Pain Management, Peripheral Nervous System Diseases, Self Management
Conditions
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.
Interventions
DEVICEProactive Self Management Program for Effects of Cancer Treatment
Sponsors
St. Joseph Mercy Health System
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. over 25 years of age 2. self-report 4/10 worst CIPN pain that has persisted three months or longer after the cessation of their neurotoxic chemotherapy regimen 3. 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) 4. 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 5. have internet access 6. self-report the ability to use a computer 7. signed informed consent 8. willingness to participate in all study activities.
Exclusion criteria
1. prognosis of less than three months 2. documented peripheral neuropathy due to other causes (diabetes, alcohol abuse, Central Nervous System malignancy, vitamin B deficiency, hereditary, nerve compression injury) 3. neurotoxic chemotherapy treatment regimens are planned to occur while enrolled in the study 4. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 30 |
| Control Treatment as usual | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 3 |
| Overall Study | Withdrawal by Subject | 4 | 3 |
Baseline characteristics
| Characteristic | Online Self Management | Control | Total |
|---|---|---|---|
| Age, Continuous | 58.93 years STANDARD_DEVIATION 9.33 | 63.37 years STANDARD_DEVIATION 8.36 | 61.15 years STANDARD_DEVIATION 9.06 |
| Amount of Computer Use About once a week | 1 Participants | 1 Participants | 2 Participants |
| Amount of Computer Use More than once a week | 28 Participants | 23 Participants | 51 Participants |
| Amount of Computer Use Once a month | 1 Participants | 6 Participants | 7 Participants |
| Cancer Stage Early I-II | 13 Participants | 9 Participants | 22 Participants |
| Cancer Stage III | 10 Participants | 11 Participants | 21 Participants |
| Cancer Stage Metastatic (IV) | 6 Participants | 9 Participants | 15 Participants |
| Cancer Stage Unknown | 1 Participants | 1 Participants | 2 Participants |
| Cancer Type Breast | 13 Participants | 10 Participants | 23 Participants |
| Cancer Type Gastrointestinal | 13 Participants | 13 Participants | 26 Participants |
| Cancer Type Genitourinary | 0 Participants | 1 Participants | 1 Participants |
| Cancer Type Lung | 1 Participants | 3 Participants | 4 Participants |
| Cancer Type Lymphoma | 2 Participants | 1 Participants | 3 Participants |
| Cancer Type Multiple | 1 Participants | 2 Participants | 3 Participants |
| Chemotherapy Name Abraxane | 1 Participants | 0 Participants | 1 Participants |
| Chemotherapy Name Bortezomib | 1 Participants | 0 Participants | 1 Participants |
| Chemotherapy Name Docetaxel | 1 Participants | 3 Participants | 4 Participants |
| Chemotherapy Name Multiple | 4 Participants | 8 Participants | 12 Participants |
| Chemotherapy Name Oxaliplatin | 13 Participants | 13 Participants | 26 Participants |
| Chemotherapy Name Paclitaxel | 9 Participants | 4 Participants | 13 Participants |
| Chemotherapy Name Vincristine | 1 Participants | 2 Participants | 3 Participants |
| Chemotherapy Type Bortezomib | 1 Participants | 0 Participants | 1 Participants |
| Chemotherapy Type Multiple | 3 Participants | 7 Participants | 10 Participants |
| Chemotherapy Type Platinums | 13 Participants | 13 Participants | 26 Participants |
| Chemotherapy Type Taxanes | 12 Participants | 8 Participants | 20 Participants |
| Chemotherapy Type Vinca Alkaloids | 1 Participants | 2 Participants | 3 Participants |
| Education College Graduate | 8 Participants | 6 Participants | 14 Participants |
| Education High School or less | 4 Participants | 6 Participants | 10 Participants |
| Education Missing/Unknown | 0 Participants | 1 Participants | 1 Participants |
| Education Post Graduate Degree | 5 Participants | 5 Participants | 10 Participants |
| Education Some College | 13 Participants | 12 Participants | 25 Participants |
| Employment Status Employed | 13 Participants | 7 Participants | 20 Participants |
| Employment Status Homemaker | 0 Participants | 1 Participants | 1 Participants |
| Employment Status Out of Work | 3 Participants | 2 Participants | 5 Participants |
| Employment Status Retired | 9 Participants | 17 Participants | 26 Participants |
| Employment Status Unable to Work | 5 Participants | 3 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 22 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 7 Participants | 12 Participants |
| Marital Status Divorced | 7 Participants | 2 Participants | 9 Participants |
| Marital Status Married | 18 Participants | 24 Participants | 42 Participants |
| Marital Status Separated | 1 Participants | 1 Participants | 2 Participants |
| Marital Status Single | 2 Participants | 2 Participants | 4 Participants |
| Marital Status Widowed | 2 Participants | 1 Participants | 3 Participants |
| Pain-related Symptoms Anxiety (40.3 -81.6) | 54.79 units on a scale STANDARD_DEVIATION 9.42 | 51.58 units on a scale STANDARD_DEVIATION 7.83 | 53.18 units on a scale STANDARD_DEVIATION 6.58 |
| Pain-related Symptoms Depression (41.0 -79.4) | 52.92 units on a scale STANDARD_DEVIATION 7.98 | 49.51 units on a scale STANDARD_DEVIATION 7.17 | 51.22 units on a scale STANDARD_DEVIATION 8.74 |
| Pain-related Symptoms Fatigue (33.7 - 75.8) | 59.18 units on a scale STANDARD_DEVIATION 8.26 | 52.73 units on a scale STANDARD_DEVIATION 8.25 | 55.95 units on a scale STANDARD_DEVIATION 7.71 |
| Pain-related Symptoms Sleep-related Impairment (30.0 - 80.1) | 58.65 units on a scale STANDARD_DEVIATION 6.67 | 55.07 units on a scale STANDARD_DEVIATION 6.09 | 56.86 units on a scale STANDARD_DEVIATION 8.81 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 27 Participants | 28 Participants | 55 Participants |
