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

• ClinicalTrials.gov Identifier: NCT02823262
• Recruitment Status: Terminated
• First Posted: July 6, 2016
• Last Update Posted: January 5, 2024
• Sponsor: Beth Israel Deaconess Medical Center
• Collaborator: Dana-Farber Cancer Institute
• Information provided by (Responsible Party): Mara Schonberg, Beth Israel Deaconess Medical Center

Tracking Information

• First Submitted Date: June 29, 2016
• First Posted Date: July 6, 2016
• Last Update Posted Date: January 5, 2024
• Actual Study Start Date: July 2016
• Actual Primary Completion Date: March 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 30, 2016)

Change in Decisional Conflict Scale at 1 week [ Time Frame: Baseline, 1 week ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 5, 2016)

• Knowledge score using our knowledge test [ Time Frame: One week, 5 Months ]
  mean of Correct Response at each time point
• Change in Stage of Decision-Making at one week using one-item tool [ Time Frame: 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.
• Self-Efficacy using 11-item scale [ Time Frame: 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 [ Time Frame: 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
• Treatment preferences using two-item tool [ Time Frame: 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.
• Desired role in decision-making using one-item tool [ Time Frame: 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
• Anxiety using 6-item Spielberger State-Trait Anxiety Inventory short-form [ Time Frame: One week, 5 months ]
  Spielberger State-Trait Anxiety Inventory short-form; 6 items used widely in cancer studies.
• Quality of Life using the SF-12 physical and mental component scores [ Time Frame: One week, 5 months ]
  Health related quality of life measured using the SF-12 physical and mental component at scores at both time points
• Preparation for Decision-Making using 10 items (1-5 scale [ Time Frame: 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.
• Actual role in decision-making using one-item tool [ Time Frame: 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.
• Decision Regret using one-item tool [ Time Frame: 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
• Satisfaction with treatment decision using 4-item tool [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 5 months ]
  Type of surgery, radiation, endocrine therapy, abstracted from medical records
• Acceptability using 0-3 scale [ Time Frame: 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

Original Secondary Outcome Measures (submitted: June 30, 2016)

• Knowledge score using our knowledge test [ Time Frame: One week, 5 Months ]
  mean of Correct Response at each time point
• Change in Stage of Decision-Making at one week using one-item tool [ Time Frame: 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.
• Self-Efficacy using 11-item scale [ Time Frame: 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 [ Time Frame: 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
• Treatment preferences using two-item tool [ Time Frame: 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.
• Desired role in decision-making using one-item tool [ Time Frame: 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
• Anxiety using 6-item Spielberger State-Trait Anxiety Inventory short-form [ Time Frame: One week, 5 months ]
  Spielberger State-Trait Anxiety Inventory short-form; 6 items used widely in cancer studies.
• Quality of Life using the SF-12 physical and mental component scores [ Time Frame: One week, 5 months ]
  Health related quality of life measured using the SF-12 physical and mental component at scores at both time points
• Preparation for Decision-Making using 10 items (1-5 scale [ Time Frame: 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.
• Actual role in decision-making using one-item tool [ Time Frame: 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.
• Decision Regret using one-item tool [ Time Frame: 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
• Satisfaction with treatment decision using 4-item tool [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: >5 months ]
  Type of surgery, radiation, endocrine therapy, abstracted from medical records
• Acceptability using 0-3 scale [ Time Frame: 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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research

Condition

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

Intervention

• 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

Study Arms

• Experimental: 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
  Intervention: Other: Breast Cancer Treatment Decision Aid for women 70+
• Active Comparator: 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
  Intervention: Other: Usual Care

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: January 3, 2024): 65
• Original Estimated Enrollment (submitted: June 30, 2016): 312
• Actual Study Completion Date: March 2022
• Actual Primary Completion Date: March 2022 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 70 Years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02823262
• Other Study ID Numbers: 16-117
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Mara Schonberg, Beth Israel Deaconess Medical Center
• Original Responsible Party: Mara Schonberg, Dana-Farber Cancer Institute, Mara Schonberg, MD, MPH
• Current Study Sponsor: Beth Israel Deaconess Medical Center
• Original Study Sponsor: Dana-Farber Cancer Institute
• Collaborators: Dana-Farber Cancer Institute

Investigators

• Principal Investigator: Mara Schonberg, MD MPH; Beth Israel Deaconess Medical Center

• PRS Account: Beth Israel Deaconess Medical Center
• Verification Date: January 2024