FatigueNCT03724331
Understanding the Post-Surgical Non-Small Cell Lung Cancer Patient's Symptom Experience
A study testing Light Physical Activity 1, Light Physical Activity 2 and Support Education Activity in people with Fatigue and Self Efficacy, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fatigue, Self Efficacy, Quality of Life
- What is being tested?
- Light Physical Activity 1, Light Physical Activity 2 and Support Education Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2019to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
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.
Read the 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.
- Conditions
- Fatigue, Self Efficacy, Quality of Life, Physical Activity, Lung Cancer, Non-Small Cell Lung Cancer
- Being tested
- Light Physical Activity 1, Light Physical Activity 2, Support Education Activity
- Keywords
- Cancer-Related Fatigue, Fatigue, Symptoms, Functional Status, Quality of Life, Lung Cancer, Rehabilitation, Exercise, Physical Activity, Self-Efficacy, Self-Management
- Medical subject headings
- Fatigue, Motor Activity, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light Physical Activity 1Behavioural
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 Physical Activity 2Behavioural
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.
Support Education ActivityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Light Physical Activity 1 | Experimental | 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. Receives: Behavioral: Light Physical Activity 1 |
| Light Physical Activity 2 | Experimental | 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. Receives: Behavioral: Light Physical Activity 2 |
| Support Education Activity | Active comparator | 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. Receives: Behavioral: Support Education Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: Immediately after discharge from the hospital
Secondary outcomes (7)
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).
Measured: about 6 weeks after discharge from the hospital
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)
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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).
Measured: about 6 weeks after discharge from the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start4 Jun 2019
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- Corewell Health West, National Cancer Institute (NCI), The Methodist Hospital Research Institute
- Responsible party
- Sponsor
- Investigators
- Amy J Hoffman, PhD, RN, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724331
- Sponsor's protocol ID
- 0560-18-EP
- Other IDs
- R01CA205025
- Status last verified
- Jul 2025
- First submitted
- 25 Oct 2018
- Last updated
- 24 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Post-Surgical Non-Small Cell Lung Cancer Patient's Symptom Experience
- ClinicalTrials.gov ID
- NCT03724331
- Acronym / sponsor ID
- 0560-18-EP
- Conditions
- Fatigue, Self Efficacy, Quality of Life, Physical Activity, Lung Cancer, Non-Small Cell Lung Cancer
- Keywords
- Cancer-Related Fatigue, Fatigue, Symptoms, Functional Status, Quality of Life, Lung Cancer, Rehabilitation, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- Corewell Health West, National Cancer Institute (NCI), The Methodist Hospital Research Institute
- Study start
- 4 Jun 2019 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 30 Oct 2018 (actual)
- Results
- Posted 24 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Light Physical Activity 1 | Experimental | Behavioral: Light Physical Activity 1Conventional 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 | Experimental | Behavioral: Light Physical Activity 2Conventional 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 comparator | Behavioral: Support Education ActivityConventional 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light Physical Activity 1Light (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. | Behavioural | Light Physical Activity 1 |
| Light Physical Activity 2Light (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. | Behavioural | Light Physical Activity 2 |
| Support Education ActivityParticipate 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. | Behavioural | Support Education Activity |
Primary outcome
Cancer-related Fatigue Severity Using The Brief Fatigue Inventory.
Time frame: about 6 weeks after discharge from the hospital
The Brief Fatigue Inventory measured the degree of cancer-related fatigue severity on an 11-point scale (0-10, 10 = most severe)
Cancer-Related Fatigue Fatigability as Assessed Using the 6 Minute Walk Test.
Time frame: Immediately after discharge from the hospital
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.
7 secondary outcomes
Other Symptoms Severity
Time frame: about 6 weeks after discharge from the hospital
Perceived Self-Efficacy for Fatigue Self-Management
Time frame: about 6 weeks after discharge from the hospital
Self-Efficacy for Walking Duration
Time frame: about 6 weeks after discharge from the hospital
Activities-Specific Balance Confidence
Time frame: about 6 weeks after discharge from the hospital
Steps Per Day
Time frame: about 6 weeks after discharge from the hospital
Functional Status Performance
Time frame: about 6 weeks after discharge from the hospital
Quality of Life as Assessed Using the Quality of Life Index
Time frame: about 6 weeks after discharge from the hospital
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy J Hoffman, PhD, RN principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light Physical Activity 1, Light Physical Activity 2 and Support Education Activity in people with Fatigue and Self Efficacy, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer-related Fatigue Severity Using The Brief Fatigue Inventory. (time frame: about 6 weeks after discharge from the hospital). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.