3.1 Patient Experiences while Setting the Stage
During this stage, patient and clinician deliberations focused on whether the patient was interested in early phase trial participation and whether the oncologist supported the patient's participation. There were two steps in this stage that occurred in no particular order. One of the two steps was to identify older adults' interest in cancer clinical trials:
“…Both my wife and I wanted to get into this clinical trial very badly and get it going as soon as possible. And we have never wavered from that approach since we started talking about clinical trials months ago.” –Patient 14.
The other step was that oncologists recommended or expressed support for clinical trial enrollment. This happened prior to older patients' exhausting standard therapies:
“There was a clinical trial that was showing great results and he really felt confident that mom would be a really good candidate [for] the clinical trial and we were definitely all for it.” —Patient/caregiver 27.
First theme: patients deferred to their oncologist to gauge their interest in clinical trials and discuss trial availability. Although some patients researched clinical trials, patients depended on their oncologists to make decisions because they expressed that their oncologists were more knowledgeable about cancer treatments and best options:
“He [oncologist] makes the same decisions I do. [Laughter] And if he has to make a different kind of decision, when he explains it to me, I know he's right, you know? I'm not thinking, ‘What?’” —Patient 29.
The oncologists' general support for enrollment played a central role in whether a patient explored trial participation. Patients deferred to their oncologist for education on the next best steps in treatment, help with decision-making, and trial possibilities:
“My decision-making is basically what [my oncologist] suggests. I do what the professionals say.” –Patient 33.
A main reason for this deference to their oncologist was that the research and decision-making could be overwhelming:
“I tried to look [at research] and they were scary… I read some but I stopped reading.” –Patient 35.
Second theme: there were modest differences between how participants age 65–70 and ≥70 approached trial exploration with their oncologists. Participants in the 65–70 subgroup tended to come to the academic center specifically to discuss trials after heavily researching potential clinical trial options or speaking with their community oncologist. Patient 9, for example, set up an online search alert for articles involving potential new therapies for his cancer. Some in the 65–70 subgroup saw early phase trials as an expected part of their therapy, whereas others saw it as a last resort:
“I researched places because we know that his only hope is doing trials. So I researched the trials to find out who was doing them, who was somewhat successful; where could we go” –Patient/caregiver 8.
The >70 subgroup were more deferential to their oncologists regarding next steps in treatment. They were less likely to explicitly seek out and discuss trial enrollment or distinguish phase 1 trials from standard of care:
“I just thought it was part of the treatment; it was what a doctor should do.” –Patient 33.
The >70 subgroup, in comparison to the 65–70 subgroup, did not express the same degree of hope in clinical trials:
“My understanding is that…this cancer was not curable but that these clinical trials could possibly reduce this illness to a chronic illness, manageable state. …. Should a trial turn out to be a miraculous cure, which nobody really expects, but should that be the case, then bonus.” –Patient 30.
The >70 subgroup were also more vocal about weighing the time commitment required for a clinical trial against the potential clinical benefit, which was not explicitly mentioned by the 65–70 subgroup:
“On the other hand, it's a time commitment that is extraordinary…Do I really want to spend my time in your waiting room?” –Patient 28.
Participants with altruistic goals of promoting scientific advancement through trial enrollment were among the >70 subgroup:
“…I've participated in several clinical trials and I like doing things that help people learn. If I could help them find a cure for cancer, that would be absolutely incredible…. Hopefully they learn from my participation.” –Patient 15.
Lastly, the >70 subgroup were more explicit about their desire for a clinical trial to maintain or enhance their quality of life:
“[My goal is] To extend it with quality, not extend the life and be miserable. No, no, no. I keep telling my sons and my grandsons, ‘If I'm going to be on the respirator for a year, no. Knock it off.’ If I not be able to be on my feet, I prefer to be on my knees for a short period of time.” –Patient 23.
3.2 Patient Experiences when Securing a Seat
During this second stage, which occurred after or alongside the first stage, clinicians and patients identified an open seat on a clinical trial, affirmed patient eligibility, and established informed consent:
“We were looking at clinical trials…I was first or second on a waiting list, but it closed out with the people that were on it… And that's when she decided to write the appeal… It's pretty forbidding when you start looking at the stuff that they send you, ‘cause I had all the application forms for it and it's pages and pages…” –Patient 28.
To be evaluated for eligibility, older adults needed to have the wherewithal to navigate a battery of tests:
“They said before you can get in the study…you have to have bone density – You have to get all these tests.”—Patient 34.
Third theme: patients heavily relied on their oncologists for guidance in setting the stage for enrollment and securing a seat to participate. After joining a trial, participants continued to rely on their oncologist to navigate the complex early phase enrollment process and make ongoing assessments of whether trial participation was appropriate. For example, one patient trusted her oncologist to withdraw her from a clinical trial before starting treatment:
“[My oncologist] presented us with a clinical trial… Just before we were ready to start it, he decided he didn't want me in there. He didn't want to take that chance. So he pulled me out of the trial and then I went into a whole series of chemo.” –Patient 32.
Despite their interest, only a subset of eligible patients in both subgroups eventually initiated a clinical trial (Table 3
). Our findings were limited to the patient interviews. Some patients were then ineligible to enroll, e.g., they had prior therapy or did not meet biologic parameters (such as having elevated liver enzymes). The participants did not mention that their age, functional status, and comorbidities were reasons for being ineligible for a trial. Overall, they trusted their oncologist to determine their eligibility and appropriateness for trial enrollment.
Like the first stage, there were subtle differences in how the >70 subgroup navigated trial initiation. They spoke in less depth and detail about their oncologist's judgement about clinical trial participation and whether a trial represented a reasonable alternative to the standard of care options. They made briefer comments about whether their oncologist told them they were eligible for a trial. This contrasts with the 65–70 subgroup, who were more detailed and specific about their eligibility and referenced their involvement in the evaluation process:
“They were still recruiting patients so we came roaring down here... ‘Cause they had three or four days of pretesting to see if you were even eligible.” –Patient 2.