NCT06902883

Brief Summary

In 2006, 2012, and 2018, under the auspices of the Pain Control Committee, Gustave Roussy stretcher-bearers conducted studies on patient pain caused by internal transport (stretchers). The first study showed that this pain is primarily experienced by patients initially in pain, and that risk factors include crossing elevator landings and threshold bars, handling, and prolonged waiting times. A progress plan was developed, and since 2006, improvement initiatives have been regularly implemented. Their effectiveness has been evaluated by patients and the professionals involved (departure department, carrier, and arrival department). Stretcher-bearing software was purchased following the original study; scheduling has been streamlined, journeys are transmitted to stretcher-bearers via smartphones, and transport times are calculated and analyzed. In 2019, a prototype for connecting patients' IV poles to wheelchairs was developed and tested, thanks to a collaboration between technical services, stretcher-bearers, and the Bureau of Biostatistics and Epidemiology. The time spent by stretcher-bearers transferring infusion sets and other syringe pumps from the patient's IV pole to the wheelchair's pole on the way out, and vice versa on the way back to the room, has been eliminated. The hypothesis is that this elimination would reduce travel times and could have an indirect impact on reducing pain. Wheelchair comfort has been continually improved since 2006: the front casters were replaced with softer and thicker ones, the rear wheels with soft wheels and then with pneumatic tires; the backrests were replaced with a memory foam model, and the seats with an "ultra-comfort" model. These improvements contribute to better pain management during transport and an improved patient experience. Wheelchair comfort could be further improved by replacing the seats with high-quality "Bultex" models. In 2022, 33,800 patients were transported in wheelchairs (round trip, one-way or one-way), representing 35% of annual transports. Technical developments and improvements in wheelchair comfort could contribute to reducing pain caused by internal transport. Primary Objective To evaluate the effect of two interventions (a system for connecting the IV pole to the wheelchair and a new seat) during the internal transport of cancer patients being treated at Gustave Roussy: Intervention 1: To evaluate the impact of using the IV pole connection system on reducing the duration of wheelchair transport for patients receiving infusions; Intervention 2: To evaluate patient preference for the comfort of a wheelchair seat. Secondary Objective To evaluate pain in transported patients (before/after)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
154

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2025

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

June 16, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2025

Completed
Last Updated

September 4, 2025

Status Verified

September 1, 2025

Enrollment Period

2 months

First QC Date

March 24, 2025

Last Update Submit

September 3, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Period of transportation

    Unit of measurement: minute

    1 day

  • Comfort of the wheelchair

    Comfort of the wheelchair evaluated according to satisfaction scale from 0 (uncomfortable) to 10 (very comfortable)

    1 day

Study Arms (2)

Wheelchair test 1

EXPERIMENTAL

Patient will test experimental wheelchair during outward journey and standard wheelchair during return journey

Device: Serum holder connected to the wheelchairDevice: wheelchair seat

Wheelchair test 2

EXPERIMENTAL

Patient will test standard wheelchair during outward journey and experimental wheelchair during return journey

Device: Serum holder connected to the wheelchairDevice: wheelchair seat

Interventions

Serum holder connected to the wheelchair

Wheelchair test 1Wheelchair test 2

wheelchair seat

Wheelchair test 1Wheelchair test 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed patient and signed informed consent
  • Age equal or greater than 18
  • Speak and read french
  • For serum holder connected to wheelchair only : patients with multiple infusion devices and transported in wheelchair
  • For wheelchair seat : patients transported in wheelchair from hospitalized unit to radiology department

You may not qualify if:

  • disoriented or confused patient
  • Patients under judicial protection (curatorship, tutorship) and/or deprived of freedom
  • pregnant or breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gustave Roussy

Villejuif, 94800, France

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2025

First Posted

March 30, 2025

Study Start

June 16, 2025

Primary Completion

August 19, 2025

Study Completion

August 19, 2025

Last Updated

September 4, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations