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

Not Applicable

Recruiting

• Conditions: Lung Cancer
• Interventions: Other: video support

• Registration Number: NCT06577844
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-11
• Status Verified: 2024-08
• Study First Submitted: 2024-08-27
• Study First Submitted QC: 2024-08-27
• Last Update Submitted: 2024-08-27
• Study First Posted: 2024-08-29
• Last Update Posted: 2024-08-29
• Primary Completion: 2026-01-11
• Study Completion: 2026-04-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 226

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental	video support	-

Primary Outcome Measures

Name	Time	Method
Immediate pre-operative anxiety	10 days	self-measurement using the HAD Scale

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Assistance publique Hopitaux de Marseille - Hopital Nord; 🇫🇷 Marseille, France