小原 泉

Clinical nurses need learning programs that are useful in nursing support for patients' decision-making (NSPDM) regarding cancer clinical trials (CCTs). The usefulness of the learning program can be evaluated if the practices of NSPDM before and after participation in the learning program can be compared. We developed a scale to measure the level of self-assessed NSPDM regarding participation in a CCT. Thirty-two items of scale were developed in Japanese based on previous literature. Based on the results of a pilot study, items with similar meanings were removed and the validity of the 26 scale items was statistically examined in terms of construct validity and reliability. The study population was clinical nurses and included clinical research nurses. We received 102 valid responses from clinical nurses. Based on the bias of the boxplot distribution and the ceiling and floor effects for the items analysis of the 26-item draft scale, 17 items remained. Exploratory factor analysis (EFA) revealed that the scale consisted of three subscales and 17 items. Regarding fit indices of the model, the goodness-of-fit index (GFI), adjusted GFI (AGFI), comparative fit index (CFI), and root mean square error of application (RMSEA) were 0.775, 0.704, 0.477, and 0.081, respectively. The Cronbach's alpha coefficient for the overall scale was 0.951, with subscales ranging from 0.820 to 0.942. The validity and reliability of this scale were acceptable. This scale may be helpful to evaluate the usefulness of learning programs, i.e., the practice level of NSPDM.

OBJECTIVES: Patients often struggle with their financial situation during cancer treatment due to treatment-related costs or loss of income. This resulting negative effect is called financial toxicity, which is a known as a side effect of cancer care. This study aimed to evaluate the association between financial toxicity and health-related quality of life among patients with gynecologic cancer using validated questionnaires. METHODS: In this multicenter study, patients with gynecologic cancer receiving anti-cancer drug treatment for > 2 months were recruited. Patients answered the COmprehensive Score for Financial Toxicity (COST) tool, EORTC-QLQ-C30, disease-specific tools (EORTC-QLQ-OV28/CX24/EN24), and EQ-5D-5L. Spearman's rank correlation coefficient was used to determine associations. RESULTS: Between April 2019 and July 2021, 109 cancer patients completed the COST questionnaire. The mean COST score was 19.82. Strong associations were observed between financial difficulty (r = - 0.616) in the EORTC-QLQ-C30 and body image (r = 0.738) in the EORTC-QLQ-CX24, while weak associations were noted between the global health status/quality of life (r = 0.207), EQ-5D-5L index score (r = 0.252), and several function and symptom scale scores with the COST score. CONCLUSIONS: Greater financial toxicity was associated with worse health-related quality of life scores, such as financial difficulty in gynecologic cancer patients and body image in cervical cancer patients as strong associations, and weakly associated with general health-related quality of life scores and several function/symptom scales.

OBJECTIVE: Financial toxicity is a financial burden of cancer care itself, which leads to worse quality of life and higher mortality and is considered an adverse effect. The COmprehensive Score for financial Toxicity (COST) tool is a patient-reported outcome measurement used to evaluate financial toxicity. We aimed to validate the internal consistency and reproducibility of the COST tool in patients with gynecologic cancer. METHODS: In this multicenter study covering the period April 2019 to July 2021, using the COST tool in Japan, patients diagnosed with ovarian, cervical, or endometrial cancer receiving systemic anti-cancer drug therapy for more than 2 months were eligible. Patients with no out-of-pocket costs for direct medical costs were excluded. The patients answered the initial test and a retest, which was completed from 2 to 14 days after the initial test. Internal consistency and reproducibility were assessed using Cronbach's alpha and intraclass correlation coefficient (ICC), respectively. Cronbach's alpha ≥0.8 indicates good internal consistency, and ICC ≥0.8 is highly reliable. RESULTS: A total of 112 patients (ovarian: 50, cervical: 26, endometrial: 36) responded to the initial test, and 89 patients answered the retest from 2 to 14 days after the initial test. The median patient age was 58 (range, 28-78) years. The median COST score was 19. Cronbach's alpha showed good internal consistency at 0.83 (95% CI 0.78 to 0.87). The ICC at 0.850 (95% CI 0.777 to 0.900) showed high reliability. CONCLUSIONS: The COST tool has good internal consistency and reliable reproducibility in patients with gynecologic cancer in Japan. The COST tool quantifies financial toxicity in the insurance system, where patients have limited out-of-pocket direct medical costs. The results support the use of the COST tool in patients with gynecologic cancer.

