Breast Cancer SurvivorPhase 2NCT06728579
Enhanced Pain Coping in Cancer (EPIC): A Study of Managing Treatment-Related Joint Pain in Breast Cancer Survivors
A Phase 2 study testing Mindfulness Oriented Recovery Enhancement (MORE), Questionnaires and Supportive Psychotherapy (SG) in people with Breast Cancer Survivor, run by Memorial Sloan Kettering Cancer Center at 9 sites in United States.
Trial summary
The researchers are doing this study to compare two different types of group therapy and find out whether they are effective approaches for helping breast cancer survivors manage joint pain caused by aromatase inhibitors (AI). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Survivor
- What is being tested?
- Mindfulness Oriented Recovery Enhancement (MORE), Questionnaires and Supportive Psychotherapy (SG)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 9 sitesUnited States
- Study dates
- 6 Dec 2024to Dec 2028
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- English-proficient women with a history of stage I, II, or III breast cancer
- Free of oncologic disease by clinical examination and history;
- Receiving third-generation AI therapy (anastrozole, letrozole, or exemestane) for at least 28 days prior to consent with plan to continue for at least another 12 months;
- Worst joint pain rated at least 4 or greater on a 0-10 numeric rating scale in the preceding week prior to consent;
- Reporting at least 15 days with pain in the preceding 30 days prior to consent;
Show all 10Show fewer
- Experiencing joint pain for at least one month;
- Pain attributed to AI therapy;
- Willing to adhere to all study-related procedures, including randomization to one of two treatment arms: Mindfulness-Oriented Recovery Enhancement (MORE) or Supportive Group Psychotherapy (SG);
- Able to attend video-call sessions in a quiet/private location.
Who cannot join
- Metastatic breast cancer (stage IV);
- Completed chemotherapy, surgery, or radiation therapy less than 4 weeks prior to enrollment;
- Pain attributed to inflammatory arthritis (i.e. rheumatoid arthritis, gout, pseudogout);
- Surgery or joint injection involving the affected joints within the last month or planned within the next six months;
- Active suicidality or psychosis as determined by the Mini-International Neuropsychiatric Interview.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920
Jun Mao, MD, MSCE, 646-888-0863
- Recruiting
Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
Commack, New York, 11725
Jun Mao, MD, MSCE, 646-888-0863
- Recruiting
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
Jun Mao, MD, MSCE, 646-888-0863
- Recruiting
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748
Jun Mao, MD, MSCE, 646-888-0863
- Recruiting
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645
Jun Mao, MD, MSCE, 646-888-0863
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Jun Mao, MD, MSCE, 646-888-0863
- Recruiting
University of California San Diego (Data collection and Data analysis)
San Diego, California, 92103
Eric Garland, PhD, LCSW, 801-581-3826
- Not yet recruiting
Florida State University
Tallahassee, Florida, 32306
Adam Hanley, PhD, adam.hanley@fsu.edu
- Recruiting
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, 11553
Jun Mao, MD, MSCE, 646-888-0863
About this study
The researchers are doing this study to compare two different types of group therapy and find out whether they are effective approaches for helping breast cancer survivors manage joint pain caused by aromatase inhibitors (AI). This type of joint pain is called AI-associated arthralgia, or AIA, and it is common in people taking AIs. AIA and its associated symptoms can make some people decide to stop taking their medication. The study will look at the effects of two different types of group therapy on participants' cancer-related symptoms (such as pain, fatigue, and anxiety), their ability to continue taking AIs on a regular schedule, and their quality of life. We will measure participants' quality of life by having them fill out questionnaires.
Both groups will have 2-hour group therapy sessions once a week, over the course of 8 weeks. During the sessions, you will be in a group of 6-10 participants, who may be a mixture of patients from both MSK and University of California San Diego (UCSD).
