Internet-Delivered Pain Management for Chemotherapy-Induced Nerve Pain

No longer recruiting at 1 trial location

Overseen By Megan B Irby, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must be taking: Opioid analgesics, Duloxetine, Pregabalin, Gabapentin

Must not be taking: Buprenorphine, Suboxone

Disqualifiers: Severe cognitive impairment, Substance use disorder, Progressive cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online program designed to manage nerve pain caused by chemotherapy. The goal is to determine if this internet-delivered pain management approach, known as Internet-delivered pain coping skills training, can reduce pain and improve daily function for cancer survivors. Those who have experienced chemotherapy-induced nerve pain for at least two years and have completed cancer treatment might find this trial suitable. Participants will engage in an 8-week online program with guided sessions to learn pain-coping skills. As an unphased trial, this study provides a unique opportunity to explore innovative pain management strategies tailored for cancer survivors.

Will I have to stop taking my current medications?

You will not have to stop taking your current medications, but you must be on a stable medication regimen for at least 30 days before joining the trial. You should not increase your medication doses during the study unless advised by your doctor.

What prior data suggests that this internet-delivered pain coping program is safe for cancer survivors with chemotherapy-induced nerve pain?

Research shows that online programs for managing pain are generally safe and effective. Studies have found that these programs can help reduce pain-related suffering in cancer patients. Delivered over the internet, the program uses methods similar to those in face-to-face sessions. Previous trials demonstrated its safety, showing improved pain management without serious side effects. Participants found the online format as effective as traditional in-person methods, with no additional safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for chemotherapy-induced nerve pain, which often involve medications like anticonvulsants or antidepressants, this innovative approach offers an online pain coping skills training program. This treatment is unique because it provides an accessible, non-drug alternative that patients can complete from the comfort of their homes. By using an automated coach to guide weekly 45-minute modules over eight weeks, it empowers patients to manage their pain actively. Researchers are excited about this treatment because it has the potential to reduce reliance on medication and its associated side effects, offering a more holistic approach to pain management.

What evidence suggests that this internet-delivered pain coping program is effective for chemotherapy-induced nerve pain?

Research has shown that online pain management training can be as effective as traditional face-to-face methods in reducing pain for cancer patients. In this trial, participants will receive cognitive behavioral pain coping skills training (PCST) through an internet-delivered program. This training helps reduce suffering related to cancer pain. The online program guides patients in managing pain through weekly, 45-minute sessions with an automated coach. Offering the same benefits as in-person sessions, this internet-based approach provides a convenient and accessible option for patients. ^{1 2 3 6 7}

Who Is on the Research Team?

Donald B Penzien, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Must be able to speak, read, and understand English

I have finished all my cancer treatments except for ongoing maintenance therapy.

I am able to care for myself and perform daily activities.

Exclusion Criteria

Has a known or suspected diagnosable substance use disorder

No reliable access to Internet, wi-fi, or compatible device, and declines the Tablet Lending Program

Reports only preexisting pain conditions deemed unrelated to CIPN

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in an 8-week internet-delivered pain coping skills training program with weekly, 45-minute modules guided by an automated coach

8 weeks

Weekly online sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at multiple timepoints

24 weeks

Assessments at baseline, 12 weeks, 24 weeks, and 36 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Internet delivered pain coping skills training

Trial Overview 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.

How Is the Trial Designed?

Group I: Internet delivered pain coping Experimental Treatment 1 Intervention

8 week online pain coping skills training program with weekly, 45-minute modules guided by an automated coach

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

HonorHealth Research Institute

Collaborator

Trials

26

Recruited

940+

Published Research Related to This Trial

Adding telephone support to the Reboot Online pain management program significantly improved participant enrollment (93% vs. 78%) and commencement rates (91% vs. 60%) compared to the program without support, indicating that clinician guidance can enhance initial engagement.

Despite the increased engagement, the overall completion rates and clinical effectiveness of the program were similar between the two groups, suggesting that while support helps get participants started, it may not influence their ability to finish the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Adjunct Telephone Support on Adherence and Outcomes of the Reboot Online Pain Management Program: Randomized Controlled Trial. Gardner, T., Schultz, R., Haskelberg, H., et al.[2022]

A brief pain coping skills training (PCST) intervention delivered via mobile health technology was found to be feasible and acceptable for 25 cancer patients, with an impressive session completion rate of 84%.

