Health Education & Coping Skills Training for Postoperative Pain After Breast Cancer Surgery

(WB ABCs Trial)

Recruiting at 1 trial location

Overseen By Dana Bovbjerg, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Under 18, Hearing impairment, Cognitive impairment

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

Compensation: Varies

Number of Visits: 3

Duration: 3 months

316 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare the benefits of skills training and health education interventions designed specifically to increase the well-being of people with persistent pain after breast surgery for lobular carcinoma in situ (LCIS), ductal carcinoma in situ (DCIS), or invasive breast cancer, and to examine the roles of psychological and physiological variables as modifiable contributors to the continuing burden of persistent pain.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current medications, but you should confirm with the trial coordinators.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the idea that Health Education & Coping Skills Training for Postoperative Pain After Breast Cancer Surgery is an effective treatment?

The available research shows that Health Education & Coping Skills Training, specifically Pain Neuroscience Education (PNE), was tested in a study called the EduCan trial. This study compared PNE to a standard biomedical explanation for pain after breast cancer surgery. The results showed that PNE did not significantly improve pain-related outcomes compared to the standard approach. Both groups had similar results in terms of pain-related disability, pain intensity, and emotional functioning over 18 months. This suggests that while PNE might not be more effective than the standard treatment, it highlights the need for more personalized approaches to improve its effectiveness. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment CST-PSP, General health education, General Health Education, Health Education Interventions, Targeted-PCST for postoperative pain after breast cancer surgery?

Research shows that educational interventions, like pain neuroscience education, can help manage pain by addressing not just the physical aspects but also the psychological and social factors. Although specific studies did not find significant differences in pain outcomes, they suggest that tailoring education to individual needs might improve effectiveness. ^{1 2 3 4 5}

What safety data exists for Health Education & Coping Skills Training for postoperative pain after breast cancer surgery?

The provided research does not directly address safety data for Health Education & Coping Skills Training or its variants like CST-PSP, General Health Education, or Targeted-PCST. The studies focus on the effectiveness of pain neuroscience education (PNE) and other educational interventions in managing pain after breast cancer surgery, but they do not specifically mention safety outcomes. Future research may need to explore safety aspects more explicitly. ^{1 2 3 6 7}

Is Health Education & Coping Skills Training for Postoperative Pain After Breast Cancer Surgery safe for humans?

The research articles reviewed do not provide specific safety data for Health Education & Coping Skills Training for Postoperative Pain After Breast Cancer Surgery, but educational interventions like Pain Neuroscience Education (PNE) have been studied in similar contexts without reported safety concerns, suggesting they are generally safe for humans. ^{1 2 3 6 7}

Is the treatment CST-PSP, General health education, Targeted-PCST a promising treatment for pain after breast cancer surgery?

The treatment CST-PSP, which includes general health education and targeted pain coping skills training, is promising because educational interventions can help improve pain management by addressing not just the physical aspects of pain, but also the psychological and social factors. This approach can potentially enhance the effectiveness of standard physical therapy and improve overall well-being after breast cancer surgery. ^{1 2 3 4 8}

How does the treatment CST-PSP differ from other treatments for postoperative pain after breast cancer surgery?

CST-PSP is unique because it combines health education with coping skills training to address postoperative pain, focusing on both the physical and emotional aspects of recovery, unlike standard treatments that may focus solely on physical therapy or medication. ^{1 2 3 4 8}

Research Team

Rebecca Shelby, PhD

Principal Investigator

Duke University

Dana Bovbjerg, PhD

Principal Investigator

University of Pittsburgh Medical Center

Eligibility Criteria

This trial is for adults who had breast cancer surgery at least 3 months ago and are experiencing persistent pain. Participants must have been diagnosed with Stage 0 to III breast cancer, DCIS or LCIS, can speak English, and provide consent. It's not for those under 18, with hearing issues that affect videoconferencing use, or cognitive impairments.

Inclusion Criteria

I was previously diagnosed with early-stage breast cancer.

I had my first breast cancer surgery over 3 months ago.

Able to provide meaningful consent

Exclusion Criteria

You have trouble hearing that makes it hard for you to use video calls for the study sessions.

I have a cognitive condition that prevents me from understanding consent forms.

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either CST-PSP, health education with an interventionist, or self-guided health education

3 months

Regular visits for intervention sessions

Follow-up

Participants are monitored for changes in pain severity, emotional distress, and other psychosocial factors

12 months

Assessments at 3, 6, and 12 months

Treatment Details

Interventions

• CST-PSP
• General health education
• Targeted-PCST

Trial Overview The study compares the effectiveness of coping skills training (CST-PSP) versus general health education in improving well-being among individuals with ongoing pain after breast cancer surgery. The impact of psychological and physiological factors on persistent pain will also be evaluated.

