Decision Aid for Breast Cancer

(CONSYDER Trial)

Recruiting at 3 trial locations

Overseen By Darima Dorzhieva

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Stage 4, Recurrent, Bilateral

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

800 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on decision-making for surgery rather than medication changes.

Is the treatment generally safe for humans?

The research mentions that selective estrogen receptor modulators and aromatase inhibitors have been shown to be safe in reducing breast cancer risk in women. Additionally, patient-reported outcomes from a trial involving tamoxifen and anastrozole indicate that side effects like joint pain and hot flashes are common, but these treatments are generally considered safe. ^{1 2 3 4 5}

How does this treatment differ from other breast cancer treatments?

This treatment is unique because it involves a decision aid, which is a tool designed to help patients make informed choices about their breast cancer treatment options by improving communication with healthcare professionals. Unlike standard treatments that focus solely on medical interventions, this approach emphasizes patient involvement and personalized decision-making. ^{6 7 8 9 10}

What is the purpose of this trial?

The goal of this study is to understand and improve the breast surgical decision-making process for young women newly diagnosed with breast cancer. As part of this study, the investigators will evaluate the impact and use a web-based tool called CONSYDER that is designed to provide useful information to young breast cancer patients. It is also meant to improve communication between young women and their surgeons with the purpose of helping patients make appropriate surgical decisions. Participants will complete surveys approximately within 1 week of the surgical consult and approximately 6 months after surgery. Patients who receive neoadjuvant chemotherapy will also be surveyed after the completion of neoadjuvant treatment but prior to surgery. Some patients will be invited for an interview after their surgery as part of the evaluation. A subset of patients/surgeons will also have their surgical consultation audio-recorded.

Research Team

Rachel Greenup, MD, MPH

Principal Investigator

Yale University

Shoshana Rosenberg, ScD, MPH

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

This trial is for young women who have recently been diagnosed with breast cancer and are facing surgical decisions. They should be willing to complete surveys around the time of their surgery consultation, after any pre-surgery chemotherapy, and six months post-surgery. Some may also participate in an interview or have their consultation recorded.

Inclusion Criteria

I am a woman aged between 18 and 44.

I have been newly diagnosed with early-stage breast cancer.

Exclusion Criteria

My breast cancer has come back after initial treatment.

I was diagnosed with Stage 4 breast cancer from the start.

I have cancer in both of my breasts.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-in Period

Participants receive usual care and are not sent CONSYDER during this period

6 months

Intervention

Participants use the CONSYDER decision aid tool to assist in surgical decision-making

6 months

Follow-up

Participants are monitored for outcomes such as decisional regret and anxiety

6 months

Treatment Details

Interventions

• CONSYDER

Trial Overview The study is testing a web-based tool called CONSYDER designed to help young breast cancer patients understand their condition better and make informed surgical choices. It aims to facilitate communication between patients and surgeons.

Participant Groups

Group I: CONSYDER decision aid Experimental Treatment 1 Intervention

Web-based breast cancer surgery decision aid

Group II: Usual care Active Control 1 Intervention

Prior to institutional crossover, participants receive care as per usual for 6 months ("run-in" period) and are not sent CONSYDER.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

In a study involving 604 breast cancer patients undergoing chemotherapy, self-reported treatment-related side effects (TSEs) showed significantly longer durations compared to doctor-reported durations, highlighting the importance of patient perspectives in assessing side effects.

The findings suggest that doctors often underestimate the incidence and duration of TSEs, indicating that incorporating patient-reported outcomes into clinical practice could provide a more accurate understanding of the total burden of side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-evaluation of duration of adjuvant chemotherapy side effects in breast cancer patients: A prospective study. Galizia, D., Milani, A., Geuna, E., et al.[2021]

In a study of 139 breast cancer patients undergoing chemotherapy, using a mobile app for symptom tracking improved the stabilization of daily functional activity when patients reviewed their data with a physician, compared to those who used the app unsupervised.

Patients using the app reported more adverse events than those using traditional questionnaires, indicating that the app enhances awareness and reporting of chemotherapy side effects, particularly when used in a supervised setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile App to Stabilize Daily Functional Activity of Breast Cancer Patients in Collaboration With the Physician: A Randomized Controlled Clinical Trial. Egbring, M., Far, E., Roos, M., et al.[2022]

Selective estrogen receptor modulators and aromatase inhibitors have been proven effective and safe in significantly reducing the risk of invasive breast cancer in women at increased risk, based on multiple randomized clinical trials.

