The Level of Patient Participation in Lung and Esophageal... | NCT06019455

Studies
The Level of Patient Participation in Lung and Esophageal Cancer Patients Treated With Definitive Radiochemotherapy.

NCT06019455

Sponsor

Sun Yat-sen University

Status

Recruiting

Last Update Posted

Dec 10, 2024Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Lung Cancer
Esophageal Cancer

Interventions

Not provided

Countries

China

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

Dec 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2022Actual

Primary Completion Date

May 30, 2027Estimated

Completion Date

May 30, 2027Estimated

First Submitted Date

Aug 25, 2023

First Submission Date that Met QC Criteria

Aug 25, 2023

First Posted Date

Aug 31, 2023Actual

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 5, 2024

Last Update Posted Date

Dec 10, 2024Actual

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

This study aims to assess the level of participation of thoracic cancer patients undergoing definitive radiotherapy and chemotherapy ± immunotherapy in their medical processes and the association between the level of participation and patients' side effects, quality of life, and long-term survival. Additionally, this study will rate the level of participation from both the patients' and medical staff's perspectives and will compare the differences in ratings from these two viewpoints, as well as their impact on treatment outcomes.

Detailed Description

Not provided

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

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observational group		Patients undergoing definitive radiochemotherapy ± immunotherapy will be assessed about the level of participation in their medical processes.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of >=Grade 3 toxicities	The percentage of patients who develop >=Grade 3 toxicities	2 years

Secondary Outcomes

Measure	Description	Time Frame
Overall survival	2-year survival rate	2 years
Progression-free survival	2-year progression-free survival rate	2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Locally advanced non-small cell lung cancer, limited-stage small cell lung cancer, and esophageal cancer.
Planned to undergo definitive chemoradiotherapy ± immunotherapy;
Males or females aged 18 to 75;
Able to communicate with medical staff.

Exclusion Criteria: Patients with cognitive impairments.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with locally advanced non-small cell lung cancer, limited-stage small cell lung cancer, or esophageal cancer

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bo Qiu	Contact	+862087343031		qiubo@sysucc.org.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sun Yat-sen University	Recruiting	Guangzhou		510060	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms
D004938	Esophageal Neoplasms

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided