Evaluation of the Contribution of a DEMaterialized VIdeo-pedagogical SUpport in the Care Pathway of Lung Cancer Surgery Patients (SUVIDEM)

August 27, 2024 updated by: Assistance Publique Hopitaux De Marseille
Uni-centric, randomized, open-label, prospective interventional-comparative study, with a control arm (patients receiving standard preoperative information) and an experimental arm (patients receiving standard preoperative information and having access to a dematerialized educational video support).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

226

Phase

  • Not Applicable

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 Locations

  • France
      • Marseille, France, 13015
        • Recruiting
        • Assistance Publique Hôpitaux de Marseille - Hôpital Nord
        • Contact:
        • Principal Investigator:
          • Alex Fourdrain, Md, PhD

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged 18 or over,
  • Patients requiring surgical management:

for therapeutic purposes (in the case of proven tumor histology) or for diagnostic and therapeutic purposes (in the absence of proven histology, but strong suspicion, after validation by RCP),

- Patients who have given their consent.

Exclusion Criteria:

  • Patients under guardianship
  • Patients with a history of thoracic surgery
  • Patients on long-term analgesic medication
  • Patients who do not speak French
  • Patients unable to read or write
  • Patients with major visual impairment
  • Patients with chronic anxiety or depression at the time of admission
  • Patients under guardianship
  • Pregnant or breast-feeding 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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
Experimental: experimental
Other: video support
video support provided to the patient before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immediate pre-operative anxiety
Time Frame: 10 days
self-measurement using the HAD Scale
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative anxiety (randomization (consultation), immediate postoperative and discharge)
Time Frame: 90 days
based on HAD scale
90 days
Post-traumatic stress disorder
Time Frame: 90 days
PCL-5 scale
90 days
Quality of life evaluation
Time Frame: 90 days
European Organisation for Research and Treatment of Cancer core health- related quality of life questionnaire (QLQ-C30).
90 days
Cumulative postoperative morbidity
Time Frame: 90 days
score CCI
90 days
Intra-hospital consumption of analgesics
Time Frame: 90 days
accounting for in-hospital consumption of analgesics
90 days

Collaborators and Investigators

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

Sponsor

Assistance Publique Hopitaux De Marseille

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)

July 11, 2024

Primary Completion (Estimated)

January 11, 2026

Study Completion (Estimated)

April 11, 2026

Study Registration Dates

First Submitted

August 27, 2024

First Submitted That Met QC Criteria

August 27, 2024

First Posted (Actual)

August 29, 2024

Study Record Updates

Last Update Posted (Actual)

August 29, 2024

Last Update Submitted That Met QC Criteria

August 27, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCAPHM22_0413

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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