Cognitive Behavioral Therapy for Breast Cancer

Overseen By Alejandra Cuartas-Abril, M.S.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must be taking: Aromatase inhibitors

Disqualifiers: Stage 4 HR+ breast cancer

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

Compensation: Varies

Number of Visits: 3

Duration: 6 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a special program using Cognitive Behavioral Therapy (a type of talk therapy) can help manage pain and other symptoms for people with breast cancer who are taking Aromatase Inhibitors (medications that lower estrogen levels). The goal is to determine if this therapy can reduce pain, improve mood and thinking, and help people adhere to their medication better than usual care. Participants may be suitable if they have stage 0-III HR+ breast cancer and seek ways to reduce symptoms and improve daily life. The trial includes two groups: one will continue with regular care, and the other will try the new therapy alongside regular care. As an unphased trial, this study offers participants the chance to explore innovative therapy options that could enhance their quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on improving adherence to Aromatase Inhibitor medications, so you may need to continue those if you are already taking them.

What prior data suggests that this Cognitive Behavioral Therapy based Pain Management Program is safe?

Studies have shown that cognitive behavioral therapy (CBT) is generally safe and well-tolerated for managing pain and distress in breast cancer patients. Research indicates that CBT can reduce pain and improve relaxation without causing serious side effects. In one study, patients using CBT reported feeling better emotionally and experiencing less anxiety. Another study found that CBT helped reduce the impact of hot flashes for women with breast cancer. Overall, these findings suggest that CBT is a safe option for breast cancer patients dealing with pain and emotional distress. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Cognitive Behavioral Therapy (CBT) for breast cancer because it offers a new way to manage pain without relying solely on medications like opioids or NSAIDs, which are common in standard care. CBT focuses on changing the way patients think about and react to pain, potentially reducing discomfort through mental and emotional strategies. This approach not only aims to alleviate pain but also empowers patients by giving them tools to manage their symptoms more effectively, adding a psychological layer to traditional medical treatments.

What evidence suggests that this Cognitive Behavioral Therapy based Pain Management Program is effective for AIMSS?

Research has shown that Cognitive Behavioral Therapy (CBT) can improve mental health and quality of life for cancer patients. One study demonstrated a moderate improvement in symptoms with CBT. Another study found that CBT helps cancer survivors with issues like trouble sleeping and fatigue. Additionally, CBT techniques have reduced distress and pain, especially in breast cancer patients. In this trial, participants in the treatment group will engage in a multicomponent pain treatment program based on CBT, while the control group will continue to receive standard care. These findings suggest that CBT can effectively manage pain and related issues in breast cancer. ^{3 6 7 8 9}

Who Is on the Research Team?

Barbara Bruce, Ph.D., LP

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for breast cancer survivors over 18 years old with Stage 0-III hormone receptor-positive (HR+) breast cancer, who have an ECOG performance status of ≤2 and are seeking ways to manage pain and improve quality of life. It's not open to those with Stage IV HR+ breast cancer or under the age of 18.

Inclusion Criteria

I can take care of myself and am up and about more than half of the day.

I have early to locally advanced hormone-receptor positive breast cancer and need symptom management.

Exclusion Criteria

My breast cancer is stage 4 and hormone receptor positive.

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the treatment group will participate in a multicomponent pain management program in addition to standard of care treatment

6 months

Regular visits as per study protocol

Follow-up

Participants are monitored for adherence to Aromatase Inhibitors and other outcomes such as pain, cognitive function, and psychological distress

6 months

Follow-up assessments at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy based Pain Management Program

Trial Overview The study tests a multidisciplinary Cognitive Behavioral Therapy (CBT) based Pain Management Program aimed at reducing pain, cognitive issues, distress, and functional problems in order to help patients better adhere to Aromatase Inhibitor medications.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 1 Intervention

Subjects randomized to the treatment group will participate in a multicomponent pain treatment program in addition to standard of care treatment.

Group II: Control Group Active Control 1 Intervention

Subjects randomized to the control group will continue to receive standard of care treatment. At the end of the study, the control group participants will be offered the multicomponent pain treatment program.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

A cognitive-behavioral pain management program was tested on 13 cancer patients with chronic pain, showing significant improvements in anxiety, depression, and physical fitness after the intervention.

The study suggests that combining physical and psychological techniques can positively impact pain coping strategies, indicating that further research is needed to evaluate the effectiveness of this approach for managing chronic pain in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pain management program for chronic cancer-treatment-related pain: a preliminary study. Robb, KA., Williams, JE., Duvivier, V., et al.[2022]

A new model has been proposed to help predict which cognitive-behavioral interventions will be effective for managing cancer pain, based on factors like a patient's skills, coping style, and past experiences with pain management.

The model aims to provide nurses with a theoretical framework to choose the most suitable intervention for each patient, but further testing is needed to validate its effectiveness and accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A model for cognitive-behavioral interventions in cancer pain management. Kwekkeboom, KL.[2019]

A study involving 327 women with stage I-III breast cancer found that both five-session and one-session cognitive-behavioral pain interventions significantly reduced pain severity and pain medication use, while increasing pain self-efficacy and coping skills.

