Supported through funding by Gilead.
In today’s complex healthcare environment, enrolling in a clinical trial presents both opportunities and obstacles for patients. Those who are enrolled in clinical trials are watched closely by the trial’s research team, adding an extra layer of care to the treatment experience. Conversely, these patients may also incur a heavy financial burden for expenses related to the trial’s extra doctor visits, travel and housing needs, or childcare. While these trials can offer access to cutting-edge therapies, a patient’s decision to participate in a clinical trial requires careful, informed consideration. As navigators, our role is to guide patients through the maze of information and empower them to make informed decisions that align with their personal health goals.
Understanding the different phases of a clinical trial is key to managing patient expectations about potential benefits and risks. Each phase has unique benefits and challenges that will impact your patients’ experiences and potential outcomes (Table).
Phase 0 clinical trials explore if and how a new drug or therapy may work and isn’t necessarily meant to provide therapeutic benefit. Phase 0 trials may be appropriate for patients with advanced disease, patients with no viable treatment options remaining, or those willing to take low doses of medication.
Phase 1 research assesses the maximum dose that patients can safely tolerate without experiencing severe side effects. Patients with advanced or refractory cancers and those with few remaining treatment options may be most appropriate for phase 1 trial enrollment. Patients who have cancer that is difficult to treat, including metastatic or rare cancers, may be willing to take on the higher degree of risk often associated with early-phase clinical trials.
Phase 2 offers more insight into potential benefits, although the risks are not yet fully understood. Patients with advanced-stage cancers who may be looking for alternative treatment options and patients with a diagnosis being specifically studied may consider enrollment. Since phase 2 trials have passed the initial safety tests, patients may feel more confident when enrolling in the experimental therapy.
Phase 3 compares an experimental treatment’s efficacy to standard therapies, while phase 4 focuses on long-term effects. Patients interested in novel treatments who still have access to proven therapies could be a good fit for phase 3 trials, and patients in remission or stable condition could help assess the long-term effects.
The gold standard for oncology trials is the randomized controlled trial, in which participants are assigned to receive either the standard treatment or the trial’s intervention by chance, reducing bias and ensuring objective results. It’s important for navigators to educate patients that this randomization can affect which treatment they receive. Another design is the crossover trial, in which all participants eventually receive both treatments, but in a different sequence, allowing patients to experience all interventions.
Navigators should educate patients about other designs, such as open-label trials (where everyone knows the assigned treatment) or single-group assignments, as these can impact patient expectations, consent, and outcome perceptions. Understanding these designs helps patients make informed decisions about participation.
Before deciding to participate in a clinical trial, it is also important for patients to understand the study’s time commitment. This includes potential travel for additional testing or provider visits.
Before deciding to participate in a clinical trial, it is also important for patients to understand the study’s time commitment. This includes potential travel for additional testing or provider visits. Some studies coincide with standard of care, but depending on the trial there may be extra visits added, extra blood draws, additional scans, or extended observation times. Due to the time involved for protocol adherence, a demanding trial schedule may keep a patient from enrolling or maintaining engagement on a study.
Under the Affordable Care Act, health insurers must cover the routine care costs for patients enrolled in approved clinical trials, such as those designated or funded by the NCI or federal agencies. Routine care includes treatments normally covered for the patient’s cancer type but excludes study-specific drugs, devices, or tests. Medicare follows similar rules.
Patients typically bear the cost of co-pays for doctor visits, lab tests, and scans. Navigators should also inform patients about expenses not covered, such as travel, lodging, and time off work, although some trials may offer financial assistance for these costs.
Due to the majority of clinical trials being conducted at large academic facilities, travel for potential participants may be difficult, depending on their location. Finding out from the study team if travel is reimbursed or subsidized could make participation more easily accessible for patients who live in more rural areas or out of state.
With decentralization becoming more appropriate, many trials are offering some parts of the study to be done remotely or at a location closer to the study participant’s home. In addition, navigators can help connect patients to beneficial resources to address any obstacles created as a result of trial enrollment.
This network of support helps connect rural communities and underserved populations to the latest in cancer treatment, navigating the obstacles many patients face in accessing the latest in healthcare advancements (Figure).
One of the hardest conversations a navigator can engage in with their patients is that of quality versus quantity of life. Many times patients will look for guidance when reaching a point in their disease progression where no approved treatment options remain. Sometimes a clinical trial is the last option someone may have before pursuing hospice care.
For navigators, knowing when clinical trials are an option is essential for providing comprehensive care. Navigators also need to maintain a balance between preserving hope and a realistic view of likely outcomes. This includes having clear and direct conversations with patients regarding how their enrollment may affect what remaining life they may have. Considerations such as unknown side effects, travel while in a weakened state, and unknown tolerance could negatively impact a patient’s quality of life.
Remain an active listener to your patients. You may be their only advocate willing to engage on their behalf toward the end of life. Engage in discussions about palliative care and hospice care early on, so that the concepts won’t be frightening toward the end of life and you can gauge your patient’s interest and openness to these services. Help your patients have the end they imagine, empower them with dignity and ownership in their own cancer experience.
Help your patients shape their cancer journey, ensuring their voices are heard and respected at every step. By empowering them to make decisions based on their own values and preferences, we can help them maintain dignity and control over their treatment experience.
In this 5-part series, we have explored the complexities surrounding clinical trial enrollment and the pivotal role navigators play in guiding patients through the process. From understanding the trial phases and designs to weighing financial and emotional considerations, patients need a comprehensive support system to navigate these decisions. By providing clear, compassionate guidance and education, navigators empower patients to make informed choices that align with their personal health goals, ultimately enhancing their treatment experience and quality of life. Together, we help patients take control of their cancer journey with knowledge, dignity, and hope.
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