SONICS: Self-Guided Online Cognitive Behavioral Strategies for Chemotherapy-Induced Peripheral Neuropathy
Sponsor
University of Michigan (Other)
Overall Status
Completed
CT.gov ID
NCT02760654
Collaborator
St. Joseph Mercy Health System (Other)
60
5
2
8
12
1.5
Study Details
Study Description
Brief Summary
The purpose of this pilot randomized wait-list controlled trial is to test the efficacy of an online cognitive behavioral pain management website called Proactive Self-Management Program for Effects of Cancer Treatment (PROPSECT) to reduce worst pain intensity for individuals with chronic painful chemotherapy-induced peripheral neuropathy (CIPN) and to explore the mediating effect of PROSPECT-induced changes in anxiety, fatigue, depression, and sleep disturbance on worst pain intensity. Another aim of this study is to determine whether PROSPECT will decrease CIPN symptom severity (e.g. non-painful numbness and tingling), average pain severity, and physical impairment. Lastly, since this intervention has never been tested in individuals with painful CIPN, the investigators will assess patients' perceptions of acceptability and satisfaction with the intervention.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Supportive Care
Official Title:
Self-Guided Online Cognitive Behavioral Strategies for Chemotherapy-Induced Peripheral Neuropathy
Study Start Date
:
Apr 1, 2016
Actual Primary Completion Date
:
Dec 1, 2016
Actual Study Completion Date
:
Dec 1, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Device: Proactive Self Management Program for Effects of Cancer Treatment
|
| No Intervention: Control Treatment as usual |
Outcome Measures
Primary Outcome Measures
- Change in 0 - 10 Numerical Rating Scale of Worst Pain Intensity Scores at 8 Weeks [Baseline to 8 weeks]
Pain is measured on the numerical rating scale of 0 - 10 where 0 is no pain and 10 is worst imaginable pain.
Secondary Outcome Measures
- Change in PROMIS Short Form Emotional Distress - Depression 4a Scores at 8 Weeks [Baseline to 8 weeks]
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.
- PROMIS Short Form Anxiety 4a [Baseline to 8 weeks]
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.
- Change in PROMIS Short Form Fatigue 4a Scores at 8 Weeks [Baseline to 8 weeks]
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.
- Change in PROMIS Short Form Sleep-Related Impairment 8a Scores at 8 Weeks [Baseline to 8 weeks]
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.
- Patient Global Impression of Change [8 week]
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.
- Change in 0 - 10 Average Pain Intensity Numerical Rating Scale Scores at 8 Weeks [Baseline to 8 weeks]
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.
- Adapted Acceptability E-Scale [8 week]
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.
- Change in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy Scale Scores at 8 Weeks [Baseline to 8 weeks]
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.
- Change in PROMIS Pain Interference 4a Scores at 8 Weeks [Baseline to 8 weeks]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
25 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
over 25 years of age
-
self-report 4/10 worst CIPN pain that has persisted three months or longer after the cessation of their neurotoxic chemotherapy regimen
-
have at least grade one sensory CIPN as defined by their oncology provider using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
-
have a stable analgesic medication regimen as evidenced by a less than 10% increase or decrease in their analgesic medication dosage in the two weeks leading up to their enrollment in the study
-
have internet access
-
self-report the ability to use a computer
-
signed informed consent
-
willingness to participate in all study activities.
