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

Completed · Not applicable

Conditions studied: Peripheral Nervous System Diseases, Pain Management, Self Management

In brief

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.

Key facts

Study ID

NCT02760654

Run by

University of Michigan

People needed

60

Starts

2016-04-01

Expected to finish

2016-12-01

Last updated by the study team

2017-11-13

Who can join

Age: 25 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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, United States

Full record on ClinicalTrials.gov

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