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

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. 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).

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. ^{1 2 3 4 5}

Is 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. ^{2 6 7 8 9}

How 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. ^{3 4 6 10 11}

Research Team

Jun Mao, MD, MSCE

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility 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.

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.

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Efficacy of meaning-centered group psychotherapy for cancer survivors: a randomized controlled trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of Mindfulness-based cancer recovery versus supportive expressive group therapy for distressed survivors of breast cancer. [2022]

3. England 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. [2018]

4. United States 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. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Cost-utility analysis of meaning-centered group psychotherapy for cancer survivors. [2019]

6. Germany 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. [2021]

7. United States 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. [2015]

8. England 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. [2018]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Qualitative Evaluation of Cancer Survivors' Experiences of Metacognitive Therapy: A New Perspective on Psychotherapy in Cancer Care. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

The Physiotherapy Intervention for Shoulder Pain in Patients Treated for Breast Cancer: Systematic Review. [2020]

11. United States 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. [2023]