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

NCT ID: NCT05877521

Last Updated: 2025-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-16

Study Completion Date

2027-05-16

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.

Detailed Description

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Conditions

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Chronic Pain Cancer Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Standard of Care for Pain Management

Intervention Type OTHER

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.

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).

Group Type EXPERIMENTAL

MORE treatments

Intervention Type BEHAVIORAL

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

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).

Group Type EXPERIMENTAL

MORE treatments

Intervention Type BEHAVIORAL

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

2-hour MORE treatments

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

Group Type EXPERIMENTAL

MORE treatments

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jun Mao, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

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23-082

Identifier Type: -

Identifier Source: org_study_id

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