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

Pain Management Clinical Trial

— SONICS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02760654
• Other study ID #: HUM00104185
• Status: Completed
• Phase: N/A
• First received: April 28, 2016
• Last updated: October 10, 2017
• Start date: April 2016
• Est. completion date: December 2016

Study information

• Verified date: October 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nervous System Diseases
• Pain Management
• Peripheral Nervous System Diseases
• Self Management

Intervention

Device:
• Proactive Self Management Program for Effects of Cancer Treatment

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	St. Joseph Mercy Canton	Canton	Michigan
United States	St. Joseph Mercy Chelsea	Chelsea	Michigan
United States	St. Joseph Mercy Livingston	Howell	Michigan
United States	St. Joseph Mercy Ann Arbor	Ypsilanti	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	St. Joseph Mercy Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline to 8 weeks
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.	Baseline to 8 weeks
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.	Baseline to 8 weeks
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.	Baseline to 8 weeks
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.	Baseline to 8 weeks
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.	8 week
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.	Baseline to 8 weeks
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.	8 week
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.	Baseline to 8 weeks
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.	Baseline to 8 weeks