The Impact of Supervision by a Health Care Professional on Quality of Life (QoL) Questionnaire Scoring and Completion:, Randomized, Cross-over Study in Cancer Patients Receiving Systemic Antineoplastic Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- EORTC QLQ-C30
研究概览
简要总结
Effect of supervision on scoring and completion on Quality of Life Questionnaire
详细描述
This protocol will study the impact of supervision on completion and scoring of sensitives domains of QoL Questionnaires and QoL Questionnaires in general in a multi-center, randomized, cross-over design in cancer patients receiving systemic antineoplastic therapy
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is ≥18 years of age and legally competent
- •Signed informed consent available
- •Systemic oncologic treatment (e.g. chemotherapy, immunotherapy, endocrine therapy)
- •Current systemic therapy started at least 4 weeks before randomization and is scheduled to continue for at least another 4 weeks after randomization in the same dose and interval
- •Patient is ready and able to complete quality of life questionnaires in German (on paper
排除标准
- •One or more of the inclusion criteria not met.
结局指标
主要结局
EORTC QLQ-C30
时间窗: 2024-2026
To study the impact of Health Care Professional supervision on scoring patterns on financially- and sexuality related questions by cancer patients receiving systemic antineoplastic therapy, compared to self-administered electronic completion at home. The null-hypothesis is tested that the method of administration does not influence patients' answers.
EORTC QLQ-SH22
时间窗: 2024-2026
To study the impact of Health Care Professional supervision on scoring patterns on financially- and sexuality related questions by cancer patients receiving systemic antineoplastic therapy, compared to self-administered electronic completion at home. The null-hypothesis is tested that the method of administration does not influence patients' answers.
Questionnaire called "Financial consequences" routinely used by the Social department of St. ClaraSpital
时间窗: 2024-2026
To study the impact of Health Care Professional supervision on scoring patterns on financially- and sexuality related questions by cancer patients receiving systemic antineoplastic therapy, compared to self-administered electronic completion at home. The null-hypothesis is tested that the method of administration does not influence patients' answers.
次要结局
- Incidence of reported sexual problems(2024-2026)
- Patient preference(2024-2026)
- Time(2024-2026)
研究者
Diana de Jong
Principal Investigator
St. Claraspital AG