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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA205025 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Corewell Health West | OTHER |
| National Cancer Institute (NCI) | NIH |
| The Methodist Hospital Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Light Physical Activity 1 | Behavioral | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Perceived Self-Efficacy for Fatigue Self-Management |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy J Hoffman, PhD, RN | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
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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Participants went through the consenting process and were given time, if requested, to consider further participation prior to initial assessments.
Prospective participants were contacted in the cardiothoracic surgeon's office and informed about the availability of the study. They were provided with contact information and gave consent to be contacted for enrolling in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Immediate Intervention (No-wait) Group (IIG) | IIG participants receive the exercise intervention during weeks 1-12 post-surgery. |
| FG001 | Wait-list Control Group (WCG) | WCG participants will receive usual care, which is standard medical care from health providers for 6 wks after hospital discharge followed by the exercise intervention during weeks 7-12. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 19, 2023 |
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| Light Physical Activity 2 | Behavioral | 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. |
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| Support Education Activity | Behavioral | 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. |
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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 |
| 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 |
| FG002 | Attention Control (Educate) Group (ACG) | ACG participants will have baseline data collected pre-surgery by a nurse recruiter and receive a pedometer and instructions for recording total steps/day and will be followed for 6 weeks. |
| Completed measures at 6 weeks (primary endpoint) |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Immediate Intervention (No-wait) Group (IIG) | IIG participants receive the exercise intervention during weeks 1-12 post-surgery. |
| BG001 | Wait-list Control Group (WCG) | WCG participants will receive usual care, which is standard medical care from health providers for 6 wks after hospital discharge followed by the exercise intervention during weeks 7-12. |
| BG002 | Attention Control (Educate) Group (ACG) | ACG participants will have baseline data collected pre-surgery by a nurse recruiter and receive a pedometer and instructions for recording total steps/day and will be followed for 6 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Brief Fatigue Inventory | The "Brief Fatigue Inventory" measures the severity of fatigue and the impact of fatigue on daily functioning. Scores are means across 9 items ranging from 0 to 10, for a possible range of 0 to 10. Higher scores indicate greater fatigue. | Mean | Standard Deviation | Scores on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Mean | Standard Deviation | Scores on a scale | about 6 weeks after discharge from the hospital |
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| Primary | 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. | Posted | Mean | Standard Deviation | Meters walked | Immediately after discharge from the hospital |
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| Secondary | 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). | Posted | Mean | Standard Deviation | Scores on a scale | about 6 weeks after discharge from the hospital |
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| Secondary | 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) | Posted | Mean | Standard Deviation | Scores on a scale | about 6 weeks after discharge from the hospital |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Scores on a scale | about 6 weeks after discharge from the hospital |
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| Secondary | 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) | Posted | Mean | Standard Deviation | Scores on a scale | about 6 weeks after discharge from the hospital |
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| Secondary | Steps Per Day | Performance in average number of walking steps taken per day per week. Measured by a pedometer. | Posted | Mean | Standard Deviation | Steps per day over a week | about 6 weeks after discharge from the hospital |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Scores on a scale | about 6 weeks after discharge from the hospital |
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| Secondary | 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). | Posted | Mean | Standard Deviation | Scores on a scale | about 6 weeks after discharge from the hospital |
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From enrollment until the end of the study; 6 weeks or up to 12 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Immediate Intervention (No-wait) Group (IIG) | IIG participants receive the exercise intervention during weeks 1-12 post-surgery. | 0 | 87 | 0 | 87 | 0 | 87 |
| EG001 | Wait-list Control Group (WCG) | WCG participants will receive usual care, which is standard medical care from health providers for 6 wks after hospital discharge followed by the exercise intervention during weeks 7-12. | 0 | 73 | 0 | 73 | 0 | 73 |
| EG002 | Attention Control (Educate) Group (ACG) | ACG participants will have baseline data collected pre-surgery by a nurse recruiter and receive a pedometer and instructions for recording total steps/day and will be followed for 6 weeks. | 0 | 75 | 0 | 75 | 0 | 75 |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin A. Kupzyk, PhD | University of Nebraska Medical Center | 402-559-7262 | kevin.kupzyk@unmc.edu |
| Jan 13, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D005221 | Fatigue |
| D009043 | Motor Activity |
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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ACG participants will have baseline data collected pre-surgery by a nurse recruiter and receive a pedometer and instructions for recording total steps/day and will be followed for 6 weeks.
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