Trial Outcomes & Findings for Understanding the Post-Surgical Non-Small Cell Lung Cancer Patient's Symptom Experience (NCT NCT03724331)
NCT ID: NCT03724331
Last Updated: 2026-02-24
Results Overview
The Brief Fatigue Inventory measured the degree of cancer-related fatigue severity on an 11-point scale (0-10, 10 = most severe)
COMPLETED
NA
235 participants
about 6 weeks after discharge from the hospital
2026-02-24
Participant Flow
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.
Participants went through the consenting process and were given time, if requested, to consider further participation prior to initial assessments.
Participant milestones
| Measure |
Immediate Intervention (No-wait) Group (IIG)
IIG participants receive the exercise intervention during weeks 1-12 post-surgery.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
87
|
73
|
75
|
|
Overall Study
Completed measures at 6 weeks (primary endpoint)
|
62
|
61
|
54
|
|
Overall Study
COMPLETED
|
20
|
36
|
63
|
|
Overall Study
NOT COMPLETED
|
67
|
37
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Understanding the Post-Surgical Non-Small Cell Lung Cancer Patient's Symptom Experience
Baseline characteristics by cohort
| Measure |
Immediate Intervention (No-wait) Group (IIG)
n=87 Participants
IIG participants receive the exercise intervention during weeks 1-12 post-surgery.
|
Wait-list Control Group (WCG)
n=73 Participants
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.
|
Attention Control (Educate) Group (ACG)
n=75 Participants
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.
|
Total
n=235 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=58 Participants
|
1 Participants
|
2 Participants
n=1 Participants
|
6 Participants
n=484 Participants
|
|
Age, Continuous
|
67.63 Years
STANDARD_DEVIATION 7.78 • n=58 Participants
|
68.21 Years
STANDARD_DEVIATION 8.71
|
67.2 Years
STANDARD_DEVIATION 7.7 • n=1 Participants
|
67.7 Years
STANDARD_DEVIATION 8.02 • n=484 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=58 Participants
|
42 Participants
|
45 Participants
n=1 Participants
|
146 Participants
n=484 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=58 Participants
|
31 Participants
|
30 Participants
n=1 Participants
|
89 Participants
n=484 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=58 Participants
|
1 Participants
|
1 Participants
n=1 Participants
|
3 Participants
n=484 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=484 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=484 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=58 Participants
|
4 Participants
|
3 Participants
n=1 Participants
|
9 Participants
n=484 Participants
|
|
Race (NIH/OMB)
White
|
82 Participants
n=58 Participants
|
67 Participants
|
65 Participants
n=1 Participants
|
214 Participants
n=484 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=484 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=58 Participants
|
1 Participants
|
6 Participants
n=1 Participants
|
9 Participants
n=484 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
82 Participants
n=58 Participants
|
72 Participants
|
67 Participants
n=1 Participants
|
221 Participants
n=484 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=58 Participants
|
0 Participants
|
6 Participants
n=1 Participants
|
8 Participants
n=484 Participants
|
|
Brief Fatigue Inventory
|
1.81 Scores on a scale
STANDARD_DEVIATION 1.79 • n=58 Participants
|
1.56 Scores on a scale
STANDARD_DEVIATION 1.87
|
2.23 Scores on a scale
STANDARD_DEVIATION 2.23 • n=1 Participants
|
1.85 Scores on a scale
STANDARD_DEVIATION 1.98 • n=484 Participants
|
PRIMARY outcome
Timeframe: about 6 weeks after discharge from the hospitalThe Brief Fatigue Inventory measured the degree of cancer-related fatigue severity on an 11-point scale (0-10, 10 = most severe)
Outcome measures
| Measure |
Wait-list Control Group (WCG)
n=61 Participants
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.
|
Immediate Intervention (No-wait) Group (IIG)
n=62 Participants
IIG participants receive the exercise intervention during weeks 1-12 post-surgery.
|
Attention Control (Educate) Group (ACG)
n=53 Participants
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.
|
|---|---|---|---|
|
Cancer-related Fatigue Severity Using The Brief Fatigue Inventory.
|
4.19 Scores on a scale
Standard Deviation 2.16
|
0.56 Scores on a scale
Standard Deviation 0.73
|
4.93 Scores on a scale
Standard Deviation 2.24
|
PRIMARY outcome
Timeframe: Immediately after discharge from the hospitalThis is a times and measured test to determine the number of meters a participant can walk in 6 minutes. Lower values indicate greater fatigability.
Outcome measures
| Measure |
Wait-list Control Group (WCG)
n=47 Participants
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.
|
Immediate Intervention (No-wait) Group (IIG)
n=52 Participants
IIG participants receive the exercise intervention during weeks 1-12 post-surgery.
|
Attention Control (Educate) Group (ACG)
n=46 Participants
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.
|
|---|---|---|---|
|
Cancer-Related Fatigue Fatigability as Assessed Using the 6 Minute Walk Test.
|
312 Meters walked
Standard Deviation 91
|
389 Meters walked
Standard Deviation 100
|
300 Meters walked
Standard Deviation 85
|
SECONDARY outcome
Timeframe: about 6 weeks after discharge from the hospitalThe 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).
