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

Primary Purpose

Chronic Pain, Cancer Pain

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MORE treatments
Standard of Care for Pain Management
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring chronic pain, cancer pain, Mindfulness-oriented Recovery Enhancement, MORE, mindfulness-based interventions, MBIs, Memorial Sloan Kettering Cancer Center, 23-082

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Wait List Control (WLC) Usual Care Procedure

16-hour MORE treatments

8-hour MORE treatments

2-hour MORE treatments

Arm Description

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.

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).

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).

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

Outcomes

Primary Outcome Measures

Rate of participant enrollment to the study
Feasibility of the intervention will be determined by Rate of participant enrollment to the study

Secondary Outcome Measures

Full Information

First Posted
May 17, 2023
Last Updated
May 17, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05877521
Brief Title
Mindfulness-oriented Recovery Enhancement (MORE) for Cancer Pain Relief
Official Title
Adapting Mindfulness-oriented Recovery Enhancement (MORE) for Cancer Pain Relief: The MORE Relief Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 16, 2023 (Actual)
Primary Completion Date
May 16, 2027 (Anticipated)
Study Completion Date
May 16, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Cancer Pain
Keywords
chronic pain, cancer pain, Mindfulness-oriented Recovery Enhancement, MORE, mindfulness-based interventions, MBIs, Memorial Sloan Kettering Cancer Center, 23-082

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Wait List Control (WLC) Usual Care Procedure
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
16-hour MORE treatments
Arm Type
Experimental
Arm Description
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).
Arm Title
8-hour MORE treatments
Arm Type
Experimental
Arm Description
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).
Arm Title
2-hour MORE treatments
Arm Type
Experimental
Arm Description
Patients in the 2-hour MORE format will receive one 2hrs treatment (as per study schema: in week 1).
Intervention Type
Behavioral
Intervention Name(s)
MORE treatments
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Standard of Care for Pain Management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of participant enrollment to the study
Description
Feasibility of the intervention will be determined by Rate of participant enrollment to the study
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Mao, MD, MSCE
Phone
646-608-8552
Email
maoj@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Shelly Latte-Naor, MD
Phone
646-608-8557
Email
lattenas@mskcc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Mao, MD, MSCE
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Mao, MD, MSCE
Phone
646-608-8552

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

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

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