Professional and governmental agencies recommend offering these drug interventions to at-risk women, as they can substantially lower breast cancer morbidity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast cancer risk reduction: Notable achievements and remaining challenges. Vogel, VG.[2020]

The study developed predictive models to assess the risk of treatment discontinuation for tamoxifen and anastrozole in postmenopausal women with ductal carcinoma in situ, using patient-reported outcome data from the NSABP B-35 clinical trial involving these women.

Key predictive factors for discontinuation included baseline body mass index (BMI) and various patient-reported symptoms, with the models showing good predictive performance (AUC of 0.76 for anastrozole and 0.78 for tamoxifen), which can help healthcare professionals identify high-risk patients and tailor interventions accordingly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial. Calsavara, VF., Henry, NL., Hays, RD., et al.[2023]

A 50-year-old breast cancer patient experienced significant adverse effects from tamoxifen, including hot flushes, hyperhidrosis, urinary frequency, and depression, which negatively impacted her quality of life.

After 25 days of treatment with traditional Korean herbal medicine and acupuncture, the patient's symptoms improved significantly, indicating that these interventions may help alleviate tamoxifen-induced side effects in breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Traditional Korean medicine treatment for tamoxifen associated adverse events of breast cancer patient: A CARE - Compliant case report. Seo, J., Lee, D., Jo, HG.[2021]

The Adjuvant! decision aid significantly influenced treatment choices for breast cancer patients, with 13.3% of patients opting out of adjuvant therapy after using the tool, indicating its effectiveness in facilitating informed decision-making.

Over 95% of patients found the decision aid easy to understand, and 81.4% of physicians reported it was useful for understanding patient preferences, highlighting its acceptability and potential to enhance patient-physician communication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A decision aid to assist in adjuvant therapy choices for breast cancer. Siminoff, LA., Gordon, NH., Silverman, P., et al.[2013]

Decision aids significantly reduced treatment decision conflicts for breast cancer patients compared to conventional methods, indicating they can help patients feel more confident in their treatment choices.

However, decision aids did not significantly impact screening decision conflicts or other factors like anxiety, decision regret, and satisfaction, suggesting their effectiveness may be limited to specific decision-making scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluate the effectiveness of breast cancer decision aids: A systematic review and meta-analysis of randomize clinical trails. Gao, JP., Jin, YH., Yu, SF., et al.[2021]

A decision aid (DA) for women considering delayed post-mastectomy breast reconstruction (PMBR) was developed and found to be highly acceptable, with 100% of 21 surveyed women recommending it to others.

The DA significantly reduced decisional conflict and increased knowledge about PMBR options, indicating it is an effective tool to support women in making informed decisions alongside standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and testing of a decision aid for women considering delayed breast reconstruction. Metcalfe, K., Zhong, T., O'Neill, AC., et al.[2019]

The study involved 12 women aged 38-68 who shared their experiences with decisional support aids during their breast cancer journey, highlighting the emotional stress and urgency they felt in making treatment decisions.

Key themes included the importance of trusting physician advice, the need for family support, and the lack of nurse involvement, indicating that oncology nurses should improve their support and communication to enhance the decision-making process for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The experience of using decisional support aids by patients with breast cancer. Lacey, MD.[2016]

Decision Aids (DAs) have been shown to significantly improve patient knowledge and decision-making in the treatment of locally advanced breast cancer (LABC), helping patients and clinicians agree on the best treatment options.

A systematic review of 17 studies revealed that while most DAs focus on treatment options, there is a notable lack of standardized methodologies and a need for further research to enhance their development and implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decision Aids for Decision Making about Locally Advance Breast Cancer: A Systematic Review. Maes-Carballo, M., Martín-Díaz, M., García-García, M., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Self-evaluation of duration of adjuvant chemotherapy side effects in breast cancer patients: A prospective study. [2021]

2. Canada pubmed.ncbi.nlm.nih.gov

A Mobile App to Stabilize Daily Functional Activity of Breast Cancer Patients in Collaboration With the Physician: A Randomized Controlled Clinical Trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Breast cancer risk reduction: Notable achievements and remaining challenges. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Traditional Korean medicine treatment for tamoxifen associated adverse events of breast cancer patient: A CARE - Compliant case report. [2021]

6. England pubmed.ncbi.nlm.nih.gov

A decision aid to assist in adjuvant therapy choices for breast cancer. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Evaluate the effectiveness of breast cancer decision aids: A systematic review and meta-analysis of randomize clinical trails. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Development and testing of a decision aid for women considering delayed breast reconstruction. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

The experience of using decisional support aids by patients with breast cancer. [2016]

10. England pubmed.ncbi.nlm.nih.gov

Decision Aids for Decision Making about Locally Advance Breast Cancer: A Systematic Review. [2023]