Enhanced Pain Coping in Cancer (EPIC): A Study of Managing Treatment-Related Joint Pain in Breast Cancer Survivors
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 9
- 主要终点
- Pain Interference
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
This is a double-blind study where PIs, biostatisticians, and the CRC who performs outcome assessments are blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
MORE Treatment Group
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.
干预措施: Mindfulness Oriented Recovery Enhancement (MORE) (Behavioral)
MORE Treatment Group
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.
干预措施: Questionnaires (Other)
Supportive Psychotherapy Control Group
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.
干预措施: Questionnaires (Other)
Supportive Psychotherapy Control Group
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.
干预措施: Supportive Psychotherapy (SG) (Behavioral)
结局指标
主要结局
Pain Interference
时间窗: 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.
次要结局
- Pain Catastrophizing(baseline, week 8, week 12, and week 24)
- Pain Severity(baseline, week 8, week 12, and week 24)
- Patient Global Impression of Change(week 8, week 12, and week 24)
- Insomnia(baseline, week 8, week 12, and week 24)
- Fatigue(baseline, week 8, week 12, and week 24)
- Reappraisal(baseline, week 8, week 12, and week 24)
- Compassion(baseline, week 8, week 12, and week 24.)
- AI Adherence(baseline, week 8, 12 and 24.)
- Journaling Daily Log(weekly throughout the 8-week interventio)
- Perceptions of aging due to arthralgia(baseline, week 8, week 12, and week 24)
- Decentering(baseline, week 8, week 12, and week 24)
- Mindfulness Daily Log(weekly throughout the 8-week intervention)
- Anxiety/Depression(baseline, week 8, week 12, and week 24)
- Global Health(baseline, week 8, week 12, and week 24)
- Pleasant and painful sensations in the body(baseline, week 8, week 12, and week 24.)
- Nondual awareness(baseline, week 8, week 12, and week 24.)
- Meaning in Life(baseline, week 8, week 12, and week 24)
- Treatment Expectancy(baseline)
- Pain Medication Diary(baseline, week 8, 12 and 24.)
- Emotion Regulation(baseline, week 8, week 12, and week 24.)
- Savoring(baseline, week 8, week 12, and week 24)
- Global self-compassion(baseline, week 8, week 12, and week 24)
- Treatment Credibility and Expectancy(baseline)