Meaning-Centered Coping Skills Training for Cancer Pain

(MCPC Trial)

Overseen By Joseph G Winger, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Cognitive impairment, Untreated mental illness, others

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

Compensation: Varies

Number of Visits: 6

Duration: 4 weeks

210 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help people with advanced cancer manage pain. It focuses on teaching skills like guided imagery and activity pacing to improve pain coping. Called Meaning-Centered Pain Coping Skills Training, this method will be compared to standard care. Participants will be randomly assigned to either this new method or standard care, with progress tracked over 12 weeks. Individuals with stage IV solid tumor cancer, experiencing pain that affects daily life, and who can speak and read English, might be eligible to join. As an unphased trial, this study offers a unique opportunity to explore innovative pain management techniques that could enhance quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on a psychosocial intervention, so it's likely you can continue your medications, but you should confirm with the trial organizers.

What prior data suggests that Meaning-Centered Pain Coping Skills Training is safe?

Research shows that Meaning-Centered Pain Coping Skills Training (MCPC) safely manages cancer pain. The risks are minimal and mainly involve common concerns in similar programs, such as maintaining privacy. This treatment includes video sessions that teach pain management techniques like mental imagery and activity pacing. Studies have found that patients often feel better after participating in MCPC. Overall, evidence suggests this approach is well-tolerated and lacks significant side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Meaning-Centered Pain Coping Skills Training because it offers a new approach to managing cancer pain through cognitive and behavioral techniques. Unlike typical pain management treatments, which often rely on medications like opioids, this method uses guided imagery and activity pacing to help patients gain control over their pain. By delivering these sessions via videoconference, it also makes support more accessible to patients, regardless of location. This innovative approach has the potential to empower patients by providing them with practical skills to handle pain, potentially reducing their dependence on medications.

What evidence suggests that Meaning-Centered Pain Coping Skills Training is effective for managing cancer pain?

Research has shown that Meaning-Centered Pain Coping Skills Training (MCPC), which participants in this trial may receive, is a promising method for managing pain in patients with advanced cancer. This approach addresses not only physical pain but also mental, social, and spiritual aspects. Early studies have found MCPC easy to use and engaging, suggesting it could be a valuable tool for improving pain management. Although further testing is needed to confirm its effectiveness, the initial results are encouraging. This method employs techniques such as guided imagery and pacing activities to help patients better manage their pain. ^{1 2 3 6 7}

Who Is on the Research Team?

Joseph G Winger, PhD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 with advanced solid tumor cancer and pain. They must have a performance status that allows daily activity (ECOG ≤2) and have experienced pain recently. It's not for those with significant cognitive issues, untreated serious mental illness, brain cancer, previous similar therapy experience, or in hospice care.

Inclusion Criteria

Ability to speak and read in English

At least moderate pain interference (8-item Patient-Reported Outcomes Measurement Information System [PROMIS] Pain Interference T-score >/= 55) in the past week at telephone screening

I have experienced pain rated above 0 in the past month.

Exclusion Criteria

I have been diagnosed with primary brain cancer.

Serious untreated mental illness

Significant cognitive impairment as indicated in medical chart or during telephone screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Meaning-Centered Pain Coping Skills Training (MCPC) through four weekly videoconference sessions focusing on cognitive-behavioral skills for managing pain.

4 weeks

4 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 8-week and 12-week follow-ups.

8 weeks

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Meaning-Centered Pain Coping Skills Training

Trial Overview

The study tests Meaning-Centered Pain Coping Skills Training (MCPC), comparing it to standard care in patients with advanced cancer-related pain. Participants are randomly assigned to either the MCPC program or regular treatment and followed up at 8 and 12 weeks.

How Is the Trial Designed?

Group I: Meaning-Centered Pain Coping Skills Training Experimental Treatment 1 Intervention

Four, 45-60 minute, videoconference-delivered sessions focus on training participants in cognitive and behavioral skills (e.g., guided imagery, activity pacing) for managing pain.

