Clinical Trials for Breast Cancer Treatment: 4 Ways to Prepare

Calendar Icon June 15, 2021
Reading Time Icon Read Time: 6 min
By Ciitizen

Historically, there have been barriers that have prevented advanced and metastatic breast cancer (BC) patients from participating in clinical trials for breast cancer treatment. These have included potential patient misconceptions and structural obstacles.

How Can You Prepare for Clinical Trials for Breast Cancer Treatment While Avoiding Potential Barriers?

Consider the following:

  • Proactively ask your oncologist and other members of your treatment team. If your healthcare team hasn’t yet discussed available clinical trials with you, be sure to ask about available trials for your specific BC type and stage.
  • Ensure that you’ve gathered all your medical records digitally. Having these available is critical in helping a clinical trial team confirm all the necessary inclusion and exclusion criteria concerning your BC type, stage, pathology results, and more. Tackling this on your own could easily lead to procrastination and delays in receiving all the necessary medical records, which are critical to your informed decision-making regarding treatment and clinical trial options. Remember that the online platform, Ciitizen, is here to help you easily collect all your patient medical records for you and digitize all your records for free.
  • Understand that if you’re considering participation in particular clinical trials for BC treatment, it’s the clinical trial team’s responsibility to provide you with all the information that you need. If you have any questions, they must provide you with sufficient, comprehensive information so you’ll be fully informed in your decision-making.

1. Understand Your Guaranteed Rights.

Whether patients elect to participate in clinical trials for breast cancer treatment or not, all patients have certain rights. Some are guaranteed by federal law, certain state statutes provide further protections, and many healthcare facilities have a Patient Bill of Rights.

  • A strong example of a “Patients Bill of Rights” is provided by the National Institute of Health (NIH) Clinical Center. Whether a patient or clinical trial participant, these rights include:
    • The right to receive safe, respectful care in a manner consistent with your beliefs
    • The right to the confidentiality of all records and communications regarding your care to the extent permitted by law
    • The right to full information concerning your diagnosis, treatment, and prognosis from your physician in easily understandable language
  • Because you are at the heart of any clinical trial, your rights, protection, and safety are critical and must be the top priorities for all members of the clinical research team. Every study must have an action plan called a “protocol,” which contains comprehensive information concerning the trial; ensures that it’s appropriate, justified, and designed to preserve participant safety; and effectively enables the study’s research questions to be answered. Such information includes:
    • Scientific background and reason for the trial
    • Study objectives
    • Trial design
    • Method and statistical considerations
    • Inclusion and exclusion criteria
    • Testing and procedures’ scheduling, number and timing of study visits, medications, and dosages
  • Every clinical trial protocol must include an “informed consent (IC).” This process is required by the Food and Drug Administration (FDA) to ensure that all potential participants receive complete information on the clinical trial before joining the study. You’ll be asked to read the IC form completely, given the opportunity to ask any questions, and asked to sign the document to ensure that you understand your role in the trial and your rights. You’ll also be provided with contact information should you have any further questions regarding the trial itself or if you develop adverse effects during the study that you need to bring to your research team’s immediate attention.

2. Understand Everyone’s Role in Clinical Trials.

Every clinical trial includes several different roles, each with its own responsibilities:

