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Summary in Thirty Seconds
People with cancer may have fears and misunderstandings about cancer clinical trials (e.g., beliefs that enrolling is an admission of a “last chance,” signing up will make someone a “guinea pig,” or risking getting a useless placebo) that result in them being less likely to sign up for such trials, resulting in low enrollment rates.
Education can not only improve a person’s impression of cancer clinical trials but can also alter their beliefs and concerns.
Changes in these areas (including fears and misconceptions) about cancer clinical trials can lead to changes in attitudes and knowledge about trials, resulting in improved willingness to enroll.
Such education can be particularly important to ethnic minorities who have traditionally had greater misconceptions about and less willingness to enroll in cancer clinical trials.
Providing education to healthcare providers can not only increase their knowledge about cancer clinical trials but can also raise awareness of new and emerging biomarkers that are targeted by cancer clinical trials.
Fears and Misunderstandings
The movie “Jaws” was released in the summer of 1975; afterward, beachgoing dipped demonstrably. Nothing had changed about the rarity of shark attacks or shark behavior; rather, fear of the unknown and uncertainty overcame facts (the rate of fatal shark attacks worldwide is 1 in 3,748,000[1] while the odds of being killed by a lightning strike are 1 in 281,000[2]). However, “Jaws” also inspired research and increased education about sharks and the rarity of shark attacks, which helped bring people back to the beach over the years (although with greater caution and wisdom).[3]
Similarly, many people have misconceptions and fears about cancer clinical trials (CCTs) that reduce their enrollment likelihood. CCTs have very low participation rates, with 2-8% enrollment in clinical trials; additionally, CCTs suffer from low rates of diversity—ethnically, geographically, and socioeconomically. Evidence shows that one effective way to improve CCT enrollment and diversity is by educating both patients and healthcare providers (HCPs). Answering patient questions and addressing concerns about CCTs and providing information about local CCTs can increase enrollment and retention. Educating HCPs about new and ongoing CCTs as well as raising awareness of biomarkers and new compounds targeting these biomarkers is another way to improve CCT enrollment.
Education to Improve CCT Attitudes and Knowledge Increases Enrollment Rates
Having a positive impression of CCTs and knowing what to expect about CCTs has been linked to higher enrollment rates.[4],[5] Memorial Sloan Kettering surveyed 1,511 consumers and found that only 40% had a positive image of CCTs with reasons such as worry over side effects, uncertainty over costs, concerns over receiving a placebo, skepticism over the unproven nature of a compound, and feelings of being a “guinea pig” listed. However, after reading a brief pamphlet describing CCTs, the number of respondents with a positive impression of CCTs increased by 50%.[6]
A study of people with lung cancer found that an education video intervention was significantly associated with patients’ self-assessed likelihood to enroll 2-week follow-up. Therapeutic CCT enrollment rates were found to be higher for those who watched the educational video versus those who did not (17.5% versus 11.1%) as well as for therapeutic and nontherapeutic CCT combined (25% versus 16%).[7]
In a study of 472 adults with cancer who had never been in a CCT, subjects received either printed educational information about clinical trials or in-person education providing similar clinical trial information as well as addressing misperceptions and concerns about CCTs. Attitudes, knowledge, self-efficacy, receptivity, and willingness to participate in CCTs were assessed 7 to 28 days later. Patients who received the in-person psychoeducational intervention showed more positive attitudes toward clinical trials and a greater willingness to participate at follow-up than patients who received only printed educational information. The authors concluded that the benefits of psychoeducation on willingness to participate were explained by improvements in attitudes toward clinical trials.[8]
A study of over 100 people with cancer evaluated their knowledge, self-efficacy, preparation for CCT participation, decisional conflict, and actual CCT participation before and after their initial consultation with an oncologist. After a brief educational intervention and the oncologist consultation, patients showed greater self-efficacy and had more knowledge, which was related to feeling prepared to make a CCT participation decision.[9]
In a study of people with lung cancer, patients expressed concerns that in a CCT, they were going to be “guinea pigs,” that all CCTs involve placebos and they would get one, that being offered a CCT was an indication from the HCP that this was a “last chance” and death was imminent, and/or that participating in a CCT would shorten their remaining lifespan. Based on these concerns, a letter was written to patients addressing their fears. Following this letter, enrollment in a specific CCT improved by 18%, and the percentage of patients on all CCTs at the study site improved over 4 years from 8% to 33%.[10]
A recent study presented at ASCO 2023 evaluated the impact of having patients, caregivers, and/or providers view two, one-hour interactive, video-based educational programs on various aspects of CCTs. 1,425 participants watched the programs, and after doing so, 81% were motivated to take one or more actions, such as researching clinical trials or discussing clinical trials with an HCP. 79% of subjects were confident to very confident about discussing clinical trials with an HCP. The study also found a 23% increase in confidence from pre- to post-activity in improving diversity in clinical trial participation.[11]
Education Improving CCT Diversity
