Mindfulness Training for Cancer Pain

Overseen By Shelly Latte-Naor, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Suicidality, Schizophrenia, Cognitive impairment, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

76 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Mindfulness-Oriented Recovery Enhancement (MORE) for cancer pain?

Mindfulness-based interventions, like MORE, have been shown to help reduce pain and improve well-being in patients with cancer by changing how they perceive and react to pain. MORE has also been effective in reducing pain and improving outcomes in people with opioid use disorder and chronic pain, suggesting it may help with cancer pain too. ^{1 2 3 4 5}

Is Mindfulness-Oriented Recovery Enhancement (MORE) safe for humans?

Research on mindfulness-based interventions, including Mindfulness-Oriented Recovery Enhancement (MORE), suggests they are generally safe for humans. Studies have shown that these interventions can be integrated with other therapies and have been used in cancer survivors without significant safety concerns. ^{4 6 7 8 9}

How is the treatment Mindfulness-Oriented Recovery Enhancement (MORE) different from other treatments for cancer pain?

Mindfulness-Oriented Recovery Enhancement (MORE) is unique because it combines mindfulness training with cognitive and behavioral techniques to help patients change their relationship with pain, potentially reducing the emotional and psychological impact of pain, unlike traditional treatments that primarily focus on physical symptoms. ^{3 4 5 10 11}

What is the purpose of this trial?

The purpose of this study is to evaluate whether or not mindfulness-based interventions/MBIs may help reduce chronic pain in participants who have cancer-related chronic pain. MBIs are therapeutic programs that use mindfulness meditation practices to help people focus on the present moment, as well as encourage acceptance of thoughts, emotions, and body sensations. The researchers think that an MBI treatment called Mindfulness-oriented Recovery Enhancement (MORE) may help people who are experiencing cancer-related chronic pain.

Research Team

Jun Mao, MD, MSCE

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for English-speaking adults (18+) with a history of any type of cancer, who are either in remission or have stable disease. Participants must be experiencing chronic pain related to cancer, rating their worst pain at 4 or higher on a scale up to 10, and have had this pain for over 3 months. They should be able to attend video calls in a private setting and commit to the study procedures.

Inclusion Criteria

Willing to adhere to all study-related procedures, including randomization to one of two treatment arms: MORE or WLC

I have experienced pain for at least 3 months, with pain on at least 15 days in the last month.

My worst pain level in the last week was 4 or higher on a scale of 0 to 10.

Exclusion Criteria

I do not have active suicidal thoughts or schizophrenia.

I plan to start treatment for pain relief within the next 12 weeks.

I am unable to complete tasks or participate in virtual meetings due to cognitive issues.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Mindfulness-oriented Recovery Enhancement (MORE) treatments

8 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Mindfulness-oriented Recovery Enhancement (MORE)

Trial Overview The trial is testing Mindfulness-oriented Recovery Enhancement (MORE), which uses mindfulness meditation practices aimed at reducing chronic cancer-related pain. Participants will either receive MORE treatments or follow standard care for managing their pain, and they'll be randomly assigned to one of these two groups.

Participant Groups

Group I: 8-hour MORE treatments Experimental Treatment 1 Intervention

Patients in the 8-hour MORE format will receive one 2hrs treatment a week for 4 consecutive weeks (as per study schema: from week 1 to week 4).

Group II: 2-hour MORE treatments Experimental Treatment 1 Intervention

Patients in the 2-hour MORE format will receive one 2hrs treatment (as per study schema: in week 1).

Group III: 16-hour MORE treatments Experimental Treatment 1 Intervention

Patients in the 16-hour MORE format will receive one 2hrs treatment a week for 8 consecutive weeks (as per study schema: from week 1 to week 8).

Group IV: Wait List Control (WLC) Usual Care Procedure Placebo Group 1 Intervention

Participants in the WLC group continue to receive their standard medical care and pain management as prescribed by their physicians or other health care providers.