目的:看護学生の生活行動と生活体験の特徴を明らかにし,看護教育の示唆を得る。方法:看護学部3年生を対象に独自に作成した調査票を配布し,得られた回答を解析した。結果:有効回答数は58名で,親元を離れている学生が55.2%であった。生活行動では,食事の支度や自室の掃除,洗濯をするのは親元を離れている学生で有意に多かった。換気,手洗い,テーブル拭き,入浴の際の湯温確認を行わない学生は3割以上いた。生活体験では,入学前に高齢者と同居経験がある学生は44.8%で,高齢者の世話の経験が有意に多かった。病人の世話の経験がある学生は41.4%だった。結論:学生の生活体験は一概に乏しいとは言えないが,高齢者や病人と入学前に関わった経験は多くなく,望ましい生活行動に関する既習知識は学生自身の日常生活で実践できていない。学生の生活行動や生活体験を理解することは,看護の対象の理解や実践方法を教授する上で有用である。(著者抄録)

目的:看護学生の生活行動と生活体験の特徴を明らかにし,看護教育の示唆を得る。方法:看護学部3年生を対象に独自に作成した調査票を配布し,得られた回答を解析した。結果:有効回答数は58名で,親元を離れている学生が55.2%であった。生活行動では,食事の支度や自室の掃除,洗濯をするのは親元を離れている学生で有意に多かった。換気,手洗い,テーブル拭き,入浴の際の湯温確認を行わない学生は3割以上いた。生活体験では,入学前に高齢者と同居経験がある学生は44.8%で,高齢者の世話の経験が有意に多かった。病人の世話の経験がある学生は41.4%だった。結論:学生の生活体験は一概に乏しいとは言えないが,高齢者や病人と入学前に関わった経験は多くなく,望ましい生活行動に関する既習知識は学生自身の日常生活で実践できていない。学生の生活行動や生活体験を理解することは,看護の対象の理解や実践方法を教授する上で有用である。(著者抄録)

臨床研究コーディネーター(CRC)の技能の熟達度と経験年数の関連を調査した。CRCの技能の熟達度は、研究者らが開発したCRC熟達度評価尺度を用いて測定した。回答者数1245名のうち、経験年数と熟達度評価尺度の全設問に回答した974名(78.2%)を解析対象者とし、経験1年目、2〜3年目、4〜5年目、6〜10年目、11年目以上の5群に対象者を分類した。熟達度評価尺度の四つの下位尺度である「知識」「基本技術」「管理技術」「態度」の一元配置分散分析結果では、四つの下位尺度のいずれについても経験年数別5群の平均値に差が認められた。経験年数別5群の中で平均値の差の多重比較を行った結果、「知識」については、2〜3年目と4〜5年目の間で有意差を認めなかった。「基本技術」については、6〜10年目と11年目以上の問で有意差を認めなかった。「管理技術」については、いずれの群間においても有意差が認められた。「態度」については、1年目と2〜3年目および4〜5年目、2〜3年目と4〜5年目、6〜10年目と11年目以上の間で有意差を認めなかった。経験年数と四つの下位尺度との間のPearsonの相関係数は、「知識」とはr=0.529、「基本技術」とはr=0.587、「管理技術」とはr=0.586、「態度」とはr=0.220で、いずれも1%水準で有意であった。

臨床研究コーディネーター(CRC)の技能の熟達度を評価する尺度の開発を試みた。CRC熟達度評価尺度の開発にあたり、尺度の信頼性について安定性は再テスト法、一貫性はクロンバックα係数より検討した。尺度の妥当性は内容的妥当性の確認後、探索的因子分析および確証的因子分析により検討した。再テスト法による級内相関係数は尺度全体で0.937であった。探索的因子分析にて第1因子を「知識」、第2因子を「態度」、第3因子を「管理技術」、第4因子を「基本技術」としたところ、尺度全体のクロンバックα係数は0.984、各因子では第1因子から順に0.979、0.968、0.964、0.943であった。確証的因子分析では、各因子に含まれた項目の標準化推定値は「知識」に含まれる38項目で0.59〜0.82、「態度」の25項目で0.60〜0.87、「管理技術」の17項目で0.64〜0.90、「基本技術」の10項目で0.69〜0.89であった。因子間相関は正の相関が得られた。CRC熟達度評価点平均値は、全項目平均で3.5点、「知識」3.3点、「基本技術」4.0点、「管理技術」3.3点、「態度」3.8点であった。

