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NCT Number: NCT06577844

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

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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance publique Hopitaux de Marseille - Hopital Nord

Marseille, 13015, France

Location status: Recruiting

Location contact

Alex Fourdrain, MD, PhD

CONTACT

[email protected]

+33 4 91 96 43 95

Alex Fourdrain, Md, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

video support

Other

video support provided to the patient before surgery

Primary outcomes

  1. Immediate pre-operative anxiety

    Time frame: 10 days

    self-measurement using the HAD Scale

Secondary outcomes

  1. Perioperative anxiety (randomization (consultation), immediate postoperative and discharge)

    Time frame: 90 days

    based on HAD scale

  2. Post-traumatic stress disorder

    Time frame: 90 days

    PCL-5 scale

  3. 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).

  4. Cumulative postoperative morbidity

    Time frame: 90 days

    score CCI

  5. Intra-hospital consumption of analgesics

    Time frame: 90 days

    accounting for in-hospital consumption of analgesics

Study contacts

Contact information is provided by the study sponsor or research team.

Mathilde Lefevre

CONTACT

[email protected]

+33 4 91 38 27 47

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Acronym: SUVIDEM

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 29, 2024
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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