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

Trial Summary

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 data supports the effectiveness of the treatment Cognitive Behavioral Therapy based Pain Management Program for breast cancer?

Research shows that cognitive-behavioral interventions, which include teaching patients strategies to manage pain, are effective in reducing pain and suffering in cancer patients. These interventions help improve patients' ability to manage their pain and may reduce the need for pain medication. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy safe for breast cancer patients?

Cognitive Behavioral Therapy (CBT) has been used safely in breast cancer patients to help manage distress and pain, with studies showing improvements in anxiety and depression without significant safety concerns. ^{1 2 5 6 7}

How does Cognitive Behavioral Therapy for Breast Cancer differ from other treatments?

Cognitive Behavioral Therapy (CBT) for breast cancer is unique because it focuses on managing pain through psychological techniques like education, relaxation, and goal setting, rather than relying solely on medications. This approach helps improve mental well-being and coping strategies, which can enhance overall quality of life for patients. ^{1 7 8 9 10}

What is the purpose of this trial?

The purpose of this research is to evaluate the effectiveness of a multidisciplinary pain management program for AIMSS in reducing pain, subjective cognitive complaints, psychological distress, and impaired functional status resulting in improved adherence to Aromatase Inhibitor medications compared to usual care. We want to identify predictors of improvement in pain, functional status, subjective cognition and mood following participation in the program.

Research Team

Barbara Bruce, Ph.D., LP

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Cognitive-behavioral interventions in management of cancer pain: principles and applications. [2019]

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

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

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

Therapeutic strategies for cancer pain management. [2018]

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

Effect of Pain Coping Skills Training on Pain and Pain Medication Use for Women With Breast Cancer. [2023]

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

Predictors of Response to an Evidence-Based Behavioral Cancer Pain Management Intervention: An Exploratory Analysis From a Clinical Trial. [2021]

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

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

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

A pain management program for chronic cancer-treatment-related pain: a preliminary study. [2022]

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

Pain Management in Breast Cancer Patients: A Multidisciplinary Approach. [2021]

9. Canada 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]

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

The Efficacy of Cognitive-Behavioral Group Therapy on Depression, Anxiety, and Pain-Coping Strategies in Women With Breast Cancer. [2023]