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

Primary Purpose

Peripheral Nervous System Diseases, Pain Management, Self Management

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Proactive Self Management Program for Effects of Cancer Treatment
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Peripheral Nervous System Diseases

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Michigan
  • St. Joseph Mercy Canton
  • St. Joseph Mercy Chelsea
  • St. Joseph Mercy Livingston
  • St. Joseph Mercy Ann Arbor

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Online Self Management

Control

Arm Description

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

Treatment as usual

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in PROMIS Short Form Emotional Distress - Depression 4a Scores at 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.
PROMIS Short Form Anxiety 4a
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.
Change in PROMIS Short Form Fatigue 4a Scores at 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.
Change in PROMIS Short Form Sleep-Related Impairment 8a Scores at 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.
Patient Global Impression of Change
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.
Change in 0 - 10 Average Pain Intensity Numerical Rating Scale Scores at 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.
Adapted Acceptability E-Scale
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.
Change in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy Scale Scores at 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.
Change in PROMIS Pain Interference 4a Scores at 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.

Full Information

First Posted
April 28, 2016
Last Updated
October 10, 2017
Sponsor
University of Michigan
Collaborators
St. Joseph Mercy Health System
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1. Study Identification

Unique Protocol Identification Number
NCT02760654
Brief Title
Self-Guided Online Cognitive Behavioral Strategies for Chemotherapy-Induced Peripheral Neuropathy
Acronym
SONICS
Official Title
Self-Guided Online Cognitive Behavioral Strategies for Chemotherapy-Induced Peripheral Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
St. Joseph Mercy Health System

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Nervous System Diseases, Pain Management, Self Management

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Online Self Management
Arm Type
Experimental
Arm Description
Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Treatment as usual
Intervention Type
Device
Intervention Name(s)
Proactive Self Management Program for Effects of Cancer Treatment
Primary Outcome Measure Information:
Title
Change in 0 - 10 Numerical Rating Scale of Worst Pain Intensity Scores at 8 Weeks
Description
Pain is measured on the numerical rating scale of 0 - 10 where 0 is no pain and 10 is worst imaginable pain.
Time Frame
Baseline to 8 weeks
Secondary Outcome Measure Information:
Title
Change in PROMIS Short Form Emotional Distress - Depression 4a Scores at 8 Weeks
Description
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.
Time Frame
Baseline to 8 weeks
Title
PROMIS Short Form Anxiety 4a
Description
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.
Time Frame
Baseline to 8 weeks
Title
Change in PROMIS Short Form Fatigue 4a Scores at 8 Weeks
Description
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.
Time Frame
Baseline to 8 weeks
Title
Change in PROMIS Short Form Sleep-Related Impairment 8a Scores at 8 Weeks
Description
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.
Time Frame
Baseline to 8 weeks
Title
Patient Global Impression of Change
Description
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.
Time Frame
8 week
Title
Change in 0 - 10 Average Pain Intensity Numerical Rating Scale Scores at 8 Weeks
Description
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.
Time Frame
Baseline to 8 weeks
Title
Adapted Acceptability E-Scale
Description
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.
Time Frame
8 week
Title
Change in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy Scale Scores at 8 Weeks
Description
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.
Time Frame
Baseline to 8 weeks
Title
Change in PROMIS Pain Interference 4a Scores at 8 Weeks
Description
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.
Time Frame
Baseline to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Knoerl, PhD, RN
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
St. Joseph Mercy Canton
City
Canton
State/Province
Michigan
ZIP/Postal Code
48188
Country
United States
Facility Name
St. Joseph Mercy Chelsea
City
Chelsea
State/Province
Michigan
ZIP/Postal Code
48118
Country
United States
Facility Name
St. Joseph Mercy Livingston
City
Howell
State/Province
Michigan
ZIP/Postal Code
48843
Country
United States
Facility Name
St. Joseph Mercy Ann Arbor
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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