- Conditions
- Breast Cancer Survivor
- Being tested
- Mindfulness Oriented Recovery Enhancement (MORE), Questionnaires, Supportive Psychotherapy (SG)
- Keywords
- Enhanced Pain Coping in Cancer, Mindfulness Oriented Recovery Enhancement, Aromatase inhibitors, Arthralgia, Ache, Cancer Pain, Cancer Survivors
- Medical subject headings
- Arthralgia, Pain, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Oriented Recovery Enhancement (MORE)Behavioural
eight weekly two-hour MORE sessions
QuestionnairesOther
filled out up to 24 weeks
Supportive Psychotherapy (SG)Behavioural
eight weekly two-hour SG sessions
| Study group | Role | What they receive |
|---|---|---|
| MORE Treatment Group | Experimental | Participants randomized to the MORE arm will participate in eight weekly, two-hour group sessions following an established protocol. MORE sessions involve instruction in three therapeutic skills: 1) mindfulness to reduce pain and increase self regulation over maladaptive pain coping habits, (2) reappraisal to decrease psychological distress and negative affect, and 3) savoring to amplify natural reward processing and evoke positive emotion (see Figure 2). Participants will be asked to engage in 15 minutes per day of skill practice at home guided by audio recording, and to record the number of minutes they engaged in skill practice via a weekly Research Electronic Data Capture (REDCap) survey. Receives: Behavioral: Mindfulness Oriented Recovery Enhancement (MORE); Other: Questionnaires |
| Supportive Psychotherapy Control Group | Active comparator | Participants randomized to SG will participate in eight weekly two-hour SG sessions led by the same instructors who deliver MORE interventions. The instructors will lead discussions on themes pertinent to chronic pain and cancer survivorship (see Figure 3) but will not teach MORE skills. To match the MORE homework requirement, SG participants will be asked to journal for 15 minutes/day on weekly session topics. Providers will employ empathic responding, elicit emotional expression, and promote a positive group climate. Receives: Other: Questionnaires; Behavioral: Supportive Psychotherapy (SG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Interference
Pain interference will be assessed using the 7-item Pain Interference subscale from the Brief Pain Inventory Short Form (BPI-SF). Each item is rated on a scale from 0 ("does not interfere") to 10 ("completely interferes"), with higher scores indicating worse interference. The BPI is a widely used, reliable, valid, and responsive tool for measuring pain (Cronbach's α 0.77-0.91). The Pain Interference subscale will be administered at baseline, weekly during the 8-week intervention, and at weeks 12 and 24. Completing the survey requires approximately 1 minute.
Measured: up to 24 weeks
Secondary outcomes (23)
Pain Severity
Pain Severity will be assessed using the 4-item Pain Severity subscale from the Brief Pain Inventory Short Form (BPI-SF). Each item is rated on a scale from 0 (no pain) to 10 (pain as bad as you can imagine), with higher scores indicating worse pain. Pain Severity will be administered at baseline, week 8, week 12, and week 24. Completing the survey requires approximately 1 minute.
Measured: baseline, week 8, week 12, and week 24
Pain Catastrophizing
Pain Catastrophizing will be assessed using a 13-item Pain Catastrophizing Scale (PCS) measuring the negative cognitive-emotional response to pain. Patients rate the degree to which they experience thoughts and feelings that may be associated with pain on a 0 (not at all) to 4 (all the time) scale. The PCS yields a total score and three subscales scores assessing rumination, magnification, and helplessness. It will be administered at baseline, week 8, week 12, and week 24. Completing the survey requires approximately 4 minutes.
Measured: baseline, week 8, week 12, and week 24
Patient Global Impression of Change
Patient Global Impression of Change (PGI-C) will be assessed on a one-item scale assessing a clinically important change from the patient's perspective. Patients respond to "How would you describe your pain since you began the treatment?" on a 7-point scale ranging from "very much worse" to "very much improved." Subjects reporting "much improved" and "very much improved" will be classified as responders. The PGI-C will be administered at week 8, week 12, and week 24. Completing the survey requires approximately 1 minute.
