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NCT Number: NCT07765069

Positioning in RT - Supine vs. Upright

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.

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Key information

Conditions

Age range

3 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location contact

Yat Tsang, PhD

CONTACT

[email protected]

416-946-4501 ext. 5302

Yat Tsang, PhD

PRINCIPAL_INVESTIGATOR

About this study

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:

  • Study participants and caregivers (if applicable) will complete standardized feedback tools for consistency.
  • During the upright positioning session (study intervention), investigators will follow a scripted set of open-ended questions to explore patient perceptions.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

Upright positioning chair

Device

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.

Primary outcomes

  1. Mean difference in comfort scores (upright minus supine), Likert scale, collected immediately post-positioning

    Time frame: 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 outcomes

  1. - Proportion preferring upright positioning

    Time frame: 24 months.

  2. Setup time

    Time frame: 24 months

  3. Age-stratified exploratory comfort/preference patterns

    Time frame: 24 months

  4. Proportion of participants with disabilities preferring upright positioning

    Time frame: 24 months

    Exploratory subgroup analysis of participants with disabilities. Positioning preference will be assessed using the study questionnaire.

  5. Rate completing both positions without interruptions

    Time frame: 24 months

  6. Key themes from patient/caregiver/radiation therapy key stakeholder interviews (qualitative)

    Time frame: 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.

  7. Mixed methods meta-integration: concordance of quantitative and qualitative acceptability/feasibility

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yat Tsang, PhD

CONTACT

[email protected]

416-946-4501 ext. 5302

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Preferences and Perspectives on Supine vs. Upright Positioning in Radiation Therapy

Acronym: Position in RT

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 14, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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