Internet-Based Pain Management Program for Cancer Survivors

(IMPACTS Trial)

Recruiting at 156 trial locations

Overseen By Karen Craver

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must not be taking: Buprenorphine, Suboxone

Disqualifiers: Severe cognitive impairment, Substance use disorder, Hospice care, others

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

Compensation: Varies

Number of Visits: 30

Duration: 10 weeks

456 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if an online program for coping with pain, combined with usual care, can help cancer survivors manage persistent pain better than usual care alone. Participants may join one of two groups: one receives only pain education, while the other receives both pain education and access to an 8-session online pain management program (Internet-based pain coping skills program). This trial suits cancer survivors who have experienced significant pain since their diagnosis or treatment and can access the internet. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could enhance pain management for cancer survivors.

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 prior data suggests that this Internet-based pain coping skills program is safe for cancer survivors?

Research has shown that online programs for managing pain are generally safe. These programs teach skills to help manage pain and are easy for participants to use. Studies have found that they not only help reduce pain but also do not cause significant side effects.

Participants in these programs reported feeling less pain and managing it better, without major negative effects. Since these programs focus on learning strategies rather than taking medicine, they are less likely to cause harm.

Overall, evidence suggests that these online programs offer a safe way to manage pain, especially for cancer survivors with ongoing pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Internet-based pain management program for cancer survivors because it offers a fresh approach to managing pain through digital means. Unlike traditional pain management options like medications, physical therapy, or in-person counseling, this program provides an accessible, flexible, and convenient way for individuals to learn coping skills from the comfort of their own homes. The program is designed to empower patients with knowledge and strategies to manage their pain independently, which can be revisited as needed, offering long-term benefits. By integrating technology into pain management, this treatment has the potential to reach a wider audience and provide support to those who might not have easy access to in-person care.

What evidence suggests that this Internet-based pain coping skills program is effective for managing pain in cancer survivors?

Studies have shown that an online program called painTRAINER can help cancer survivors manage pain more effectively. This program includes interactive sessions that teach various pain-coping strategies. In this trial, one group of participants will receive access to the Internet-based pain program plus pain education, while another group will receive pain education only. Research indicates that people who completed the program reported less pain and improved pain management skills. For example, one study found that participants experienced less pain and needed fewer pain medications after using the program. Another study showed that the training boosted participants' confidence in managing their pain. Overall, these findings suggest that the online program could be a helpful tool for cancer survivors dealing with ongoing pain. ^{5 6 7 8 9}

Who Is on the Research Team?

Glenn Lesser, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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.

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).

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Internet-based pain coping skills program

Trial Overview The 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.

How Is the Trial Designed?

Group I: Internet-based program + Pain Education Experimental Treatment 1 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 Only Active Control 1 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.

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+

Published Research Related to This Trial

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]

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]

The Web-based pain coping skills training (PCST) program significantly reduced maladaptive coping strategies and increased adaptive coping strategies among 107 participants with hip/knee osteoarthritis, indicating improved pain management skills.

Participants who underwent PCST reported lower perceived risk of pain and higher self-efficacy in managing pain, suggesting that the program not only helps in coping with pain but also boosts confidence in handling pain-related situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in Identification of Possible Pain Coping Strategies by People with Osteoarthritis who Complete Web-based Pain Coping Skills Training. Rini, C., Katz, AWK., Nwadugbo, A., et al.[2022]

In a study of 94 cancer patients undergoing bone marrow transplants, those who received relaxation and imagery training reported significantly less pain compared to those receiving standard treatment or therapist support.

Adding cognitive-behavioral coping skills to relaxation and imagery did not provide additional pain relief benefits, suggesting that relaxation techniques alone are effective for managing cancer treatment-related pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relaxation and imagery and cognitive-behavioral training reduce pain during cancer treatment: a controlled clinical trial. Syrjala, KL., Donaldson, GW., Davis, MW., et al.[2021]

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]

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]

The study aims to evaluate the feasibility and acceptability of an 8-week web-based cognitive behavioral treatment (WebMAP) for chronic pain in childhood cancer survivors, with 34 participants and their parents involved in the research.

Initial enrollment has begun, and the study will assess the impact of WebMAP on pain intensity, activity limitations, and mental health symptoms, which is crucial for improving pain management in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Delivered Cognitive Behavioral Treatment for Chronic Pain in Adolescent Survivors of Childhood Cancer: Protocol for a Single-Group Feasibility Trial. Patton, M., Carlson, LE., Noel, M., et al.[2023]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.TPS12151

Internet-delivered management of pain among cancer ... PainTRAINER, is an 8-week, interactive PCST program using tailoring algorithms, a knowledge database, and a virtual coach to guide development ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S155171442400363X

Web-Based Pain Coping Skills Training (PCST) for ... By bridging the critical gap in evidence-based behavioral pain interventions, our study aims to improve outcomes for breast cancer survivors using AIs.

3. cancer.gov cancer.gov/clinicaltrials/NCI-2023-07169

Pain Coping Skills Training to Improve Pain and Poor ... This clinical trial evaluates the effect of an online pain coping skills training program (painTRAINER) in combination with enhanced usual care.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39706331/

Web-Based Pain Coping Skills Training (PCST) for Managing ... Although AIs decrease cancer recurrence rates and improve survival rates, approximately 50 % of patients experience arthralgia-persistent pain related to worse ...

5. jpsmjournal.com jpsmjournal.com/article/S0885-3924(23)00445-1/fulltext

Effect of Pain Coping Skills Training on ... Both conditions led to improvements in pain, pain medication use, pain self-efficacy, and coping skills use, and 5-session PCST showed the greatest benefits.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05703178

Web-based Pain Coping Skills Training for Breast Cancer ... The main goal of this clinical trial is to test benefits of completing online pain coping skills training program in women who have been diagnosed with ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4402249/

Automated, Internet-based Pain Coping Skills Training to ... PCST focuses specifically on educating people about cognitive and behavioral pain coping skills and helping them master those skills so they can become more ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0885392415002353

A Pilot Study of a Mobile Health Pain Coping Skills ... Pain coping skills training (PCST) interventions have shown efficacy for reducing pain and providing other benefits in patients with cancer.

9. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCT04462302

An Internet-Based Program to Help Cancer Survivors ... This phase III trial compares the effect of adding an internet-based pain program (painTRAINER) to enhanced usual care versus enhanced usual care alone in ...