Trial Outcomes & Findings for Self-Guided Online Cognitive Behavioral Strategies for Chemotherapy-Induced Peripheral Neuropathy (NCT NCT02760654)
NCT ID: NCT02760654
Last Updated: 2017-11-13
Results Overview
Pain is measured on the numerical rating scale of 0 - 10 where 0 is no pain and 10 is worst imaginable pain.
COMPLETED
NA
60 participants
Baseline to 8 weeks
2017-11-13
Participant Flow
Participant milestones
| Measure |
Online Self Management
Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.
Proactive Self Management Program for Effects of Cancer Treatment
|
Control
Treatment as usual
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
23
|
24
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
| Measure |
Online Self Management
Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.
Proactive Self Management Program for Effects of Cancer Treatment
|
Control
Treatment as usual
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
Baseline Characteristics
Self-Guided Online Cognitive Behavioral Strategies for Chemotherapy-Induced Peripheral Neuropathy
Baseline characteristics by cohort
| Measure |
Online Self Management
n=30 Participants
Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.
Proactive Self Management Program for Effects of Cancer Treatment
|
Control
n=30 Participants
Treatment as usual
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.93 years
STANDARD_DEVIATION 9.33 • n=5 Participants
|
63.37 years
STANDARD_DEVIATION 8.36 • n=7 Participants
|
61.15 years
STANDARD_DEVIATION 9.06 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Education
High School or less
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Education
Some College
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Education
College Graduate
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Education
Post Graduate Degree
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Education
Missing/Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Employment Status
Employed
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Employment Status
Out of Work
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Employment Status
Homemaker
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Employment Status
Retired
|
9 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Employment Status
Unable to Work
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Marital Status
Single
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Marital Status
Married
|
18 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Marital Status
Separated
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Marital Status
Divorced
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Marital Status
Widowed
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Amount of Computer Use
Once a month
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Amount of Computer Use
About once a week
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Amount of Computer Use
More than once a week
|
28 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Cancer Stage
Early I-II
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Cancer Stage
III
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Cancer Stage
Metastatic (IV)
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Cancer Stage
Unknown
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Cancer Type
Breast
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Cancer Type
Gastrointestinal
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Cancer Type
Lung
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Cancer Type
Multiple
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Cancer Type
Lymphoma
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Cancer Type
Genitourinary
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Chemotherapy Type
Platinums
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Chemotherapy Type
Taxanes
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Chemotherapy Type
Bortezomib
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Chemotherapy Type
Vinca Alkaloids
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Chemotherapy Type
Multiple
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Chemotherapy Name
Oxaliplatin
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Chemotherapy Name
Paclitaxel
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Chemotherapy Name
Docetaxel
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Chemotherapy Name
Abraxane
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Chemotherapy Name
Vincristine
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Chemotherapy Name
Bortezomib
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Chemotherapy Name
Multiple
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Pain-related Symptoms
Anxiety (40.3 -81.6)
|
54.79 units on a scale
STANDARD_DEVIATION 9.42 • n=5 Participants
|
51.58 units on a scale
STANDARD_DEVIATION 7.83 • n=7 Participants
|
53.18 units on a scale
STANDARD_DEVIATION 6.58 • n=5 Participants
|
|
Pain-related Symptoms
Depression (41.0 -79.4)
|
52.92 units on a scale
STANDARD_DEVIATION 7.98 • n=5 Participants
|
49.51 units on a scale
STANDARD_DEVIATION 7.17 • n=7 Participants
|
51.22 units on a scale
STANDARD_DEVIATION 8.74 • n=5 Participants
|
|
Pain-related Symptoms
Fatigue (33.7 - 75.8)
|
59.18 units on a scale
STANDARD_DEVIATION 8.26 • n=5 Participants
|
52.73 units on a scale
STANDARD_DEVIATION 8.25 • n=7 Participants
|
55.95 units on a scale
STANDARD_DEVIATION 7.71 • n=5 Participants
|
|
Pain-related Symptoms
Sleep-related Impairment (30.0 - 80.1)
|
58.65 units on a scale
STANDARD_DEVIATION 6.67 • n=5 Participants
|
55.07 units on a scale
STANDARD_DEVIATION 6.09 • n=7 Participants
|
56.86 units on a scale
STANDARD_DEVIATION 8.81 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 8 weeksPopulation: Only 19 people in each arm out of the 23 and 24 that completed the study actually completed the information for this measure. Thus only 19 are analyzed.
Pain is measured on the numerical rating scale of 0 - 10 where 0 is no pain and 10 is worst imaginable pain.
Outcome measures
| Measure |
Online Self Management
n=19 Participants
Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.
