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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether mindfulness practices can reduce chronic pain in individuals with cancer-related pain. Participants will engage in a mindfulness program called Mindfulness-oriented Recovery Enhancement (MORE), which emphasizes meditation and acceptance of thoughts and feelings. The trial will compare various lengths of the MORE program to determine the most effective duration. Individuals who have had cancer and regularly experience moderate or worse pain might find this trial suitable. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important early findings.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Mindfulness-Oriented Recovery Enhancement (MORE) is generally safe and well-tolerated by participants. In studies involving individuals with chronic pain, those who tried MORE reported very few side effects, suggesting it is likely a low-risk treatment option. Another study with cancer survivors found similar results, with participants experiencing no serious side effects. MORE involves mindfulness meditation, a safe and gentle method. Overall, evidence supports that MORE is safe for people, including those with chronic pain or a history of cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Mindfulness-oriented Recovery Enhancement (MORE) treatments for cancer pain because they offer a fresh approach compared to traditional pain management methods like opioids and over-the-counter pain relievers. Unlike these standard options, MORE focuses on mindfulness techniques that help patients manage pain by enhancing their mental and emotional well-being. The different formats—16-hour, 8-hour, and 2-hour MORE treatments—allow for flexibility in treatment duration, potentially accommodating various patient needs and schedules. This innovative focus on mindfulness could lead to reduced reliance on medication, fewer side effects, and improved overall quality of life for cancer patients.

What evidence suggests that this trial's treatments could be effective for cancer-related chronic pain?

Research has shown that Mindfulness-oriented Recovery Enhancement (MORE) can reduce chronic pain. In earlier studies, about half of the patients using MORE experienced a significant decrease in pain levels. MORE also boosts overall well-being and reduces symptoms of depression. In this trial, participants will receive different formats of MORE treatments, including 16-hour, 8-hour, and 2-hour sessions. For cancer patients, mindfulness-based treatments have improved social support and strengthened their sense of purpose and spirituality. These findings suggest that MORE could help manage chronic pain related to cancer. ^{1 3 6 7 8}

Who Is on the Research Team?

Jun Mao, MD, MSCE

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24780180/

Mindfulness-oriented recovery enhancement ... - PubMed Findings demonstrate preliminary efficacy of MORE as a treatment for pain-related functional impairments and suggest that effects may be more pronounced and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05877521

Mindfulness-oriented Recovery Enhancement (MORE) for ... 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- ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0272735824001260

Positive health outcomes of mindfulness-based ... Among cancer patients, these interventions have demonstrated improvements in mindfulness, social support, well-being, meaningfulness, and spirituality (Carlson ...

4. drericgarland.com drericgarland.com/about-m-o-r-e/

Mindfulness in Therapy | M.O.R.E. In addition, 50% of patients treated with MORE achieved clinically-significant reductions in chronic pain. MORE also demonstrated robust anti-depressant effects ...

5. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2789279

Mindfulness-Oriented Recovery Enhancement vs ... Participants receiving MORE also reported significant improvements in chronic pain symptoms compared with those receiving supportive ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6552347/

Mindfulness-Oriented Recovery Enhancement ... Methods: Female overweight and obese cancer survivors (N = 51; mean age = 57.92 ± 10.04; 88% breast cancer history; 96% white) were randomized ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S088539241400219X

Mindfulness-Oriented Recovery Enhancement Ameliorates ... Chronic pain patients (N = 115; mean age, 48 ± 14 years; 68% female) were randomly assigned to either eight weeks of MORE or a support group.

8. bpspubs.onlinelibrary.wiley.com bpspubs.onlinelibrary.wiley.com/doi/abs/10.1111/bcp.16147

Mindfulness‐Oriented Recovery Enhancement: Implementing ... A novel, evidence-based intervention for chronic pain, opioid use and OUD called Mindfulness-Oriented Recovery Enhancement (MORE).