NCT07765069

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
14mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 14, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Last Updated

August 14, 2026

Status Verified

August 1, 2026

Enrollment Period

1.2 years

First QC Date

June 9, 2026

Last Update Submit

August 12, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

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

    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).

    24 months.

Secondary Outcomes (7)

  • - 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

  • +2 more secondary outcomes

Study Arms (3)

Patients

Patients undergoing RT (as part of routine clinical care) who are in stable clinical condition.

Device: Upright positioning chair

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).

Interventions

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.

Patients

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing RT (as part of routine clinical care) who are in stable clinical condition.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Yat Tsang, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2026

First Posted

August 14, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

November 30, 2027

Last Updated

August 14, 2026

Record last verified: 2026-08

Locations