Outcome measures
| Measure |
Wait-list Control Group (WCG)
n=61 Participants
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.
|
Immediate Intervention (No-wait) Group (IIG)
n=62 Participants
IIG participants receive the exercise intervention during weeks 1-12 post-surgery.
|
Attention Control (Educate) Group (ACG)
n=53 Participants
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.
|
|---|---|---|---|
|
Other Symptoms Severity
|
1.57 Scores on a scale
Standard Deviation 1.03
|
0.81 Scores on a scale
Standard Deviation 0.79
|
1.93 Scores on a scale
Standard Deviation 1.18
|
SECONDARY outcome
Timeframe: about 6 weeks after discharge from the hospitalA persons's perception of ability to manage fatigue on an 11-point scale (0-10, 10 = very certain)
Outcome measures
| Measure |
Wait-list Control Group (WCG)
n=61 Participants
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.
|
Immediate Intervention (No-wait) Group (IIG)
n=62 Participants
IIG participants receive the exercise intervention during weeks 1-12 post-surgery.
|
Attention Control (Educate) Group (ACG)
n=53 Participants
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.
|
|---|---|---|---|
|
Perceived Self-Efficacy for Fatigue Self-Management
|
6.31 Scores on a scale
Standard Deviation 2.57
|
9.39 Scores on a scale
Standard Deviation 0.94
|
5.3 Scores on a scale
Standard Deviation 2.29
|
SECONDARY outcome
Timeframe: about 6 weeks after discharge from the hospitalA 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.
Outcome measures
| Measure |
Wait-list Control Group (WCG)
n=61 Participants
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.
|
Immediate Intervention (No-wait) Group (IIG)
n=62 Participants
IIG participants receive the exercise intervention during weeks 1-12 post-surgery.
|
Attention Control (Educate) Group (ACG)
n=53 Participants
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.
|
|---|---|---|---|
|
Self-Efficacy for Walking Duration
|
5.15 Scores on a scale
Standard Deviation 3.83
|
7.99 Scores on a scale
Standard Deviation 2.28
|
4.59 Scores on a scale
Standard Deviation 2.78
|
SECONDARY outcome
Timeframe: about 6 weeks after discharge from the hospitalA person's perception of balance during every day activities using an 11-point scale (0-10; 0=0% confident, 10 = 100% confident)
Outcome measures
| Measure |
Wait-list Control Group (WCG)
n=55 Participants
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.
|
Immediate Intervention (No-wait) Group (IIG)
n=60 Participants
IIG participants receive the exercise intervention during weeks 1-12 post-surgery.
|
Attention Control (Educate) Group (ACG)
n=54 Participants
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.
|
|---|---|---|---|
|
Activities-Specific Balance Confidence
|
8 Scores on a scale
Standard Deviation 2.07
|
9.1 Scores on a scale
Standard Deviation 1.26
|
7.54 Scores on a scale
Standard Deviation 2.44
|
SECONDARY outcome
Timeframe: about 6 weeks after discharge from the hospitalPerformance in average number of walking steps taken per day per week. Measured by a pedometer.
Outcome measures
| Measure |
Wait-list Control Group (WCG)
n=55 Participants
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.
|
Immediate Intervention (No-wait) Group (IIG)
n=58 Participants
IIG participants receive the exercise intervention during weeks 1-12 post-surgery.
|
Attention Control (Educate) Group (ACG)
n=46 Participants
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.
|
|---|---|---|---|
|
Steps Per Day
|
3620 Steps per day over a week
Standard Deviation 2837
|
3939 Steps per day over a week
Standard Deviation 2181
|
2802 Steps per day over a week
Standard Deviation 2044
|
SECONDARY outcome
Timeframe: about 6 weeks after discharge from the hospitalSF36 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.
Outcome measures
| Measure |
Wait-list Control Group (WCG)
n=55 Participants
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.
|
Immediate Intervention (No-wait) Group (IIG)
n=60 Participants
IIG participants receive the exercise intervention during weeks 1-12 post-surgery.
|
Attention Control (Educate) Group (ACG)
n=54 Participants
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.
|
|---|---|---|---|
|
Functional Status Performance
|
39.51 Scores on a scale
Standard Deviation 10.56
|
45.97 Scores on a scale
Standard Deviation 7.62
|
35.57 Scores on a scale
Standard Deviation 9.23
|
SECONDARY outcome
Timeframe: about 6 weeks after discharge from the hospitalTotal 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).
Outcome measures
| Measure |
Wait-list Control Group (WCG)
n=55 Participants
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.
|
Immediate Intervention (No-wait) Group (IIG)
n=60 Participants
IIG participants receive the exercise intervention during weeks 1-12 post-surgery.
|
Attention Control (Educate) Group (ACG)
n=54 Participants
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.
|
|---|---|---|---|
|
Quality of Life as Assessed Using the Quality of Life Index
|
23.61 Scores on a scale
Standard Deviation 4.76
|
24.98 Scores on a scale
Standard Deviation 3.91
|
21.92 Scores on a scale
Standard Deviation 5.64
|
Adverse Events
Immediate Intervention (No-wait) Group (IIG)
Wait-list Control Group (WCG)
Attention Control (Educate) Group (ACG)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kevin A. Kupzyk, PhD
University of Nebraska Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place