自我管理效能感与情绪对抗肿瘤药物临床试验受试者依从性影响研究

    Effects of self-care self-efficacy and emotion on the compliance of subjects in clinical trials of antitumor drugs

    • 摘要:
      目的调查抗肿瘤药物临床试验中自我管理效能感和情绪状态现状,并分析其对受试者治疗依从性的影响。
      方法采取随机抽样法,选取2020年在我院参加抗肿瘤药物临床试验的受试者110例为研究对象。采用一般资料调查问卷、中文版癌症自我管理效能感量表和正性负性情绪量表对受试者自我管理效能感和正性、负性情绪水平进行调查,并随访观察受试者试验依从情况。
      结果抗肿瘤药物临床试验受试者自我管理效能感总分为(81.86±18.73)分,正性情绪得分为(26.14±5.54)分,负性情绪得分为(24.45±6.95)分;不同自我管理效能水平受试者依从性存在差异具有统计学意义(P < 0.01);不同正性情绪水平的受试者依从率和不同负性情绪水平的受试者依从率差异均有统计学意义(P < 0.01和P < 0.05);二元logistic回归分析发现,自我效能水平越高,受试者依从性越好(P < 0.01)。
      结论在抗肿瘤药物临床试验中,受试者的自我管理效能感和情绪状态影响受试者的治疗依从性,临床试验人员可根据受试者具体情况对其自我管理效能感和情绪状态进行评估和有效干预,提高其在临床试验中的依从性,保证临床试验质量。

       

      Abstract:
      ObjectiveTo investigate the current situation of self-care self-efficacy and emotional state in clinical trials of antitumor drugs, and analyse its impact on the treatment compliance of subjects, so as to provide reference basis for the management of subjects in clinical trials of antitumor drugs.
      MethodsUsing the convenient sampling method, a total of 110 eligible subjects participating in clinical trials of antitumor drugs in our hospital from January 2020 to December 2020 were selected.The general information questionnaire, Chinese version of the strategies used by people to promote health, and positive and negative affect scale were used to determine the self-care self-efficacy and emotional state, respectively.The subjects' compliance was followed up.
      ResultsSubjects had a self-care self-efficacy total score of(81.86±18.73) points, positive mood score of(26.14±5.54) points, and negative mood score of(24.45±6.95) points.There were significant differences in the compliance rate among subjects with different levels of self-care self-efficacy(P < 0.01).There were significant differences in the compliance rate of subjects with different positive emotion levels(P < 0.01) and the compliance rate of subjects with different negative emotion levels(P < 0.05).Binary logistic regression analysis showed that the higher the level of self-care self-efficacy, the better the subjects' compliance(P < 0.01).
      ConclusionsIn clinical trials of antitumor drugs, subjects' self-care self-efficacy and emotional state affect their treatment compliance.According to subjects' specific conditions, the clinical trial personnel should evaluate and effectively intervene the subjects' self-care self-efficacy and emotional state, so as to improve their compliance in the clinical trial, and ensure the smooth progress of the clinical trial.

       

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