A Breast Cancer Treatment Decision Aid for Women Aged 70 and Older

Beth Israel Deaconess Medical Center65 enrolled

Overview

The purpose of this research study is to evaluate a decision aid to help women aged 70 and older decide on treatment for their breast cancer.

The investigators aim to use this information to further refine and evaluate a decision aid to help newly-diagnosed women aged 70 and older with breast cancer understand the risks and benefits of different types of breast cancer treatment. The Decision Aid (DA) was created for women 70 years or older diagnosed with ER+, HER2-, clinically LN-, 3cm or less breast cancers deciding on breast cancer treatment. The DA was designed considering the health literary, cognitive abilities, treatment outcomes, and competing health issues of older women. Phase I : \- The investigators will obtain and incorporate additional feedback on the DA from women 70 years or older who were diagnosed with breast cancer \> 6 months ago, their family members, and clinicians, so that the DA can be refined and evaluated by women who were recently treated for breast cancer but not newly diagnosed with breast cancer. Phase II \- The investigators plan to test the efficacy of the revised DA in a randomized control trial (RCT) of 230 diverse women 70 years or older newly diagnosed with ER+, LN-, HER2-, 3 cm or less breast cancer.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Breast Cancer Estrogen Receptor Positive Breast Cancer Node-negative Breast Cancer Human Epidermal Growth Factor 2 Negative Carcinoma of Breast

Interventions

Breast Cancer Treatment Decision Aid for women 70+OTHER

We developed a decision aid on breast cancer treatment for women 70 years or older newly diagnosed with estrogen receptor positive (ER+), clinically lymph node negative (LN-), HER2 negative (HER2-), breast cancers that are 3 centimeters or less. The DA was written using low literacy principles and provides information on the benefits and risks of mastectomy vs. breast conserving surgery (BCS), radiotherapy after BCS, and of hormonal therapies (e.g., anastrozole). It also considers the impact of competing health issues on older women's treatment choices.

Usual CareOTHER

Eligibility

Sex: FEMALEMin age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Phase I * Patient age ≥ 70 yrs * Female patient diagnosed with a first primary ER+, HER2-, LN-, 3cm or less breast cancer \>6 months ago but \<2 years ago * Caregiver age \>21 years * English speaking * Phase II * Female patient age ≥ 70 yrs newly diagnosed with a first primary ER+, HER2-, LN-, 3cm or less breast cancer * Women newly diagnosed with breast cancer on the day of surgical consult Exclusion Criteria: * Phase I * Patient Age \< 70 years * Women diagnosed with Paget's disease, inflammatory breast cancer or a phyllodes tumor * Signs of Dementia * Score \>10 on the Orientation-Memory-Concentration (OMC) test * Non-English Speaking; * Caregiver age \< 21 years * Women who do not have capacity to participate. --- Before enrolling women in this study, possible participants will be asked 7 questions about the benefits and risks of the study. Women that answer 3 or more of these questions incorrectly will be excluded. * Phase II * Women with a history of breast cancer (invasive and non-invasive) * Diagnosed with Paget's disease, inflammatory breast cancer or a phyllodes tumor * Signs of Dementia * Score \>10 on the OMC test (indicative of dementia). * Women who do not have capacity to participate. --- Before enrolling women in this study, possible participants will be asked 7 questions about the benefits and risks of the study. Women that answer 3 or more of these questions incorrectly will be excluded.

Locations (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Change in Decisional Conflict Scale at 1 week

Scores on the decisional conflict scale (DCS, range from 0 \[none\] to 100 \[extremely high decisional conflict\]

Time frame: Baseline, 1 week

Secondary Outcomes

Knowledge score using our knowledge test

mean of Correct Response at each time point

Time frame: One week, 5 Months

Change in Stage of Decision-Making at one week using one-item tool

One item (responses vary from "haven't begun to think about the choices to "considering the options", to "have already made a decision.") This tool is used to differentiate women who are at earlier stages of decision-making compared to women who are in later stages.

Time frame: Baseline, One week

Self-Efficacy using 11-item scale

11 item scale (each 5 points), measures self-confidence in making an informed treatment choice. (e.g., I feel confident that I can get the facts about the treatment choices available to me, ask questions without feeling dumb)

Time frame: One week

Values using importance scale 1-10

How important is it to you to (0-10): 1) keep your breast, 2) minimize chance of cancer coming back in breast, 3) avoid radiation, 4) do everything possible to treat my breast cancer, 5) minimize length of treatment, 6) do what doctor thinks is best, 7) avoid side effects of treatment

Time frame: One week

Treatment preferences using two-item tool

Which surgery do you want to treat your early stage breast cancer? Lumpectomy, lumpectomy and radiation, mastectomy, other surgery, I am not sure; Which medication do you want to treat your early stage breast cancer? tamoxifen, aromatase inhibitor, neither, not sure.

Data from ClinicalTrials.gov

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