抗がん剤臨床試験の経過に伴う患者の体験と看護支援の検討

Experience of Patients during the Process of Cancer Clinical Trials and Nursing Care

要旨

　本研究の目的は，抗がん剤臨床試験の経過に伴う患者の体験を明らかにし，求められる看護示唆を得ることである．第1相または第2相の抗がん剤臨床試験に初めて参加する患者7名を対象として，臨床試験開始前から終了時における体験について半構成的面接調査を行った．得られたデータは現象学的に分析した．

　分析の結果抽出された29のテーマは，臨床試験の経過に伴い2つの時期に分けられた．

　＜臨床試験の説明前から意思決定までの体験＞は，対象者は，がんの診断や進行による衝撃の体験を経て，何もしなければ死という現実に追い詰められていた．＜臨床試験の導入から終了までの体験＞は，対象者は臨床試験の負担に困惑し継続をためらいながらも，自分にはこれしかないと奮起していた．そして，常に転移やがんの進行の恐怖に囚われながら，臨床試験による制約に責務として従っていた．また，臨床試験が中止となった対象者は，がんの進行に慌てふためき突然のことに戸惑っていた．

　看護師は，進行期のがん患者が，これしかない臨床試験に参加するという脆弱性を十分に考慮して積極的に負担の軽減に努めるとともに，臨床試験の結果にかかわらず患者の生き方を支え続けることが必要である．

Abstract

　This study aimed to clarify how patients go through cancer clinical trials and to identify nursing interventions to support cancer patients. This study investigated seven advanced cancer patients who participated for the first time in phase 1 or 2 of clinical trials of anticancer drugs. Semi-structured interviews were used to collect data on the experiences of participants from trial recruitment to trial completion. These data were analyzed using the phenomenological methods of A. Giorgi. The 29 themes that emerged from the analysis according to the clinical trial process were divided into two periods. The first period is"Patients' experience of trial recruitment up to decision-making."During this period, participants faced the fear of death if they were not participating in a cancer clinical trail, by experiencing the impact of cancer diagnosis and disease progression. The second period is "Patients' experience in the cancer clinical trial from the beginning to the end."In this period, the fear of death spurred participants to continue the trial as a duty even though the burden of the clinical trial caught them in a dilemma. Moreover, participants were frustrated and perplexed when the trial was suddenly stopped unexpectedly. The results suggest the need for nurses to be aware of the fear that makes advanced cancer patients vulnerable and the need to reduce their burden in order to continue a clinical trial. The results also show the importance of nurses providing support for cancer patients regardless of the outcome of clinical trials.