Oncologist-Reported Barriers and Facilitators to Offering Cancer Clinical Trials to Their Patients
Abstract
:1. Introduction
2. Materials and Methods
3. Results
3.1. Participant Characteristics
3.2. Summary of Findings
3.2.1. Barriers
3.2.2. Trial Level
“Some of those exclusions for comorbidities and very strict lab test requirements can unintentionally exclude more patients from minority and underserved populations. That’s not their intent, but that’s their effect”.
“I see a lot of rare forms of cancer, and when people ask about clinical trials my answer will be, ‘We don’t have clinical trials and, honestly, no one does because there’s so few cases of this that no one will ever be able to formulate a clinical trial’”.
3.2.3. Provider Level
“The people who maybe I won’t bring it up as frequently with are the ones who initially express, hey, I live too far and I’m not interested if they express initially ‘it’s too much for me to come out’. But if there’s still a trial that comes up I will kind of mention it in passing. They usually have made up their mind”.
“There are very few people who I wouldn’t approach. There are patients who I’ve mentioned to, ‘There’s a clinical trial that you would be eligible for, but I don’t think it’s a good idea for you right now for these reasons’. I do it that way partly so that if I’m giving more weight to the reasons why I don’t think this is a good idea for them [to see if they] correct me or challenge me on that”.
“There’s these other components of the trial that maybe I didn’t go into as much detail with her because it was a brand-new trial to me”.
“There are perceptions that certainly patients have, but some physicians as well, that trials are the thing you do when there’s nothing else left to do. That doesn’t help”.
3.2.4. Patient Level
“If they need to start treatment immediately and they don’t have time to really consider clinical trials”.
“Things like Tuskegee and other incidents in history… the Native American population is another one that hasn’t been offered clinical trials enough, but also there’s a skepticism of when it is offered. I would say that there is even when it’s offered, maybe a swift decline to proceed with discussion, or even after learning, they decline to move forward with it based on ethnicity and background”.
“I can put up a wall due to some of my minority patients in terms of the notions that they don’t want to be experimented on. That’s how sometimes they feel. I’ve had a couple of patients that tell me that, and therefore this wall is up, and I can’t get through it regardless. And there is no further discussion. It’s a big wall. Some of it is due to historical experiences with trials, how they affect minorities in the country”.
“Especially if the patient is elderly, and their adult children who assume the role of the primary caregiver and primary responsibility for the family might shield their parent. When clinical trials are broached, it’s almost taken as an offense, like ‘you’re going to experiment on my loved one,’ and so the conversation can’t go forward”.
3.3. Facilitators
3.3.1. System Level
3.3.2. Trial Level
3.3.3. Provider Level
“We screen every patient that comes to our center. We have three clinics, radiation oncology and two hematology-oncology. Each of the nurses here is in charge of one of the clinics. We screen all those patients for all our clinical trials. All the patients that come, whether they’re new or they’re follow-up, we continue to screen. If we find a patient that might qualify, we approach the physician, and then we ask the patient”.
“I always do it in the context of ‘this is standard of care and then this is investigational’. I present both options. I like to draw it out for them. I compare and contrast what is considered standard of care and what is the clinical trial option for them.
3.3.4. Patient Level
“At follow up visits if we’re dealing with a metastatic patient, if they have progressive disease I usually will say, ‘we have this trial or, unfortunately there are no trials right now’”.
“If they’re already coming in either knowing about clinical trials or asking to do it, then you’re like, “Okay, great”. It’s less explaining and trying to convince them that it is a potentially better option. It always helps if patients are asking about clinical trials or already interested in clinical trials”.
“The biggest issue I find in those populations are, one, mistrust and, two, a lack of understanding of what a clinical trial means. We try to introduce clinical trials earlier in their care. Before they see me, we’ve tried to have the surgeons introduce that. Because people tend to have a bond with their surgeon. If the surgeon is saying, ‘there are things called clinical trials’ or ‘there’s a trial that you should look out for’, that’s one of the things that we tried to do earlier on”.
