Chronic PainPhase 2NCT05877521
Mindfulness-oriented Recovery Enhancement (MORE) for Cancer Pain Relief
A Phase 2 study testing MORE treatments in people with Chronic Pain and Cancer Pain, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Cancer Pain
- What is being tested?
- MORE treatments
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2023to 16 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
About this study
Official title: 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.
- Conditions
- Chronic Pain, Cancer Pain
- Being tested
- MORE treatments, Standard of Care for Pain Management
- Keywords
- chronic pain, cancer pain, Mindfulness-oriented Recovery Enhancement, MORE, mindfulness-based interventions, MBIs, Memorial Sloan Kettering Cancer Center, 23-082
- Medical subject headings
- Chronic Pain, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MORE treatmentsBehavioural
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
Standard of Care for Pain ManagementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: 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). Receives: 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). Receives: Behavioral: MORE treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of participant enrollment to the study
Feasibility of the intervention will be determined by Rate of participant enrollment to the study
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start16 May 2023
- Primary completion16 May 2027 (estimated)
- Study completion16 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Mao, MD, MSCE, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05877521
- Sponsor's protocol ID
- 23-082
- Status last verified
- Sep 2026
- First submitted
- 17 May 2023
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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 Apr;71(4):547-559. doi: 10.1016/j.jpainsymman.2025.12.024. Epub 2026 Jan 3.
PubMed 41490669
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting Mindfulness-oriented Recovery Enhancement (MORE) for Cancer Pain Relief: The MORE Relief Trial
- ClinicalTrials.gov ID
- NCT05877521
- Acronym / sponsor ID
- 23-082
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 16 May 2023 (actual)
- Primary completion
- 16 May 2027 (estimated)
- Study completion
- 16 May 2027 (estimated)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Wait List Control (WLC) Usual Care Procedure | Placebo comparator | Other: Standard of Care for Pain ManagementParticipants 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 | Experimental | Behavioral: MORE treatmentsPatients 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). |
| 8-hour MORE treatments | Experimental | Behavioral: MORE treatmentsPatients 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). |
| 2-hour MORE treatments | Experimental | Behavioral: MORE treatmentsPatients in the 2-hour MORE format will receive one 2hrs treatment (as per study schema: in week 1). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MORE treatmentsMORE participants will also be asked to engage in 15 minutes/day of skill practice at home, and complete daily diaries of mindfulness practice time | Behavioural | 16-hour MORE treatments, 2-hour MORE treatments, 8-hour MORE treatments |
| Standard of Care for Pain ManagementParticipants 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 | Wait List Control (WLC) Usual Care Procedure |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Derived from this study: PubMed 41490669Bryl 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 Apr;71(4):547-559. doi: 10.1016/j.jpainsymman.2025.12.024. Epub 2026 Jan 3.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Mao, MD, MSCE principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MORE treatments in people with Chronic Pain and Cancer Pain, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of participant enrollment to the study (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05877521, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.