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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02835066
Enrollment
0
Registered
2016-07-15
Start date
2016-07-31
Completion date
2018-07-31
Last updated
2018-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Neoplasms, Smoking

Keywords

Stage I, Stage II, Stage IIIA, Stage IIIB, Stage IV, Non-Small Cell

Brief 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.

Detailed 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.

Interventions

OTHERIntegrated Fitness Assessment

Undergo function/fitness assessment

PROCEDUREPsychosocial Assessment and Care

Undergo psychosocial health assessments

PROCEDUREQuality-of-Life Assessment

Complete EORTC QLQ-C30 and QLQ-LC13 questionnaires

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Newly diagnosed lung cancer

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Patient function/fitnessUp to 6 monthsAssessed by standard health measurements.
Patient well-beingUp to 6 monthsAssessed by questionnaires.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026