Understanding the Post-Surgical Non-Small Cell Lung Cancer Patient's Symptom Experience

Among 13 core symptoms across 3,106 breast, colorectal, prostate, and lung cancer patients, persons with lung cancer were the most symptomatic, with moderate to severe fatigue being reported with the greatest prevalence. This is a proposed randomized controlled trial of a novel rehabilitative intervention for persons with non-small cell lung cancer after surgery that promotes self-management of cancer-related fatigue (CRF) and is practical, portable, low cost, and safe. The results of the study will provide a novel exercise intervention, and its optimal timing, that helps a vulnerable population by reducing CRF severity and fatigability and is applicable to nearly all post-thoracotomy lung cancer patients.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Fatigue; Physical Activity; Non-Small Cell Lung Cancer; Lung Cancer; Self Efficacy
• Intervention / Treatment: Behavioral: Light Physical Activity 1; Behavioral: Light Physical Activity 2; Behavioral: Support Education Activity

Detailed Description

Persons with non-small cell lung cancer (NSCLC) report significantly more unmet supportive care needs than other cancer populations, yet they are among the most vulnerable and least studied. Two of the most prevalent unmet supportive care needs include overcoming fatigue and attaining adequate exercise to meet physical demands of daily living. Cancer-related fatigue (CRF) is a prevalent, persistent, and distressing symptom in the NSCLC population. Cancer-related fatigue correlates with greater severity of 15 other symptoms, leading to lower physical function for persons with NSCLC. Among 13 core symptoms across 3,106 breast, colorectal, prostate, and lung cancer patients, persons with lung cancer were the most symptomatic, with moderate to severe fatigue being reported with the greatest prevalence. While surgery is the standard curative treatment for NSCLC, no formal guidelines exist for post-surgical rehabilitation. This is a proposed randomized controlled trial (RCT) of a novel rehabilitative intervention for persons with NSCLC after surgery. The intervention promotes self-management of CRF and tests the intervention's impact on CRF severity and fatigability with analysis by age. A previous study incorporating the proposed intervention exceeded goals for recruitment, retention, adherence, acceptability, and preliminary efficacy, with no adverse events reported. The investigator's long-term goal is to develop interventions to increase perceived self-efficacy for CRF self-management in order to improve CRF, symptom status, functional status, and quality of life (QOL) for persons with NSCLC. The objective in this application is to determine the efficacy, optimal timing, and sustainability of this innovative home-based exercise intervention. This study has the potential to transform the current standard by providing a rehabilitative exercise intervention after surgery. The intervention is home-based, self-paced, and builds in duration upon discharge from the hospital after surgery. Aim 1: Determine efficacy by comparing the immediate intervention group with wait-list control (usual care) and attention control by age. Aim 2: Determine efficacy of initiating the exercise intervention 6 wks post-discharge and compare results with the immediate intervention group for all ages. Aim 3: Determine the immediate intervention's sustainability by analyzing 3a) rates of extension, adherence, and retention; 3b) acceptability; and 3c) efficacy of primary and secondary outcomes. IMPACT: The results of this study will provide a novel exercise intervention, and its optimal timing, and fill the gap for a vulnerable population by providing a practical, portable, and low-cost means of reducing CRF severity and fatigability that is enjoyable and applicable to nearly all post-thoracotomy lung cancer patients.

• Study Type: Interventional
• Enrollment (Actual): 235
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women and men
• At least 18 years of age (Michigan) and 19 years of age in (Nebraska)
• With suspected non-small cell lung cancer to be confirmed after surgery
• Karnofsky Performance Status score of at least 70%
• Thoracic surgeon approval pre- and post-surgery
• Medically stable comorbid conditions allowing for non-small cell lung cancer surgery clearance
• Has phone access capability
• Able to speak and write English
• Able to hear and speak for phone interviews
• Owns a television
• Lives within 2 hours driving distance of recruitment site

Exclusion Criteria:

