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Completed

NCT Number: NCT02760654

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

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.

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Key information

Conditions

Peripheral Nervous System Diseases Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Neuromuscular Diseases Pain Management Pathological Conditions, Signs and Symptoms Perceptual Disorders Self Management Signs and Symptoms

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan, Ann Arbor, Michigan, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Proactive Self Management Program for Effects of Cancer Treatment

Device

Primary outcomes

  1. Change in 0 - 10 Numerical Rating Scale of Worst Pain Intensity Scores at 8 Weeks

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. PROMIS Short Form Anxiety 4a

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  5. Patient Global Impression of Change

    Time frame: 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.

  6. Change in 0 - 10 Average Pain Intensity Numerical Rating Scale Scores at 8 Weeks

    Time frame: 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.

  7. Adapted Acceptability E-Scale

    Time frame: 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.

  8. Change in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy Scale Scores at 8 Weeks

    Time frame: 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.

  9. Change in PROMIS Pain Interference 4a Scores at 8 Weeks

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • St. Joseph Mercy Health System

Registry information

Acronym: SONICS

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 3, 2016
Registry last updated
Nov 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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