← Back to Search

Behavioral Intervention

Internet-Delivered Pain Management for Chemotherapy-Induced Nerve Pain

N/A
Recruiting
Led By Donald B Penzien, PhD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have completed all planned anticancer therapy except maintenance therapy
Must have ECOG performance status of 0, 1, or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 weeks, 24 weeks, and 36 weeks
Awards & highlights

Study Summary

This trial is testing an internet-based pain coping program for cancer survivors with nerve pain. They will assess how well the program works and how it affects pain, function, psychological distress, and coping.

Who is the study for?
This trial is for adult cancer survivors who've finished their main cancer treatments, have stable medication use, and suffer from moderate to severe peripheral neuropathy caused by chemotherapy. Participants must speak English, be able to access the internet, and not have progressive cancer or unrelated preexisting pain conditions.Check my eligibility
What is being tested?
The study tests an 8-week online program designed to help manage pain and discomfort due to chemotherapy-induced peripheral neuropathy. It aims to see if this internet-delivered training can reduce pain interference with daily activities and improve psychological well-being.See study design
What are the potential side effects?
Since the intervention involves non-pharmaceutical coping skills training delivered over the internet, there are no direct medical side effects associated with traditional drug trials. However, participants may experience emotional distress or fatigue related to engaging with the material.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have finished all my cancer treatments except for ongoing maintenance therapy.
Select...
I am able to care for myself and perform daily activities.
Select...
I have cancer that needs treatment which may affect my nerves.
Select...
I experience moderate to severe numbness, pain, or weakness in my hands or feet after chemotherapy.
Select...
I experience pain or discomfort on most days of the week.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 weeks, 24 weeks, and 36 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 weeks, 24 weeks, and 36 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability of the Intervention
Adherence Rate
Pain Interference Score
+1 more
Secondary outcome measures
Change in Medication and substance amount use
Change in Objective physical function Scores - PROMIS Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue scale
Change in Objective physical function Scores - Patient-Reported Outcomes Measurement Information System (PROMIS)
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Internet delivered pain copingExperimental Treatment1 Intervention
8 week online pain coping skills training program with weekly, 45-minute modules guided by an automated coach

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,235 Previous Clinical Trials
1,001,970 Total Patients Enrolled
1 Trials studying Peripheral Neuropathy
22 Patients Enrolled for Peripheral Neuropathy
HonorHealth Research InstituteOTHER
25 Previous Clinical Trials
880 Total Patients Enrolled
Donald B Penzien, PhDPrincipal InvestigatorWake Forest University Health Sciences
3 Previous Clinical Trials
40 Total Patients Enrolled

Media Library

Internet delivered pain coping skills training (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05556447 — N/A
Peripheral Neuropathy Research Study Groups: Internet delivered pain coping
Peripheral Neuropathy Clinical Trial 2023: Internet delivered pain coping skills training Highlights & Side Effects. Trial Name: NCT05556447 — N/A
Internet delivered pain coping skills training (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05556447 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for individuals to participate in this experiment?

"This clinical trial is not recruiting at present, as indicated on the website of clinicaltrials.gov. Last updated in October 25th 2022, this study was first posted January 1st 2023. Although there are no applicants being accepted for this particular medical trial today, 161 other trials are actively seeking candidates to participate in them."

Answered by AI

What results is the team hoping to achieve through this medical experiment?

"The primary goal of this 12-week trial is to measure the Adherence Rate. Secondary objectives include evaluating change in Psychological distress Scores (General Anxiety Disorder scale - GAD 7) ranging from 0-4 (minimal anxiety), 5-9 (mild anxiety), 10-14(moderate anxiety) and 15-21 (severe anxiety); Change in Objective physical function Scores via PROMIS Functional Assessment of Chronic Illness Therapy Fatigue Scale, which uses a 4 point Likert scale ranging from 'not at all fatigued' to 'very much fatigued'; and lastly Change in Objective physical function Scores through Patient Reported Out"

Answered by AI
~17 spots leftby Nov 2024