Enhanced Pain Coping in Cancer (EPIC): A Study of Managing Treatment-Related Joint Pain in Breast Cancer Survivors
- Conditions
- Breast Cancer Survivor
- Registration Number
- NCT06728579
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Brief 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). 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 200
- 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;
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Pain Interference 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.
- Secondary Outcome Measures
Name Time Method Pain Severity baseline, week 8, week 12, and week 24 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.
Pain Catastrophizing baseline, week 8, week 12, and week 24 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.
Patient Global Impression of Change week 8, week 12, and week 24 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.
Insomnia baseline, week 8, week 12, and week 24 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.
Fatigue baseline, week 8, week 12, and week 24 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.
Reappraisal baseline, week 8, week 12, and week 24 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.
Compassion baseline, week 8, week 12, and week 24. 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.
AI Adherence baseline, week 8, 12 and 24. 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.
Journaling Daily Log weekly throughout the 8-week interventio 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.
Perceptions of aging due to arthralgia baseline, week 8, week 12, and week 24 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.
Decentering baseline, week 8, week 12, and week 24 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.
Mindfulness Daily Log weekly throughout the 8-week intervention 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.
Anxiety/Depression baseline, week 8, week 12, and week 24 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.
Global Health baseline, week 8, week 12, and week 24 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.
Pleasant and painful sensations in the body baseline, week 8, week 12, and week 24. 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.
Nondual awareness baseline, week 8, week 12, and week 24. 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.
Meaning in Life baseline, week 8, week 12, and week 24 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.
Treatment Expectancy baseline 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.
Pain Medication Diary baseline, week 8, 12 and 24. 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.
Emotion Regulation baseline, week 8, week 12, and week 24. 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.
Savoring baseline, week 8, week 12, and week 24 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.
Global self-compassion baseline, week 8, week 12, and week 24 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.
Treatment Credibility and Expectancy baseline 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.
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Trial Locations
- Locations (9)
Memorial Sloan Kettering Monmouth (All Protocol Activities)
🇺🇸Middletown, New Jersey, United States
Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
🇺🇸Commack, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
🇺🇸New York, New York, United States
Memorial Sloan Kettering Nassau (All Protocol Activities)
🇺🇸Uniondale, New York, United States
University of California San Diego (Data collection and Data analysis)
🇺🇸San Diego, California, United States
Florida State University
🇺🇸Tallahassee, Florida, United States
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
🇺🇸Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Bergen (All Protocol Activities)
🇺🇸Montvale, New Jersey, United States
Memorial Sloan Kettering Westchester (All Protocol Activities)
🇺🇸Harrison, New York, United States