NCT06019455

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
10mo left

Started Jun 2022

Longer than P75 for all trials

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 Progress84%
Jun 2022May 2027

Study Start

First participant enrolled

June 1, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 31, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2027

Last Updated

December 10, 2024

Status Verified

December 1, 2024

Enrollment Period

5 years

First QC Date

August 25, 2023

Last Update Submit

December 5, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of >=Grade 3 toxicities

    The percentage of patients who develop \>=Grade 3 toxicities

    2 years

Secondary Outcomes (2)

  • Overall survival

    2 years

  • Progression-free survival

    2 years

Study Arms (1)

Observational group

Patients undergoing definitive radiochemotherapy ± immunotherapy will be assessed about the level of participation in their medical processes.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University

Guangzhou, 510060, China

RECRUITING

MeSH Terms

Conditions

Lung NeoplasmsEsophageal Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 25, 2023

First Posted

August 31, 2023

Study Start

June 1, 2022

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

May 30, 2027

Last Updated

December 10, 2024

Record last verified: 2024-12

Locations