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Mindfulness Training for Cancer Pain

Phase 2

Recruiting

Led By Jun Mao, MD, MSCE

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Having had pain for at least 3 months and at least 15 days with pain in the preceding 30 days

Having a pain (musculoskeletal, generalized, or neuropathic) rating of 4 or greater in worst pain on a 0-10 numerical rating scale in the preceding week

Must not have

Active suicidality or schizophrenia

Cognitive impairment preventing completing PRO independently or participate in virtual MORE as evaluated by study clinicians

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Summary

This trial aims to see if mindfulness-based interventions, like Mindfulness-oriented Recovery Enhancement, can help reduce chronic pain in cancer patients. #mindfulness #meditation #cancer #pain

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Mindfulness-based interventions like MORE typically do not involve medication; therefore, physical side effects are minimal. However, participants may experience emotional discomfort as they become more aware of thoughts and sensations during mindfulness practice.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have active suicidal thoughts or schizophrenia.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of participant enrollment to the study

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: 8-hour MORE treatmentsExperimental Treatment1 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 treatmentsExperimental Treatment1 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 treatmentsExperimental Treatment1 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 ProcedurePlacebo Group1 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.

0 / 4Eligibility criteria met