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

NCT02823262 | Terminated

• 1 other identifier: 16-117
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Decisional Conflict Scale at 1 week

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

  Baseline, 1 week

Secondary Outcomes (15)

• Knowledge score using our knowledge test

  One week, 5 Months

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

  Baseline, One week

• Self-Efficacy using 11-item scale

  One week

• Values using importance scale 1-10

  One week

• Treatment preferences using two-item tool

  One week

Study Arms (2)

Decision Aid

EXPERIMENTAL

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

Other: Breast Cancer Treatment Decision Aid for women 70+

No Decision Aid

ACTIVE COMPARATOR

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

Other: Usual Care

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.

Decision Aid

Usual Care OTHER

No Decision Aid

Eligibility Criteria

• Age: 70 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Dana-Farber Cancer Institute: collaborator

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mara Schonberg, MD MPH

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mara Schonberg, MD, MPH

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: July 6, 2016
• Study Start: July 1, 2016
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)