Clinical trial NCT02760654: Self-Guided Online Cognitive Behavioral Strategies for Chemotherapy-Induced Peripheral Neuropathy
Official title: Self-Guided Online Cognitive Behavioral Strategies for Chemotherapy-Induced Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Nervous System Diseases
Pain Management
Self Management
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: St. Joseph Mercy Health System
First posted: 2016-05-03
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in 0 - 10 Numerical Rating Scale of Worst Pain Intensity Scores at 8 Weeks
timeFrame: Baseline to 8 weeks
Secondary outcomes:
measure: Change in PROMIS Short Form Emotional Distress - Depression 4a Scores at 8 Weeks
timeFrame: Baseline to 8 weeks
measure: PROMIS Short Form Anxiety 4a
timeFrame: Baseline to 8 weeks
measure: Change in PROMIS Short Form Fatigue 4a Scores at 8 Weeks
timeFrame: Baseline to 8 weeks
measure: Change in PROMIS Short Form Sleep-Related Impairment 8a Scores at 8 Weeks
timeFrame: Baseline to 8 weeks
measure: Patient Global Impression of Change
timeFrame: 8 week
measure: Change in 0 - 10 Average Pain Intensity Numerical Rating Scale Scores at 8 Weeks
timeFrame: Baseline to 8 weeks
measure: Adapted Acceptability E-Scale
timeFrame: 8 week
measure: Change in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy Scale Scores at 8 Weeks
timeFrame: Baseline to 8 weeks
measure: Change in PROMIS Pain Interference 4a Scores at 8 Weeks
timeFrame: Baseline to 8 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Canton
country: United States
facility: St. Joseph Mercy Canton
state: Michigan
city: Chelsea
country: United States
facility: St. Joseph Mercy Chelsea
state: Michigan
city: Howell
country: United States
facility: St. Joseph Mercy Livingston
state: Michigan
city: Ypsilanti
country: United States
facility: St. Joseph Mercy Ann Arbor
state: Michigan
Study officials:
affiliation: University of Michigan
name: Robert Knoerl, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: