Meaning-Centered Coping Skills Training for Cancer Pain

(MCPC Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Joseph G Winger, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Duke University

Disqualifiers: Cognitive impairment, Untreated mental illness, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study is a randomized controlled trial of a psychosocial pain management intervention called, Meaning-Centered Pain Coping Skills Training (MCPC). Patients with advanced solid tumor cancer and pain interference (N=210) will be randomized to MCPC or a standard care control condition. Patient-reported outcomes will be assessed at baseline and 8- and 12-week follow-ups. The risk and safety issues in this trial are low and limited to those common to a psychosocial intervention (e.g., loss of confidentiality).

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 data supports the effectiveness of the treatment Meaning-Centered Pain Coping Skills Training (MCPC) for cancer pain?

Research shows that MCPC is feasible and well-received by patients with advanced cancer, with high satisfaction and regular use of coping skills learned. Participants reported improvements in pain severity, pain interference, and spiritual well-being after the intervention. ^{1 2 3 4 5}

Is Meaning-Centered Coping Skills Training for Cancer Pain safe for humans?

The Meaning-Centered Pain Coping Skills Training (MCPC) has been tested in patients with advanced cancer and showed strong feasibility and acceptability, with high satisfaction reported by participants. No specific safety concerns were noted in the studies, suggesting it is generally safe for humans. ^{1 2 4 5 6}

How is Meaning-Centered Pain Coping Skills Training (MCPC) different from other treatments for cancer pain?

MCPC is unique because it combines cognitive-behavioral techniques with a focus on enhancing personal meaning and purpose, helping patients connect with valued aspects of their lives while managing pain. ^{1 2 3 4 5}

Research Team

Joseph G Winger, PhD

Principal Investigator

Duke University

Eligibility Criteria

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

Trial Timeline

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)

Treatment Details

Interventions

• Meaning-Centered Pain Coping Skills Training (Behavioral Intervention)

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.

Participant Groups

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+

Mary E. Klotman

Duke University

Chief Executive Officer since 2017

MD from Duke University School of Medicine

Michelle McMurry-Heath

Duke University

Chief Medical Officer since 2020

MD from Duke University School of Medicine

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Dr. Larry Weiss

American Cancer Society, Inc.

Chief Medical Officer since 2016

MD from Duke University Medical Center

Dr. Wayne A. I. Frederick

American Cancer Society, Inc.

Chief Executive Officer

MD from Howard University, MBA from Howard University

Findings from Research

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]

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]

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]

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 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]

References

1. United States 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. [2023]

2. 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]

3. England pubmed.ncbi.nlm.nih.gov

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

4. England 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. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Meaning-centered pain coping skills training for patients with metastatic cancer: Results of a randomized controlled pilot trial. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Caregiver-guided pain coping skills training for patients with advanced cancer: Results from a randomized clinical trial. [2022]