Understanding the Post-Surgical Non-Small Cell Lung Cancer Patient's Symptom Experience
2 other identifiers
interventional
235
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2018
CompletedFirst Posted
Study publicly available on registry
October 30, 2018
CompletedStudy Start
First participant enrolled
June 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2023
CompletedResults Posted
Study results publicly available
February 24, 2026
CompletedFebruary 24, 2026
July 1, 2025
4.4 years
October 25, 2018
January 15, 2026
February 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (7)
Other Symptoms Severity
about 6 weeks after discharge from the hospital
Perceived Self-Efficacy for Fatigue Self-Management
about 6 weeks after discharge from the hospital
Self-Efficacy for Walking Duration
about 6 weeks after discharge from the hospital
Activities-Specific Balance Confidence
about 6 weeks after discharge from the hospital
Steps Per Day
about 6 weeks after discharge from the hospital
- +2 more secondary outcomes
Study Arms (3)
Light Physical Activity 1
EXPERIMENTALConventional 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.
Light Physical Activity 2
EXPERIMENTALConventional 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.
Support Education Activity
ACTIVE COMPARATORConventional 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Nebraskalead
- Corewell Health Westcollaborator
- National Cancer Institute (NCI)collaborator
- The Methodist Hospital Research Institutecollaborator
Study Sites (1)
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
In 2025, the university made a finding of research misconduct involving this project and communicated this to the NIH Chief Extramural Research Integrity Officer. Given the nature of the misconduct, it is not possible to validate the authenticity of a sufficient proportion of the records for meaningful analysis of the impact of the intervention. Given this situation, analysis for Aims 1, 2, and 3c cannot be performed in a manner that will yield rigorous conclusions with confidence.
Results Point of Contact
- Title
- Kevin A. Kupzyk, PhD
- Organization
- University of Nebraska Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Amy J Hoffman, PhD, RN
University of Nebraska
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2018
First Posted
October 30, 2018
Study Start
June 4, 2019
Primary Completion
November 1, 2023
Study Completion
November 1, 2023
Last Updated
February 24, 2026
Results First Posted
February 24, 2026
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share
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.