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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

235 participants

Primary outcome timeframe

about 6 weeks after discharge from the hospital

Results posted on

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

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

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 hospital

The Brief Fatigue Inventory measured the degree of cancer-related fatigue severity on an 11-point scale (0-10, 10 = most severe)

Outcome measures

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 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.

Outcome measures

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 hospital

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).

Outcome measures

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 hospital

A persons's perception of ability to manage fatigue on an 11-point scale (0-10, 10 = very certain)

Outcome measures

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 hospital

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.

Outcome measures

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 hospital

A person's perception of balance during every day activities using an 11-point scale (0-10; 0=0% confident, 10 = 100% confident)

Outcome measures

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 hospital

Performance in average number of walking steps taken per day per week. Measured by a pedometer.

Outcome measures

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 hospital

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.

Outcome measures

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 hospital

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).

Outcome measures

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)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Wait-list Control Group (WCG)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Attention Control (Educate) Group (ACG)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: 402-559-7262

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place