Study yields insights into patient perceptions of cancer clinical trial benefits, burdens

research shows that patient dropouts from cancer clinical trials can lead to systematic bias, poor research outcomes, and loss of valuable scientific knowledge. JAMA network open.

Much attention has been focused on cancer clinical trial recruitment, but less attention has been paid to the factors associated with patient retention in these trials, particularly those related to perceived benefits and burdens.

“I was motivated to study the association between perceived benefits/burdens and discontinuation of clinical trials for several reasons. It’s what I wanted,” said the attending physician. Dr. Connie M. Ulrich MSN, RNs, Lillian S. Brunner, Lillian S. Brunner Chair of Medical and Surgical Nursing, Professor of Nursing, and Professor of Medical Ethics and Health Policy at Penn Nursing, told Healio. “They have unique perspectives that they can share based on lived experience, and those that researchers and institutional review board members perceive to be the benefits and burdens of the proposed research are encouraged to participate. may differ significantly from the perceptions of individuals. clinical trials“

Ulrich and colleagues at the University of Pennsylvania studied 334 adult cancer patients who were enrolled in cancer treatment trials at NCI-designated comprehensive cancer centers. The researcher said he collected data between September 2015 and he June 2019, and data analysis continues until he October 2022.

Ulrich spoke to Healio about her research findings and how this information can be used to improve retention in clinical trials.

Helio: Why is it important to understand what motivates patients to drop out of cancer clinical trials?

Ulrich: Recruiting and retaining individuals in clinical trials remains a challenge, and this could provide new ways to treat cancer and reduce the physical, emotional, and other effects of cancer on patients. Important for a better understanding of drugs, tests, and procedures.

Helio: your survey Indicated 2 of three top recognition Patient The benefits of cancer clinical trials were altruistically motivated (46.3% wishing you a cure, 32.3% help future patients).do you find this hopeful?

Ulrich: It is heartening to see that many of our patients have shown that, although they may not be personally helpful, they have stepped in to help others. , many people participate in hopes of benefiting. But helping others is a way of giving back. It may be comforting to know that your contributions may pave the way for innovation in the treatment of certain types of cancer, where treatment options are limited.

Helio: concern almost Receiving a placebo was the most agreed burden in the survey (61.3%). Does this suggest that the use of placebos in clinical trials should be reconsidered or handled differently?

Ulrich: No, sometimes there is a placebo when there is no standard treatment for cancer.However, in these cases, in addition to standard treatment placebo Patients are receiving aggressive treatment as they combine standard therapy with the new drug being tested. What I think is a problem is that there is still a lot of confusion around the term “placebo” and we need a better understanding of what patients and their families mean when they use the term and how it is used in research. This is what we need to be able to do.

Helio: Other perceived burdens include having to reorganize one’s life (41.9%) and experiencing adverse effects (41.6%)., Be aware of the seriousness of their cancer (35.4%) and pay for clinical trial-related costs (26.9%). How can clinical trial developers alleviate these burdens and facilitate adherence to clinical trials?

Ulrich: For example, people who work full-time, live in remote areas, don’t have ready transportation to drive to a cancer center for treatment, or don’t have access to support for clinical trials. You need to think about how you can provide access to You may have other health concerns that will help you access clinical trials at home or alter your ability to drive. During COVID-19, we did a lot with telemedicine. This may be one of his methods of monitoring adverse effects on individuals and providing a way for individuals to stay out of the way and avoid potentially very costly travel distances.

Paying for clinical trials remains a concern. The financial burden of cancer can be enormous, and we as researchers and clinicians need to be cognizant of that. Covers some of the normal costs associated with participation in HIV/AIDS, but the policy is to reduce the financial burden on patients diagnosed with cancer who volunteer to participate and their families. is required. clinical trials. These are for patients and their families to discuss with researchers and insurance companies and clarify what is covered and what is not covered.

Helio “RAwareness of the seriousness of one’s cancer” was one of the top perceived burdens. in your investigation. be patient No yet Do you realize the seriousness of their illness at this point?

Ulrich: Denying a cancer diagnosis or declining attention to its seriousness is a coping mechanism for some people and a way to deal with the physical and psychological changes that may follow. It’s a way to prepare yourself emotionally. More research is needed to better understand why patients believe that participating in a clinical trial made them realize the seriousness of their cancer. Some percentage of our participants thought they had no choice but to participate in a clinical trial, whether this was the point at which they realized the seriousness of their cancer, and all other The standard of care was exhausting with neither remission nor improvement in their disease.

Helio: What else do you think is important?

Ulrich: I would like to reiterate how important it is for patients (and their families) to be heard. Thank you for taking the time to better understand why I and my research team are participating in clinical trials. I feel burdened and unwell. In many ways, a focus on risk/burden has overshadowed a focus on the benefits of research participation in clinical trials. We found that patients perceived many benefits of participating in the study. More dialogue is needed about these benefits and how to rationally discuss them with potential participants in cancer clinical trials while meeting ethical and regulatory requirements.

For more information:

Dr. Connie M. Ulrich, MSN, RN, It can be reached at the University of Pennsylvania School of Nursing, Claire M. Fagin Hall, 418 Curie Blvd., Philadelphia, PA 19104. Email: [email protected]