Pre-Implementation Study of Improving Thoracic Surgical C... | NCT05311670

Studies
Pre-Implementation Study of Improving Thoracic Surgical Care Using Electronic Patient-Reported Outcomes (ePROS)

NCT05311670

Sponsor

UNC Lineberger Comprehensive Cancer Center

Status

Completed

Last Update Posted

Dec 20, 2023Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Thoracic Surgery

Interventions

Patient-reported outcomes monitoring

Countries

United States

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

ID	Type	Description	Link
1K23HL157765-01A1	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Dec 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

Apr 7, 2022Actual

Primary Completion Date

Oct 10, 2022Actual

Completion Date

Oct 10, 2022Actual

First Submitted Date

Mar 10, 2022

First Submission Date that Met QC Criteria

Apr 4, 2022

First Posted Date

Apr 5, 2022Actual

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

Dec 14, 2023

Last Update Posted Date

Dec 20, 2023Actual

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 purpose of the LCCC 2202 is to evaluate the barriers and facilitators to implementing perioperative "ePRO monitoring". This study will inform a future hybrid effectiveness study (LCCC 2141:Improving Thoracic Surgical Care Using Electronic Patient-Reported Outcomes (ePROS). Eligible thoracic surgery patients will be enrolled to ePRO monitoring using web-based or telephone surveys. Patients will be asked to self-report symptoms for remote monitoring by their care team. Patients will be approached for a semi-structured interview to understand the barriers and facilitators to ePRO use.

Detailed Description

This is a single-site, non-randomized study in patients receiving major thoracic surgery, which commonly involves chest wall incisions and overnight admission Eligible patients will be approached at any time point between their preoperative clinic visit and up to 30 days after discharge from the hospital. Approximately 60 patients will be enrolled in the study. Patients will complete symptom surveys via email or telephone. Concerning symptoms will generate alerts for the clinical care team who will follow their usual protocols for the management of symptoms. Patients will be purposively selected and invited to participate in a semi-structured interview to understand their experience using ePRO. Interviews will continue until 30 complete interviews are obtained and/or thematic saturation is reached.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single-arm		Participants will be assigned to the single-arm involving monitoring of their symptoms.	Behavioral: Patient-reported outcomes monitoring

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Patient-reported outcomes monitoring	Behavioral	o Patient-reported outcomes will be collected from patients through web or telephone and alerts sent to providers.	Single-arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Barriers to use of ePROs among patients	Semi-structured interview with patients to evaluate ePRO use.	Up to one year (From one month after the study start until the thematic saturation is reached)
Facilitators to use of ePROs among patients	Semi-structured interview with patients to evaluate ePRO use.	Up to one year (From one month after the study start until the thematic saturation is reached)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years or older
English speaking
Able and willing to complete a web-based or telephonic symptom survey
Planned to undergo surgery within 90 days or have undergone and been discharged from major thoracic surgery within the last 30 days.

Exclusion Criteria:

Not completing planned surgery within 3 months of obtaining informed consent (for subjects recruited preoperatively)
Inability to read and speak English
Planned for foregut surgery (e.g. paraesophageal hernia repair, esophageal resection or repair)
Having undergone only minor thoracic surgery (e.g. bronchoscopy, cervical mediastinoscopy)
Dementia, altered mental status, or any psychiatric condition as determined by thoracic surgery provider team that would prohibit the understanding or rendering of informed consent.
Current incarceration
Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Subjects scheduled thoracic surgery at UNC Chapel Hill Hospital.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gita Mody	University of North Carolina, Chapel Hill	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of North Carolina at Chapel Hill		Chapel Hill	North Carolina	27599	United States

Label	URL
Clinical trials at UNC Lineberger	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

No plan as of now to make IPD available to other researchers.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided