NCT06577844

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
226

participants targeted

Target at P50-P75 for not_applicable lung-cancer

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 11, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2026

Completed
Last Updated

August 29, 2024

Status Verified

August 1, 2024

Enrollment Period

1.5 years

First QC Date

August 27, 2024

Last Update Submit

August 27, 2024

Conditions

Keywords

lung cancersurgeryanxietyvideo support

Outcome Measures

Primary Outcomes (1)

  • Immediate pre-operative anxiety

    self-measurement using the HAD Scale

    10 days

Secondary Outcomes (5)

  • Perioperative anxiety (randomization (consultation), immediate postoperative and discharge)

    90 days

  • Post-traumatic stress disorder

    90 days

  • Quality of life evaluation

    90 days

  • Cumulative postoperative morbidity

    90 days

  • Intra-hospital consumption of analgesics

    90 days

Study Arms (2)

experimental

EXPERIMENTAL
Other: video support

control

NO INTERVENTION

Interventions

video support provided to the patient before surgery

experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance publique Hopitaux de Marseille - Hopital Nord

Marseille, 13015, France

RECRUITING

MeSH Terms

Conditions

Lung NeoplasmsAnxiety Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2024

First Posted

August 29, 2024

Study Start

July 11, 2024

Primary Completion

January 11, 2026

Study Completion

April 11, 2026

Last Updated

August 29, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations