NCT05877521

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for phase_2 chronic-pain

Timeline
13mo left

Started May 2023

Longer than P75 for phase_2 chronic-pain

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
May 2023May 2027

Study Start

First participant enrolled

May 16, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 17, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 26, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2027

Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

4 years

First QC Date

May 17, 2023

Last Update Submit

September 22, 2025

Conditions

Keywords

chronic paincancer painMindfulness-oriented Recovery EnhancementMOREmindfulness-based interventionsMBIsMemorial Sloan Kettering Cancer Center23-082

Outcome Measures

Primary Outcomes (1)

  • Rate of participant enrollment to the study

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

    12 months

Study Arms (4)

Wait List Control (WLC) Usual Care Procedure

PLACEBO COMPARATOR

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

16-hour MORE treatments

EXPERIMENTAL

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

8-hour MORE treatments

EXPERIMENTAL

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

2-hour MORE treatments

EXPERIMENTAL

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

Behavioral: MORE treatments

Interventions

MORE treatmentsBEHAVIORAL

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

16-hour MORE treatments2-hour MORE treatments8-hour MORE treatments

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.

Wait List Control (WLC) Usual Care Procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

Location

Related Publications (1)

  • Bryl KL, Hanley AW, Baser RE, Desai K, Dowd M, Li Q, Sandweiss B, Garland EL, Mao JJ. Mindfulness-Oriented Recovery Enhancement for Cancer Pain Relief: Pilot Randomized Controlled Trial. J Pain Symptom Manage. 2026 Jan 3:S0885-3924(25)01035-8. doi: 10.1016/j.jpainsymman.2025.12.024. Online ahead of print.

Related Links

MeSH Terms

Conditions

Chronic PainCancer Pain

Interventions

Standard of CarePain Management

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationTherapeuticsDisease ManagementPatient Care Management

Study Officials

  • Jun Mao, MD, MSCE

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2023

First Posted

May 26, 2023

Study Start

May 16, 2023

Primary Completion (Estimated)

May 16, 2027

Study Completion (Estimated)

May 16, 2027

Last Updated

September 23, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

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.

Locations