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

April 11, 2024 updated by: Memorial Sloan Kettering Cancer Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

76

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jun Mao, MD, MSCE
  • Phone Number: 646-608-8552
  • Email: maoj@mskcc.org

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
        • Contact:
          • Jun Mao, MD, MSCE
          • Phone Number: 646-608-8552

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Jun Mao, MD, MSCE, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2023

Primary Completion (Estimated)

May 16, 2027

Study Completion (Estimated)

May 16, 2027

Study Registration Dates

First Submitted

May 17, 2023

First Submitted That Met QC Criteria

May 17, 2023

First Posted (Actual)

May 26, 2023

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-082

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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