Clinical trial NCT02823262: A Breast Cancer Treatment Decision Aid for Women Aged 70 and Older
Official title: A Breast Cancer Treatment Decision Aid for Women Aged 70 and Older
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
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
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Dana-Farber Cancer Institute
First posted: 2016-07-06
Enrollment: 65
Sex: FEMALE
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Change in Decisional Conflict Scale at 1 week
timeFrame: Baseline, 1 week
Secondary outcomes:
measure: Knowledge score using our knowledge test
timeFrame: One week, 5 Months
measure: Change in Stage of Decision-Making at one week using one-item tool
timeFrame: Baseline, One week
measure: Self-Efficacy using 11-item scale
timeFrame: One week
measure: Values using importance scale 1-10
timeFrame: One week
measure: Treatment preferences using two-item tool
timeFrame: One week
measure: Desired role in decision-making using one-item tool
timeFrame: One week
measure: Anxiety using 6-item Spielberger State-Trait Anxiety Inventory short-form
timeFrame: One week, 5 months
measure: Quality of Life using the SF-12 physical and mental component scores
timeFrame: One week, 5 months
measure: Preparation for Decision-Making using 10 items (1-5 scale
timeFrame: One week, 5 months
measure: Actual role in decision-making using one-item tool
timeFrame: 5 months
measure: Decision Regret using one-item tool
timeFrame: 5 months
measure: Satisfaction with treatment decision using 4-item tool
timeFrame: 5 months
measure: Satisfaction with the decision process using 4-item tool
timeFrame: 5 months
measure: Treatment received using chart abstraction
timeFrame: 5 months
measure: Acceptability using 0-3 scale
timeFrame: 1 week
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Mara Schonberg, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: