---
title: Patient Function/Fitness and Psychosocial Health in Improving Health-Related Quality of Life in Patients With Stage I-IV Non-Small Cell Lung Cancer
nct_id: NCT02835066
overall_status: WITHDRAWN
sponsor: Wake Forest University Health Sciences
study_type: OBSERVATIONAL
primary_condition: Smoking
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02835066.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02835066"
ct_last_update_post_date: 2018-07-27
last_seen_at: "2026-05-12T06:22:31.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Patient Function/Fitness and Psychosocial Health in Improving Health-Related Quality of Life in Patients With Stage I-IV Non-Small Cell Lung Cancer

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

**NCT ID:** [NCT02835066](https://clinicaltrials.gov/study/NCT02835066)

## Key Facts

- **Status:** WITHDRAWN
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 0
- **Lead Sponsor:** Wake Forest University Health Sciences
- **Collaborators:** National Cancer Institute (NCI)
- **Conditions:** Smoking, Lung Neoplasms
- **Start Date:** 2016-07
- **Completion Date:** 2018-07
- **CT.gov Last Update:** 2018-07-27

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Newly diagnosed lung cancer

Exclusion Criteria:

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

## Arms

- **Ancillary-Correlative (HRQOL, fitness and psychosocial health)** — 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.

## Interventions

- **Integrated Fitness Assessment** (OTHER) — Undergo function/fitness assessment
- **Psychosocial Assessment and Care** (PROCEDURE) — Undergo psychosocial health assessments
- **Quality-of-Life Assessment** (PROCEDURE) — Complete EORTC QLQ-C30 and QLQ-LC13 questionnaires

## Primary Outcomes

- **Patient function/fitness** _(time frame: Up to 6 months)_ — Assessed by standard health measurements.
- **Patient well-being** _(time frame: Up to 6 months)_ — Assessed by questionnaires.
- **Patient function/fitness** _(time frame: Up to 6 months)_ — Assessed by performance-based measures.
- **Patient well-being** _(time frame: Up to 6 months)_ — Assessed by psychosocial health questions.

## Locations (1)

- Comprehensive Cancer Center of Wake Forest University, Winston-Salem, North Carolina, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.comprehensive cancer center of wake forest university|winston-salem|north carolina|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02835066.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02835066*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*