目的:本研究の目的は,看護学生の生活行動,生活体験および学習態度を明らかにすることである。方法;A大学看護学部3年生を対象に独自に作成した質問紙と既存の大学生調査票を用いた自記式調査を実施し,記述統計を行った。結果:26名の生活行動は,食事前の手洗いありが50%,入浴あるいはシャワーの際の湯温確認は61.5%に認められた。自動水洗トイレの住宅への居住経験ありは57.7%,湯の保温機能つきの風呂の住宅への居住経験ありが76.9%であった。学習行動の第1位は図書館の利用であったが,高校と大学での勉強や学習の仕方の違いに戸惑った,授業についていけなかった,という回答も上位10位以内に含まれていた。結論:一概に学生の生活体験が乏しいとはいえないが,利便性の高い生活環境で育った背景やグループ学習やインターネット利用といったこの世代の学生が好む学習スタイルを理解し,効果的な教授方法を開発することが求められる。(著者抄録)

ケアリングの様子を明らかにするために半構造的インタビュー調査を実施した。A施設およびB施設で一般病棟での勤務経験を経て、緩和ケア病棟に現在勤務中の緩和ケア病棟の経験が3年目以上で、終末期の若年性がん患者のプライマリーナースとしての経験がある看護師4名を対象とした。インタビュー内容を録音し、逐語録を作成し、分析を行った結果、終末期の若年性がん患者に対する緩和ケア病棟看護師のケアリングの本質的意味として108個が得られ、サブテーマ37個、テーマ17個、「若くして亡くなる不条理に対峙できない壁を感じ取る」「役に立ちたい思いで精一杯の手を尽くす」「心を開いて歩み寄り世代の近い者同士の関わりを積み重ねていく」「どんなに辛くても真摯に生きぬく力強さに惹きつけられる」「残された時間の中にある日常を尊ぶ」「悲しみを噛みしめながら普段通りの自分で向き合い続ける」などの、本質的要素が抽出できた。

Purpose/Objectives: To reveal the decision-making process in patients considering participation in cancer phase I clinical trials. Design: Grounded theory approach. Setting: Cancer center in a metropolitan area of Tokyo, Japan. Participants: 25 patients with cancer, including individuals who ultimately declined to participate in a phase I trial. Methodologic Approach: Semistructured interviews and unstructured observations were conducted. Main Research Variables: Patients' decision-making process and influencing factors. Findings: The core category of patients' decision-making process was searching for a way to live to the end. The process consisted of four phases: only waiting for death to come if nothing is done, assessing the value of the phase I trial, finding decisive factors, and reminding oneself that this is the right decision. Factors influencing the process included patients' perceptions of physicians' explanations of the phase I trial, patients' perceptions of their families' attitudes toward the phase I trial, patients' experiences with past anticancer therapies, and patients' attitudes toward living with cancer. Conclusions: Patient decision-making is a challenging process associated with issues about how to live at the end of life. The pattern of searching for a way to live to the end differed depending on the levels of the four factors that influenced patients' decision-making process. Implications for Nursing: Nurses play pivotal roles in talking to patients about phase I trials, discussing what is important for the rest of their lives, and recognizing that patients made a satisfying decision for themselves.

Factor that complicate or aid substitute voice acquisition in older laryngectomee were investigated. 170 patients from a group of patients who underwent laryngectomy during the last three years in Tokyo served as subjects. The following items were analyzed: age, type of surgery, therapy (outpatient), participation in esophageal speech class, substitute voice acquisition, general health, restricted daily living activity, assistance from patients group, and self-esteem. Approximately 30% of the patients acquired a substitute voice and were able to use it in their social life, and more than 60% of patients over 70 years-old quit attending classes. These patients experienced difficulty in communicating with their family members. Furthermore, the health of patients over 65 years-old who quit attending classes was poor. The sense of restricted daily living activity was especially high for quit attending classes due to factors such as, limited range of movement and stress from eating. It was thought that these are the factors that determine whether or not older patients attend voice classes. Results of the present study suggest that it would be necessary to provide a voice rehabilitation program that is based on assessment by a medical team soon after surgery to minimize risks for each patients, and to establish an assistance system in which both medical professionals and patients group work together.