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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05877521

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain Cancer Pain	Behavioral: MORE treatments Other: Standard of Care for Pain Management	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 16, 2023

Anticipated Primary Completion Date :

May 16, 2027

Anticipated Study Completion Date :

May 16, 2027

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Wait List Control (WLC) Usual Care Procedure 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 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.
Experimental: 16-hour MORE treatments 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 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
Experimental: 8-hour MORE treatments 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 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
Experimental: 2-hour MORE treatments Patients in the 2-hour MORE format will receive one 2hrs treatment (as per study schema: in week 1).	Behavioral: MORE treatments 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

Outcome Measures

Primary Outcome Measures

Rate of participant enrollment to the study [12 months]
Feasibility of the intervention will be determined by Rate of participant enrollment to the study

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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