Psychotherapy for Joint Pain in Breast Cancer Survivors

Recruiting at 8 trial locations

Overseen By Karolina Bryl, PhD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: Aromatase inhibitors

Disqualifiers: Metastatic cancer, Inflammatory arthritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 10

Duration: 8 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of group therapy to help breast cancer survivors manage joint pain caused by aromatase inhibitors (AI), a common medication side effect. Researchers aim to determine if these therapies can improve symptoms such as pain, fatigue, and anxiety, and assist patients in continuing their AI treatment. Participants will attend weekly group therapy sessions for eight weeks, focusing on either mindfulness and emotion skills (Supportive Psychotherapy With Mindfulness-Oriented Recovery Enhancement (MORE) Interventions) or supportive discussions (Supportive Psychotherapy Without MORE Interventions). Women with a history of stage I-III breast cancer, experiencing significant joint pain due to AI therapy, and able to join video sessions may be suitable candidates. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both types of group therapy being studied—Supportive Psychotherapy with MORE Interventions and Supportive Psychotherapy without MORE Interventions—are generally well-tolerated by participants.

For Supportive Psychotherapy with MORE Interventions, previous studies found that mindfulness-based therapies can reduce chronic pain in cancer patients without serious side effects. These therapies focus on mindfulness, altering perceptions of pain, and enhancing positive experiences, which are generally safe practices.

Supportive Psychotherapy without MORE Interventions also has a good safety record. Studies have shown that these therapies effectively manage pain in breast cancer survivors. Although over 45% of survivors still experience chronic pain, these therapies improve quality of life and emotional well-being without significant negative effects.

Overall, both therapy approaches are considered safe options for managing joint pain in breast cancer survivors. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these psychotherapy approaches for joint pain in breast cancer survivors because they offer a fresh take on pain management by focusing on mental well-being. Unlike conventional treatments that often rely on medication, the MORE Treatment Group uses mindfulness, reappraisal, and savoring techniques to help manage pain and enhance emotional health. These methods aim to reduce psychological distress and improve self-regulation, offering a holistic approach to pain management. The Supportive Psychotherapy Control Group, while not incorporating MORE skills, emphasizes emotional expression and group support, which can also be valuable for coping with chronic pain. This trial could potentially offer new pathways for improving quality of life among cancer survivors.

What evidence suggests that these group therapies could be effective for managing joint pain in breast cancer survivors?

Research has shown that Mindfulness Oriented Recovery Enhancement (MORE), which participants in this trial may receive, can help manage chronic pain. MORE teaches skills such as mindfulness, rethinking negative thoughts, and enjoying positive experiences. Studies have found that mindfulness-based methods can also improve mood in cancer patients. These techniques are particularly beneficial for breast cancer survivors experiencing joint pain from aromatase inhibitors. By using these methods, patients may better manage their symptoms and adhere to their medication schedules. Participants in the supportive psychotherapy control group will engage in discussions on themes relevant to chronic pain and cancer survivorship without learning MORE skills. ^{1 4 6 7 8}

Who Is on the Research Team?

Jun Mao, MD, MSCE

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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

I have experienced pain on most days in the last month.

I experience pain due to my aromatase inhibitor therapy.

Able to attend video-call sessions in a quiet/private location

Exclusion Criteria

Active suicidality or psychosis as determined by the Mini-International Neuropsychiatric Interview

I haven't had or planned any surgery or injections in my affected joints recently.

My breast cancer has spread to other parts of my body.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Supportive Psychotherapy With MORE Interventions
• Supportive Psychotherapy Without MORE Interventions

Trial Overview 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.

How Is the Trial Designed?

Group I: MORE Treatment Group Experimental Treatment 2 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 Group Active Control 2 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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

Shoulder pain and joint dysfunction are common side effects after breast cancer treatment, affecting 12% to 51% of patients, highlighting the need for effective physiotherapy interventions.

Targeted physiotherapy, including active exercises and multidisciplinary approaches, is essential for managing different types of shoulder pain in breast cancer survivors, with a focus on supervised exercise programs for optimal recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Physiotherapy Intervention for Shoulder Pain in Patients Treated for Breast Cancer: Systematic Review. Giacalone, A., Alessandria, P., Ruberti, E.[2020]

Mindfulness-based cognitive therapy (MBCT) significantly reduced pain intensity in women treated for breast cancer, with a robust effect size (d = 0.61) observed in a study of 129 participants over an 8-week program.

MBCT also improved quality of life and reduced the use of nonprescription pain medication, indicating its potential as an effective pain management strategy for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Mindfulness-Based Cognitive Therapy on Late Post-Treatment Pain in Women Treated for Primary Breast Cancer: A Randomized Controlled Trial. Johannsen, M., O'Connor, M., O'Toole, MS., et al.[2022]

In a study involving 271 distressed breast cancer survivors, mindfulness-based cancer recovery (MBCR) was found to be more effective than supportive-expressive therapy (SET) in reducing stress symptoms and improving quality of life and social support.

Both MBCR and SET helped maintain healthier cortisol levels over time compared to a control group, indicating that these interventions can positively influence stress-related biological responses in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of Mindfulness-based cancer recovery versus supportive expressive group therapy for distressed survivors of breast cancer. Carlson, LE., Doll, R., Stephen, J., et al.[2022]

In a study involving 271 distressed breast cancer survivors, those who participated in their preferred program (Mindfulness-based cancer recovery or supportive-expressive therapy) showed greater improvements in quality of life and spiritual well-being, highlighting the importance of patient preferences in treatment outcomes.

