A Breast Cancer Treatment Decision Aid for Women Aged 70 and Older
- Conditions
- Estrogen Receptor Positive Breast CancerBreast CancerNode-negative Breast CancerHuman Epidermal Growth Factor 2 Negative Carcinoma of Breast
- Interventions
- Other: Breast Cancer Treatment Decision Aid for women 70+Other: Usual Care
- Registration Number
- NCT02823262
- Lead Sponsor
- Beth Israel Deaconess Medical Center
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 65
-
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
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Decision Aid Breast Cancer Treatment Decision Aid for women 70+ 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 No Decision Aid Usual Care 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
- Primary Outcome Measures
Name Time Method Change in Decisional Conflict Scale at 1 week Baseline, 1 week Scores on the decisional conflict scale (DCS, range from 0 \[none\] to 100 \[extremely high decisional conflict\]
- Secondary Outcome Measures
Name Time Method Self-Efficacy using 11-item scale One week 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)
Values using importance scale 1-10 One week 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
Desired role in decision-making using one-item tool One week Which best describes how you like to make treatment decisions: a) the doctor decides what should be done and does it; b) the doctor presents his or her recommendations to you to accept or reject; c) the doctor discusses alternatives with you and the two of you decide together how to proceed; or d) the doctor presents all available options and allows you to decide
Decision Regret using one-item tool 5 months If I had to do it over I would make a different decision about breast cancer treatment (strongly agree to strongly disagree); will ask specifically about surgery/radiation/endocrine therapy
Anxiety using 6-item Spielberger State-Trait Anxiety Inventory short-form One week, 5 months Spielberger State-Trait Anxiety Inventory short-form; 6 items used widely in cancer studies.
Acceptability using 0-3 scale 1 week Length; amount of information; clarity (scale 0-3); balance (e.g. the information was slanted towards getting radiation); anxiety provoking (scale 0-3); helpful (scale 0-3); amount read
Change in Stage of Decision-Making at one week using one-item tool Baseline, One week 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.
Treatment preferences using two-item tool One week 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.
Preparation for Decision-Making using 10 items (1-5 scale One week, 5 months Patient's perception of how useful the DA is in preparing to communicate with their clinician; 10 items (1-5 scale), Ex: Did this educational material help you organize your thoughts? Assessed at both time points.
Knowledge score using our knowledge test One week, 5 Months mean of Correct Response at each time point
Quality of Life using the SF-12 physical and mental component scores One week, 5 months Health related quality of life measured using the SF-12 physical and mental component at scores at both time points
Actual role in decision-making using one-item tool 5 months Which best describes how treatment decisions with your surgeon (will also ask about decision with their radiation oncologist/oncologist) were made: a) the surgeon decided what should be done and did it; b) the surgeon presented his/her recommendation to you to accept or reject; c) the surgeon discussed alternatives with you and the two of you decided together how to proceed; d) the surgeon presented all available options and allowed you to decide.
Satisfaction with treatment decision using 4-item tool 5 months 4 items (scores 4-20). Higher scores\> satisfaction; Subjects level of agreement with: a) I was adequately informed about the issues; b) the decision about which treatment I would receive was the best decision for me; c) treatment decisions were consistent with my personal values; d) I am satisfied with my treatment choice.
Satisfaction with the decision process using 4-item tool 5 months 4 items (scores 4-20). Higher scores \> satisfaction (Cronbach's alpha =0.91). Subjects level of agreement with: a) I wish I would have given more consideration to my options; b) I would have liked to had more information; c) I would have like to have been more active in the decision-making process; d) I did not have as much say as I would have liked.
Treatment received using chart abstraction 5 months Type of surgery, radiation, endocrine therapy, abstracted from medical records
Trial Locations
- Locations (2)
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States