Self-Guided Online Cognitive Behavioral Strategies for Chemotherapy-Induced Peripheral Neuropathy

Not Applicable

Completed

• Conditions: Peripheral Nervous System Diseases; Pain Management; Self Management
• Interventions: Device: Proactive Self Management Program for Effects of Cancer Treatment

• Registration Number: NCT02760654
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-28
• Study First Submitted QC: 2016-04-30
• Study First Posted: 2016-05-03
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Results First Submitted: 2017-03-04
• Results First Submitted QC: 2017-04-26
• Results First Posted: 2017-06-02
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-10
• Last Update Posted: 2017-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Online Self Management	Proactive Self Management Program for Effects of Cancer Treatment	Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (5)

St. Joseph Mercy Canton; 🇺🇸 Canton, Michigan, United States

St. Joseph Mercy Chelsea; 🇺🇸 Chelsea, Michigan, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

St. Joseph Mercy Livingston; 🇺🇸 Howell, Michigan, United States

St. Joseph Mercy Ann Arbor; 🇺🇸 Ypsilanti, Michigan, United States