| Region of Enrollment United States | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 23 Participants | 22 Participants | 45 Participants |
| Sex: Female, Male Male | 7 Participants | 8 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Change in 0 - 10 Numerical Rating Scale of Worst Pain Intensity Scores at 8 Weeks
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Online Self Management | 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 |
| Control | Change in 0 - 10 Numerical Rating Scale of Worst Pain Intensity Scores at 8 Weeks | 0 units on a scale | Standard Deviation 1.31 |
p-value: <0.05ANCOVA
Secondary
Adapted Acceptability E-Scale
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Online Self Management | Adapted Acceptability E-Scale | How understandable was the content presented withi | 4.58 units on a scale | Standard Deviation 0.69 |
| Online Self Management | Adapted Acceptability E-Scale | How much did you enjoy using the website? | 3.26 units on a scale | Standard Deviation 1.05 |
| Online Self Management | Adapted Acceptability E-Scale | How helpful was it to read and participate in the | 3.36 units on a scale | Standard Deviation 0.96 |
| Online Self Management | Adapted Acceptability E-Scale | Was the amount of time it took to complete the act | 4 units on a scale | Standard Deviation 1.11 |
| Online Self Management | 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 |
| Online Self Management | Adapted Acceptability E-Scale | Overall, how would you rate your satisfaction with | 3.95 units on a scale | Standard Deviation 0.71 |
| Online Self Management | 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 |
Secondary
Change in 0 - 10 Average Pain Intensity Numerical Rating Scale Scores at 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.
Time frame: Baseline to 8 weeks
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Online Self Management | Change in 0 - 10 Average Pain Intensity Numerical Rating Scale Scores at 8 Weeks | 0.21 units on a scale | Standard Deviation 2.59 |
| Control | Change in 0 - 10 Average Pain Intensity Numerical Rating Scale Scores at 8 Weeks | 1.44 units on a scale | Standard Deviation 2.87 |
p-value: >0.05ANCOVA
Secondary
Change in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy Scale Scores at 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.
Time frame: Baseline to 8 weeks
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Online Self Management | 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 |
| Online Self Management | 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 |
| Control | 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 | 4.04 units on a scale | Standard Deviation 13.57 |
| Control | 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 | -3.08 units on a scale | Standard Deviation 14.37 |
p-value: >0.05ANCOVA
Secondary
Change in PROMIS Pain Interference 4a Scores at 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.
Time frame: Baseline to 8 weeks
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Online Self Management | Change in PROMIS Pain Interference 4a Scores at 8 Weeks | -1.10 units on a scale | Standard Deviation 7.58 |
| Control | Change in PROMIS Pain Interference 4a Scores at 8 Weeks | -0.89 units on a scale | Standard Deviation 2.89 |
p-value: >0.05ANCOVA
Secondary
Change in PROMIS Short Form Emotional Distress - Depression 4a Scores at 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.
Time frame: Baseline to 8 weeks
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Online Self Management | Change in PROMIS Short Form Emotional Distress - Depression 4a Scores at 8 Weeks | -0.46 units on a scale | Standard Deviation 6.15 |
| Control | Change in PROMIS Short Form Emotional Distress - Depression 4a Scores at 8 Weeks | -1.27 units on a scale | Standard Deviation 5.02 |
p-value: >0.05ANCOVA
Secondary
Change in PROMIS Short Form Fatigue 4a Scores at 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.
Time frame: Baseline to 8 weeks
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Online Self Management | Change in PROMIS Short Form Fatigue 4a Scores at 8 Weeks | -2.53 units on a scale | Standard Deviation 5.99 |
| Control | Change in PROMIS Short Form Fatigue 4a Scores at 8 Weeks | -1.69 units on a scale | Standard Deviation 5.26 |
p-value: >0.05ANCOVA
Secondary
Change in PROMIS Short Form Sleep-Related Impairment 8a Scores at 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.
Time frame: Baseline to 8 weeks
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Online Self Management | Change in PROMIS Short Form Sleep-Related Impairment 8a Scores at 8 Weeks | -2.42 units on a scale | Standard Deviation 4.05 |
| Control | Change in PROMIS Short Form Sleep-Related Impairment 8a Scores at 8 Weeks | -1.29 units on a scale | Standard Deviation 3.39 |
p-value: >0.05ANCOVA
Secondary
Patient Global Impression of Change
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
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Online Self Management | Patient Global Impression of Change | Improved | 9 Participants |
| Online Self Management | Patient Global Impression of Change | No Change/Worse | 10 Participants |
| Control | Patient Global Impression of Change | Improved | 6 Participants |
| Control | Patient Global Impression of Change | No Change/Worse | 16 Participants |
p-value: >0.05Fisher Exact
Secondary
PROMIS Short Form Anxiety 4a
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Online Self Management | PROMIS Short Form Anxiety 4a | -1.26 units on a scale | Standard Deviation 5.42 |
| Control | PROMIS Short Form Anxiety 4a | -1.05 units on a scale | Standard Deviation 8.46 |
p-value: >0.05ANCOVA