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

NCT02760654 | Completed Results DMC

• 1 other identifier: HUM00104185
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

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.

Conditions

Peripheral Nervous System Diseases; Pain Management; Self Management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change in PROMIS Short Form Emotional Distress - Depression 4a Scores at 8 Weeks

  Baseline to 8 weeks

• PROMIS Short Form Anxiety 4a

  Baseline to 8 weeks

• Change in PROMIS Short Form Fatigue 4a Scores at 8 Weeks

  Baseline to 8 weeks

• Change in PROMIS Short Form Sleep-Related Impairment 8a Scores at 8 Weeks

  Baseline to 8 weeks

• Patient Global Impression of Change

  8 week

Study Arms (2)

Online Self Management

EXPERIMENTAL

Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.

Device: Proactive Self Management Program for Effects of Cancer Treatment

Control

NO INTERVENTION

Treatment as usual

Interventions

Proactive Self Management Program for Effects of Cancer Treatment DEVICE

Online Self Management

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Michigan: lead
• St. Joseph Mercy Health System: collaborator

Study Sites (5)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

St. Joseph Mercy Canton

Canton, Michigan, 48188, United States

Location

St. Joseph Mercy Chelsea

Chelsea, Michigan, 48118, United States

Location

St. Joseph Mercy Livingston

Howell, Michigan, 48843, United States

Location

St. Joseph Mercy Ann Arbor

Ypsilanti, Michigan, 48104, United States

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Agnosia

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Small sample size, high drop out, lack of active monitoring of intervention usage, lack of generalizability to any specific type of chronic painful neuropathy, and changes in pain medications during the trial may have confounded the primary analysis.

Results Point of Contact

• Title: Robert Knoerl, Doctoral Student
• Organization: University of Michigan School of Nursing

rjknoerl@umich.edu

734-536-9369

Study Officials

• Robert Knoerl, PhD, RN

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: May 3, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 13, 2017
• Results First Posted: June 2, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)