  • You, the patient: Taking certain steps during your participation will directly impact the accuracy of the trial’s results and ultimately, the safety, efficacy, and availability of potential new cancer treatments. Be sure to keep the following in mind:
    • Keep a calendar that records all your study visits and any additional appointments that you’ll need, e.g., blood tests and imaging studies.
    • Arrive for your study visits on the exact days that they’re assigned. Postponing appointments could result in skewed data or even prevent your continued trial participation.
    • Always check with your trial’s principal investigator (PI) before making any dose changes to any agent(s) that you’re receiving as part of the study. Also, speak with the PI before taking any new medications or receiving vaccinations.
    • Keep a journal to record and track any symptoms, side effects, and conditions that you’re experiencing, and share this information with the study’s clinical research coordinator (CRC) and staff, even if you think that it might be inconsequential. These findings can be critical regarding your health and the trial outcome and determination of overall safety and efficacy.
    • Be accurate and thorough when completing any questionnaires and/or study dosing diaries, and hand them in according to the trial’s schedule.
  • CRC: Often certified nurses, CRCs are specialized research professionals who work under the direction of the clinical trial’s PI. They coordinate, facilitate, and support daily clinical trial responsibilities, handling much of the logistics and regulatory requirements for clinical trials. They are also a vital supportive and informational resource for trial participants.
  • PI: A PI is responsible for conducting research that will provide high-quality, independent, reproducible results. The PI guides the overall oversight, management, and integrity of trial design, conduct, reporting, monitoring, compliance, as well as personnel coordination and financial aspects per federal regulatory and sponsor procedures and policies. The PI also ensures compliance with Institutional Review Board (IRB) requirements and is required to notify the IRB of any protocol deviations as soon as possible.
  • IRB: IRBs are groups formally tasked with protecting the safety, well-being, and rights of clinical trial participants. Per the FDA, IRB members must be collectively qualified to review ethical, medical, and scientific aspects of clinical trials. Their responsibilities include reviewing all study-related materials, including the clinical trial protocol and IC documentation and process, before allowing a site to start patient enrollment, as well as continuing reviews and any changes.
  • Sponsors: Sponsors may be pharmaceutical companies or individuals responsible for oversight to ensure a trial’s success. Responsibilities include determining qualified investigators to conduct the trials, providing information on and oversight of trial design, trial monitoring, ensuring that the trial is conducted per protocol, and confirming proper mechanisms for prompt notification to the FDA and all investigators regarding significant adverse effects.

3. Ensure That You Have a Strong Supportive Network.

Understand that your support network becomes even more critical when you begin participating in your clinical trial:

  • Establish your “caring team.” These are people whom you know that you can always rely on for their support:
    • Family members, friends, and co-workers
    • Members of your external support network, e.g., your primary care physician, oncologist, oncology nurses, physical therapist, psychotherapist, spiritual advisor, patient support groups, etc.
    • Members of your clinical trial team, including the PI and CRCs
  • Be open, and let them know when you need their help. Many cancer patients worry about being a burden to their loved ones and friends. But it’s crucial to recognize that they genuinely want to help, yet they may not know how unless you tell them specifically. Let them help you with appointments, cleaning, meal planning, and whatever else you need.
  • Provide them with information about your clinical trial. Have honest conversations about how the trial may be impacting you emotionally and physically.
  • Be open with your healthcare and trial team about any concerns or problems that you may be having. They may provide you with helpful, supportive suggestions that can make the clinical trial participation process more manageable and comfortable for you.

4. Recognize How Trial Participation May Affect Your Personal Life and Finances.

Although the financial costs of trial participation may not be that expensive, be sure to consider potential indirect expenses:

  • Federal law requires that most health insurance plans cover routine care costs during clinical trials if you’re eligible for an approved trial. However, Medicaid may not cover the experimental drug.
  • Health insurance plans are not required to pay for a trial’s research costs, e.g., repeated MRI scans or blood tests. However, in many cases, trial sponsors will cover these costs for participants.
  • Health insurance plans existing prior to March 2010 when the Accountable Care Act became law are “grandfathered,” so they are not required to cover routine patient care costs in trials.
  • Federal law currently does not require coverage of routine patient care costs for trial participants on Medicaid.
  • Consider travel costs to and from study visits, and ask whether the trial’s sponsor reimburses transportation and parking costs.
  • Calculate potentially lost income due to lost work days if you anticipate required time off during trial participation.
  • Remember to account for costs of childcare, babysitting, doggy daycare, and/or house-cleaning.
  • Speak with your CRC for help in anticipating any additional indirect expenses that you should take into account.

Ciitizen is a free service that helps patients get more out of their health records. Our platform enables patients to find better treatment options and gives them the opportunity to advance the research for cures.

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