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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 weeks, 24 weeks, and 36 weeks
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 12 weeks, 24 weeks, and 36 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 weeks, 24 weeks, and 36 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability of the Intervention
Adherence Rate
Pain Interference Score
+1 moreSecondary study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,395 Previous Clinical Trials
2,460,179 Total Patients Enrolled
1 Trials studying Peripheral Neuropathy
20 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
31 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have finished all my cancer treatments except for ongoing maintenance therapy.I am able to care for myself and perform daily activities.I have cancer that needs treatment which may affect my nerves.I do not have a working email address.I experience moderate to severe numbness, pain, or weakness in my hands or feet after chemotherapy.My cancer is growing or getting worse.I cannot complete study activities due to a disability or condition.I had nerve pain or tingling before starting chemotherapy.I am currently taking buprenorphine or suboxone.I am currently enrolled in hospice or end-of-life care.I experience pain or discomfort on most days of the week.It has been over 2 years since I started chemotherapy that can affect the nerves.I am 18 years old or older.My medication has not changed in the last 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: Internet delivered pain coping
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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