Measured: week 8, week 12, and week 24
Anxiety/Depression
Anxiety and Depression will be assessed on a 14-item Hospital Anxiety and Depression Scale (HADS) assessing anxiety (7 items) and depression (7 items) on a 4-point scale (0-3). Scores range from 0-21, with higher scores indicating higher symptomatology. Established cutoffs classify symptoms as not significant (0-7), subclinical (8-10), or clinically significant (11-21). The HADS will be administered at baseline, week 8, week 12, and week 24. Completing the survey requires approximately 4 minutes.
Measured: baseline, week 8, week 12, and week 24
Insomnia
Insomnia severity will be assessed on a 7-item Insomnia Severity Index (ISI) measuring subjective insomnia severity on a 0-4 scale, with higher scores indicating more severe insomnia symptoms. Established cutoffs classify ISI as "no clinically significant insomnia (< 8,), "subthreshold insomnia (8-14)", "clinical insomnia (moderate severity; 15-21)", and "clinical insomnia (severe, > 21)". It will be administered at baseline, week 8, week 12, and week 24. Completing the survey requires approximately 2 minutes.
Measured: baseline, week 8, week 12, and week 24
Fatigue
Fatigue will be assessed on a 9-item Brief Fatigue Inventory (BFI) instrument assessing fatigue severity (3 items) at its "worst," "usual," and "now" during normal waking hours and amount that fatigue has interfered (6 items) with different aspects of the patient's life during the past 24 hours. Responses are measured on a 0-10 scale. Higher scores indicate worse fatigue and interference. It will be administered at baseline, week 8, week 12, and week 24. Completing the survey requires approximately 3 minutes.
Measured: baseline, week 8, week 12, and week 24
Global Health
Global Health will be assessed using a 10-item PROMIS Global Health Scale (PROMIS-GHS) survey assessing health-related quality of life, including physical, mental, social, and overall health. Each item is rated on a 5-point scale, with higher scores indicating better overall health. It will be administered at baseline, week 8, week 12, and week 24. Completing the survey requires approximately 3 minutes.
Measured: baseline, week 8, week 12, and week 24
Perceptions of aging due to arthralgia
Perceptions of aging due to arthralgia will be measured on a 8-item Penn Arthralgia Aging Scale (PAAS) assessing how joint pain affects body image and mental state. Each item is rated on a 0 (not at all) to 4 (completely) scale. Ratings from all items are added together to create a PAAS total score, ranging from 0 to 32. Higher scores indicate more intense perceptions of arthralgia-associated aging. It will be administered at baseline, week 8, week 12, and week 24. Completing the survey requires approximately 2 minutes.
Measured: baseline, week 8, week 12, and week 24
Pleasant and painful sensations in the body
Pleasant and painful sensations in the body will be measured on Sensation Manikin 2.0 (SM 2.0) - a digital, front- and back-facing human figure silhouette overlaid with a grid of 469 "sensation" pixels where patients can report the distribution of pleasant and painful sensations in the body. SM 2.0 provides three scores: 1) unpleasant sensation score representing the total body area experienced as unpleasant; 2) pleasant sensation score, representing the total body area experienced as pleasant; and 3) a sensation ratio score. It will be administered at baseline, week 8, week 12, and week 24. Completing the survey requires approximately 3 minutes.
Measured: baseline, week 8, week 12, and week 24.
Reappraisal
Reappraisal will be measured on a 9-item Mindful Reappraisal of Pain Sensations Scale (MRPS) questionnaire assessing the frequency of various forms of mindful reinterpretation of pain. Respondents rate how often they used the different ways of coping with pain in the past week on a Likert-type scale ranging from 0 (never do that) to 6 (always do that). It will be administered at baseline, week 8, week 12, and week 24. Completing the survey requires approximately 2 minutes.
Measured: baseline, week 8, week 12, and week 24
Decentering
Decentering will be measured on a Metacognitive Processes of Decentering Scale (MPoD). The MPoD consists of the 15-item Trait (MPoD-t) and 3-item State (MPoD-s) subscales assessing decentering and the metacognitive process of decentering including meta-awareness, (dis)identification with internal experience, and (non)reactivity to internal experience. We will use the MPoD-T (Trait subscale) only. It will be administered at baseline, week 8, week 12, and week 24. Completing the survey requires approximately 2 minutes.
