Pre-operative Counselling in Laryngectomized Patients | NCT04491487

Studies
Pre-operative Counselling in Laryngectomized Patients

NCT04491487

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Status

Completed

Last Update Posted

Feb 17, 2023Actual

Enrollment

28Actual

Phase

Not Applicable

Conditions

Total Laryngectomy

Interventions

pre-operative counselling

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2020Actual

Primary Completion Date

Feb 2, 2021Actual

Completion Date

Apr 1, 2021Actual

First Submitted Date

Jul 22, 2020

First Submission Date that Met QC Criteria

Jul 25, 2020

First Posted Date

Jul 29, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2023

Last Update Posted Date

Feb 17, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

LONGOBARDI YLENIA, researcher, Fondazione Policlinico Universitario Agostino Gemelli IRCCSPrincipal Investigator

Lead Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCSOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators aim to verify the effects of pre-operative Speech-Language Pathology (SLP) counselling on patients undergoing total laryngectomy in terms of levels of distress, post-traumatic stress symptoms, anxious-depressive symptoms, acquisition and acceptance of the new voice.

This is a randomized controlled trial (RCT) of patients undergoing total laryngectomy and primary tracheoesophageal puncture. Patients will be randomized into two groups: an Experimental group that will receive a pre-operative SLP counselling session and a Control group that will not receive it. The investigators will administer a structured interview and three questionnaires: the Impact of Event Scale - Revised (IES-R), the Psychological Distress Inventory (PDI), the Hospital Anxiety and Depression Scale (HADS). The data will be collected between the 5th and 7th day after surgery (T0), 1-month (T1) and 3-months (T2) after being discharged from hospital.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental group	Experimental		Other: pre-operative counselling
Control group	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pre-operative counselling	Other	pre-operative Speech-Language Pathology (SLP) counselling before Total Laryngectomy	Experimental group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Impact of Event Scale-revised	presence of post-traumatic symptoms	Between the fifth and seventh post-operative day (T0)
Impact of Event Scale-revised	presence of post-traumatic symptoms	one month after being discharged from hospital (T1)
Impact of Event Scale-revised	presence of post-traumatic symptoms	three months after being discharged from hospital (T2)

Secondary Outcomes

Measure	Description	Time Frame
Psychological Distress Inventory	psychological distress levels	Between the fifth and seventh post-operative day (T0)
Psychological Distress Inventory	psychological distress levels

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 18 years and over;
patients waiting for TL and primary TEP;
patients able and willing to provide written informed consent.

Exclusion Criteria:

positive history for psychiatric or psychological disorders,
neurological disorders,
ineligibility for voice prosthesis rehabilitation.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Longobardi	Otolaryngology department	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondazione Policlinico Universitario A.Gemelli IRCCS		Roma		00168	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided