Back to resultsA Breast Cancer Treatment Decision Aid for Women Aged 70 and Older
Primary Purpose
Breast Cancer, Estrogen Receptor Positive Breast Cancer, Node-negative Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breast Cancer Treatment Decision Aid for women 70+
Usual Care
Sponsored by
About this trial
This is an interventional health services research trial for Breast Cancer focused on measuring Breast Cancer, Estrogen Receptor Positive Breast Cancer, Node-negative Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
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.
Sites / Locations
- Beth Israel Deaconess Medical Center
- Dana Farber Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Decision Aid
No Decision Aid
Arm Description
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
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
Outcomes
Primary Outcome Measures
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]
Secondary Outcome Measures
Knowledge score using our knowledge test
mean of Correct Response at each time point
Change in Stage of Decision-Making at one week using one-item tool
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
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
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
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
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
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
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
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
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
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
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
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
Type of surgery, radiation, endocrine therapy, abstracted from medical records
Acceptability using 0-3 scale
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
Full Information
NCT ID
NCT02823262
First Posted
June 29, 2016
Last Updated
June 9, 2023
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Dana-Farber Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT02823262
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
March 2022 (Actual)
Study Completion Date
March 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Dana-Farber Cancer Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Decision Aid
Arm Type
Experimental
Arm Description
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
Arm Title
No Decision Aid
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Breast Cancer Treatment Decision Aid for women 70+
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Primary Outcome Measure Information:
Title
Change in Decisional Conflict Scale at 1 week
Description
Scores on the decisional conflict scale (DCS, range from 0 [none] to 100 [extremely high decisional conflict]
Time Frame
Baseline, 1 week
Secondary Outcome Measure Information:
Title
Knowledge score using our knowledge test
Description
mean of Correct Response at each time point
Time Frame
One week, 5 Months
Title
Change in Stage of Decision-Making at one week using one-item tool
Description
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.
Time Frame
Baseline, One week
Title
Self-Efficacy using 11-item scale
Description
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)
Time Frame
One week
Title
Values using importance scale 1-10
Description
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
Time Frame
One week
Title
Treatment preferences using two-item tool
Description
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.
Time Frame
One week
Title
Desired role in decision-making using one-item tool
Description
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
Time Frame
One week
Title
Anxiety using 6-item Spielberger State-Trait Anxiety Inventory short-form
Description
Spielberger State-Trait Anxiety Inventory short-form; 6 items used widely in cancer studies.
Time Frame
One week, 5 months
Title
Quality of Life using the SF-12 physical and mental component scores
Description
Health related quality of life measured using the SF-12 physical and mental component at scores at both time points
Time Frame
One week, 5 months
Title
Preparation for Decision-Making using 10 items (1-5 scale
Description
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.
Time Frame
One week, 5 months
Title
Actual role in decision-making using one-item tool
Description
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.
Time Frame
5 months
Title
Decision Regret using one-item tool
Description
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
Time Frame
5 months
Title
Satisfaction with treatment decision using 4-item tool
Description
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.
Time Frame
5 months
Title
Satisfaction with the decision process using 4-item tool
Description
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.
Time Frame
5 months
Title
Treatment received using chart abstraction
Description
Type of surgery, radiation, endocrine therapy, abstracted from medical records
Time Frame
5 months
Title
Acceptability using 0-3 scale
Description
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
Time Frame
1 week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mara Schonberg, MD MPH
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Breast Cancer Treatment Decision Aid for Women Aged 70 and Older
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