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

NCT ID: NCT02823262

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2022-03-31

Brief Summary

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.

Detailed Description

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Decision Aid

Post Initial Surgical Consultation

• Including background questionnaire and randomization into Decision Aid Group or Control Group:
• The Decision Aid Group (workbook and CD) explains each treatment including its benefits and risks.

-- The DA asks women 10 questions about their health;the response to each question is associated with a point value and women are asked to tally their points. The DA groups women into 4 health categories based on their health score.

• Assessment at One week after participants surgical consultation and five months after surgical consultation

Group Type: EXPERIMENTAL

Breast Cancer Treatment Decision Aid for women 70+

Intervention Type: 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.

No Decision Aid

Post Initial Surgical Consultation

• Including background questionnaire and randomization into Decision Aid Group or Control Group:
• Participant will receive Usual Care assistance when making treatment decisions.
• Assessment at One week after participants surgical consultation and five months after surgical consultation

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

Interventions

Breast Cancer Treatment Decision Aid for women 70+

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.

Intervention Type: OTHER

Usual Care

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Mara Schonberg

Mara Schonberg, MD, MPH

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mara Schonberg, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

16-117

Identifier Type: -

Identifier Source: org_study_id