• J Pain Symptom Manage · Dec 2021

    The possibility of conducting a clinical trial on palliative care: A survey of whether a clinical study on cancer dyspnea is acceptable to cancer patients and their relatives.

    • Kozue Suzuki, Tomoo Ikari, Ryo Matsunuma, Yoshinobu Matsuda, Yoshihisa Matsumoto, Satoru Miwa, Masanori Mori, Takashi Yamaguchi, Hiroaki Watanabe, and Keiko Tanaka.
    • Department of Palliative Care, Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital (K.S., K.T.), Tokyo, Japan. Electronic address: kozue-suzuki@cick.jp.
    • J Pain Symptom Manage. 2021 Dec 1; 62 (6): 1262-1272.

    ContextConducting randomized controlled trials on palliative care is difficult owing to barriers like fragility of the patients' health status and health care providers' concerns for patients. However, quality randomized controlled trials are required for care improvement.ObjectivesTo investigate the willingness of cancer patients and their relatives to participate in a clinical study on cancer dyspnea and identify feasible clinical study designs for this condition.MethodsA nationwide, cross-sectional, web-based survey was conducted with 206 cancer patients and 206 relatives of cancer patients. Their willingness to participate in clinical studies on cancer dyspnea and factors influencing this willingness were assessed in two scenarios: outpatients receiving anticancer treatment and terminally ill inpatients.ResultsAbout 23% patients and 23% relatives were willing to participate in clinical trials while 40% and 32%, respectively, were unwilling. Factors related to patient participation were quick and easy trials (outpatient 57%, terminally ill 53%) and oral medication with minimal potential side effects (outpatient 48%). Factors related to unwillingness to participate were placebo-controlled trials (outpatient 51%, terminally ill 50%), disagreements about participation between patients and families (outpatient 49%, terminally ill 49%), and continuous injections (outpatient 61%, terminally ill 47%). Compared to patients, relatives responded more reluctantly, especially for patients in terminal care. Conversely, patients were less reluctant in the terminal setting than the outpatient setting.ConclusionSome patients and relatives were reluctant to participate in clinical trials on cancer dyspnea. Thus, trials need to be minimally invasive, quick, and fully explained to and understood by patients and families.Copyright © 2021 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

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