Internet-Delivered Pain Management for Chemotherapy-Induced Nerve Pain

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

Trial Summary

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 data supports the effectiveness of the Internet-delivered pain coping skills training treatment for chemotherapy-induced nerve pain?

Research shows that Internet-based pain coping skills training can be as effective as traditional in-person methods for reducing pain in cancer patients. Studies have found that these online programs can decrease pain severity and improve patients' ability to manage their pain, making them a promising option for increasing access to pain management. ^{1 2 3 4 5}

Is Internet-delivered pain management safe for humans?

Internet-based pain management programs, including those for pain coping skills, have been studied and generally show promise for safety in humans. While specific safety data is limited, these programs are designed to be non-invasive and focus on behavioral strategies, which are typically safe. ^{1 3 4 5 6}

How is the Internet-delivered pain coping skills training treatment different from other treatments for chemotherapy-induced nerve pain?

This treatment is unique because it is delivered over the internet, making it more accessible to patients who face barriers to in-person care, such as travel or time constraints. It provides behavioral pain management strategies that can be used at home, which is different from traditional in-person therapies. ^{1 2 3 4 6}

What is the purpose of this trial?

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 in order to assess program feasibility and preliminary understanding of how participation in the program may influence pain interference. Also proposed is a secondary focus on subjective and objective function, medication use, psychological distress, and coping.

Research Team

Donald B Penzien, PhD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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

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

Has a known or suspected diagnosable substance use disorder

Reports only preexisting pain conditions deemed unrelated to CIPN

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

A behavioral cancer pain intervention: A randomized noninferiority trial comparing in-person with videoconference delivery. [2023]

2. United States 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. [2020]

3. England 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. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

A Pilot Study of a Mobile Health Pain Coping Skills Training Protocol for Patients With Persistent Cancer Pain. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Can pain be managed through the Internet? A systematic review of randomized controlled trials. [2022]

6. Canada 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. [2022]