N/A
N=60
Self-Guided Online Cognitive Behavioral Strategies for Chemotherapy-Induced Peripheral Neuropathy
Peripheral Nervous System Diseases · Pain Management · Self Management
Bottom Line
View on ClinicalTrials.gov: NCT02760654 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Change in 0 - 10 Numerical Rating Scale of Worst Pain Intensity Scores at 8 Weeks — -0.94; 0 units on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Proactive Self Management Program for Effects of Cancer Treatment (Device)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in 0 - 10 Numerical Rating Scale of Worst Pain Intensity Scores at 8 Weeks |
-0.94; 0 | <0.05 sig |
| SECONDARY Change in PROMIS Short Form Emotional Distress - Depression 4a Scores at 8 Weeks |
-0.46; -1.27 | >0.05 |
| SECONDARY PROMIS Short Form Anxiety 4a |
-1.26; -1.05 | >0.05 |
| SECONDARY Change in PROMIS Short Form Fatigue 4a Scores at 8 Weeks |
-2.53; -1.69 | >0.05 |
| SECONDARY Change in PROMIS Short Form Sleep-Related Impairment 8a Scores at 8 Weeks |
-2.42; -1.29 | >0.05 |
| SECONDARY Patient Global Impression of Change |
9; 6; 10; 16 | >0.05 |
| SECONDARY Change in 0 - 10 Average Pain Intensity Numerical Rating Scale Scores at 8 Weeks |
0.21; 1.44 | >0.05 |
| SECONDARY Adapted Acceptability E-Scale |
4.58; 4.58; 3.26; 3.36; 4; 4.42 | — |
| SECONDARY Change in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy Scale Scores at 8 Weeks |
-8.93; 4.04; -7.3; -3.08 | >0.05 |
| SECONDARY Change in PROMIS Pain Interference 4a Scores at 8 Weeks |
-1.10; -0.89 | >0.05 |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02760654). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.