Proactive Self Management Program for Effects of Cancer Treatment
|
Control
n=19 Participants
Treatment as usual
|
|---|---|---|
|
Change in 0 - 10 Numerical Rating Scale of Worst Pain Intensity Scores at 8 Weeks
|
-0.94 units on a scale
Standard Deviation 1.36
|
0 units on a scale
Standard Deviation 1.31
|
SECONDARY outcome
Timeframe: Baseline to 8 weeksPopulation: Only 19 in the people in the online self-management group and 23 in the Control group of the 23 and 24 that completed the study actually completed the information for this measure. Thus only 19 and 23 respectively are analyzed.
The PROMIS short form emotional distress depression 4a Scores are measured on a scale whose lowest possible score is 41.0 and highest is 79.4 where 41 is no emotional distress and 79.4 is extreme distress.
Outcome measures
| Measure |
Online Self Management
n=19 Participants
Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.
Proactive Self Management Program for Effects of Cancer Treatment
|
Control
n=23 Participants
Treatment as usual
|
|---|---|---|
|
Change in PROMIS Short Form Emotional Distress - Depression 4a Scores at 8 Weeks
|
-0.46 units on a scale
Standard Deviation 6.15
|
-1.27 units on a scale
Standard Deviation 5.02
|
SECONDARY outcome
Timeframe: Baseline to 8 weeksPopulation: Only 19 in the people in the online self-management group and 23 in the Control group of the 23 and 24 that completed the study actually completed the information for this measure. Thus only 19 and 23 respectively are analyzed.
The PROMIS Short Form Anxiety 4a is scored on a scale of 40.3 - 81.6, with a score of 40.3 meaning no anxiety and a score of 81.6 meaning high anxiety.
Outcome measures
| Measure |
Online Self Management
n=19 Participants
Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.
Proactive Self Management Program for Effects of Cancer Treatment
|
Control
n=23 Participants
Treatment as usual
|
|---|---|---|
|
PROMIS Short Form Anxiety 4a
|
-1.26 units on a scale
Standard Deviation 5.42
|
-1.05 units on a scale
Standard Deviation 8.46
|
SECONDARY outcome
Timeframe: Baseline to 8 weeksPopulation: Only 19 in the people in the online self-management group and 23 in the Control group of the 23 and 24 that completed the study actually completed the information for this measure. Thus only 19 and 23 respectively are analyzed.
The PROMIS Short Form Fatigue 4a is scored on a scale of 33.7 to 75.8, with a score of 33.7 meaning no fatigue and a score of 75.8 meaning high fatigue.
Outcome measures
| Measure |
Online Self Management
n=19 Participants
Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.
Proactive Self Management Program for Effects of Cancer Treatment
|
Control
n=23 Participants
Treatment as usual
|
|---|---|---|
|
Change in PROMIS Short Form Fatigue 4a Scores at 8 Weeks
|
-2.53 units on a scale
Standard Deviation 5.99
|
-1.69 units on a scale
Standard Deviation 5.26
|
SECONDARY outcome
Timeframe: Baseline to 8 weeksPopulation: Only 19 in the people in the online self-management group and 23 in the Control group of the 23 and 24 that completed the study actually completed the information for this measure. Thus only 19 and 23 respectively are analyzed.
The PROMIS Short Form Sleep-Related Impairment 8a is scored on a scale of 30.0 to 80.1 with a score of 30.0 meaning no sleep-related impairment and a score of 80.1 meaning a high degree of impairment in daily activities due to poor sleep.
Outcome measures
| Measure |
Online Self Management
n=19 Participants
Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.
Proactive Self Management Program for Effects of Cancer Treatment
|
Control
n=23 Participants
Treatment as usual
|
|---|---|---|
|
Change in PROMIS Short Form Sleep-Related Impairment 8a Scores at 8 Weeks
|
-2.42 units on a scale
Standard Deviation 4.05
|
-1.29 units on a scale
Standard Deviation 3.39
|
SECONDARY outcome
Timeframe: 8 weekPopulation: Only 19 in the people in the online self-management group and 22 in the Control group of the 23 and 24 that completed the study actually completed the information for this measure. Thus only 19 and 22 respectively are analyzed.
The Patient Global Impression of Change is scored on a scale of 1 - 7, with a score of 1 representing that the patient was very much worse following the trial, and a score of 7 representing that the patient was very much improved following the course of the trial.
Outcome measures
| Measure |
Online Self Management
n=19 Participants
Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.
Proactive Self Management Program for Effects of Cancer Treatment
|
Control
n=22 Participants
Treatment as usual
|
|---|---|---|
|
Patient Global Impression of Change
Improved
|
9 Participants
|
6 Participants
|
|
Patient Global Impression of Change
No Change/Worse
|
10 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Baseline to 8 weeksPopulation: Only 19 in the people in the online self-management group and 23 in the Control group of the 23 and 24 that completed the study actually completed the information for this measure. Thus only 19 and 23 respectively are analyzed.
