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Distress among caregivers of phase I trial participants: a cross-sectional study

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Abstract

Purpose

The number of patients with cancer enrolling in phase I trials is expected to increase as these trials incorporate patient selection and exhibit greater efficacy in the era of targeted therapies. Despite the fact that people with advanced cancer often require a caregiver, little is known about the experience of caregivers of people enrolling in oncology phase I clinical trials. We conducted a cross-sectional study assessing the distress and emotion regulation of caregivers of phase I trial participants to inform the design of future interventions targeting the unique needs of this population.

Methods

Caregivers of oncology patients were approached at the patient’s phase I clinical trial screening visit. Caregiver participants completed a one-time survey incorporating validated instruments to comprehensively assess distress and emotion regulation. Basic demographic information about both the caregiver and patient was collected.

Results

Caregivers exhibited greater distress than population norms. Emotion regulation was also moderately impaired. Respondents identified positive aspects of caregiving despite exhibiting moderate distress.

Conclusion

Enrollment of a patient in a phase I clinical trial is a time of stress for their caregivers. This pilot study demonstrates the feasibility of engaging caregivers of phase I trial participants and the need to better support them through this component of their caregiving experience.

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Conflict of interest

There are no further conflicts of interest to disclose. The authors have full control of all primary data, which is available for review.

Funding

The funding of this study is provided through the following: 1K07AG030337 (JK), 3R01CA126971 (MLL), 2P30CA046934 (SGE, JK), and PCORI Contract CE-1304-6208 (MLL).

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Authors and Affiliations

  1. Division of Medical Oncology, Department of Medicine, University of Colorado School of Medicine, MS 8117, 12801 E 17th Avenue, Aurora, CO, 80045, USA

    Elizabeth R. Kessler, S. Gail Eckhardt & Daniel W. Bowles

  2. University of Colorado Cancer Center, MS 8117, 12801 E 17th Avenue, Aurora, CO, 80045, USA

    Elizabeth R. Kessler, S. Gail Eckhardt, Mark L. Laudenslager, Daniel W. Bowles & Sharon Hecker

  3. Department of Biostatistics and Informatics, Colorado School of Public Health, Aurora, CO, USA

    Diane L. Fairclough

  4. Department of Psychiatry, University of Colorado School of Medicine, Aurora, CO, USA

    Mark L. Laudenslager

  5. Department of Psychology, University of Colorado Denver, Denver, CO, USA

    Kristin Kilbourn

  6. Department of Psychology, University of California, Berkeley, CA, USA

    Iris B. Mauss

  7. Division of General Internal Medicine, Department of Medicine, University of Colorado School of Medicine, Aurora, CO, USA

    Jean S. Kutner

  8. Colorado Health Outcomes Program, University of Colorado Anschutz Medical Campus, Aurora, CO, USA

    Angela Moss

Authors
  1. Elizabeth R. Kessler
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  2. Angela Moss
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  3. S. Gail Eckhardt
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  4. Mark L. Laudenslager
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  5. Kristin Kilbourn
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  6. Iris B. Mauss
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  7. Daniel W. Bowles
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  8. Sharon Hecker
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  9. Diane L. Fairclough
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  10. Jean S. Kutner
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Corresponding author

Correspondence to Elizabeth R. Kessler.

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Kessler, E.R., Moss, A., Eckhardt, S.G. et al. Distress among caregivers of phase I trial participants: a cross-sectional study. Support Care Cancer 22, 3331–3340 (2014). https://doi.org/10.1007/s00520-014-2380-3

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  • DOI: https://doi.org/10.1007/s00520-014-2380-3

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