Measured: baseline, week 8, week 12, and week 24
Nondual awareness
Nondual awareness will be measured on a Nondual Awareness Dimensional Assessment (NADA) scale. The NADA consists of two measures that assess experiences of nondual awareness (NDA), including a 13-item trait-based assessment (NADA-T) and 3-item state-based assessment (NADA-S). Respondents answer each item of the NADA-T on a 5-point Likert-type scale ranging from 1 (never or very rarely) to 5 (very often or always), and each item of the NADA-S on a 11-point Likert-type scale ranging from 0 (not at all) to 10 (very much). It will be administered at baseline, week 8, week 12, and week 24. Completing the survey requires approximately 4 minutes.
Measured: baseline, week 8, week 12, and week 24.
Meaning in Life
Meaning in Life will be measured on a 10-item Meaning in Life Questionnaire (MLQ) designed to measure two dimensions of meaning in life: (1) Presence of Meaning (how much respondents feel their lives have meaning), and (2) Search for Meaning (how much respondents strive to find meaning and understanding in their lives). Respondents answer each item on a 7-point Likert-type scale ranging from 1 (Absolutely True) to 7 (Absolutely Untrue). It will be administered at baseline, week 8, week 12, and week 24. Completing the survey requires approximately 2 minutes.
Measured: baseline, week 8, week 12, and week 24
Emotion Regulation
Emotion Regulation will be measured on a 10-item Emotion Regulation Questionnaire (ERQ) designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal (6 items) and (2) Expressive Suppression (4 items). Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree). We will use the Reappraisal subscale only (ERQ-SE). It will be administered at baseline, week 8, week 12, and week 24. Completing the survey requires approximately 2 minutes.
Measured: baseline, week 8, week 12, and week 24.
Savoring
Savoring will be measured on a 4-item Brief Savoring Inventory (BSI) scale consisting of four items that assess methods of intensifying or prolonging positive experiences by focusing on present-moment experience. Respondents answer each item on a 5-point Likert scale from 1 (Strongly Disagree) to 5 (Strongly Agree). It will be administered at baseline, week 8, week 12, and week 24. Completing the survey requires approximately 1 minute.
Measured: baseline, week 8, week 12, and week 24
Compassion
Compassion will be measured on a 5-item Compassion Subscale of Dispositional Positive Emotion Scale (CS-DPES) subscale derived from the Dispositional Positive Emotion Scale, consisting of seven subscales (joy, contentment, pride, love, compassion, amusement and awe) that measure one's dispositional tendencies to feel positive emotions towards others in their daily lives. Respondents are asked how much they identify with each of the items within each subscale (or emotions) on a 7-point Likert scale ranging from 1 (Strongly disagree) to 7 (Strongly agree). It will be administered at baseline, week 8, week 12, and week 24. Completing the survey requires approximately 1 minute.
Measured: baseline, week 8, week 12, and week 24.
Global self-compassion
Global self-compassion will be measured on a 6-item State Self-Compassion Scale (SSCS-S). Respondents answer each item of the SSCS-S on a 5-point Likert-type scale ranging from 1 (Not at all true for me) to 5 (Very true for me). It will be administered at baseline, week 8, week 12, and week 24. Completing the survey requires approximately 1 minute.
Measured: baseline, week 8, week 12, and week 24
Treatment Credibility and Expectancy
Treatment Credibility and Expectancy will be measured on a 6-item Credibility and Expectancy Questionnaire (CEQ) measuring treatment expectancy and credibility on a 9-point scale. It will be administered at baseline. Completing the survey requires approximately 1 minute.
Measured: baseline
Treatment Expectancy
Treatment Expectancy a 4-item Treatment Expectancy Scale (TES) modified to measure MORE and SG treatment expectation. It will be administered at baseline. Completing the survey requires approximately 1 minute.
Measured: baseline
Pain Medication Diary
Pain Medication Diaries will be administered weekly from baseline to the end of the intervention (week 8), and at weeks 12 and 24. Completing the diary requires approximately 3 minutes.
