Study on the Effectiveness and Comfort of Innovative Solutions for the Internal Transport of Patients in Wheelchairs in a Hospital Setting (PreDoPTI)

September 3, 2025 updated by: Gustave Roussy, Cancer Campus, Grand Paris

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
154

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Villejuif, France, 94800
        • Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Wheelchair test 1
Patient will test experimental wheelchair during outward journey and standard wheelchair during return journey
Device: Serum holder connected to the wheelchair
Serum holder connected to the wheelchair
Device: wheelchair seat
wheelchair seat
Experimental: Wheelchair test 2
Patient will test standard wheelchair during outward journey and experimental wheelchair during return journey
Device: Serum holder connected to the wheelchair
Serum holder connected to the wheelchair
Device: wheelchair seat
wheelchair seat

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Period of transportation
Time Frame: 1 day
Unit of measurement: minute
1 day
Comfort of the wheelchair
Time Frame: 1 day
Comfort of the wheelchair evaluated according to satisfaction scale from 0 (uncomfortable) to 10 (very comfortable)
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 16, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 19, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 19, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-A00077-40/1
  • 2024/3801 (Other Identifier: CSET number (Gustave Roussy ID))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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