Decision Aid for Breast Cancer

(CONSYDER Trial)

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Shoshana Rosenberg, ScD, MPH

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Stage 4, Recurrent, Bilateral

Stay on Your Current Meds

No Placebo Group

Trial Summary

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.

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}

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 speak English or Spanish.

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.

Trial 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 (Behavioural Intervention)

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Dana-Farber Cancer Institute Boston, MA

Weill Cornell Medicine New York, NY

Yale Cancer Center New Haven, CT

Duke Cancer Institute Durham, NC

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1103

Patients Recruited

1,157,000+

National Cancer Institute (NCI)

Collaborator

Trials

14080

Patients Recruited

41,180,000+

National Institutes of Health (NIH)

Collaborator

Trials

2896

Patients Recruited

8,053,000+

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] We recently reported that self-evaluation of the incidence and severity of treatment-related side effects (TSEs) using a National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0-based questionnaire was feasible and more informative than doctor reports in patients undergoing standard adjuvant chemotherapy for operable breast cancer. Here, we compare self- and doctor-evaluated day of onset and duration of TSEs in the same population.

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] The well-being of breast cancer patients and reporting of adverse events require close monitoring. Mobile apps allow continuous recording of disease- and medication-related symptoms in patients undergoing chemotherapy.

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

Breast cancer risk reduction: Notable achievements and remaining challenges. [2020] Millions of women in the United States are at increased risk of breast cancer. Multiple prospective, randomized clinical trials have demonstrated both the efficacy and safety of selective estrogen receptor modulators and aromatase inhibitors in reducing substantially the risk of invasive breast cancer in women at increased risk. Published tables are available to aid clinicians in shared decision-making regarding drug interventions with their patients who are at increased risk of breast cancer. Both professional and governmental agencies have advised that these interventions should be offered to women at increased risk of breast cancer. Doing so would reduce breast cancer morbidity substantially.

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] Predicting an individual's risk of treatment discontinuation is critical for the implementation of precision chemoprevention. We developed partly conditional survival models to predict discontinuation of tamoxifen or anastrozole using patient-reported outcome (PRO) data from postmenopausal women with ductal carcinoma in situ enrolled in the NSABP B-35 clinical trial. In a secondary analysis of the NSABP B-35 clinical trial PRO data, we proposed two models for treatment discontinuation within each treatment arm (anastrozole or tamoxifen treated patients) using partly conditional Cox-type models with time-dependent covariates. A 70/30 split of the sample was used for the training and validation datasets. The predictive performance of the models was evaluated using calibration and discrimination measures based on the Brier score and AUC from time-dependent ROC curves. The predictive models stratified high-risk versus low-risk early discontinuation at a 6-month horizon. For anastrozole-treated patients, predictive factors included baseline body mass index (BMI) and longitudinal patient-reported symptoms such as insomnia, joint pain, hot flashes, headaches, gynecologic symptoms, and vaginal discharge, all collected up to 12 months [Brier score, 0.039; AUC, 0.76; 95% confidence interval (CI), 0.57-0.95]. As for tamoxifen-treated patients, predictive factors included baseline BMI, and time-dependent covariates: cognitive problems, feelings of happiness, calmness, weight problems, and pain (Brier score, 0.032; AUC, 0.78; 95% CI, 0.65-0.91). A real-time calculator based on these models was developed in Shiny to create a web-based application with a future goal to aid healthcare professionals in decision-making.

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] Adverse events of endocrine therapy reduce the breast cancer patient's quality of life and adversely affect treatment compliance.

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

A decision aid to assist in adjuvant therapy choices for breast cancer. [2013] Decision aids are tools that help patients make specific and deliberative choices among options. This study was a group randomized controlled trial of a novel decision aid to help patients with breast cancer make adjuvant therapy (AT) decisions.

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] To assess the effectiveness of decision aids in the treatment, prevention and screening of breast cancer patients.

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

Development and testing of a decision aid for women considering delayed breast reconstruction. [2019] The decision to have post-mastectomy breast reconstruction (PMBR) is highly complex and many women feel ill equipped to make this decision. Decision aids have been advocated to promote patient involvement in decision-making by streamlining and standardizing communication between the patient and the health care professional. In this study, we report on the development and testing of a decision aid (DA) for breast cancer survivors considering delayed PMBR.

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

The experience of using decisional support aids by patients with breast cancer. [2016] To explore the lived experience of patients with breast cancer using decisional support aids during the prediagnosis, diagnosis, and treatment phases of their disease.

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

Decision Aids for Decision Making about Locally Advance Breast Cancer: A Systematic Review. [2023] Locally advanced breast cancer (LABC) is a subset of breast cancer with locoregional progression without distant metastasis. The multimodality treatment (surgery, chemotherapy, radiotherapy, hormonal and targeted therapy if required) could significantly improve results in this specific group of patients. The complex and multiple options of treatment with similar mortality rates but different outcomes depending on the patient's desires, preferences and social environment require aid to facilitate the individual patient's decisions (e.g. Decision Aids (DAs) targeting patients considering primary or adjuvant treatment in LABC). In this context, DAs have been proven fundamental to help patients and clinicians share and agree on the best value option. The current systematic review aimed to evaluate the existing DAs related to these patients with LABC and identify current status and possible improvement areas (possible scarcity and heterogeneity of instruments, the status of their development, explanation of their purpose,…). No previous systematic reviews have been published on this topic. Following Prospero registration no: CRD42021286173, studies about LABC DAs were identified, without data or language restrictions, through a systematic search of bibliographic databases in December 2021. Quality was assessed using Qualsyst criteria (range 0.0-1.0). The quality of the 17 selected studies ranged from 0.46 to 0.95. Of them, 14/17 (82%) were DAs about treatment, only one (6%) about diagnosis, and 2/17 (12%) about the employment of DAs. No screening or follow-up DAs were retrieved. Twelve (70.6%) DAs were online tools. They varied broadly regarding their characteristics and purposes. Most of the studies focused on developing and testing different DAs (5/17; 29.4%) and their impact (7/17; 41.2%). Only 4/17 (23.5%) analysed their implementation and cost. These instruments have proven to improve patient's knowledge and decision-making, decrease patient anxiety, and patients tend to undergo treatment. However, nowadays, there is still a need for further research and consensus on methodology to develop practical DAs.