Participants experienced significant improvements in pain, physical symptoms, psychological distress, and pain catastrophizing after the intervention, suggesting that mHealth delivery can effectively enhance access to pain management resources for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study of a Mobile Health Pain Coping Skills Training Protocol for Patients With Persistent Cancer Pain. Somers, TJ., Abernethy, AP., Edmond, SN., et al.[2018]

A pilot study with 30 cancer patients showed that mobile pain coping skills training (mPCST) delivered via Skype is feasible and has low burden on patients, leading to high engagement and acceptability.

Patients using mPCST experienced significant reductions in pain severity and improved self-efficacy for pain management, with results comparable to those receiving traditional in-person training, indicating that mPCST can be an effective alternative for managing cancer pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Small Randomized Controlled Pilot Trial Comparing Mobile and Traditional Pain Coping Skills Training Protocols for Cancer Patients with Pain. Somers, TJ., Kelleher, SA., Westbrook, KW., et al.[2020]

Mobile health pain coping skills training (mPCST) is significantly more feasible than traditional in-person pain coping skills training (PCST-traditional), making it easier for cancer patients to access and complete the program.

Both mPCST and PCST-traditional showed similar effectiveness in reducing pain severity and interference, indicating that mPCST is a viable alternative to traditional methods for managing cancer-related pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A behavioral cancer pain intervention: A randomized noninferiority trial comparing in-person with videoconference delivery. Kelleher, SA., Winger, JG., Dorfman, CS., et al.[2023]

An 8-week web-based pain coping skills training (PCST) program was found to be highly acceptable to cancer patients, providing both emotional and physical benefits, which could improve pain management for those with cancer-related bone pain.

Healthcare providers expressed support for the web-based PCST program, suggesting that it could be effectively integrated into clinical care if barriers such as provider familiarity and patient workload are addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A qualitative study of patient and provider perspectives on using web-based pain coping skills training to treat persistent cancer pain. Rini, C., Vu, MB., Lerner, H., et al.[2020]

A systematic review of 17 randomized controlled trials involving 2503 patients found that Internet-based cognitive and behavioral therapy interventions significantly improved pain and activity limitations, with 77.8% of studies showing positive outcomes.

While there is promising evidence for Internet-based peer support programs and social networking in reducing pain, the overall effectiveness varies, and more high-quality studies are needed to determine which patient groups benefit the most.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can pain be managed through the Internet? A systematic review of randomized controlled trials. Bender, JL., Radhakrishnan, A., Diorio, C., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05556447

Internet-delivered Management of Chemotherapy-Induced ... Cognitive behavioral pain coping skills training (PCST) has shown effectiveness for reducing pain-related suffering among patients with cancer pain as well as ...

2. withpower.com withpower.com/trial/phase-chemotherapy-induced-peripheral-neuropathy-cipn-9-2022-a9765

Internet-Delivered Pain Management for Chemotherapy ... Research shows that Internet-based pain coping skills training can be as effective as traditional in-person methods for reducing pain in cancer patients.

3. ctv.veeva.com ctv.veeva.com/study/internet-delivered-management-of-chemotherapy-induced-peripheral-neuropathy-cipn

Internet-delivered Management of Chemotherapy-Induced ... This is a small pilot trial (n=26) among cancer survivors with CIPN who will utilize an internet-delivered pain coping program for 8 weeks ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11274737/

Chemotherapy-Induced Peripheral Neuropathy (CIPN) This article outlines a framework for the development and maintenance of chemotherapy-induced peripheral neuropathy using the 3P model.

5. digitalcommons.wku.edu digitalcommons.wku.edu/ijesab/vol16/iss3/165/

feasibility and acceptability of pain coping skills training ... The purpose of this research is to conduct a pilot trial examining the feasibility and acceptability of painTRAINER among patients with CIPN.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9642075/

Updates in the treatment of chemotherapy-induced peripheral ... Chemotherapy-induced peripheral neuropathy (CIPN) is a common toxicity associated with treatment with platinum-based agents, taxanes, vinca alkaloids, and ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1526590017307861

Self-Guided Online Cognitive Behavioral Strategies for ... This 8-week, randomized controlled pilot trial showed that a self-guided online cognitive behavioral pain management program—PROSPECT—significantly improved ...