Psychotherapy for Joint Pain in Breast Cancer Survivors
Recruiting in Palo Alto (17 mi)
+8 other locations
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Memorial Sloan Kettering Cancer Center
Must be taking: Aromatase inhibitors
Disqualifiers: Metastatic cancer, Inflammatory arthritis, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does require that you continue taking aromatase inhibitors (AIs) for at least another 12 months.
What data supports the effectiveness of the treatment Supportive Psychotherapy With MORE Interventions for joint pain in breast cancer survivors?
Research shows that mindfulness-based interventions, like those used in Mindfulness-Oriented Recovery Enhancement (MORE), can help reduce persistent pain in women treated for breast cancer. This suggests that incorporating MORE into supportive psychotherapy might be effective for managing joint pain in breast cancer survivors.
12345Is psychotherapy safe for breast cancer survivors?
Psychotherapy, including supportive-expressive therapy and mindfulness-based interventions, is generally considered safe for breast cancer survivors, as studies have shown they are well-validated and accepted by participants.
26789How does the treatment Supportive Psychotherapy With MORE Interventions differ from other treatments for joint pain in breast cancer survivors?
This treatment is unique because it combines supportive psychotherapy with Mindfulness-Oriented Recovery Enhancement (MORE) interventions, which focus on mindfulness and cognitive techniques to help manage pain and improve psychological well-being, unlike traditional treatments that may focus solely on physical therapy or medication.
3461011Eligibility Criteria
This trial is for English-speaking women over 18 with a history of stage I-III breast cancer, currently free of cancer and taking third-generation AI therapy for at least 28 days. They must have significant joint pain attributed to their medication and be willing to attend video-call therapy sessions.Inclusion Criteria
Able to attend video-call sessions in a quiet/private location
I have experienced pain on most days in the last month.
I have been experiencing joint pain for at least one month.
+7 more
Exclusion Criteria
I haven't had or planned any surgery or injections in my affected joints recently.
Active suicidality or psychosis as determined by the Mini-International Neuropsychiatric Interview
My breast cancer has spread to other parts of my body.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants engage in either Supportive Psychotherapy or MORE Treatment, consisting of eight weekly two-hour group sessions.
8 weeks
8 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at weeks 12 and 24.
16 weeks
2 visits (in-person)
Participant Groups
The study compares two group therapies for managing joint pain in breast cancer survivors on AIs: Mindfulness-Oriented Recovery Enhancement (MORE) versus Supportive Group Psychotherapy (SG). It will assess the impact on symptoms like pain, fatigue, anxiety, adherence to AI medication, and overall quality of life through questionnaires.
2Treatment groups
Experimental Treatment
Active Control
Group I: MORE Treatment GroupExperimental Treatment2 Interventions
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.
Group II: Supportive Psychotherapy Control GroupActive Control2 Interventions
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Memorial Sloan Kettering Monmouth (All Protocol Activities)Middletown, NJ
Memorial Sloan Kettering Bergen (All Protocol Activities)Montvale, NJ
Memorial Sloan Kettering Nassau (All Protocol Activities)Uniondale, NY
Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)Commack, NY
More Trial Locations
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Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
National Institutes of Health (NIH)Collaborator
References
Efficacy of meaning-centered group psychotherapy for cancer survivors: a randomized controlled trial. [2022]The aim of this study was to assess the efficacy of meaning-centered group psychotherapy for cancer survivors (MCGP-CS) to improve personal meaning, compared with supportive group psychotherapy (SGP) and care as usual (CAU).
Randomized controlled trial of Mindfulness-based cancer recovery versus supportive expressive group therapy for distressed survivors of breast cancer. [2022]To compare the efficacy of the following two empirically supported group interventions to help distressed survivors of breast cancer cope: mindfulness-based cancer recovery (MBCR) and supportive-expressive group therapy (SET).
Clinical and psychological moderators of the effect of mindfulness-based cognitive therapy on persistent pain in women treated for primary breast cancer - explorative analyses from a randomized controlled trial. [2018]Mindfulness-based intervention has been found efficacious in reducing persistent pain in women treated for breast cancer. Little, however, is known about possible moderators of the effect. We explored clinical and psychological moderators of the effect on pain intensity previously found in a randomized controlled trial of mindfulness-based cognitive therapy (MBCT) with women treated for breast cancer with persistent pain.
Efficacy of Mindfulness-Based Cognitive Therapy on Late Post-Treatment Pain in Women Treated for Primary Breast Cancer: A Randomized Controlled Trial. [2022]To assess the efficacy of mindfulness-based cognitive therapy (MBCT) for late post-treatment pain in women treated for primary breast cancer.
Cost-utility analysis of meaning-centered group psychotherapy for cancer survivors. [2019]Meaning-centered group psychotherapy for cancer survivors (MCGP-CS) improves meaning, psychological well-being, and mental adjustment to cancer and reduces psychological distress. This randomized controlled trial was conducted to investigate the cost-utility of MCGP-CS compared with supportive group psychotherapy (SGP) and care-as-usual (CAU).