Participants who underwent the five-session pain coping skills training (PCST) experienced greater reductions in pain and medication use, as well as higher self-efficacy and coping skills, suggesting that longer interventions may be more effective in managing pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Pain Coping Skills Training on Pain and Pain Medication Use for Women With Breast Cancer. Fisher, HM., Hyland, KA., Winger, JG., et al.[2023]

Cognitive Behavioral Therapy (CBT) techniques significantly reduce distress and pain in breast cancer patients, with effect sizes indicating that 62% and 69% of patients experienced less distress and pain, respectively, compared to control groups.

Individual CBT treatments were more effective for reducing distress than group treatments, highlighting the importance of personalized approaches in managing psychological and physical symptoms in breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy techniques for distress and pain in breast cancer patients: a meta-analysis. Tatrow, K., Montgomery, GH.[2018]

Cognitive-behavioral group therapy significantly reduces depression and anxiety in women with breast cancer, based on a study involving 50 participants divided into experimental and control groups.

The therapy also enhances pain-coping strategies, indicating its effectiveness not only in improving mental health but also in helping patients manage pain better.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of Cognitive-Behavioral Group Therapy on Depression, Anxiety, and Pain-Coping Strategies in Women With Breast Cancer. Mansouri, A., Javedani, M., Rezazadeh Yazd, SA., et al.[2023]

Cognitive-behavioral interventions have been shown to effectively control symptoms and reduce suffering in patients experiencing cancer pain, highlighting their importance as a nonmedical treatment option.

The article provides theoretical and technical principles of these interventions, supported by two case reports that demonstrate their practical application in real-world scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral interventions in management of cancer pain: principles and applications. Fishman, B., Loscalzo, M.[2019]

In a study of 178 cancer patients undergoing pain coping skills training (PCST), 34% experienced significant reductions in pain severity and 46% in pain interference, highlighting the intervention's effectiveness.

Factors such as education level, cancer type, and marital status influenced the likelihood of experiencing pain relief, suggesting that tailored approaches could enhance the benefits of PCST for different patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Response to an Evidence-Based Behavioral Cancer Pain Management Intervention: An Exploratory Analysis From a Clinical Trial. Check, DK., Winger, JG., Jones, KA., et al.[2021]

The management of pain in oncology patients involves a combination of cognitive-behavioral, psychosocial, and pharmacologic strategies, each offering unique benefits for patient care.

These approaches not only help alleviate pain but also enhance patients' understanding of their condition and improve their coping mechanisms for dealing with cancer-related pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic strategies for cancer pain management. Miller, TW., Spiro, K., Jay, LL.[2018]

Effective management of chronic pain in breast cancer patients requires a thorough evaluation of pain causes and psychosocial factors, with a focus on rapid and complete pain control as judged by the patient.

The guidelines recommend using the WHO 3-step approach for analgesic administration, emphasizing oral opioids as the first choice, and careful monitoring when switching opioids or adjusting dosages to ensure safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The management of chronic pain in patients with breast cancer. The Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer. Canadian Society of Palliative Care Physicians. Canadian Association of Radiation Oncologists. [2018]

Effective pain management in breast cancer patients is crucial for improving their quality of life, and it requires a thorough evaluation of the pain's cause to tailor treatments appropriately.

Both pharmacological methods, including opioids and non-opioids following the WHO's 'ladder' approach, and non-pharmacological therapies, such as complementary and alternative medicine, are important in managing pain, but they must be used cautiously to ensure safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain Management in Breast Cancer Patients: A Multidisciplinary Approach. Alhazmi, LSS., Bawadood, MAA., Aljohani, AMS., et al.[2021]

Citations

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The efficacy of cognitive behavioral therapy for mental health ... Across 132 clinical trials and 1030 effect size estimates, we identified that CBT moderately improves MH and QoL in cancer patients d = 0.388, ...

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Effectiveness of cognitive behavioral therapy in improving ... Cognitive behavioral therapy (CBT) improves functional health in cancer survivors. CBT has the strongest treatment effect on insomnia, followed by fatigue.

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Efficacy of Cognitive Behavioral Therapy and Physical ... CBT and PE can have salutary effects on endocrine symptoms and, to a lesser degree, on sexuality and physical functioning of patients with breast cancer.

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Cognitive behavioral therapy techniques for distress and pain ... This meta-analysis is the first to examine cognitive behavioral therapy (CBT) techniques for distress and pain specifically in breast cancer patients.

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Cognitive behavioral therapy techniques for distress and pain ... This meta-analysis is the first to examine cognitive behavioral therapy (CBT) techniques for distress and pain specifically in breast cancer patients.

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Perioperative cognitive behavioural therapy compared with ... Our primary outcome was the difference in the BPI-SF 'average' pain severity score between the CBT and PEM study groups at 3 months after breast cancer surgery.

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The Effects of Cognitive-Behavioral Stress Management for... Cognitive-behavioral stress management can help breast cancer patients develop skills to increase relaxation, benefit finding, and positive affect.

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The Efficacy of Internet-Based Cognitive Behavioral Therapy ... Results demonstrated that ICBT is an effective treatment for improving depressive symptoms in breast cancer patients, which was consistent with ...