Measured: baseline, week 8, 12 and 24.
AI Adherence
Adherence to AI will be assessed using patient EMRs, including records of treatment interruptions, premature discontinuations, and treatment changes. Self-reported adherence will be measured using the PROMIS Medication Adherence 4-item questionnaire.
Measured: baseline, week 8, 12 and 24.
Mindfulness Daily Log
The Mindfulness Daily Log tracks participants' engagement with at-home mindfulness practice, recording daily practice duration (minutes/day). This log will be collected weekly throughout the 8-week intervention for participants in the MORE treatment group. Completing the log requires approximately 1 minute.
Measured: weekly throughout the 8-week intervention
Journaling Daily Log
The Journaling Daily Log tracks participants' engagement with at-home journaling practice, recording daily practice duration (minutes/day). This log will be collected weekly throughout the 8-week intervention for participants in the SG treatment group. Completing the log requires approximately 1 minute.
Measured: weekly throughout the 8-week interventio
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start6 Dec 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurvivorStudies 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
- Model description
- Two-arm, parallel group, RCT
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Jun Mao, MD, MSCE, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728579
- Sponsor's protocol ID
- 24-171
- Status last verified
- Sep 2026
- First submitted
- 6 Dec 2024
- Last updated
- 22 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Pain Coping in Cancer (EPIC): A Study of Managing Treatment-Related Joint Pain in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT06728579
- Acronym / sponsor ID
- 24-171
- Conditions
- Breast Cancer Survivor
- Keywords
- Enhanced Pain Coping in Cancer, Mindfulness Oriented Recovery Enhancement, Aromatase inhibitors, Arthralgia, Ache, Cancer Pain, Cancer Survivors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 6 Dec 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 11 Dec 2024 (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 researchers are doing this study to compare two different types of group therapy and find out whether they are effective approaches for helping breast cancer survivors manage joint pain caused by aromatase inhibitors (AI). This type of joint pain is called AI-associated arthralgia, or AIA, and it is common in people taking AIs. AIA and its associated symptoms can make some people decide to stop taking their medication. The study will look at the effects of two different types of group therapy on participants' cancer-related symptoms (such as pain, fatigue, and anxiety), their ability to continue taking AIs on a regular schedule, and their quality of life. We will measure participants' quality of life by having them fill out questionnaires.
Both groups will have 2-hour group therapy sessions once a week, over the course of 8 weeks. During the sessions, you will be in a group of 6-10 participants, who may be a mixture of patients from both MSK and University of California San Diego (UCSD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm, parallel group, RCT
| Arm | Type | Receives |
|---|---|---|
| MORE Treatment Group | Experimental | Behavioral: Mindfulness Oriented Recovery Enhancement (MORE), Other: QuestionnairesParticipants randomized to the MORE arm will participate in eight weekly, two-hour group sessions following an established protocol. MORE sessions involve instruction in three therapeutic skills: 1) mindfulness to reduce pain and increase self regulation over maladaptive pain coping habits, (2) reappraisal to decrease psychological distress and negative affect, and 3) savoring to amplify natural reward processing and evoke positive emotion (see Figure 2). Participants will be asked to engage in 15 minutes per day of skill practice at home guided by audio recording, and to record the number of minutes they engaged in skill practice via a weekly Research Electronic Data Capture (REDCap) survey. |
| Supportive Psychotherapy Control Group | Active comparator | Other: Questionnaires, Behavioral: Supportive Psychotherapy (SG)Participants randomized to SG will participate in eight weekly two-hour SG sessions led by the same instructors who deliver MORE interventions. The instructors will lead discussions on themes pertinent to chronic pain and cancer survivorship (see Figure 3) but will not teach MORE skills. To match the MORE homework requirement, SG participants will be asked to journal for 15 minutes/day on weekly session topics. Providers will employ empathic responding, elicit emotional expression, and promote a positive group climate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18 years
- English-proficient women with a history of stage I, II, or III breast cancer
- Free of oncologic disease by clinical examination and history;
- Receiving third-generation AI therapy (anastrozole, letrozole, or exemestane) for at least 28 days prior to consent with plan to continue for at least another 12 months;
- Worst joint pain rated at least 4 or greater on a 0-10 numeric rating scale in the preceding week prior to consent;
Key exclusion criteria (5 listed)
- Metastatic breast cancer (stage IV);
- Completed chemotherapy, surgery, or radiation therapy less than 4 weeks prior to enrollment;
- Pain attributed to inflammatory arthritis (i.e. rheumatoid arthritis, gout, pseudogout);
- Surgery or joint injection involving the affected joints within the last month or planned within the next six months;
- Active suicidality or psychosis as determined by the Mini-International Neuropsychiatric Interview.