Group II: Standard Care Active Control 1 Intervention

Information and referrals for free services available through the Duke Cancer Patient Support Program.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Published Research Related to This Trial

Meaning-Centered Pain Coping Skills Training (MCPC) is a feasible and effective intervention for managing pain in patients with advanced cancer, showing significant improvements in pain severity and self-efficacy after 10 weeks.

In a study of 60 adults with stage IV solid tumors, those receiving MCPC reported better pain management outcomes compared to usual care, with moderate-to-large effect sizes in pain severity and interference, indicating its potential as a valuable addition to standard pain management practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meaning-centered pain coping skills training for patients with metastatic cancer: Results of a randomized controlled pilot trial. Winger, JG., Kelleher, SA., Ramos, K., et al.[2023]

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 randomized controlled trial involving 202 patients with advanced cancer and their caregivers showed that a caregiver-guided pain coping skills training intervention significantly improved caregiver satisfaction and reduced anxiety compared to standard treatment.

Both caregivers and patients experienced enhanced self-efficacy and reduced psychological distress, indicating that pain education and coping skills training can positively impact pain management outcomes in advanced cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caregiver-guided pain coping skills training for patients with advanced cancer: Results from a randomized clinical trial. Porter, LS., Steel, JL., Fairclough, DL., et al.[2022]

The Meaning-Centered Pain Coping Skills Training (MCPC) intervention was found to be feasible and acceptable for 30 participants with stage IV cancer, with a high completion rate of 90% for intervention sessions and 87% for post-intervention assessments.

Participants reported significant improvements in pain severity, pain interference, and spiritual well-being after the intervention, along with high satisfaction levels, indicating that MCPC could be a beneficial approach for managing pain in advanced cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meaning-Centered Pain Coping Skills Training: A Pilot Feasibility Trial of a Psychosocial Pain Management Intervention for Patients with Advanced Cancer. Winger, JG., Ramos, K., Kelleher, SA., et al.[2023]

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]

Patients with advanced cancer found the Meaning-Centered Pain Coping Skills Training (MCPC) helpful in connecting with meaningful aspects of their lives while learning coping strategies for pain, indicating its potential efficacy as a psychosocial intervention.

Most participants preferred remote delivery of the MCPC sessions, as it could make accessing the program easier, especially for those with mobility issues or other barriers to attending in-person sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing meaning in the face of advanced cancer and pain: Qualitative evaluation of a meaning-centered psychosocial pain management intervention. Winger, JG., Ramos, K., Steinhauser, KE., et al.[2021]

Citations

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37173865/

Meaning-centered pain coping skills training for patients with ...

Conclusions: MCPC is a highly feasible, engaging, and promising approach for improving pain management in advanced cancer. Future efficacy ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1551714423002860

Meaning-centered pain coping skills training for patients ...

Our MCPC intervention is the first to systematically address the biopsychosocial-spiritual aspects of pain in patients with advanced cancer.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05385965

Meaning-Centered Pain Coping Skills Training for Cancer ...

This study is a randomized controlled trial of a psychosocial pain management intervention called, Meaning-Centered Pain Coping Skills Training (MCPC).

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10330450/

Meaning-Centered Pain Coping Skills Training for Patients ...

Conclusions: MCPC is a highly feasible, engaging, and promising approach for improving pain management in advanced cancer. Future efficacy testing is warranted.

5.

liebertpub.com

liebertpub.com/doi/10.1089/jpm.2021.0081

Meaning-Centered Pain Coping Skills Training

In this study we examined the feasibility and acceptability of MCPC, a psychosocial intervention for patients with advanced cancer and pain. To our knowledge, ...

6.

sciencedirect.com

sciencedirect.com/science/article/am/pii/S1551714423002860

Meaning-centered pain coping skills training for patients ...

Our team developed Meaning-Centered Pain Coping Skills Training (MCPC) to systematically address the challenges of coping with pain from advanced cancer and ...

7.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT05385965/meaning-centered-pain-coping-skills-training-for-cancer-pain

Meaning-Centered Pain Coping Skills Training for Cancer ...

Patient-reported outcomes will be assessed at baseline and 8- and 12-weeks after baseline. As in the investigators' extensive pilot work, MCPC's ...