Preferences and Perspectives on Supine vs. Upright Positioning in Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Mean difference in comfort scores (upright minus supine), Likert scale, collected immediately post-positioning
研究概览
简要总结
This is a single-center, non-therapeutic prospective pilot cohort study evaluating patient-reported comfort levels between upright and supine positioning in patients receiving radiation therapy across all age groups using a concurrent mixed-methods design.
Following standard-of-care RT planning or delivery in the conventional supine position, patients and caregivers will complete a questionnaire evaluating the current treatment position. Patients will then be positioned upright in a chair, using similar immobilization to their supine setup when feasible. This position will be maintained for up to 15 minutes, as tolerated by the patient. During the upright positioning session, patients and caregivers will be asked open-ended questions exploring their perceptions of comfort, stability, and overall experience with the upright chair. No radiation or therapeutic intervention will be delivered during the upright session; the upright positioning procedure is non-therapeutic and conducted solely for assessment purposes. Patients and their caregivers will again be asked to complete a questionnaire evaluating the upright position.
Key stakeholders involved in RT (including Radiation Therapists, Registered Nurses, Radiation Oncologists, or Medical Physicists), will participate in one semi-structured interview to explore perspectives on supine versus upright positioning for RT. Each interview will take up to 60 minutes and will be conducted in-person or virtual using UHN's Microsoft Teams. All sessions will be audio recorded and transcribed on the UHN Microsoft cloud, which is encrypted and stored securely.
详细描述
This is a mixed methods concurrent study design. Feedback will be collected from multiple participant groups as part of both the quantitative and qualitative components of the study.
Quantitative Component Patients: Participants will provide feedback, rank preferences, and compare their experiences between supine and upright positioning, focusing on comfort, anxiety, overall acceptability, and demographic information.
Caregivers: Caregivers will report their observations and preferences regarding both positioning approaches, including perceived comfort and distress levels.
Qualitative Component Patients: During the upright positioning session (the study intervention), patients will be asked open-ended questions exploring their perceptions of comfort, stability, and overall experience.
Key Stakeholders: Radiation Therapists, Registered Nurses, Radiation Oncologists, and Medical Physicists will participate in semi-structured interviews to share their perspectives on the feasibility and implementation of upright versus supine positioning.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric and adult patients aged 3 years and older, undergoing radiation therapy as part of standard clinical care.
- •Lansky or Karnofsky score 40 or greater
- •Ability to provide informed consent (or if appropriate, provided by parent or legal guardian).
- •Ability to understand and speak English or with appropriate assistance
排除标准
- 未提供
研究组 & 干预措施
Patients
Patients undergoing RT (as part of routine clinical care) who are in stable clinical condition.
干预措施: Upright positioning chair (Device)
Caregivers
Caregivers of the patients undergoing RT (when applicable).
Key Stakeholders
Key stakeholders involved in radiation therapy (including Radiation Therapists, Registered Nurses, Radiation Oncologists, and Medical Physicists).
结局指标
主要结局
Mean difference in comfort scores (upright minus supine), Likert scale, collected immediately post-positioning
时间窗: 24 months.
The primary analysis will focus on within-subject comparisons of patient reported data from the questionnaire between supine and upright positioning. Ranking preference will be reported descriptively. Inferential statistics will be used to compare continuous and categorical outcomes (including paired t-tests, Wilcoxon signed-rank tests).
次要结局
- - Proportion preferring upright positioning(24 months.)
- Setup time(24 months)
- Age-stratified exploratory comfort/preference patterns(24 months)
- Proportion of participants with disabilities preferring upright positioning(24 months)
- Rate completing both positions without interruptions(24 months)
- Key themes from patient/caregiver/radiation therapy key stakeholder interviews (qualitative)(24 months)
- Mixed methods meta-integration: concordance of quantitative and qualitative acceptability/feasibility(24 months)