The 0 - 10 Average Pain Intensity Numerical Rating Scale was scored on a scale of 0 - 10, with a score of 0 meaning no pain, and a score of 10 meaning worst pain imaginable.
Outcome measures
| Measure |
Online Self Management
n=19 Participants
Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.
Proactive Self Management Program for Effects of Cancer Treatment
|
Control
n=23 Participants
Treatment as usual
|
|---|---|---|
|
Change in 0 - 10 Average Pain Intensity Numerical Rating Scale Scores at 8 Weeks
|
0.21 units on a scale
Standard Deviation 2.59
|
1.44 units on a scale
Standard Deviation 2.87
|
SECONDARY outcome
Timeframe: 8 weekPopulation: Only 19 in the people in the online self-management group of the 23 that completed the study actually completed the information for this measure. Thus only 19 are analyzed. No participants in the control group were administered this measure because the questions pertained to the acceptability and satisfaction of the online self management program.
The Adapted Acceptability E- Scale contains 7 items that are scored on a 1 - 5 scale, with a score of 1 representing low ratings of acceptability and satisfaction with the online self management program, and a score of 5 representing high ratings of acceptability and satisfaction with the online self management program. This measure was only administered to individuals participating in the online self management program.
Outcome measures
| Measure |
Online Self Management
n=19 Participants
Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.
Proactive Self Management Program for Effects of Cancer Treatment
|
Control
Treatment as usual
|
|---|---|---|
|
Adapted Acceptability E-Scale
How easy was it to access the website on your comp
|
4.58 units on a scale
Standard Deviation 0.84
|
—
|
|
Adapted Acceptability E-Scale
How understandable was the content presented withi
|
4.58 units on a scale
Standard Deviation 0.69
|
—
|
|
Adapted Acceptability E-Scale
How much did you enjoy using the website?
|
3.26 units on a scale
Standard Deviation 1.05
|
—
|
|
Adapted Acceptability E-Scale
How helpful was it to read and participate in the
|
3.36 units on a scale
Standard Deviation 0.96
|
—
|
|
Adapted Acceptability E-Scale
Was the amount of time it took to complete the act
|
4 units on a scale
Standard Deviation 1.11
|
—
|
|
Adapted Acceptability E-Scale
Was the amount of time it took to complete the stu
|
4.42 units on a scale
Standard Deviation 1.02
|
—
|
|
Adapted Acceptability E-Scale
Overall, how would you rate your satisfaction with
|
3.95 units on a scale
Standard Deviation 0.71
|
—
|
SECONDARY outcome
Timeframe: Baseline to 8 weeksPopulation: Only 19 in the people in the online self-management group and 23 in the Control group of the 23 and 24 that completed the study actually completed the information for this measure. Thus only 19 and 23 respectively are analyzed.
The European Organization of Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy contains three subscales: Sensory, Motor, and Autonomic. Each subscale is scored on a scale of 0 - 100, with a score of 0 representing no neuropathy symptoms and functional impairment due to neuropathy, and a score of 100 represents severe neuropathy symptoms and functional impairment due to neuropathy. Only the Sensory and Motor subscales were used in this current study.
Outcome measures
| Measure |
Online Self Management
n=19 Participants
Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.
Proactive Self Management Program for Effects of Cancer Treatment
|
Control
n=23 Participants
Treatment as usual
|
|---|---|---|
|
Change in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy Scale Scores at 8 Weeks
Sensory Subscale
|
-8.93 units on a scale
Standard Deviation 17.69
|
4.04 units on a scale
Standard Deviation 13.57
|
|
Change in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy Scale Scores at 8 Weeks
Motor Subscale
|
-7.3 units on a scale
Standard Deviation 15.6
|
-3.08 units on a scale
Standard Deviation 14.37
|
SECONDARY outcome
Timeframe: Baseline to 8 weeksPopulation: Only 19 in the people in the online self-management group and 23 in the Control group of the 23 and 24 that completed the study actually completed the information for this measure. Thus only 19 and 23 respectively are analyzed.
The PROMIS Pain Interference 4a is scored on a scale of 41.6 to 75.6, with a score of 41.6 meaning little or no interference with daily activities due to pain severity, and a score of 75.6 meaning a high degree of interference with daily activities due to pain severity.
Outcome measures
| Measure |
Online Self Management
n=19 Participants
Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.
Proactive Self Management Program for Effects of Cancer Treatment
|
Control
n=23 Participants
Treatment as usual
|
|---|---|---|
|
Change in PROMIS Pain Interference 4a Scores at 8 Weeks
|
-1.10 units on a scale
Standard Deviation 7.58
|
-0.89 units on a scale
Standard Deviation 2.89
|
Adverse Events
Online Self Management
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Robert Knoerl, Doctoral Student
University of Michigan School of Nursing
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place