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

NCT ID: NCT02760654

Last Updated: 2017-11-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Peripheral Nervous System Diseases Pain Management Self Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Proactive Self Management Program for Effects of Cancer Treatment

Intervention Type DEVICE

Control

Treatment as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Proactive Self Management Program for Effects of Cancer Treatment

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Joseph Mercy Health System

UNKNOWN

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Robert Knoerl

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Knoerl, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

St. Joseph Mercy Canton

Canton, Michigan, United States

Site Status

St. Joseph Mercy Chelsea

Chelsea, Michigan, United States

Site Status

St. Joseph Mercy Livingston

Howell, Michigan, United States

Site Status

St. Joseph Mercy Ann Arbor

Ypsilanti, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00104185

Identifier Type: -

Identifier Source: org_study_id