• Severe impairment of sight, hearing, speaking
• Active treatment for malignancy within past 3 months (other than non-melanoma skin cancer or long-term hormonal treatment for common cancers such as breast and prostate if disease is stable
• Weight greater than 330 pounds
• History of photosensitive seizures
• Any condition or disorder that would impede safe participation as directed
• Plans to relocate outside the area during the study period or unable to fully participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Light Physical Activity 1; Conventional treatment for cancer as prescribed by the participant's health care providers and will receive a home-based light (mild) physical activity program that begins approximately within one week after discharge from the hospital with the physical activity program starting approximately within the first week post-discharge from the hospital.	Behavioral: Light Physical Activity 1; Light (mild) physical activity program that corresponds with normal every day activities of daily living (< 3.0 metabolic equivalents, METs), with a time commitment starting at 5 minutes a day 5 days a week gradually increasing to 30 minutes a day 5 days a week as you are able by week 6 as guided by your Registered Nurse researcher. The program begins approximately within one week after discharge from the hospital with the physical activity program starting approximately within the first week post-discharge from the hospital.
Experimental: Light Physical Activity 2; Conventional treatment for cancer as prescribed by the participant's health care providers and will receive a home-based light (mild) physical activity program that begins approximately within one week after discharge from the hospital with the physical activity program starting approximately 7 weeks post-discharge from the hospital.	Behavioral: Light Physical Activity 2; Light (mild) physical activity program that corresponds with normal every day activities of daily living (< 3.0 metabolic equivalents, METs), with a time commitment starting at 5 minutes a day 5 days a week gradually increasing to 30 minutes a day 5 days a week as you are able by week 6 as guided by your Registered Nurse researcher. The program begins approximately within one week after discharge from the hospital with the physical activity program starting approximately 7 weeks post-discharge from the hospital.
Active Comparator: Support Education Activity; Conventional treatment for cancer as prescribed by the participant's health care providers and will participate in a supportive cancer-related education activity each week for 6-weeks after returning home from the hospital.	Behavioral: Support Education Activity; Participate in a supportive cancer-related education activity including a direct 10 - 15 minute phone conversation with a Registered Nurse researcher each week for 6-weeks after returning home from the hospital. Wear a pedometer each day of the study. Recording pedometer steps in the daily diary each day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cancer-related Fatigue Severity Using The Brief Fatigue Inventory.	The Brief Fatigue Inventory measured the degree of cancer-related fatigue severity on an 11-point scale (0-10, 10 = most severe)	about 6 weeks after discharge from the hospital
Cancer-Related Fatigue Fatigability as Assessed Using the 6 Minute Walk Test.	This is a times and measured test to determine the number of meters a participant can walk in 6 minutes. Lower values indicate greater fatigability.	Immediately after discharge from the hospital

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Self-Efficacy for Fatigue Self-Management	A persons's perception of ability to manage fatigue on an 11-point scale (0-10, 10 = very certain)	about 6 weeks after discharge from the hospital
Other Symptoms Severity	The MD Anderson Symptom Inventory (MDASI) Severity subscale measures the severity of multiple symptoms in daily life on an 11-point scale (0-10, 10 = most severe).	about 6 weeks after discharge from the hospital
Self-Efficacy for Walking Duration	A person's perception to complete incremental 5-minute periods of walking using an 11-point scale (0-10; 0 = 0% confident to 10 = 100% confident). No walking periods are actually performed. This measures their confidence in their ability to perform walking for 5 minutes, 10 minutes, 15 minutes etc. up to 60 minutes. Scores are an average across all 12 intervals. Higher scores indicate higher confidence to walk for longer periods.	about 6 weeks after discharge from the hospital
Activities-Specific Balance Confidence	A person's perception of balance during every day activities using an 11-point scale (0-10; 0=0% confident, 10 = 100% confident)	about 6 weeks after discharge from the hospital
Steps Per Day	Performance in average number of walking steps taken per day per week. Measured by a pedometer.	about 6 weeks after discharge from the hospital
Functional Status Performance	SF36 Health & Well-Being - Physical Component Score. The SF36 measures performance of daily mental and physical activities that people do in the normal course of their lives measured with eight subscales that focus on the physical and mental health components producing normative scores (0-100, 100 = higher functional status). Items are weighted per developer-provided scalars, averaged, and transformed into a 0-100 scale. In norm-based scoring (provided here), a score of 50 represents the population average, with 10 points representing one standard deviation. Lower scores reflect greater physical limitations and pain, while higher scores indicate better, more functional physical health.	about 6 weeks after discharge from the hospital
Quality of Life as Assessed Using the Quality of Life Index	Total scores reported from the Quality of Life Index - CANCER III Versions. Satisfaction with various aspects of life (33 aspects) and the importance of each aspect of life to the person using a 6 point-rating scale (1-6, 6 = very satisfied and very important). Total scores are an averaged combination of each aspect's satisfaction and importance using a formula provided by the developer; total scores can range from 0 (very low quality of life) to 30 (very high quality of life).	about 6 weeks after discharge from the hospital

Collaborators and Investigators

• Sponsor: University of Nebraska
• Collaborators: National Cancer Institute (NCI); The Methodist Hospital Research Institute; Corewell Health West
• Investigators: Principal Investigator: Amy J Hoffman, PhD, RN, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2019
• Primary Completion (Actual): November 1, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: October 25, 2018
• First Submitted That Met QC Criteria: October 28, 2018
• First Posted (Actual): October 30, 2018

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Rehabilitation; Physical Activity; Exercise; Lung Cancer; Quality of Life; Fatigue; Self-Management; Self-Efficacy; Symptoms; Functional Status; Cancer-Related Fatigue
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Lung Neoplasms; Fatigue; Carcinoma, Non-Small-Cell Lung; Motor Activity
• Other Study ID Numbers: 0560-18-EP; R01CA205025 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We will disseminate the results from this study at national/international meetings. We also expect that the findings of this study will be disseminated through scientific journals with multiple manuscripts prepared by the investigators from this study for publication in peer-reviewed journals. The investigators agree to continue to abide by the NIH Public Access Policy by submitting final peer-reviewed journal manuscripts to the digital archive, PubMed Central, upon acceptance for publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No