recommend that women 75 years and older be informed of the benefits and harms of mammography before screening.OBJECTIVE To test the effects of receipt of a paper-based mammography screening decision aid (DA) for women 75 years and older on their screening decisions. DESIGN, SETTING, AND PARTICIPANTSA cluster randomized clinical trial with clinician as the unit of randomization. All analyses were completed on an intent-to-treat basis. The setting was 11 primary care practices in Massachusetts or North Carolina. Of 1247 eligible women reached, 546 aged 75 to 89 years without breast cancer or dementia who had a mammogram within 24 months but not within 6 months and saw 1 of 137 clinicians (herein referred to as PCPs) from November 3, 2014, to January 26, 2017, participated. A research assistant (RA) administered a previsit questionnaire on each participant's health, breast cancer risk factors, sociodemographic characteristics, and screening intentions. After the visit, the RA administered a postvisit questionnaire on screening intentions and knowledge.INTERVENTIONS Receipt of the DA (DA arm) or a home safety (HS) pamphlet (control arm) before a PCP visit.MAIN OUTCOMES AND MEASURES Participants were followed up for 18 months for receipt of mammography screening (primary outcome). To examine the effects of the DA, marginal logistic regression models were fit using generalized estimating equations to allow for clustering by PCP. Adjusted probabilities and risk differences were estimated to account for clustering by PCP. RESULTSOf 546 women in the study, 283 (51.8%) received the DA. Patients in each arm were well matched; their mean (SD) age was 79.8 (3.7) years, 428 (78.4%) were non-Hispanic white, 321 (of 543 [59.1%]) had completed college, and 192 (35.2%) had less than a 10-year life expectancy. After 18 months, 9.1% (95% CI, 1.2%-16.9%) fewer women in the DA arm than in the control arm had undergone mammography screening (51.3% vs 60.4%; adjusted risk ratio, 0.84; 95% CI, 0.75-0.95; P = .006). Women in the DA arm were more likely than those in the control arm to rate their screening intentions lower from previsit to postvisit (69 of 283 [adjusted %, 24.5%] vs 47 of 263 [adjusted %, 15.3%]), to be more knowledgeable about the benefits and harms of screening (86 [adjusted %, 25.5%] vs 32 [adjusted %, 11.7%]), and to have a documented discussion about mammography with their PCP (146 [adjusted %, 47.4%] vs 111 [adjusted %, 38.9%]). Almost all women in the DA arm (94.9%) would recommend the DA. CONCLUSIONS AND RELEVANCEProviding women 75 years and older with a mammography screening DA before a PCP visit helps them make more informed screening decisions and leads to fewer women choosing to be screened, suggesting that the DA may help reduce overscreening.

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Acceptability of a companion patient guide to support expert consensus guidelines on surveillance mammography in older breast cancer survivors

Freedman

Revette

Gagnon

et al. 2022

Breast Cancer Res Treat

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Purpose To support shared decision-making, patient-facing resources are needed to complement recently published guidelines on approaches for surveillance mammography in breast cancer survivors aged ≥ 75 or with < 10-year life expectancy. We created a patient guide to facilitate discussions about surveillance mammography in older breast cancer survivors. Methods The “Are Mammograms Still Right for Me?” guide estimates future ipsilateral and contralateral breast (in-breast) cancer risks, general health, and the potential benefits/harms of mammography, with prompts for discussion. We conducted in-clinic acceptability testing of the guide by survivors and their clinicians at a National Cancer Institute-designated comprehensive cancer center, including two community practices. Patients and clinicians received the guide ahead of a clinic visit and surveyed patients (pre-/post-visit) and clinicians (post-visit). Acceptability was defined as ≥ 75% of patients and clinicians reporting that the guide (a) should be recommended to others, (b) is clear, (c) is helpful, and (d) contains a suitable amount of information. We also elicited feedback on usability and mammography intentions. Results We enrolled 45 patients and their 21 clinicians. Among those responding in post-visit surveys, 33/37 (89%) patients and 15/16 (94%) clinicians would recommend the guide to others; 33/37 (89%) patients and 15/16 (94%) clinicians felt everything/most things were clear. All other pre-specified acceptability criteria were met. Most patients reported strong intentions for mammography (100% pre-visit, 98% post-visit). Conclusion Oncology clinicians and older breast cancer survivors found a guide to inform mammography decision-making acceptable and clear. A multisite clinical trial is needed to assess the guide’s impact mammography utilization. Trial registration : ClinicalTrials.gov-NCT03865654, posted March 7, 2019. Supplementary Information The online version contains supplementary material available at 10.1007/s10549-022-06676-3.

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Evaluation of a Mammography Screening Decision Aid for Women Aged 75 and Older: Protocol for a Cluster-randomized Controlled Trial

Cited by 8 publications

References 71 publications

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

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

Effect of a Mammography Screening Decision Aid for Women 75 Years and Older

Acceptability of a companion patient guide to support expert consensus guidelines on surveillance mammography in older breast cancer survivors

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