Cancer
Conditions
Brief summary
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.
Detailed description
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. A description of the measures taken to minimize/avoid bias. To minimize bias in the study, the following measures will be implemented: 1. Study participants and caregivers (if applicable) will complete standardized feedback tools for consistency. 2. During the upright positioning session (study intervention), investigators will follow a scripted set of open-ended questions to explore patient perceptions. 3. For semi-structured interviews, investigators will use neutral language and encourage equal participation among all interviewees. A description of the trial treatment(s)/ intervention Patient participants will undergo the study intervention following a regularly scheduled radiation treatment. This involves being positioned upright in a chair using immobilization similar to their treatment setup, where feasible. No radiation or therapeutic procedures will be administered during the upright positioning session, which involves sitting in a chair for up to 15 minutes, as tolerated. There is no further study-related follow-up visit. Data collection from patients and caregivers will be completed on the same day as the positioning sessions. Key stakeholders including Radiation Therapists, Registered Nurses, Radiation Oncologists, or Medical Physicists will participate in a semi-structured interview to explore perspectives on supine versus upright positioning for RT.
Interventions
DEVICEUpright positioning chair
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.
Sponsors
University Health Network, Toronto
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Pediatric and adult patients aged 3 years and older, undergoing radiation therapy as part of standard clinical care. 2. Lansky or Karnofsky score 40 or greater 3. Ability to provide informed consent (or if appropriate, provided by parent or legal guardian). 4. Ability to understand and speak English or with appropriate assistance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean difference in comfort scores (upright minus supine), Likert scale, collected immediately post-positioning | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| - 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 | Exploratory subgroup analysis of participants with disabilities. Positioning preference will be assessed using the study questionnaire. |
| Rate completing both positions without interruptions | 24 months | — |
| Key themes from patient/caregiver/radiation therapy key stakeholder interviews (qualitative) | 24 months | A total of 12 key stakeholders will be enrolled in the qualitative study. There will be semi-structured interviews conducted with each stakeholder group, including Radiation Therapists, Registered Nurses, Radiation Oncologists, or Medical Physicists. There will be approximately one to three stakeholders in each interview. |
| Mixed methods meta-integration: concordance of quantitative and qualitative acceptability/feasibility | 24 months | The open-ended questions and the transcripts from the semi-structure interviews with the key stakeholders will undergo Braun and Clark's six steps of thematic analysis. Inductive coding will be done to generate themes and patterns using NVivo v.15. Additionally, a second coder will validate. The transcripts will undergo a thorough review, and codes will be sorted and re-evaluated to identify themes related to the perspectives of supine versus upright positioning feasibility and implementation for radiation therapy. |
Countries
Canada
Contacts
CONTACTYat Tsang, PhD
Outcome results
None listed