Patient Function/Fitness and Psychosocial Health in Improving Health-Related Quality of Life in Patients With Stage I-IV Non-Small Cell Lung Cancer

Smoking Clinical Trial

Official title:

A Pilot Study Investigating Patient Function/Fitness and Psychosocial Health in Patients With Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02835066
• Other study ID #: CCCWFU 98515
• Secondary ID: NCI-2016-00649CC
• Status: Withdrawn
• Start date: July 2016
• Est. completion date: July 2018

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This pilot trial studies patient function/fitness and psychosocial health in improving health-related quality of life and decreasing treatment-related toxicity in patients with stage I-IV non-small cell lung cancer. Studying function/fitness and psychosocial health may help doctors improve conventional therapy in patients with non-small cell lung cancer.

Description:

PRIMARY OBJECTIVES:

I. To determine the correlation of patient-reported health-related quality of life (HRQOL) outcomes with clinical/treatment variables as well as a panel of both function/fitness and psychosocial health assessments in non-small cell lung cancer (NSCLC).

SECONDARY OBJECTIVES:

I. To investigate the panel of function/fitness and psychosocial health assessments with patient's smoking history/status as a predictor for treatment related toxicity.

TERTIARY OBJECTIVES:

I. The documentation of the NSCLC lung population from this prospective combined with others.

OUTLINE:

Patients scheduled for surgery, radiation therapy, or chemotherapy complete the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-core 30 (C30) and QLQ-Lung Cancer 13 (LC13) in addition to psychosocial health and smoking status questions from baseline up to 2 weeks prior to the start of treatment, 5-6 weeks after treatment begins, and 5-6 months from the start of treatment. During the same time points, patients also undergo function/fitness assessments including standard health measurements, short physical performance battery (SPPB), 6 minute walk test (6MWT), and a grip strength test.

After completion of study treatment, patients are followed up every 3-6 months.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Newly diagnosed lung cancer

Exclusion Criteria:

• Previous or active lung cancer treatment at the time of registration

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Smoking

Intervention

Other:
• Integrated Fitness Assessment
Undergo function/fitness assessment

Procedure:
• Psychosocial Assessment and Care
Undergo psychosocial health assessments
• Quality-of-Life Assessment
Complete EORTC QLQ-C30 and QLQ-LC13 questionnaires

Locations

Country	Name	City	State
United States	Comprehensive Cancer Center of Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient function/fitness	Assessed by standard health measurements.	Up to 6 months
Primary	Patient well-being	Assessed by questionnaires.	Up to 6 months
Primary	Patient function/fitness	Assessed by performance-based measures.	Up to 6 months
Primary	Patient well-being	Assessed by psychosocial health questions.	Up to 6 months