“There were times early in my career where I gave clinical trials a brief mention to someone who had very low education level thinking this is going to go nowhere and they had great questions, were fully engaged, wanted to participate, and saw this as ‘hopefully this will help me, but if not, it will help someone else’. They articulated that altruistic goal of this is a way that I can make something good come from something bad, and that’s powerful. I’ve tried to learn from those experiences and not let that stop me from offering trials”.
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Appendix A
Appendix A.1. In Depth-Interview Questions
- 1.
- Do you discuss clinical trials as a form of treatment with patients?
- 2.
- What are the barriers to discussing clinical trials with patients? Any others?
- 2a.
- Are there specific types of patients for whom you do not discuss clinical trials? Anything else?
- 3.
- What are some factors that facilitate a discussion about clinical trials with patients? Any others? Probe to fully explain answer.
- 3a.
- And then at what point in the patient’s care would you normally discuss clinical trials
- 4.
- Are there any specific types of patients for whom you do discuss clinical trials? Anything else?
- 5.
- What are the things in the health care delivery system in which you practice that help you to discuss clinical trials? Any others?
- 6.
- Can you name some positive or negative characteristics or aspects of clinical trials or research that influence whether you do or do not incorporate the topic during your discussion?
- 6a.
- Clinical trial/research positive characteristics
- 6b.
- Clinical trial/research negative characteristics
- 7.
- What are strategies that could help you increase your own rates of discussing clinical trials with patients?
Appendix A.2. Chart-Stimulated Recall Protocol
- 1.
- Inclusion/Exclusion Criteria
- A patient who was seen in the previous 1–3 weeks
- Patient age >18 or parent/guardian present if ≤18
- 2.
- Rating recall of each chart
- 3.
- Patient summary
- Age
- Race/ethnicity
- Major comorbidities
- Reason for visit
- Presence or absence of a discussion about clinical trials at index visit
- What was discussed?
- What factors facilitated your discussion of clinical trials?
- How, if at all, did the patient’s race or ethnicity affect your decision to discuss clinical trials?
- Did the patient pursue clinical trial enrollment?
- What factors inhibited you from discussing clinical trials?
- Was there a discussion of clinical trials at any previous visit?
- When was that visit? What was the type of visit?
- Did the patient pursue clinical trial enrollment?
- How, if at all, did the patient’s race or ethnicity affect your decision not to discuss clinical trials at this visit and at any previous visit?
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Barrier to Discussion of CCT Cited during In-Depth Interview (Number of Participants Who Reported Barrier) | Number of Times Barrier Was Cited during Chart Stimulated Recall | Facilitator to Discussion of CCTs Cited during Interview (Number of Participants Who Reported Facilitator) | Number of Times Facilitator Was Cited during Chart-Stimulated Recall | |
---|---|---|---|---|
System | Distance to CCT site (2) | Robust CCT workforce: conducting prescreening, consents (9) | ||
Time (9) | System that keeps track of patients who providers have discussed CCTs with | |||
Lack of a sufficient research workforce | Program integrated into the EMR that identifies clinical trials, reminds providers to discuss CCT and/or access to research team members who can discuss trial.EMR as a tool for matching and communicating (5) | |||
Financial toxicity | Being a part of a cooperative group CCT (2) | |||
Insurance: out of network restrictions (3) | Larger physical space | 1 | ||
Limited visitation policy during the COVID-19 pandemic, less family members helping process CCT discussion | Interpreters, translators (3) | |||
Too many CCT options | Chart/checklist with available CCTs | |||
Transportation to CCT site | Database that facilitates prescreening | |||
Multidisciplinary clinics | ||||