Women with higher psychological distress at the start of the study benefited more from receiving their preferred intervention, suggesting that aligning treatment options with patient preferences can enhance the effectiveness of psycho-oncological therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Carlson, LE., Tamagawa, R., Stephen, J., et al.[2015]

In a study of 252 distressed breast cancer survivors, mindfulness-based cancer recovery (MBCR) was found to significantly reduce mood disturbances and stress symptoms immediately after the intervention compared to supportive expressive group therapy (SET).

MBCR not only improved psychological well-being more effectively than SET but also provided lasting benefits over a year, helping participants develop long-term coping strategies for dealing with cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized-controlled trial of mindfulness-based cancer recovery versus supportive expressive group therapy among distressed breast cancer survivors (MINDSET): long-term follow-up results. Carlson, LE., Tamagawa, R., Stephen, J., et al.[2018]

Metacognitive therapy (MCT) is a brief and effective psychological intervention for cancer survivors, helping them manage distress by teaching them to view their thoughts as just thoughts and regain control over their emotional responses.

Participants reported feeling empowered and less overwhelmed by worry after MCT, indicating that the therapy successfully challenged their thinking patterns and provided a sense of freedom, although some individuals struggled to apply the techniques to all their thoughts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative Evaluation of Cancer Survivors' Experiences of Metacognitive Therapy: A New Perspective on Psychotherapy in Cancer Care. Cherry, MG., Salmon, P., Byrne, A., et al.[2022]

In a study of 129 women with persistent pain after breast cancer treatment, mindfulness-based cognitive therapy (MBCT) significantly reduced pain intensity, particularly in those with higher levels of attachment avoidance.

Radiotherapy may also influence the effectiveness of MBCT, as it was associated with a smaller reduction in pain intensity, suggesting that these factors could help identify patients who would benefit most from this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Johannsen, M., O'Toole, MS., O'Connor, M., et al.[2018]

Meaning-centered group psychotherapy for cancer survivors (MCGP-CS) significantly improved personal meaning and psychological well-being compared to care as usual, with notable effects on various psychological measures such as goal-orientedness and fighting spirit.

MCGP-CS also demonstrated long-term benefits by reducing psychological distress and depression over a 6-month follow-up, indicating its efficacy as a supportive intervention for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of meaning-centered group psychotherapy for cancer survivors: a randomized controlled trial. van der Spek, N., Vos, J., van Uden-Kraan, CF., et al.[2022]

Both mindfulness-based cognitive therapy (MBCT) and mindfulness meditation programs (MMP) significantly improved distress, quality of life, and mindfulness in women with breast and gynecologic cancer, with medium to large effect sizes observed in both interventions.

Participants found both interventions beneficial and acceptable, suggesting that shorter, less resource-intensive mindfulness programs could be effective options for improving mental health in patients with cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the acceptability and benefits of two mindfulness-based interventions in women with breast or gynecologic cancer: a pilot study. Stafford, L., Thomas, N., Foley, E., et al.[2021]

A randomized trial will investigate the effectiveness of three behavioral interventions for persistent post-surgical pain (PSP) in breast cancer patients, focusing on psychological factors like catastrophic thoughts and self-efficacy as potential targets for treatment.

Participants will be assessed over 12 months to evaluate the severity and interference of PSP, as well as emotional distress, helping to identify the psychological and physiological factors that contribute to ongoing pain after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Stalls, JM., Bovbjerg, DH., Somers, TJ., et al.[2023]

In a study involving 170 cancer survivors, meaning-centered group psychotherapy for cancer survivors (MCGP-CS) was found to be more cost-effective than care-as-usual (CAU), with lower total costs (€4492 for MCGP-CS vs. €5304 for CAU) and higher quality-adjusted life years (QALYs) at 0.540 compared to 0.507 for CAU.

MCGP-CS had a 74% probability of being both less costly and more effective than CAU, and a 49% probability compared to supportive group psychotherapy (SGP), indicating strong evidence for its economic and therapeutic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-utility analysis of meaning-centered group psychotherapy for cancer survivors. van der Spek, N., Jansen, F., Holtmaat, K., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06728579

Enhanced Pain Coping in Cancer (EPIC): A Study of ... 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 ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-10271

Mindfulness-Based Interventions for Managing Chronic ... Mindfulness Oriented Recovery Enhancement (MORE) appears to be a particularly effective MBI for chronic pain treatment. MORE improves pain-related outcomes in ...

3. trials.arthritis.org trials.arthritis.org/trials/NCT06728579

A Study of Managing Treatment-Related Joint Pain in Breast ... 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)

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8200136/

Mindfulness-Based Interventions in Cancer Survivors Among cancer patients, multiple systematic reviews have provided evidence for the efficacy of MBIs in reducing symptoms of mood disturbance, ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.22.01357

Integrative Medicine for Pain Management in Oncology Many studies showed joint pain results in nonadherence to AIs and such behavior can lead to increased recurrence and mortality for women with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8886485/

Mindfulness-Oriented Recovery Enhancement vs ... The supportive psychotherapy intervention involved discussions about coping with pain, the adverse effects of opioids, and the use of ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05877521

Mindfulness-oriented Recovery Enhancement (MORE) for ... 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- ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2451865422000795

Protocol for mindfulness-oriented recovery enhancement ... Mindfulness-based interventions have been demonstrated to be effective tools in mitigating self-reported pain in LBP patients. This paper describes the protocol ...