Exclusion Criteria:
-
prognosis of less than three months
-
documented peripheral neuropathy due to other causes (diabetes, alcohol abuse, Central Nervous System malignancy, vitamin B deficiency, hereditary, nerve compression injury)
-
neurotoxic chemotherapy treatment regimens are planned to occur while enrolled in the study
-
have participated in cognitive behavioral pain management in the past or plan to enroll in cognitive behavioral pain management during the course of the intervention.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
| 2 | St. Joseph Mercy Canton | Canton | Michigan | United States | 48188 |
| 3 | St. Joseph Mercy Chelsea | Chelsea | Michigan | United States | 48118 |
| 4 | St. Joseph Mercy Livingston | Howell | Michigan | United States | 48843 |
| 5 | St. Joseph Mercy Ann Arbor | Ypsilanti | Michigan | United States | 48104 |
Sponsors and Collaborators
- University of Michigan
- St. Joseph Mercy Health System
Investigators
- Principal Investigator: Robert Knoerl, PhD, RN, University of Michigan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Robert Knoerl,
Dr.,
University of Michigan
ClinicalTrials.gov Identifier:
NCT02760654
Other Study ID Numbers:
- HUM00104185
First Posted:
May 3, 2016
Last Update Posted:
Nov 13, 2017
Last Verified:
Oct 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Online Self Management | Control |
|---|---|---|
| Arm/Group Description | 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 | Treatment as usual |
| Period Title: Overall Study | ||
| STARTED | 30 | 30 |
| COMPLETED | 23 | 24 |
| NOT COMPLETED | 7 | 6 |
Baseline Characteristics
| Arm/Group Title | Online Self Management | Control | Total |
|---|---|---|---|
| Arm/Group Description | 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 | Treatment as usual | Total of all reporting groups |
| Overall Participants | 30 | 30 | 60 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
58.93
(9.33)
|
63.37
(8.36)
|
61.15
(9.06)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
23
76.7%
|
22
73.3%
|
45
75%
|
| Male |
7
23.3%
|
8
26.7%
|
15
25%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
0
0%
|
1
3.3%
|
1
1.7%
|
| Not Hispanic or Latino |
25
83.3%
|
22
73.3%
|
47
78.3%
|
| Unknown or Not Reported |
5
16.7%
|
7
23.3%
|
12
20%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
2
6.7%
|
1
3.3%
|
3
5%
|
| White |
27
90%
|
28
93.3%
|
55
91.7%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
1
3.3%
|
1
3.3%
|
2
3.3%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
30
100%
|
30
100%
|
60
100%
|
| Education (Count of Participants) | |||
| High School or less |
4
13.3%
|
6
20%
|
10
16.7%
|
| Some College |
13
43.3%
|
12
40%
|
25
41.7%
|
| College Graduate |
8
26.7%
|
6
20%
|
14
23.3%
|
| Post Graduate Degree |
5
16.7%
|
5
16.7%
|
10
16.7%
|
| Missing/Unknown |
0
0%
|
1
3.3%
|
1
1.7%
|
| Employment Status (Count of Participants) | |||
| Employed |
13
43.3%
|
7
23.3%
|
20
33.3%
|
| Out of Work |
3
10%
|
2
6.7%
|
5
8.3%
|
| Homemaker |
0
0%
|
1
3.3%
|
1
1.7%
|
| Retired |
9
30%
|
17
56.7%
|
26
43.3%
|
| Unable to Work |
5
16.7%
|
3
10%
|
8
13.3%
|
| Marital Status (Count of Participants) | |||
| Single |
2
6.7%
|
2
6.7%
|
4
6.7%
|
| Married |
18
60%
|
24
80%
|
42
70%
|
| Separated |
1
3.3%
|
1
3.3%
|
2
3.3%
|
| Divorced |
7
23.3%
|
2
6.7%
|
9
15%
|
| Widowed |
2
6.7%
|
1
3.3%
|
3
5%
|
| Amount of Computer Use (Count of Participants) | |||
| Once a month |
1
3.3%
|
6
20%
|
7
11.7%
|
| About once a week |
1
3.3%
|
1
3.3%
|
2
3.3%
|
| More than once a week |
28
93.3%
|
23
76.7%
|
51
85%
|
| Cancer Stage (Count of Participants) | |||
| Early I-II |
13
43.3%
|
9
30%
|
22
36.7%
|
| III |
10
33.3%
|
11
36.7%
|
21
35%
|
| Metastatic (IV) |
6
20%
|
9
30%
|
15
25%
|
| Unknown |
1
3.3%
|
1
3.3%
|
2
3.3%
|
| Cancer Type (Count of Participants) | |||
| Breast |
13
43.3%
|
10
33.3%
|
23
38.3%
|
| Gastrointestinal |
13
43.3%
|
13
43.3%
|
26
43.3%
|
| Lung |
1
3.3%
|
3
10%
|
4
6.7%
|
| Multiple |
1
3.3%
|
2
6.7%
|
3
5%
|
| Lymphoma |
2
6.7%
|
1
3.3%
|
3
5%
|
| Genitourinary |
0
0%
|
1
3.3%
|
1
1.7%
|
| Chemotherapy Type (Count of Participants) | |||
| Platinums |
13
43.3%
|
13
43.3%
|
26
43.3%
|
| Taxanes |
12
40%
|
8
26.7%
|
20
33.3%
|
| Bortezomib |
1
3.3%
|
0
0%
|
1
1.7%
|
| Vinca Alkaloids |
1
3.3%
|
2
6.7%
|
3
5%
|
| Multiple |
3
10%
|
7
23.3%
|
10
16.7%
|
| Chemotherapy Name (Count of Participants) | |||
| Oxaliplatin |
13
43.3%
|
13
43.3%
|
26
43.3%
|
| Paclitaxel |
9
30%
|
4
13.3%
|
13
21.7%
|
| Docetaxel |
1
3.3%
|
3
10%
|
4
6.7%
|
| Abraxane |
1
3.3%
|
0
0%
|
1
1.7%
|
| Vincristine |
1
3.3%
|
2
6.7%
|
3
5%
|
| Bortezomib |
1
3.3%
|
0
0%
|
1
1.7%
|
| Multiple |
4
13.3%
|
8
26.7%
|
12
20%
|
| Pain-related Symptoms (units on a scale) [Mean (Standard Deviation) ] | |||
