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How did partners experience cancer patients' participation in a phase I study? An observational study after a patient's death

Published online by Cambridge University Press:  17 December 2015

Simone M.C.H. Langenberg ,
Marlies E.W.J. Peters ,
Winette T.A. van der Graaf ,
Anke N. Machteld Wymenga ,
Judith B. Prins  and
Carla M.L. van Herpen
Simone M.C.H. Langenberg*
Affiliation:
Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands
Marlies E.W.J. Peters
Affiliation:
Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands
Winette T.A. van der Graaf
Affiliation:
Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands
Anke N. Machteld Wymenga
Affiliation:
Department of Medical Oncology, Medisch Spectrum Twente, Enschede, The Netherlands
Judith B. Prins
Affiliation:
Department of Medical Psychology, Radboud University Medical Center, Nijmegen, The Netherlands
Carla M.L. van Herpen
Affiliation:
Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands
*
Address correspondence and reprint requests to: Simone Langenberg, Department of Medical Oncology, Radboud University Medical Center, P.O. Box 9101, Route 452, 6500 HB Nijmegen, The Netherlands. E-mail: [email protected].
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Abstract

Objective:

It can be assumed that patients' participation in a phase I study will have an important impact on their partners' life. However, evaluation of partners' experiences while patients are undergoing experimental treatment and of their well-being after the patient's death is lacking. We aimed to explore partners' experience of patients' participation in phase I studies and to investigate their well-being after a patient's death.

Method:

This was an observational study conducted after the patient's death. Partners of deceased patients who had participated in a phase I study completed a questionnaire designed by us for experience evaluation and the Beck Depression Inventory for Primary Care, the Hospital Anxiety and Depression Scale, the Inventory of Traumatic Grief, and the RAND-36 Health Survey.

Results:

The median age of the 58 participating partners was 58 years (range: 51–65), and 67% was female. Partners reported negative effects on patients' quality of life, but only 5% of partners regretted patients' participation. Approximately two years after the patients' death, 19% of partners scored for depression, 36% for psychological distress, and 46% for complicated grief, and partners generally scored significantly lower on social and mental functioning compared to normative comparators.

Significance of Results:

Although partners reported negative consequences on patients' quality of life, most did not regret patients' participation in the phase I studies. Prevalence of depression, psychological distress, and complicated grief seemed important problems after a patient's death, and these must be considered when shaping further support for partners of patients participating in phase I trials.

Keywords

BereavementDepressionPhase I clinical trialPsychological distressSpouses
Type
Original Articles
Information
Palliative & Supportive Care , Volume 14 , Issue 3 , June 2016 , pp. 241 - 249
Copyright
Copyright © Cambridge University Press 2015 

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