Educational Intervention Seeks to Decrease Barriers to Cancer Clinical Trial Enrollment

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Results from a quality improvement project, which were shared during the 50th Annual Oncology Nursing Society Congress, showed that many people diagnosed with cancer were aware of cancer clinical trials (CCTs) but had not considered them as a treatment option, and that education in this arena could help address existing patient barriers and encourage future participation.1

The education intervention took place at an integrated health system in the Washington DC region where no CCT education had been provided to patients with cancer unless they were potentially eligible to participate. Findings indicated that CCT knowledge scores did not significantly differ from pre- to post-education (Z = 1.73; P = .084), although this was partially due to high pre-education scores.

Moreover, no significant changes were noted with regard to attitudes to randomized trials from pre- to post-education. One component of the intervention focused on preparedness for patients to make a decision (PrepDM); overall scores ranged from 57 to 100, with a mean of 83.9 (standard deviation = 14.4) and a median of 80.0, which suggested a high level of preparedness.

“CCT education is important for people with cancer, [and] people with cancer find the education valuable,” Leslie Greenberg, DNP, MBA, RN, CCRP, OCN, of the Mid-Atlantic Permanente Medical Group, Mid-Atlantic Permanente Research Institute, wrote in a poster detailing the initiative. “People with cancer can view CCTs as a treatment option.”

Raising the Clinical Question and Examining the Scope of the Problem

It is known that cancer represents a public health problem and is the second leading cause of death in the United States alone. Participation on CCTs is imperative to advancing care; however, according to the American Cancer Society Cancer Action Network, adult participation on these trials is low with only approximately 6% of patients treated at centers that participate in these trials. Existing barriers to participation could be clinical, structural, or related to providers or patients. Approaches to overcome these challenges are needed.

To this end, Greenberg and colleagues sought to determine whether an educational intervention dedicated to boosting awareness and understanding of CCTs could improve attitudes and knowledge of such trials among adult patients with cancer who are not currently participating in one.

Taking a Deep Dive Into the Project

Greenberg and colleagues pooled together a table of evidence comprising 17 studies that collectively demonstrated that education could impact knowledge and attitudes about CCTs; this evidence provided the rationale for the quality improvement project, which utilized a pre-post design.

A total of 11 participants were recruited and enrolled; all were adults who had received a cancer diagnosis within the past 6 months. Of the 11 CCT education patients, 72.7% were male and 81.8% were White. With regard to marital status, 36.4% were married and 9.1% were divorced; this information was unknown for 54.5% of patients. Cancer diagnosis and stage included stage IIB prostate cancer (36.4%), stage I prostate cancer (18.2%), stage I melanoma (9.1%), stage IV lung cancer (9.1%), stage IA breast cancer (9.1%), stage I bladder cancer (9.1%), and stage I tongue cancer (9.1%). Following the educational intervention, 1 patient enrolled in a clinical trial.

These participants first completed 2 surveys. Questions included for the Knowledge Statements About Clinical Trials survey and correct answers are as follows:

• If I were to enter a trial, I would have to stay in it until the trial is over (False)
• “Informed Consent” means that I am given information about the trial so I can freely decide whether to participate (True)
• The treatments generally being used are called “standard treatments” (True)
• Standard treatments are never as good as new research treatments (False)
• Treatments used in clinical trials may cause side effects (True)
• It is up to me to decide whether to be in a clinical trial (True)
• Patients in clinical trials must get their care at different places from patients getting standard treatments (False)
• If I were to join a clinical trial, I could decide to stop at any time (True)
• “Randomization” means that my treatment will be chosen by chance (True)
• Once I join a clinical trial, my own doctor will not know what happens to me (False)

Questions included for the Attitudes to Randomized Trial Questionnaire (ARTQ) are as follows:

1. Do you think that patients should be asked to take part in medical research?
2. Suppose that you were asked to take part in a research study comparing 2 treatments, both of which were suitable for your illness. Would you be prepared to take part in a study comparing different treatments?
3. Usually, the only scientific way to compare one treatment with another is for the choice between the two to be made randomly, rather like tossing a coin. Would you be prepared to. Take part in a study where the treatment was chosen at random?

They then watched the Preparatory Education About Clinical Trials (PRE-ACT) web-based videos that were developed to boost preparation for decision making with regard to CCTs. Notably, these videos were short and featured actors of all races. They were also easy to access in that participants did not need to create an account; they were also able to personalize the content. They also attended a question-and-answer session led by CCT staff. After watching the videos, participants were asked to complete the surveys again.

Percentages of correct answers for the Knowledge Statements About Clinical Trials survey pre-intervention were 72.7%, 100%, 72.7%, 100%, 90.9%, 100%, 81.8%, 90.9%, 72.7%, and 81.8%. Respective percentages of correct answers post-intervention were 90.9%, 100%, 72.7%, 100%, 100%, 100%, 100%, 100%, 81.8%, and 90.9%.

For the ARTQ, pre-intervention, all patients answered “yes” to the first question; 9.1% answered no, 72.7% answered yes, and 18.2% answered don’t know for the second question; and 18.2% answered no, 63.6% answered yes, and 18.2% answered don’t know for the third question. Post-intervention, all patients again answered yes for the first question; 9.1% answered no and 90.9% answered yes for the second question; and 9.1% answered no, 72.7% answered yes, and 18.2% answered don’t know for the third question.

Patients also completed the PrepDM Scale, which comprised 10 items rated on a 1 to 5 scale, which were defined as “not at all” to “a great deal,” respectively. The answers were totaled and then divided by 10 to achieve a mean rating. One was subtracted from the mean rating and then the result was multiplied by 25 to calculate an overall score on a scale ranging from 1 to 100. Mean scores ranged from 3 to 5, with a mean of 4.35 (SD = 0.58) and a median of 4.20.

“The sample was underpowered limiting the ability to determine statistical significance,” Greenberg wrote in the abstract. “However, all participants stated that they saw value in the CCT education.”

Reference

Greenberg L. Using education to overcome barriers to clinical trial participation. Presented at: 50th Annual Oncology Nursing Society Congress; April 9-13, 2025; Denver, Colorado. Abstract P237.