| Anxiety (40.3 -81.6) |
54.79
(9.42)
|
51.58
(7.83)
|
53.18
(6.58)
|
| Depression (41.0 -79.4) |
52.92
(7.98)
|
49.51
(7.17)
|
51.22
(8.74)
|
| Fatigue (33.7 - 75.8) |
59.18
(8.26)
|
52.73
(8.25)
|
55.95
(7.71)
|
| Sleep-related Impairment (30.0 - 80.1) |
58.65
(6.67)
|
55.07
(6.09)
|
56.86
(8.81)
|
Outcome Measures
| Title | Change in 0 - 10 Numerical Rating Scale of Worst Pain Intensity Scores at 8 Weeks |
|---|---|
| Description | Pain is measured on the numerical rating scale of 0 - 10 where 0 is no pain and 10 is worst imaginable pain. |
| Time Frame | Baseline to 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Online Self Management | Control |
|---|---|---|
| Arm/Group Description | 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 | Treatment as usual |
| Measure Participants | 19 | 19 |
| Mean (Standard Deviation) [units on a scale] |
-0.94
(1.36)
|
0
(1.31)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Online Self Management, Control |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Title | Change in PROMIS Short Form Emotional Distress - Depression 4a Scores at 8 Weeks |
|---|---|
| Description | 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. |
| Time Frame | Baseline to 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Online Self Management | Control |
|---|---|---|
| Arm/Group Description | 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 | Treatment as usual |
| Measure Participants | 19 | 23 |
| Mean (Standard Deviation) [units on a scale] |
-0.46
(6.15)
|
-1.27
(5.02)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Online Self Management, Control |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | >0.05 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Title | PROMIS Short Form Anxiety 4a |
|---|---|
| Description | 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. |
| Time Frame | Baseline to 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Online Self Management | Control |
|---|---|---|
| Arm/Group Description | 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 | Treatment as usual |
| Measure Participants | 19 | 23 |
| Mean (Standard Deviation) [units on a scale] |
-1.26
(5.42)
|
-1.05
(8.46)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Online Self Management, Control |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | >0.05 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Title | Change in PROMIS Short Form Fatigue 4a Scores at 8 Weeks |
|---|---|
| Description | 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. |
| Time Frame | Baseline to 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Online Self Management | Control |
|---|---|---|
| Arm/Group Description | 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 | Treatment as usual |
| Measure Participants | 19 | 23 |
| Mean (Standard Deviation) [units on a scale] |
-2.53
(5.99)
|
-1.69
(5.26)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Online Self Management, Control |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | >0.05 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Title | Change in PROMIS Short Form Sleep-Related Impairment 8a Scores at 8 Weeks |
|---|---|
| Description | 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. |
| Time Frame | Baseline to 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Online Self Management | Control |
|---|---|---|
| Arm/Group Description | 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 | Treatment as usual |
| Measure Participants | 19 | 23 |
| Mean (Standard Deviation) [units on a scale] |
-2.42
(4.05)
|
-1.29
(3.39)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Online Self Management, Control |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | >0.05 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Title | Patient Global Impression of Change |
|---|---|
| Description | 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. |
| Time Frame | 8 week |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Online Self Management | Control |
|---|---|---|
| Arm/Group Description | 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 | Treatment as usual |
| Measure Participants | 19 | 22 |
| Improved |
9
30%
|
6
20%
|
| No Change/Worse |
10
33.3%
|
16
53.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Online Self Management, Control |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | >0.05 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Title | Change in 0 - 10 Average Pain Intensity Numerical Rating Scale Scores at 8 Weeks |
|---|---|
| Description | 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. |
| Time Frame | Baseline to 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Online Self Management | Control |
