456 Participants Needed

Internet-Based Pain Management Program for Cancer Survivors

(IMPACTS Trial)

Recruiting at 145 trial locations
KC
Overseen ByKaren Craver
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

To determine whether an Internet-based pain coping skills program plus enhanced usual care, compared to enhanced usual care alone, yields significant improvements in the co-primary outcomes of pain severity (as measured by the Brief Pain Inventory (BPI)) and pain interference (also measured by the BPI) from baseline to the post-intervention assessment for cancer survivors with persistent pain.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications, but if you are on pain medications, you need to be on a stable dose for at least 14 days before joining. You should not plan to increase your pain medication dose during the study, but you can decrease it if needed.

What data supports the effectiveness of the Internet-based pain management treatment for cancer survivors?

Research shows that Internet-based pain coping skills training (PCST) can effectively reduce pain and improve pain management in cancer patients, with benefits similar to traditional in-person methods. Studies also indicate that this approach is accessible, feasible, and engaging for patients, making it a promising option for managing cancer-related pain.12345

Is the Internet-Based Pain Management Program for Cancer Survivors safe for humans?

The Internet-Based Pain Management Program, including versions like painTRAINER and Pain Coping Skills Training (PCST), has been studied in cancer patients and is generally considered safe. These programs are designed to help manage pain and have been found to be acceptable and engaging for patients, with no significant safety concerns reported in the studies.12346

How is the Internet-Based Pain Management Program for Cancer Survivors different from other treatments?

This treatment is unique because it is delivered over the internet, making it more accessible to cancer survivors who face barriers like travel and cost. It focuses on teaching pain coping skills, which are behavioral strategies to manage pain, and can be done from home, unlike traditional in-person therapies.12378

Research Team

GL

Glenn Lesser, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for adult cancer survivors with persistent pain, who've been treated with surgery, radiation, or chemotherapy. They must have stable cancer and not be planning major treatment changes during the study. Participants need reliable internet access and should understand English. Those on a steady pain medication regimen can join but shouldn't plan to increase their dosage.

Inclusion Criteria

Must have a score of "Most Days" or higher on the Graded Chronic Pain Scale Revised (Abbreviated) using the Pain Eligibility Interview.
It's been over two weeks since my last minor surgery.
I have never had only superficial skin cancers or in situ malignancy.
See 16 more

Exclusion Criteria

Has a disability that precludes completion of study activities (e.g., severe vision or hearing impairment, diagnosis of dementia or clinical evidence of severe cognitive impairment, diagnosis or clinical evidence of severe psychiatric disorder, or diagnosed drug or alcohol abuse disorder), as per patient report or documented in the medical record.
Has a known or suspected diagnosable substance use disorder or opioid overuse disorder (according to DSM-5 criteria), or is actively receiving treatment for a substance use disorder, as per patient report or documented in the medical record.
My only pain conditions are not related to my cancer (like arthritis or migraines).
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an Internet-based pain coping skills program plus enhanced usual care or enhanced usual care alone

10 weeks
8 sessions (online)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks
Assessments at 22 and 34 weeks

Treatment Details

Interventions

  • Internet-based pain coping skills program
Trial OverviewThe study tests an Internet-based program designed to help manage pain against usual care alone in cancer survivors. It measures how well the program reduces pain severity and interference using the Brief Pain Inventory before and after the intervention.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Internet-based program + Pain EducationExperimental Treatment1 Intervention
If you are in this group, in additional to your usual care, you will be provided access to the 8-session Internet-based pain program plus pain education. You will need to complete your sessions within 10 weeks of being provided your log-in code. You will be allowed to revisit sessions that you have completed during this 10 weeks. After completion of the study, you will still be provided access to the 8-session Internet-based pain program.
Group II: Pain Education OnlyActive Control1 Intervention
If you are in this group, in addition to your usual care, you will be provided pain education at your initial clinic visit. After you have completed the 6-month follow up assessment, you will be provided a secure log-in code and invited to complete the 8 sessions of this Internet-based pain program on your own.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials
1,403
Recruited
655,000+

Findings from Research

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

References

A qualitative study of patient and provider perspectives on using web-based pain coping skills training to treat persistent cancer pain. [2020]
A Pilot Study of a Mobile Health Pain Coping Skills Training Protocol for Patients With Persistent Cancer Pain. [2018]
A behavioral cancer pain intervention: A randomized noninferiority trial comparing in-person with videoconference delivery. [2023]
A Small Randomized Controlled Pilot Trial Comparing Mobile and Traditional Pain Coping Skills Training Protocols for Cancer Patients with Pain. [2020]
Changes in Identification of Possible Pain Coping Strategies by People with Osteoarthritis who Complete Web-based Pain Coping Skills Training. [2022]
Relaxation and imagery and cognitive-behavioral training reduce pain during cancer treatment: a controlled clinical trial. [2021]
Internet-Delivered Cognitive Behavioral Treatment for Chronic Pain in Adolescent Survivors of Childhood Cancer: Protocol for a Single-Group Feasibility Trial. [2023]
The Effect of Adjunct Telephone Support on Adherence and Outcomes of the Reboot Online Pain Management Program: Randomized Controlled Trial. [2022]