NCT02823262

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: Female
• Age: 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	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.
OTHER	Usual Care

Timeline

• Start date: 2016-07-01
• Primary completion: 2022-03-01
• Completion: 2022-03-01
• First posted: 2016-07-06
• Last updated: 2024-01-05

Locations

2 sites across 1 country: United States