Department of Oncology, Hospital Unit West Jutland, Herning, Denmark
AmbuFlex, Occupational Medicine, University Research Clinic, Aarhus University, Hospital Unit West Jutland, Herning, Denmark.
BMJ Open. 2020 Jun 17;10(6):e035673. doi: 10.1136/bmjopen-2019-035673.
To design an electronic questionnaire for symptom monitoring and to evaluate the feasibility, usability and acceptability when applied to patients with metastatic lung cancer.
Single-centre feasibility study.
Patients with stage IV lung cancer in antineoplastic treatment.
This study describes the first three phases of a complex intervention design: phase 1, development of the intervention; phase 2, feasibility testing and phase 3, evaluation of the intervention. In phase 1, items were selected for the questionnaire and adjusted following patient interviews. In phase 2, patients completed the electronic questionnaire weekly during a 3-week feasibility test. In case of symptom deterioration, a nurse was notified with the aim to contact the patient. In phase 3, patients evaluated phase 2 by paper questionnaires, and interviews were conducted with the participating nurses.
The study outcomes: phase 1, usability and relevance; phase 2, recruitment rate, compliance and threshold functionality and phase 3, usability, acceptability and relevance.
In phase 1, a questionnaire was designed and reviewed by patients (n=8). The interviews revealed high usability and relevance of the intervention.For phases 2 and 3, 20 of 29 approached patients (69%) responded to the questionnaire on a weekly basis. Two patients did not complete any questionnaires (compliance 90%). The remaining 18 patients completed 65 of a total of 72 possible questionnaires (7 missed, 93% completed). Reported symptoms led to a phone call from a nurse in 30% of the responses.The patients reported high usability and acceptability of questionnaire and software. The substance of the telephonic conversations was relevant, and the study set-up was logistically acceptable.
An electronic questionnaire designed for symptom monitoring revealed high usability, acceptability and relevance in the target population. In conclusion, the study set-up was considered feasible for a randomised controlled trial.
NCT03529851.
设计用于症状监测的电子问卷，并评估其在转移性肺癌患者中的可行性、可用性和可接受性。
单中心可行性研究。
接受抗肿瘤治疗的 IV 期肺癌患者。
本研究描述了一项复杂干预设计的前三个阶段：第 1 阶段，干预措施的制定；第 2 阶段，可行性测试；第 3 阶段，干预措施的评估。在第 1 阶段，选择问卷项目并根据患者访谈进行调整。在第 2 阶段，患者在 3 周的可行性测试中每周完成电子问卷。如果症状恶化，护士会收到通知，目的是联系患者。在第 3 阶段，患者通过纸质问卷评估第 2 阶段，并对参与的护士进行访谈。
研究结果：第 1 阶段，可用性和相关性；第 2 阶段，招募率、依从性和功能阈值；第 3 阶段，可用性、可接受性和相关性。
在第 1 阶段，设计并由患者（n=8）审查了一份问卷。访谈显示干预措施具有较高的可用性和相关性。对于第 2 阶段和第 3 阶段，29 名受邀患者中有 20 名（69%）每周回复问卷。有 2 名患者未完成任何问卷（依从性为 90%）。其余 18 名患者完成了总共 72 份问卷中的 65 份（漏答 7 份，完成率为 93%）。报告的症状导致护士回电 30%的回复。患者报告了问卷和软件的高可用性和可接受性。电话交谈的内容具有相关性，研究设置在后勤上是可以接受的。
为症状监测设计的电子问卷在目标人群中显示出较高的可用性、可接受性和相关性。总之，研究设置被认为对于随机对照试验是可行的。
NCT03529851。