The lack of diversity in CCTs is a well-established problem.[12] Research finds that clinical trial awareness and knowledge is higher in younger individuals, Caucasian people, and persons from higher socioeconomic backgrounds; furthermore, people in one or all of these demographics are more likely to participate in clinical trials than persons who do not fit this sociodemographic profile.[13] Therefore, education focused on improving awareness of the health problem of interest and clinical trial education[14] and increasing health and scientific literacy among ethnic minorities[15] may be particularly effective in reducing barriers to clinical trial participation in these groups. Video-based education may be especially effective in increasing knowledge about research, improving attitudes toward research, and increasing enrollment in research studies among hard-to-reach populations.[16],[17]
A 2022 ASCO study surveyed 102 Black women with metastatic breast cancer (MBC). Forty percent of respondents reported that no one on their care team had discussed trials. Respondents gave two main reasons for not participating in a trial: concerns about side effects and doubts as to effectiveness. Compared with non-Black respondents, Black participants were more likely to believe unstudied treatments might be harmful and have less trust in CCTs. This study concluded that Black patients with MBC are willing to consider participating in clinical trials, and the following interventions were recommended to increase Black patient participation:
enhance awareness about trials by informing patients, increasing education, training HCPs to deliver patient-friendly information in an unbiased manner, and providing messaging from people of shared racial/ethnic identity and health experience;
build trust through clear communication;
address concerns about side effects, effectiveness, harm, and fair treatment; and help patients find and access trials.[18]
Educating Physicians
Increasing patient participation in CCTs can also be accomplished by educating HCPs who might be reluctant to encourage participation due to a lack of knowledge/awareness of CCTs. An MSK survey (referenced above) contacted 594 practicing physicians and found that 56% only considered a CCT for their patients in the late stages of treatment, and 28% stated that they consider a clinical trial a “treatment of last resort.”[19] These results indicate the lack of knowledge of HCPs, as referring patients too late may mean that they are no longer eligible for the trial and/or cannot fully benefit from it.[20]
Clinical trials are primarily conducted in academic teaching hospitals, and usually, physicians from those hospitals are aware of the trials happening and can inform patients and encourage participation. However, roughly 80% of newly diagnosed people with cancer are cared for in a community-based hospital.[21] This leaves many patients who may be willing to participate in a CCT unaware of trials and not informed of them by their HCP. A Research America online survey of 1,000 American adults found 76% said they are likely to participate in a clinical research study; however, only 6% said their doctor ever suggested they do so.[22]
In a national survey of 1,030 oncologists (58% were not in academic practice), large differences were seen in physician intention and practices related to clinical trial accrual. Whereas 80% of respondents reported being likely or very likely to recommend trials in the future, only 20% reported discussing trials with their patients within the past 5 years.[23] Similarly, in a National Brain Tumor Society survey of brain tumor patients, only 24% of surveyed patients were informed of clinical trials by their HCPs at the time of diagnosis.[24]
Given the rapidly growing number of biomarkers and treatments targeting these biomarkers in cancer, educating pathologists to increase their awareness and knowledge of emerging biomarkers can help increase CCT enrollment. When pathologists are aware of new biomarkers, they can help connect patients and their primary oncologists (and other HCPs) to CCTs focused on compounds targeting newly discovered biomarkers. [25] With gains in biomarker awareness through education, pathologists can also interpret results that help guide clinical care and direct appropriate CCT options.[26]
Stepping on the Sand of Clinical Trials with Facts, not Fear
People returned to the beach in the years following “Jaws” through factual education and outreach about sharks leading to a better understanding of the rarity of attacks and how most shark species fear humans. So, education can change attitudes and actions, getting people to feel better about stepping on the sand again. People’s willingness to sign up for CCTs has been, at times, suppressed by beliefs that enrolling is an admission of a “last chance,” signing up means being a “guinea pig,” or joining risks getting a placebo. Education can alter such sincere but misguided beliefs and increase the likelihood of enrolling in a CCT. Additionally, educating HCPs about CCTs and new/emerging biomarkers can raise awareness and increase the likelihood that oncologists will refer their patients to CCTs or pathologists will alert oncologists to new biomarkers being targeted by new compounds in CCTs.
[1] worldanimalfoundation.org/advocate/shark-attack-statistics [2] oddsofdying.com/lightning [3] daily.jstor.org/sharks-before-and-after-jaws [4] J Clin. Oncol. 2001; 19(15): 3554-3561 [5] J Clin Oncol. 2012; 30(20):2516-2521 [6] J Comm & Supp. Oncol. 2018; 16(2):e81-88 [7] J Thor. Oncol. 2008; 3(1):23-29 [8] J Clin Oncol. 2012; 30(20):2516-2521 [9] Psycho-Oncol. 2012; 22(3):481-489 [10] J Thorac. Oncol. 2007; 2(3):191-196 [11] J Clin Oncol. 2023; 41(16_Suppl):6510 [12] J Natl. Cancer Inst. 2002; 94(5):334-357 [13] J Clin Oncol. 2016; 20(8):2109-2117 [14] PLoS Med. 2010; 7(11):e1000368 [15] J Canc Educ. 2012; 27:299-305 [16] J Thorac. Oncol.2008; 3:23-29 [17] Prevent. Med. 2004; 39:99-110 [18] J Clin Oncol. 2022; 40(16_Suppl):1014 [19] www.mskcc.org/news-releases/ [20] www.news-medical.net/life-sciences/Is-Education-Key-to-Accelerating-Clinical-Trial-Participation.aspx [21] Am. J Clin Oncol. 2020; 43(8):537-538 [22] www.policymed.com/2010/05/research-america-study [23] J Clin Oncol. 2021; 39(Suppl_15):1527 [24] Neuro Oncol. 2017; 19(Suppl_6):vi109 [25] Arch. Pathol. & Lab. Med. 2023; 147(4):474-491 [26] Arch of Path. & Lab. Med. 2020; 144(6):706-724