Mindfulness-oriented Recovery Enhancement (MORE) is already approved in United States for the following indications:

Approved in United States as Mindfulness-Oriented Recovery Enhancement for:

• Chronic pain
• Opioid misuse
• Cancer-related chronic pain

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Findings from Research

The Mindfulness-Oriented Recovery Enhancement Fidelity Measure (MORE-FM) was developed and validated to assess therapist competence and adherence to the MORE treatment manual, showing high internal consistency and adequate reliability across 40 treatment sessions involving 295 participants.

Higher fidelity in delivering the MORE treatment was linked to significant reductions in opioid misuse, suggesting that the MORE-FM is an effective tool for ensuring treatment integrity and predicting positive clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mindfulness-Oriented Recovery Enhancement Fidelity Measure (MORE-FM): Development and Validation of a New Tool to Assess Therapist Adherence and Competence. Hanley, AW., Garland, EL.[2022]

The 8-week Mindfulness-Oriented Recovery Enhancement (MORE) intervention significantly improved emotional regulation in women undergoing treatment for opioid use disorder, as evidenced by decreased difficulty in managing emotions after the program.

Functional MRI results showed increased connectivity in brain regions associated with affect regulation after the MORE intervention, suggesting that this mindfulness approach may enhance brain function related to emotional control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-oriented recovery enhancement in opioid use disorder: Extended emotional regulation and neural effects and immediate effects of guided meditation in a pilot sample. Ray, S., Bhanji, J., Kennelly, N., et al.[2023]

In a study of 30 individuals undergoing methadone maintenance treatment (MMT), those who participated in Mindfulness-Oriented Recovery Enhancement (MORE) experienced significantly fewer days of illicit drug use and lower cravings compared to those receiving standard treatment alone over a 16-week follow-up period.

Participants in the MORE group also reported reduced pain, lower levels of depression and anxiety, and improved well-being and social functioning, suggesting that MORE may effectively address both chronic pain and opioid use disorder in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomized clinical trial of mindfulness-oriented recovery enhancement as an adjunct to methadone treatment for people with opioid use disorder and chronic pain: Impact on illicit drug use, health, and well-being. Cooperman, NA., Hanley, AW., Kline, A., et al.[2022]

In a study of 129 women with persistent pain after breast cancer treatment, mindfulness-based cognitive therapy (MBCT) significantly reduced pain intensity, particularly in those with higher levels of attachment avoidance.

Radiotherapy may also influence the effectiveness of MBCT, as it was associated with a smaller reduction in pain intensity, suggesting that these factors could help identify patients who would benefit most from this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and psychological moderators of the effect of mindfulness-based cognitive therapy on persistent pain in women treated for primary breast cancer - explorative analyses from a randomized controlled trial. Johannsen, M., O'Toole, MS., O'Connor, M., et al.[2018]

Approximately 50% of cancer patients experience pain that can lead to a complex state of 'total pain,' which may not respond well to traditional medications.

Mindfulness-based interventions can help patients change their perception of pain, potentially reducing pain catastrophizing and improving overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Interventions for Hematology and Oncology Patients with Pain. Hess, D.[2019]

The pilot study involving 51 overweight and obese female cancer survivors showed that integrating the Mindfulness-Oriented Recovery Enhancement (MORE) intervention with exercise and nutrition counseling was feasible, with 82% of participants completing the program.

The MORE intervention significantly improved interoceptive awareness and reduced maladaptive eating behaviors, which were linked to decreases in waist-to-hip ratio, suggesting it effectively targets mechanisms related to obesity in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Oriented Recovery Enhancement Restructures Reward Processing and Promotes Interoceptive Awareness in Overweight Cancer Survivors: Mechanistic Results From a Stage 1 Randomized Controlled Trial. Thomas, EA., Mijangos, JL., Hansen, PA., et al.[2020]

A 4-week mindfulness program for 36 cancer survivors led to significant reductions in perceived stress and sedentary time, along with improvements in sleep quality and daily physical activity after the intervention.

