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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06577844
Acronym
SUVIDEM
Enrollment
226
Registered
2024-08-29
Start date
2024-07-11
Completion date
2026-04-11
Last updated
2024-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

lung cancer, surgery, anxiety, video support

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).

Interventions

OTHERvideo support

video support provided to the patient before surgery

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Immediate pre-operative anxiety10 daysself-measurement using the HAD Scale

Secondary

MeasureTime frameDescription
Perioperative anxiety (randomization (consultation), immediate postoperative and discharge)90 daysbased on HAD scale
Post-traumatic stress disorder90 daysPCL-5 scale
Quality of life evaluation90 daysEuropean Organisation for Research and Treatment of Cancer core health- related quality of life questionnaire (QLQ-C30).
Cumulative postoperative morbidity90 daysscore CCI
Intra-hospital consumption of analgesics90 daysaccounting for in-hospital consumption of analgesics

Countries

France

Contacts

Primary ContactMathilde Lefevre
promotion.interne@ap-hm.fr+33 4 91 38 27 47

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026