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

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ClinicalTrials.gov Identifier: NCT02760654
Recruitment Status : Completed
First Posted : May 3, 2016
Results First Posted : June 2, 2017
Last Update Posted : November 13, 2017
Sponsor:
Collaborator:
St. Joseph Mercy Health System
Information provided by (Responsible Party):
Robert Knoerl, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Peripheral Nervous System Diseases Pain Management Self Management Device: Proactive Self Management Program for Effects of Cancer Treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Self-Guided Online Cognitive Behavioral Strategies for Chemotherapy-Induced Peripheral Neuropathy
Study Start Date : April 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Online Self Management
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
No Intervention: Control
Treatment as usual



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02760654


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
St. Joseph Mercy Canton
Canton, Michigan, United States, 48188
St. Joseph Mercy Chelsea
Chelsea, Michigan, United States, 48118
St. Joseph Mercy Livingston
Howell, Michigan, United States, 48843
St. Joseph Mercy Ann Arbor
Ypsilanti, Michigan, United States, 48104
Sponsors and Collaborators
University of Michigan
St. Joseph Mercy Health System
Investigators
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Principal Investigator: Robert Knoerl, PhD, RN University of Michigan
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Responsible Party: Robert Knoerl, Dr., University of Michigan
ClinicalTrials.gov Identifier: NCT02760654    
Other Study ID Numbers: HUM00104185
First Posted: May 3, 2016    Key Record Dates
Results First Posted: June 2, 2017
Last Update Posted: November 13, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases