Patient, Relative and Staff Experiences of Clinical Trial Participation in Neurooncology: “Maybe You Can Also Show the Positive, No Matter How It Ends”

Abstract

Purpose

There is a lack of evidence regarding how patients with malignant brain tumor and their relatives experience participation in neurooncological clinical trials. Similarly, insights from the perspective of trial staff caring for this group of patients are missing. This study aims to investigate patient, relative and trial staff experiences regarding participation in clinical neurooncological trials.

Methods

Within a qualitative exploratory study, 29 semi-structured interviews with brain tumor patients, relatives and trial staff were conducted and analyzed using reflexive thematic analysis (RTA) by Braun and Clarke. A patient researcher and patient council were involved in data analysis and interpretation.

Results

Four themes were developed reflecting significant aspects of the trial experience: 1. “It all revolves around hope”; 2. “Trial participation: experiencing unique medical care”; 3. “Everyone’s roles are changing”; 4. “Communication as a possible area of conflict”. Experiencing trial participation and general medical treatment were found to be interconnected to such a degree that they were often not meaningfully distinguished by patients and relatives.

Conclusion

In addition to assessing traditional endpoints for patient outcomes, we recommend increased emphasis on investigating the impact of the “soft” components constituting trial participation. Due to the interconnectedness of medical treatment and trial participation, we recommend further investigation in comparison to experiences in regular care. A deeper understanding of trial participation is needed to inform improvements for patient experiences and staff satisfaction alongside medical and scientific progress.

Plain Language Summary

The treatment options available to patients with (malignant) brain tumors are currently very limited. Therefore, patients are sometimes offered to participate in a clinical trial. This means that they receive an experimental treatment (eg new medicine) for which it is not yet clear whether it works better than regular medical care. Currently, little is known about how this group of patients, their relatives and the hospital staff who care for them experience the participation in these clinical trials – which is what we aimed to explore in our study reported here.

Based on interviews with patients, relatives and staff, we found that:

• trial participation mainly revolves around hope;

• trial participation entails experiencing unique medical care;

• trial participation significantly changes the previous roles of patients, relatives and staff;

• trial participation intensifies communication as a possible area of conflict.

By providing information on how patients, relatives and staff make sense of their trial experiences, this study constitutes an important addition to the traditional focus of clinical trials on medical and scientific endpoints (eg progression-free survival). This may help clinicians and researchers involved in cancer research and treatment to understand why “unsuccessful” trials can still be perceived as positive by patients or how hopeful communication may support their patients even when perceived as “unrealistic” from the clinicians’ perspective. An in depth understanding of trial participation from the perspective of those affected is needed for improved care experiences alongside medical and scientific progress for cancer treatment.

Keywords:

• cancer research
• brain tumor
• qualitative research
• care experiences

Data Availability

While publication of anonymized quotes is permitted, the sharing of interview transcripts is not, as per the ethics committee’s requirements. Reuse of interview transcripts outside the research team is also not permitted as per the ethics committee’s requirements.

Acknowledgments

We would like to thank all study participants for their contribution to this study. We are grateful to the Patient Council of the Department of Neurology for their time and expertise. We would also like to thank our colleagues at the Department of Neurology who shared their expertise with us and provided support for many practical aspects of the study. We are especially grateful to the patient researcher who provided invaluable expertise, time and support to the research team. Due to deteriorating health, we were not able to discuss the implications of co-authorship on disclosure of identity and therefore could not include the patient researcher as co-author, as we would have wished. For the publication fee we acknowledge financial support by Heidelberg University.

Disclosure

The authors report no conflicts of interest in this work.

Additional information

Funding

No external funding.