CCT educational resources: literature, website (3) | ||||
Principal investigator sending introduction of trials/reminders | ||||
Trial | Disease factors: no CCT available for specific malignancy | 2 | Greater CCT availability (5) | 2 |
Requirement of additional tissue biopsy | Additional care providers: e.g., another nurse, another clinical trial coordinator involved in patient care | |||
CCTs that require frequent visits (2) | CCTs often offer opportunities for more imaging studies | |||
Language: lack of availability of consent forms in different languages (3) | Having consent forms in different languages | |||
The toxicity of CCT treatments | CCTs provide more treatment options | |||
Explaining genomic profiling or biomarker concept to patient | Phase 2 CCTs: (excitement of receiving a new treatment, every patient will receive the treatment) | |||
Eligibility criteria (4) | 7 | |||
CCT that has been open for years | ||||
Treatment drugs that are too new | ||||
Specific design features: RCT/the concept of randomization, placebo-controlled CCTs, CCTs that are not treatment-based (non-therapeutic clinical trials), correlative studies (4) | ||||
Provider | Assumptions (4) | 2 | Systematic approach to screening (6) | 8 |
Inadequate knowledge (2) | 3 | Awareness of CCTs | 1 | |
Forgetfulness: to prepare charts, to do patient prescreening | Comparison of standard of care vs. investigational therapies (2) | 1 | ||
The responsibility of discussing CCTs falls solely on the provider | Accountability: leadership or board of directors maintaining providers accountable | |||
CCTs are seen as a last treatment option | 3 | Provider is a researcher | ||
Fear of disappointing patients if they are unable participate in CCT | Research staff to remind provider about CCT | |||
CCT participation is more difficult than giving standard of care | ||||
Patient | Disease factors: urgent or emergent need for treatment | 3 | Newly diagnosed patient (2) | |
Negative attitudes about CCTs (10) | Disease factors: patient needs a new treatment option (6) | 3 | ||
Patient’s comorbidities | Patient is interested in CCTs (4) | |||
Language: limited English proficiency (3) | Younger age (2) | 1 | ||
Psychosocial | 1 | Earlier introduction to CCTs (2) | 1 | |
Patient’s poor performance status | 1 | CCT or second opinion referral (3) | 3 | |
Living far away from CCT site (2) | Good support system (2) | |||
Social determinants of health: insurance, finance, transportation (2) | Patient has a good performance status | 1 | ||
Culture (2) | 1 | Lack of comorbidities | 2 | |
CCT participation would stop alternative therapies | Patient adherence | |||
Fear of CCT associated side effects | Patient positive attitudes: altruism and trust (4) | 1 | ||
Knowledge of CCTs(4) | 2 | Involvement with advocacy organizations | ||
Low patient interest | 1 | Motivation and engagement (5) | 2 |
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Share and Cite
Castillo, B.S.; Boehmer, L.; Schrag, J.; Howson, A.; Oyer, R.; Pierce, L.; Barrett, N.J.; Guerra, C.E. Oncologist-Reported Barriers and Facilitators to Offering Cancer Clinical Trials to Their Patients. Curr. Oncol. 2024, 31, 3017-3029. https://doi.org/10.3390/curroncol31060230
Castillo BS, Boehmer L, Schrag J, Howson A, Oyer R, Pierce L, Barrett NJ, Guerra CE. Oncologist-Reported Barriers and Facilitators to Offering Cancer Clinical Trials to Their Patients. Current Oncology. 2024; 31(6):3017-3029. https://doi.org/10.3390/curroncol31060230
Chicago/Turabian StyleCastillo, Brenda S., Leigh Boehmer, Janelle Schrag, Alexandra Howson, Randall Oyer, Lori Pierce, Nadine J. Barrett, and Carmen E. Guerra. 2024. "Oncologist-Reported Barriers and Facilitators to Offering Cancer Clinical Trials to Their Patients" Current Oncology 31, no. 6: 3017-3029. https://doi.org/10.3390/curroncol31060230
APA StyleCastillo, B. S., Boehmer, L., Schrag, J., Howson, A., Oyer, R., Pierce, L., Barrett, N. J., & Guerra, C. E. (2024). Oncologist-Reported Barriers and Facilitators to Offering Cancer Clinical Trials to Their Patients. Current Oncology, 31(6), 3017-3029. https://doi.org/10.3390/curroncol31060230