Trial Outcomes & Findings for The Symptom Experience Study in Persons With Non-Small Cell Lung Cancer (NCT NCT01786187)
NCT ID: NCT01786187
Last Updated: 2019-02-25
Results Overview
Rates of recruitment were measured by the percentage of those eligible who enrolled.
COMPLETED
PHASE1/PHASE2
87 participants
At the beginning of the study.
2019-02-25
Participant Flow
Participants were recruited from 3 university teaching hospitals in Michigan.This study incorporated a 2-arm randomized controlled trial design. Participants were persons who were undergoing surgery for non-small cell lung cancer and randomly assigned to 1 of 2 groups following successful completion of informed consent and baseline assessments.
Patients could become ineligible prior to starting the study postsurgery after discharge from the hospital to home at baseline data collection. For example, 3 patients decided not to have surgery and underwent chemotherapy instead and 2 patients became ineligible before hospital discharge because they no longer had a television to participate.
Participant milestones
| Measure |
Symptom Experience Group
Conventional treatment for cancer as prescribed by the participant's health care providers and will receive planned, structured, weekly telephone visits to report the experience of symptoms and health-related quality of life information.
Symptom Experience Report: Conventional treatment for cancer as prescribed by the participant's health care providers and will receive planned, structured, weekly telephone visits to report the experience of symptoms and health-related quality of life information.
|
Light Physical Activity Group
Conventional treatment for cancer as prescribed by the participant's health care providers and will receive a home-based light physical activity program to help manage a specific symptom related to cancer and cancer treatment.
Light Physical Activity: Conventional treatment for cancer as prescribed by the participant's health care providers and will receive a home-based light physical activity program to help manage a specific symptom related to cancer and cancer treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
47
|
|
Overall Study
COMPLETED
|
35
|
37
|
|
Overall Study
NOT COMPLETED
|
5
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Symptom Experience Study in Persons With Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Symptom Experience Group
n=35 Participants
Conventional treatment for cancer as prescribed by the participant's health care providers and will receive planned, structured, weekly telephone visits to report the experience of symptoms and health-related quality of life information.
Symptom Experience Report: Conventional treatment for cancer as prescribed by the participant's health care providers and will receive planned, structured, weekly telephone visits to report the experience of symptoms and health-related quality of life information.
|
Light Physical Activity Group
n=37 Participants
Conventional treatment for cancer as prescribed by the participant's health care providers and will receive a home-based light physical activity program to help manage a specific symptom related to cancer and cancer treatment.
Light Physical Activity: Conventional treatment for cancer as prescribed by the participant's health care providers and will receive a home-based light physical activity program to help manage a specific symptom related to cancer and cancer treatment.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.6 years
STANDARD_DEVIATION 10.1 • n=93 Participants
|
67.4 years
STANDARD_DEVIATION 9.7 • n=4 Participants
|
66.6 years
STANDARD_DEVIATION 9.9 • n=27 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Cancer-related fatigue severity
|
4.1 units on a scale
STANDARD_DEVIATION 1.9 • n=93 Participants
|
3.9 units on a scale
STANDARD_DEVIATION 2.7 • n=4 Participants
|
4.03 units on a scale
STANDARD_DEVIATION 2.31 • n=27 Participants
|
PRIMARY outcome
Timeframe: At the beginning of the study.Population: The overall number of participants analyzed, is the number of eligible participants after screening.
Rates of recruitment were measured by the percentage of those eligible who enrolled.
Outcome measures
| Measure |
All Participants Recruited
n=131 Participants
All Participants Recruited.
|
Symptom Experience Group
Standard of Care
|
|---|---|---|
|
Determine Feasibility as Measured by Rates of Recruitment.
|
66 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: 6-weeks.Population: Only measured in the light physical activity group.
Adherence is the percentage of those adhering to the recommended exercise.
Outcome measures
| Measure |
All Participants Recruited
n=37 Participants
All Participants Recruited.
|
Symptom Experience Group
Standard of Care
|
|---|---|---|
|
Feasibility as Measured by Adherence.
|
93 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: 6-weeks.Population: Only measured in the Light Physical Activity Group.
Retention is the percentage of those enrolled and completed and finished the program.
Outcome measures
| Measure |
All Participants Recruited
n=37 Participants
All Participants Recruited.
|
Symptom Experience Group
Standard of Care
|
|---|---|---|
|
Feasibility as Measured by Retention.
|
97 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: 6-weeks.Adverse Events is the percentage of participant's who had an adverse event.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 6-weeks.Adverse Events is the percentage of participant's who had an adverse event.
Outcome measures
| Measure |
All Participants Recruited
n=37 Participants
All Participants Recruited.
|
Symptom Experience Group
n=35 Participants
Standard of Care
|
|---|---|---|
|
Feasibility as Measured by Adverse Events.
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: At six weeks after discharge from the hospital after surgery for lung cancer.The range of the score was 0 to 10 with 10 meaning the worst cancer-related fatigue and zero meaning no cancer-related fatigue.
Outcome measures
| Measure |
All Participants Recruited
n=35 Participants
All Participants Recruited.
|
Symptom Experience Group
n=37 Participants
Standard of Care
|
|---|---|---|
|
Cancer-Related Fatigue Severity
|
4 units on a scale
Standard Deviation 2
|
0.7 units on a scale
Standard Deviation 0.7
|
Adverse Events
Symptom Experience Group
Light Physical Activity Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place