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 |
|---|---|---|
| Mindfulness Oriented Recovery Enhancement (MORE)eight weekly two-hour MORE sessions | Behavioural | MORE Treatment Group |
| Questionnairesfilled out up to 24 weeks | Other | MORE Treatment Group, Supportive Psychotherapy Control Group |
| Supportive Psychotherapy (SG)eight weekly two-hour SG sessions | Behavioural | Supportive Psychotherapy Control Group |
Primary outcome
Pain Interference
Time frame: up to 24 weeks
Pain interference will be assessed using the 7-item Pain Interference subscale from the Brief Pain Inventory Short Form (BPI-SF). Each item is rated on a scale from 0 ("does not interfere") to 10 ("completely interferes"), with higher scores indicating worse interference. The BPI is a widely used, reliable, valid, and responsive tool for measuring pain (Cronbach's α 0.77-0.91). The Pain Interference subscale will be administered at baseline, weekly during the 8-week intervention, and at weeks 12 and 24. Completing the survey requires approximately 1 minute.
23 secondary outcomes
Pain Severity
Time frame: baseline, week 8, week 12, and week 24
Pain Catastrophizing
Time frame: baseline, week 8, week 12, and week 24
Patient Global Impression of Change
Time frame: week 8, week 12, and week 24
Anxiety/Depression
Time frame: baseline, week 8, week 12, and week 24
Insomnia
Time frame: baseline, week 8, week 12, and week 24
Fatigue
Time frame: baseline, week 8, week 12, and week 24
Global Health
Time frame: baseline, week 8, week 12, and week 24
Perceptions of aging due to arthralgia
Time frame: baseline, week 8, week 12, and week 24
Pleasant and painful sensations in the body
Time frame: baseline, week 8, week 12, and week 24.
Reappraisal
Time frame: baseline, week 8, week 12, and week 24
Decentering
Time frame: baseline, week 8, week 12, and week 24
Nondual awareness
Time frame: baseline, week 8, week 12, and week 24.
Meaning in Life
Time frame: baseline, week 8, week 12, and week 24
Emotion Regulation
Time frame: baseline, week 8, week 12, and week 24.
Savoring
Time frame: baseline, week 8, week 12, and week 24
Compassion
Time frame: baseline, week 8, week 12, and week 24.
Global self-compassion
Time frame: baseline, week 8, week 12, and week 24
Treatment Credibility and Expectancy
Time frame: baseline
Treatment Expectancy
Time frame: baseline
Pain Medication Diary
Time frame: baseline, week 8, 12 and 24.
AI Adherence
Time frame: baseline, week 8, 12 and 24.
Mindfulness Daily Log
Time frame: weekly throughout the 8-week intervention
Journaling Daily Log
Time frame: weekly throughout the 8-week interventio
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 22 Sep 2026.
- 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.
Jun Mao, MD, MSCE principal investigator
Memorial Sloan Kettering Cancer Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mindfulness Oriented Recovery Enhancement (MORE), Questionnaires and Supportive Psychotherapy (SG) in people with Breast Cancer Survivor, run by Memorial Sloan Kettering Cancer Center at 9 sites 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 10 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 22 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 9 sites 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. 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?
Contact Jun Mao, MD, MSCE (646-608-8553, maoj@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Interference (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2026.