Patient-reported outcomes leveraged to overcome barriers to clinical trial enrollment
Click Here to Manage Email Alerts
Key takeaways:
- Significant response to trial enrollment observed after individuals received an invitation based on patient-reported outcomes.
- Trial recruitment with patient-reported outcomes could reduce burden on clinicians.
Participation in cancer-related clinical trials could increase dramatically if researchers screened and recruited individuals using routine care patient-reported outcomes, according to results published in JAMA Oncology.
A randomized study found a significant number of individuals responded to and enrolled in a trial involving cancer-related fatigue after being contacted via an online patient portal that generated invitations to the participate based on responses to a patient-reported outcomes (PROs) questionnaire distributed weekly during radiation therapy. Meanwhile, a bare minimum of patients enrolled in the same trial when recruitment relied on the standard approach of referral.
“This method overcomes so many barriers that exist in oncology trial recruitment and could help facilitate enrolling patients in trials and taking some of that burden off of physicians,” Nicholas P. Verdini, MD, research fellow at Memorial Sloan Kettering Cancer Center, told Healio.
A ‘pretty cumbersome’ recruitment process
Estimates of adult enrollment in clinical cancer trials can be as low as 5%, although Healio recently reported new estimates of 7% in treatment trials and roughly 20% for all studies.
The low percentage can stem from location, eligibility constraints and low awareness, according to background information provided by researchers.
Increasing that number is critical. However, researchers wanted to find a potential solution that did not add obligations for clinicians.
“It’s already pretty cumbersome,” Verdini said of the recruitment process. “One important thing that we learned through prior research is that more patients are usually willing to enroll in clinical trials than are actually invited.”
PROs have become a routine part of care for many centers, and they could provide information needed for determining a patient’s eligibility for a trial.
Researchers partnered with another study examining symptom intervention on cancer-related fatigue at Memorial Sloan Kettering to investigate.
Patients with breast cancer, who had received weekly PROs surveys as part of standard care, could be included if they had eligible fatigue criteria.
Study investigators randomly assigned study participants to receive an invitation to a trial from the patient portal via their primary oncology team or a referral service, or from their physician as part of the standard of care. Physicians in the standard-of-care arm knew about the fatigue study.
The portal cohort consisted of 210 patients (73.3% white) and the standard-of-care group had 184 (58.6% white). Both arms had a median age of 55 years.
The portal cohort produced 73 responses and 41 enrollments in the fatigue trial vs. one response and 0 enrollments in the standard-of-care of group (P < .001).
“We didn’t expect it to be so high,” Verdini said. “Outside of the clinical trial room, 20% might not sound that high, but that’s actually very successful for this intervention. We were surprised that patients were so responsive.”
The referral service had a 44% response rate vs. 26% for the oncology team (P = .01), but those had no significant difference on enrollment.
Increasing enrollment, with greater diversity
The results defied expectations because previous research indicated patients would be more likely to respond to a message from their oncologist, Verdini said.
“You can actually use patient-reported data to directly pursue patients who may be interested in potential trials,” he added.
However, Verdini stressed this might not be applicable for all studies, particularly treatment trials.
“We were not studying a new drug therapy with these trials that we were recruiting patients for,” he said. “That relies more so on information from their provider, compared with a symptomatic trial where we’re trying to address their fatigue or address their neuropathy or address their anxiety. Those things are lower-risk trials.”
Verdini said more research is expected to determine what trials PRO surveys might be useful for, but other steps should be taken as well to fully optimize PROs in the study setting, the first being adding a consent to contact in the PRO survey.
“That way, patients feel confident that if they don’t want their PROs to be contacted from a research team, then they have that option,” Verdini said.
Automation could be valuable too because manual screening of PROs can be labor intensive.
“I had to physically screen through every PRO survey document and look for these patients with certain symptoms, and then I physically messaged them through the portal message and then would have the call with them,” Verdini said. “That takes time and resources. Finding a way to make this method a little more automated ... would be helpful.”
Fixing these issues could lead to greater enrollment, including in underserved populations.
“It’s been documented time and time again that there is implicit bias in inviting patients to clinical trials where minority patients are less likely to be invited,” Verdini said. “This overcomes that implicit bias by just directly inviting the patient from the trial team and not relying on that physician-patient interaction to do it.”
For more information:
Erin Gillespie, MD MPH, can be reached at eringill@uw.edu.
Collapse
Click Here to Manage Email Alerts