November 14 2023The Caregiver Experience with Clinical Trials:Understanding the Emotions and Clarifying the Details for PatientsOur gratitude to Kris Kimball for sharing her story for this issue of our newsletter.
Kristen ‘Kris’ Kimball is a caregiver advocate who is passionate about promoting awareness to the benefits of clinical research as well as improving and educating physicians on the patient experience in the lung cancer community. Kris’ mission extends from her personal experiences with her late husband Dave’s battle with stage 4 EGFR-positive lung cancer and his involvement on three phase II clinical trials. Through her husband’s journey, Kris became enlightened on the questions many patients have or face when navigating their cancer treatment and she has dedicated her time to make physicians aware of these barriers. Today, Kris is on the board of the White Ribbon Project and is on the National Lung Cancer Roundtable’s Survivorship Task Group.She also volunteers on numerous projects with the Lungevity Foundation, Massachusetts General Hospital, and the Lung Cancer Research Foundation.
Kris’ husband Dave was diagnosed in May 2012 and was put on a first-line drug (Erlotinib) for EGFR-positive lung cancer while being treated at Yale University. Erlotinib worked for Dave for about a year before he started showing resistance to the drug around 13-14 months of treatment. This was watched until further progression occurred, and a known resistance mutation was found on his biopsy in December 2013. Dave’s oncologist advised that he relocate his treatment to Massachusetts General Hospital (MGH) to have access to clinical trials that were more suitable for patients with his subtype of lung cancer.
At MGH, Dave was under the care of Dr. Lecia Sequist, who Kris still remains in contact with today. Dr. Sequist recommended he enroll into a Clovis Oncology clinical trial studying Rociletinib, a specific blocker for his mutation. While waiting for this trial to open, Dave received Gamma Knife stereotactic brain radiation for his first set of brain metastases in January 2014. Dave was officially enrolled into the Clovis Oncology study in March 2014, but his second set of metastases appeared in June 2014. Similar to his experience with Erlotinib, Rociletinib worked at first, however the blocker eventually caused significant side effects, including bilateral cataracts. Rociletinib also stopped working within 6 months of the treatment and his cancer progressed in his lungs and in his brain. In September 2014, Dave moved to one more clinical trial with AstraZeneca studying Osimertinib targeting the same receptor. Finally, this trial was a success and the Osimertinib was able to clear up the cancer in his lungs and brain. Dave was even one of the first patients to establish that this new drug crossed the blood-brain barrier. Thanks to this experimental drug, Dave’s life and his quality of life was able to be extended. Osimertinib eventually failed in his lungs in November, 2016, and he enrolled in a third trial which did not work out. Osimertinib however prevented the cancer from spreading back to his brain until shortly before he passed from the disease. In Dave’s circumstance, he agreed to a rapid autopsy during his hospice at MGH as he wished to contribute to the knowledge of his disease following his passing.
Kris noted many important takeaways from her experience along Dave’s journey as well as countless conversations with peers that she and Dave met in the lung cancer community: one of the biggest being the emotional rollercoaster that surrounds a patient and their loved ones from diagnoses, through treatment, and through remission or death from disease. Patients and loved ones feel waves of fear, sadness, and anxiety mixed with glimpses of hope and anticipation. Kris compiled some of the ways that physicians can help make this road clearer and ease some of the anxiety surrounding treatment for patients:
Patients need clear, concise explanations of what a trial involves. Any materials patients receive, and any information conveyed by the doctor really needs to be broken down as much as possible to make sure that the patient fully understands what they are signing up for and their options. At a time when many patients feel life is out of their control, they need to realize that they do have control and a choice in what path they take for their treatment. Patients need to understand whether they are enrolled in a phase I, 2, or 3 trial and what that means, what their disease is, what the drugs they are taking are for, and any other specifics that can be given. There can be still a strong misconception to patients that enrolling in a clinical trial means they are a being treated like a lab rat who may only be receiving a placebo instead of actual treatment. As a whole, there could be a lot more information on what signing up for a clinical trials actual means to a patient and the pros that can come from this. For some lung cancer patients, for example; a clinical trial might even be a reasonable first-line treatment option.
Patients need to understand the time commitment. When signing up for a trial, patients should be made fully aware of all the time that is needed of them. The time investment starts with commuting to and from the clinic, as well as the time that is expected of them while they are there each visit. In Dave’s situation, Kris and Dave had two-day visits when scans were involved and one long day when scans were not involved, and their regular clinic visits were every three weeks. MGH was a two-hour drive from their home in Connecticut. Kris at the time was teaching two large lectures twice a week at the University of Connecticut and had an extremely supportive co-instructor and department, so managing the treatment schedule with work was feasible for them. However, work schedules may not be as flexible for many other patients or caregivers who are working around the treatment schedules. Other, less obvious time-stealers can include the actual medication regimen – which may require multiple doses/day; and managing side effects, which can include lost time due to fatigue! Having an idea of these timeframes upfront can help with the family planning around this schedule.
Patients need to be aware of the side effects. All side effects should be completely clear patients and caregivers in both physician-patient communications and any materials received on the treatment. For example, in Dave’s situation Rociletinib had caused major side effects that were impacting his quality of life. Managing side effects can be incredibly challenging and treatment progresses. Other examples of side effects can include skin rash, diarrhea, fatigue, and more serious issues such as heart or lung problems.Patients will need to be assured that they will be in close contact with their doctors and research nurses and can quickly notify them of any issues.
Patients need to be aware of the financial burden. In addition to the previously discussed time commitment, many times involvement in these trials cost money. Outside of just treatment and insurance alone, some treatment days may require hotel bills, parking bills, restaurant bills, etc. that are not often comped. Patients and caregivers may need to take time off work.Patients need to be aware of this burden ahead of time in order to properly prepare for their clinical trial journey.
Kris noted that clinical trials are a reasonable and hopeful treatment for many and have the potential to prolong a patient’s life while maintaining their quality of life, as that was her and Dave’s experience. She encourages others who are facing a cancer diagnosis to not be afraid of considering trials as an important option ifavailable.
The experiences and accounts of patients and caregivers who have been involved in clinical trials help to shape the future design and delivery of our trials and treatment options. NRG Oncology looks forward to the continued advice of our patient and caregiver advocates to continue to improve the future of oncology.