Time Trends in Waiting Times of NSCLC Patients.

Time Trends in Diagnostic Delay and Waiting Times of Four Patient Cohorts, Diagnosed With Non-small Cell Lung Cancer, Treated With High Dose Radiotherapy.

A large group of non-small cell lung cancer patients is treated with radiotherapy. Delivery of very high radiation doses is needed to obtain local control, but due to the large tumor and nodal volume this is often impossible without causing unrepairable damage to the normal tissue of the mediastinum, spinal cord, esophagus and lung.

Although every tumor is different with respect to the speed with which it grows and spreads, it is obvious that time plays an important role in cancer therapy. Recently it was reported that disease progression or increase of tumor volume occurred during the time interval between diagnosis and treatment.(1, 2) This could lead to a less optimal radiation treatment and consequently have an impact on overall survival. Moreover, the increasing number of diagnostic procedures, aimed at obtaining more accurate information about the tumor extension and biology, as well as the use of more sophisticated but labor intense radiation techniques could prolong the time interval between clinical symptoms and the start of the treatment. However, the influence of new diagnostic procedures or the applied radiotherapy techniques on waiting times is not yet known. The investigators therefore want to investigate 1) time trends in the waiting time for NSCLC patients, 2) the correlation between waiting times and the use of more advanced diagnostic or therapeutic procedures, and 3) the correlation between waiting times and overall survival.

The hypotheses of the study:

1. The diagnostic delay for NSCLC patients has increased during the last 12 years.
2. The preparation time for radiotherapy of NSCLC patients has increased during the last 12 years.
3. Prolonged waiting times are associated with worse overall survival outcome.

Study Overview

• Status: Withdrawn
• Conditions: Non-Small Cell Lung Cancer

Detailed Description

A large group of non-small cell lung cancer patients is treated with radiotherapy. Delivery of very high radiation doses is needed to obtain local control, but due to the large tumor and nodal volume this is often impossible without causing unrepairable damage to the normal tissue of the mediastinum, spinal cord, esophagus and lung.

Although every tumor is different with respect to the speed with which it grows and spreads, it is obvious that time plays an important role in cancer therapy. Recently it was reported that disease progression or increase of tumor volume occurred during the time interval between diagnosis and treatment.(1, 2) This could lead to a less optimal radiation treatment and consequently have an impact on overall survival. Moreover, the increasing number of diagnostic procedures, aimed at obtaining more accurate information about the tumor extension and biology, as well as the use of more sophisticated but labor intense radiation techniques could prolong the time interval between clinical symptoms and the start of the treatment. However, the influence of new diagnostic procedures or the applied radiotherapy techniques on waiting times is not yet known. The investigators therefore want to investigate 1) time trends in the waiting time for NSCLC patients, 2) the correlation between waiting times and the use of more advanced diagnostic or therapeutic procedures, and 3) the correlation between waiting times and overall survival.

The hypotheses of the study:

1. The diagnostic delay for NSCLC patients has increased during the last 12 years.
2. The preparation time for radiotherapy of NSCLC patients has increased during the last 12 years.
3. Prolonged waiting times are associated with worse overall survival outcome.

The IKL collected data on waiting times and treatment of NSCLC patients treated in 2001 and 2004. These data will be used for this project. In addition, the MAASTRO lung database contains information of patients treated in 2006 and 2010. Additional information about the diagnostic procedure and radiation treatment preparation will be collected by reviewing the patient charts. For this study a data request has to be submitted to the IKL and access to MAASTRO patient data (charts and EMD) is needed.

The investigators aim to collect the following variables: Date of consultation pulmonologist; Date of multidisciplinary meeting; Date of first consultancy at radiotherapy; Date of start radiotherapy; Information about diagnostic procedure (PET/CT/Pathology/EBUS/EUS); Information about RT procedure (3Dconventional/IMRT); General patient characteristics; Overall survival

• Study Type: Observational

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229 ET
      • Maastro clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Four cohorts of NSCLC patients will be analyzed. Patients were all treated with radiotherapy with or without chemotherapy. To investigate the time trends, cohorts referred for radiotherapy treatment in 2001, 2004, 2006 and 2010 will be analyzed.

Description

Inclusion Criteria:

Patients with NSCLC treated in the Dutch province Limburg from 2001 onwards.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Radiotherapy in 2001
Radiotherapy in 2004
Radiotherapy in 2006
Radiotherapy in 2010

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of waiting times	Retrospective analysis of the time passed between consultation and start of radiotherapy (an expected average time frame of two weeks).	From intake to start of radiotherapy
Correlation of waiting times and treatment outcome	Is there a correlation between the time passed between consultation and start of radiotherapy and treatment outcome? (Time frame: 12 years)	From treatment until date of censoring (12 years)

Collaborators and Investigators

• Sponsor: Maastricht Radiation Oncology
• Collaborators: Comprehensive Cancer Centre The Netherlands

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): September 1, 2016
• Study Completion (Anticipated): September 1, 2016

Study Registration Dates

• First Submitted: September 3, 2013
• First Submitted That Met QC Criteria: September 16, 2013
• First Posted (Estimate): September 19, 2013

Study Record Updates

• Last Update Posted (Estimate): September 30, 2015
• Last Update Submitted That Met QC Criteria: September 29, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: Waiting Times