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

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University of Michigan

Status

Completed

Conditions

Pain Management
Peripheral Nervous System Diseases
Self Management

Treatments

Device: Proactive Self Management Program for Effects of Cancer Treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT02760654
HUM00104185

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

25+ years old

Volunteers

No 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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Online Self Management
Experimental group
Description:
Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.
Treatment:
Device: Proactive Self Management Program for Effects of Cancer Treatment
Control
No Intervention group
Description:
Treatment as usual

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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