Comparison of the acceptability and benefits of two mindfulness-based interventions in women with breast or gynecologic cancer: a pilot study. [2021]The aim of this study was to compare the relative benefits and acceptability of two different group-based mindfulness psychotherapy interventions among women with breast and gynecologic cancer.
Tailoring mind-body therapies to individual needs: patients' program preference and psychological traits as moderators of the effects of mindfulness-based cancer recovery and supportive-expressive therapy in distressed breast cancer survivors. [2015]Mindfulness-based cancer recovery (MBCR) and supportive-expressive therapy (SET) are well-validated psycho-oncological interventions, and we have previously reported health benefits of both programs. However, little is known about patients' characteristics or program preferences that may influence outcomes. Therefore, this study examined moderators of the effects of MBCR and SET on psychological well-being among breast cancer survivors.
Randomized-controlled trial of mindfulness-based cancer recovery versus supportive expressive group therapy among distressed breast cancer survivors (MINDSET): long-term follow-up results. [2018]Mindfulness-based cancer recovery (MBCR) and supportive expressive group therapy (SET) are two well-validated psychosocial interventions, but they have not been directly compared, and little is known about long-term outcomes. This comparative effectiveness study measured the effects of these two interventions immediately following the groups and for 1 year thereafter in distressed breast cancer survivors.
Qualitative Evaluation of Cancer Survivors' Experiences of Metacognitive Therapy: A New Perspective on Psychotherapy in Cancer Care. [2022]Preliminary evidence suggests that metacognitive therapy (MCT), a brief, process-focused psychological intervention, alleviates distress in cancer survivors. In a longitudinal qualitative study nested in an open trial of MCT for cancer survivors, we explored how patients understood, experienced and applied MCT.
The Physiotherapy Intervention for Shoulder Pain in Patients Treated for Breast Cancer: Systematic Review. [2020]Pain and joint dysfunction of the upper limb following treatment for mammary carcinoma are defined as the most frequent side effects of surgery for mammary carcinoma by calculating a prevalence range in the USA that varies between 12% and 51% with regard to pain and between 1.5% and 50% for joint dysfunction. This objective of this study was to describe physiotherapy interventions that demonstrate efficacy based on the type of pain present in patients with shoulder pain who have been treated for breast cancer. We conducted a search for relevant publications in the last 10 years (2009-2019) on the PubMed, Medline, CINAHL, and Cochrane databases. The articles obtained were selected on the basis of correlation criteria, with themes concerning shoulder pain after mammary carcinoma and physiotherapy performed to treat this pain. Studies suggest treating musculoskeletal pain through active exercises, joint and tissue mobilization techniques, with accessory joint mobilization and neurodynamics performed by experienced physiotherapists. In order to treat radio-induced and drug-induced neuropathic pain, both aerobic and strengthening exercises are supervised by an experienced physiotherapist and carried out twice weekly for a total of 150 minutes of exercise. Finally, the treatment suggested to deal with chronic pain uses a multidisciplinary approach, including pain education interventions, pharmacological interventions, psychological interventions, and physiotherapy interventions. To conclude. the classification of different types of shoulder pain following mammary carcinoma treatments requires specific and targeted physiotherapy interventions in which active therapeutic exercise has a central role.
Improving well-being for individuals with persistent pain after surgery for breast cancer, lobular carcinoma in situ, or ductal carcinoma in situ: A randomized clinical trial. [2023]>276,000 Americans will be diagnosed with invasive breast cancer, lobular carcinoma in situ, or ductal carcinoma in situ this year and most will undergo breast surgery as part of their care. Although prognosis is excellent, many patients experience persistent post-surgical pain (PSP), which has no satisfactory pharmacological treatment. The causal contributions of pain-associated psychological factors (e.g., catastrophic thoughts about pain, psychological flexibility, self-efficacy) to the continuing burden of PSP have not yet been determined and may be opportune intervention targets. The randomized trial described here will compare the benefits of three manualized behavioral interventions for individuals with PSP. Participants will receive either: 1) self-guided health education (SGHE); 2) interventionist-guided health education (IGHE); or 3) interventionist-guided pain coping skills training with elements of acceptance and commitment therapy that specially target catastrophic thoughts about pain, self-efficacy, and psychological flexibility (CST-PSP). Participants will prospectively complete validated assessments of primary outcomes (PSP severity and interference) at baseline (pre-intervention) and 3-, 6-, and 12-months later. Validated measures of emotional distress and cancer-specific distress will be assessed as secondary outcomes. To test their roles as drivers of PSP, catastrophic thoughts about pain, self-efficacy, and psychological flexibility, will be assessed and statistically analyzed as mediators of hypothesized beneficial effects. The interventions' impacts on pain sensitivity and central sensitization will be investigated to test these physiological pathways as proximal drivers of PSP. To better characterize the patient experience, additional validated measures will be explored for associations with PSP, along with demographic and clinical factors. Trial registration: https://clinicaltrials.gov/ct2/show/NCT04225585, registered January 13, 2020.