|---|---|---|
| Arm/Group Description | 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 | Treatment as usual |
| Measure Participants | 19 | 23 |
| Mean (Standard Deviation) [units on a scale] |
0.21
(2.59)
|
1.44
(2.87)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Online Self Management, Control |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | >0.05 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Title | Adapted Acceptability E-Scale |
|---|---|
| Description | 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. |
| Time Frame | 8 week |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Online Self Management | Control |
|---|---|---|
| Arm/Group Description | 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 | Treatment as usual |
| Measure Participants | 19 | 0 |
| How easy was it to access the website on your comp |
4.58
(0.84)
|
|
| How understandable was the content presented withi |
4.58
(0.69)
|
|
| How much did you enjoy using the website? |
3.26
(1.05)
|
|
| How helpful was it to read and participate in the |
3.36
(0.96)
|
|
| Was the amount of time it took to complete the act |
4
(1.11)
|
|
| Was the amount of time it took to complete the stu |
4.42
(1.02)
|
|
| Overall, how would you rate your satisfaction with |
3.95
(0.71)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Online Self Management |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Equivalence | |
| Comments | Descriptive statistics (Mean, SD) were calculated for the 7 items of the Adapted Acceptability E-Scale | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Calculated Mean and Standard Deviation |
| Estimated Value | 0.05 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy Scale Scores at 8 Weeks |
|---|---|
| Description | 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. |
| Time Frame | Baseline to 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Online Self Management | Control |
|---|---|---|
| Arm/Group Description | 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 | Treatment as usual |
| Measure Participants | 19 | 23 |
| Sensory Subscale |
-8.93
(17.69)
|
4.04
(13.57)
|
| Motor Subscale |
-7.3
(15.6)
|
-3.08
(14.37)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Online Self Management, Control |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | >0.05 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Title | Change in PROMIS Pain Interference 4a Scores at 8 Weeks |
|---|---|
| Description | 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. |
| Time Frame | Baseline to 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Online Self Management | Control |
|---|---|---|
| Arm/Group Description | 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 | Treatment as usual |
| Measure Participants | 19 | 23 |
| Mean (Standard Deviation) [units on a scale] |
-1.10
(7.58)
|
-0.89
(2.89)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Online Self Management, Control |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | >0.05 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Adverse Events
| Time Frame | Adverse event data was collected from the Baseline (Time of randomization) to the Week 8 (Final) time points. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | We called participants 4 and 8 weeks after beginning the study to ask them if they experienced any negative effects from participating in the study. | |||
| Arm/Group Title | Online Self Management | Control | ||
| Arm/Group Description | 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 | Treatment as usual | ||
All Cause Mortality |
||||
| Online Self Management | Control | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/30 (0%) | 0/30 (0%) | ||
Serious Adverse Events |
||||
| Online Self Management | Control | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/30 (0%) | 0/30 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Online Self Management | Control | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/30 (0%) | 0/30 (0%) | ||
Limitations/Caveats
Small sample size, high drop out, lack of active monitoring of intervention usage, lack of generalizability to any specific type of chronic painful neuropathy, and changes in pain medications during the trial may have confounded the primary analysis.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Robert Knoerl, Doctoral Student |
|---|---|
| Organization | University of Michigan School of Nursing |
| Phone | 734-536-9369 |
| rjknoerl@umich.edu |
Responsible Party:
Robert Knoerl,
Dr.,
University of Michigan
ClinicalTrials.gov Identifier:
NCT02760654
Other Study ID Numbers:
- HUM00104185
First Posted:
May 3, 2016
Last Update Posted:
Nov 13, 2017
Last Verified:
Oct 1, 2017