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Breast CancerNCT02823262

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

A study testing Breast Cancer Treatment Decision Aid for women 70+ in people with Breast Cancer and Estrogen Receptor Positive Breast Cancer, run by Beth Israel Deaconess Medical Center at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 70 years and older, women only
What is being tested?
Breast Cancer Treatment Decision Aid for women 70+
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
2 sitesUnited States
Study dates
Jul 2016to Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • Women only
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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;
Show all 14Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02115

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

Other trials in United States

About this study

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.

Read the 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.
Being tested
Breast Cancer Treatment Decision Aid for women 70+, Usual Care
Keywords
Breast Cancer, Estrogen Receptor Positive Breast Cancer, Node-negative Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • Usual CareOther

Study groups in NCT02823262
Study groupRoleWhat they receive
Decision AidExperimentalPost 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
Receives: Other: Breast Cancer Treatment Decision Aid for women 70+
No Decision AidActive comparatorPost 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
Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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]

    Measured: Baseline, 1 week

Secondary outcomes (15)

  1. Knowledge score using our knowledge test

    mean of Correct Response at each time point

    Measured: One week, 5 Months

  2. 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.

    Measured: Baseline, One week

  3. 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)

    Measured: One week

  4. 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

    Measured: One week

  5. 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.

    Measured: One week

  6. 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

    Measured: One week

  7. 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.

    Measured: One week, 5 months

  8. 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

    Measured: One week, 5 months

  9. 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.

    Measured: One week, 5 months

  10. 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.

    Measured: 5 months

  11. 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

    Measured: 5 months

  12. 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.

    Measured: 5 months

  13. 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.

    Measured: 5 months

  14. Treatment received using chart abstraction

    Type of surgery, radiation, endocrine therapy, abstracted from medical records

    Measured: 5 months

  15. 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

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionMar 2022
  4. Study completionMar 2022

Why it stopped: Did not receive funding for the trial.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02823262
Sponsor's protocol ID
16-117
Status last verified
Jan 2024
First submitted
29 Jun 2016
Last updated
5 Jan 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Breast Cancer Treatment Decision Aid for women 70+ in people with Breast Cancer and Estrogen Receptor Positive Breast Cancer, run by Beth Israel Deaconess Medical Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Did not receive funding for the trial.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Decisional Conflict Scale at 1 week (time frame: Baseline, 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02823262.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.

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