The study suggests that abbreviated mindfulness interventions are feasible and effective for cancer survivors, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of a 4-Week Mindfulness Intervention among Cancer Survivors Compared to a Breathing Control. Wirth, MD., Franco, R., Wagner Robb, S., et al.[2019]

An 8-week Mindfulness-Based Stress Reduction (MBSR) program significantly improved sleep quality in 63 cancer patients, with overall sleep disturbance reduced (p < .001).

Participants also experienced significant reductions in stress, mood disturbance, and fatigue, suggesting that MBSR can enhance the overall quality of life for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of mindfulness-based stress reduction (MBSR) on sleep, mood, stress and fatigue symptoms in cancer outpatients. Carlson, LE., Garland, SN.[2018]

In a study of 82 breast cancer patients, mindfulness-based stress reduction therapy (MBSR) significantly enhanced the activation of T cells and improved the Th1/Th2 cytokine balance, particularly in those who completed treatment less than 12 weeks prior.

MBSR therapy led to a quicker recovery of functional T cells, suggesting that stress reduction can positively influence immune recovery after cancer treatment, while B and natural killer (NK) cells showed recovery independent of such interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lymphocyte recovery after breast cancer treatment and mindfulness-based stress reduction (MBSR) therapy. Lengacher, CA., Kip, KE., Post-White, J., et al.[2012]

Mindfulness training significantly increased pain tolerance in 42 university students compared to a control group that received guided visual imagery, indicating its potential as an effective intervention for managing pain.

While mindfulness skills showed a strong trend of improvement in the mindfulness group, this increase was not directly linked to the enhanced pain tolerance, suggesting that other mechanisms may be at play.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomized control trial investigating the effect of mindfulness practice on pain tolerance, psychological well-being, and physiological activity. Kingston, J., Chadwick, P., Meron, D., et al.[2022]

Mindfulness-based cognitive therapy (MBCT) significantly reduced pain intensity in women treated for breast cancer, with a robust effect size (d = 0.61) observed in a study of 129 participants over an 8-week program.

MBCT also improved quality of life and reduced the use of nonprescription pain medication, indicating its potential as an effective pain management strategy for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Mindfulness-Based Cognitive Therapy on Late Post-Treatment Pain in Women Treated for Primary Breast Cancer: A Randomized Controlled Trial. Johannsen, M., O'Connor, M., O'Toole, MS., et al.[2022]

References

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

The Mindfulness-Oriented Recovery Enhancement Fidelity Measure (MORE-FM): Development and Validation of a New Tool to Assess Therapist Adherence and Competence. [2022]

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

Mindfulness-oriented recovery enhancement in opioid use disorder: Extended emotional regulation and neural effects and immediate effects of guided meditation in a pilot sample. [2023]

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

A pilot randomized clinical trial of mindfulness-oriented recovery enhancement as an adjunct to methadone treatment for people with opioid use disorder and chronic pain: Impact on illicit drug use, health, and well-being. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Clinical and psychological moderators of the effect of mindfulness-based cognitive therapy on persistent pain in women treated for primary breast cancer - explorative analyses from a randomized controlled trial. [2018]

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

Mindfulness-Based Interventions for Hematology and Oncology Patients with Pain. [2019]

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

Mindfulness-Oriented Recovery Enhancement Restructures Reward Processing and Promotes Interoceptive Awareness in Overweight Cancer Survivors: Mechanistic Results From a Stage 1 Randomized Controlled Trial. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of a 4-Week Mindfulness Intervention among Cancer Survivors Compared to a Breathing Control. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Impact of mindfulness-based stress reduction (MBSR) on sleep, mood, stress and fatigue symptoms in cancer outpatients. [2018]

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

Lymphocyte recovery after breast cancer treatment and mindfulness-based stress reduction (MBSR) therapy. [2012]

10. England pubmed.ncbi.nlm.nih.gov

A pilot randomized control trial investigating the effect of mindfulness practice on pain tolerance, psychological well-being, and physiological activity. [2022]

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

Efficacy of Mindfulness-Based Cognitive Therapy on Late Post-Treatment Pain in Women Treated for Primary Breast Cancer: A Randomized Controlled Trial. [2022]