Mindfulness-oriented Recovery Enhancement (MORE) for Cancer Pain Relief

Study Overview
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Brief Summary
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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.

Official Title
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Adapting Mindfulness-oriented Recovery Enhancement (MORE) for Cancer Pain Relief: The MORE Relief Trial

Conditions
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Chronic Pain, Cancer Pain

Intervention / Treatment
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* Behavioral: MORE treatments
* Other: Standard of Care for Pain Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English speaking Age ≥ 18 years or older A history of cancer with no restrictions placed on type of cancer Determined to be either no-evidence of disease or stable oncological disease by referring or study physicians/advanced practice providers 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 Having had pain for at least 3 months and at least 15 days with pain in the preceding 30 days Willing to adhere to all study-related procedures, including randomization to one of two treatment arms: MORE or WLC Ability to attend video-call session and a quiet/private location Exclusion Criteria: Active suicidality or schizophrenia Plan to initiate palliative radiation or interventional pain procedure within the next 12 weeks Cognitive impairment preventing completing PRO independently or participate in virtual MORE as evaluated by study clinicians

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Wait List Control (WLC) Usual Care Procedure<br>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. | Other: Standard of Care for Pain Management<br>* 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.<br>|
| Experimental: 16-hour MORE treatments<br>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). | Behavioral: MORE treatments<br>* MORE participants will also be asked to engage in 15 minutes/day of skill practice at home, and complete daily diaries of mindfulness practice time<br>|
| Experimental: 8-hour MORE treatments<br>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). | Behavioral: MORE treatments<br>* MORE participants will also be asked to engage in 15 minutes/day of skill practice at home, and complete daily diaries of mindfulness practice time<br>|
| Experimental: 2-hour MORE treatments<br>Patients in the 2-hour MORE format will receive one 2hrs treatment (as per study schema: in week 1). | Behavioral: MORE treatments<br>* MORE participants will also be asked to engage in 15 minutes/day of skill practice at home, and complete daily diaries of mindfulness practice time<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of participant enrollment to the study | Feasibility of the intervention will be determined by Rate of participant enrollment to the study | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic pain, cancer pain, Mindfulness-oriented Recovery Enhancement, MORE, mindfulness-based interventions, MBIs, Memorial Sloan Kettering Cancer Center, 23-082