Participant Groups

Group I: Coping Skills Training for Persistent Post-Surgical Pain Experimental Treatment 1 Intervention

novel pain coping skills training intervention designed specifically for people with persistent pain (PP) following breast cancer surgery

Group II: Self-guided health education Active Control 1 Intervention

general health education intervention

Group III: General health education with a coach Active Control 1 Intervention

general health education intervention

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

University of Pittsburgh Medical Center

Collaborator

Trials

78

Recruited

77,600+

Findings from Research

In a study involving 184 women who underwent breast cancer surgery, pain neuroscience education (PNE) did not show a significant advantage over traditional biomedical education in reducing pain-related disability over 12 months post-surgery.

Both educational interventions resulted in similar outcomes for pain intensity, upper limb function, and emotional functioning, suggesting that further research is needed to develop more personalized approaches to pain management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of pain neuroscience education after breast cancer surgery on pain, physical, and emotional functioning: a double-blinded randomized controlled trial (EduCan trial). Dams, L., Van der Gucht, E., Devoogdt, N., et al.[2023]

A study involving 184 participants found that adding pain neuroscience education (PNE) to standard physical therapy after breast cancer surgery did not significantly improve somatosensory functioning compared to traditional biomedical pain education over an 18-month period.

The results suggest that while PNE addresses pain from multiple perspectives, it may not be universally effective, indicating a need for future research to identify which patients could benefit most from this type of education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of pain neuroscience education on somatosensory functioning after surgery for breast cancer: A double-blinded randomized controlled trial. Dams, L., Van der Gucht, E., Haenen, V., et al.[2023]

The Cancer Pain Education for Patients and the Public (CPEPP) project aims to enhance pain management by providing essential education to patients and the public about cancer-related pain.

The CPEPP curriculum offers resources and support to ensure effective implementation of pain education, highlighting its importance in improving overall pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer pain education for patients and the public. Ferrell, BR., Juarez, G.[2019]

Patient education significantly improved global quality of life, emotional quality of life, and reduced fatigue in adult breast cancer survivors, based on a systematic review of 14 studies involving 1749 participants.

However, the improvements were classified as 'not important' and did not show significant effects on pain severity or fear of recurrence, indicating that while patient education can be beneficial, its impact may be limited in certain areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of patient education on quality-of-life, pain and fatigue in breast cancer survivors: A systematic review and meta-analysis. Martínez-Miranda, P., Casuso-Holgado, MJ., Jesús Jiménez-Rejano, J.[2022]

Patient education significantly improves cancer pain management and should be a standard practice in all healthcare settings, as it empowers patients to self-manage their care.

The most effective patient education strategies are those that are tailored to individual needs, integrated into healthcare communication, and combined with other methods to ensure comprehensive pain assessment and management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient education, coaching, and self-management for cancer pain. Lovell, MR., Luckett, T., Boyle, FM., et al.[2022]

Cancer patient education should go beyond just providing information; it must also include teaching coping skills and new strategies to manage the disease, which can lead to better treatment adherence and reduced anxiety.

Focusing on the different phases of cancer care can help identify essential educational content, and ongoing research is crucial for developing effective teaching methods and evaluating their impact on patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Information and education across the phases of cancer care. Adams, M.[2019]

An 11-minute educational movie on chronic pain significantly increased pain knowledge among 95 adolescent students, with a notable effect size indicating strong effectiveness (ηp2 = 0.544).

Students who reported frequent pain (at least once a week) showed a greater increase in knowledge about managing chronic pain compared to those without frequent pain, suggesting targeted educational interventions may be particularly beneficial for this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of a short educational movie on promoting chronic pain health literacy in school: A feasibility study. Wager, J., Stahlschmidt, L., Heuer, F., et al.[2019]

In a study involving women post-breast cancer surgery, pain neuroscience education led to a higher return-to-work rate at 12 months (71%) compared to biomedical pain education (53%), although this difference was not statistically significant (p=0.07).

By 18 months, the difference in return-to-work rates decreased to 9% and no significant differences were found in time until work resumption or changes in self-estimated ability to return to work, indicating that both educational approaches may have similar outcomes in the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Returning to Work After Breast Cancer Surgery: A Randomised Controlled Trial on the Effect of Pain Neuroscience Education. De Groef, A., Van der Gucht, E., Devoogdt, N., et al.[2023]

References

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

Effect of pain neuroscience education after breast cancer surgery on pain, physical, and emotional functioning: a double-blinded randomized controlled trial (EduCan trial). [2023]

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

Effectiveness of pain neuroscience education on somatosensory functioning after surgery for breast cancer: A double-blinded randomized controlled trial. [2023]

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

Cancer pain education for patients and the public. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Effect of patient education on quality-of-life, pain and fatigue in breast cancer survivors: A systematic review and meta-analysis. [2022]

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

Patient education, coaching, and self-management for cancer pain. [2022]

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

Information and education across the phases of cancer care. [2019]

7. England pubmed.ncbi.nlm.nih.gov

The impact of a short educational movie on promoting chronic pain health literacy in school: A feasibility study. [2019]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Returning to Work After Breast Cancer Surgery: A Randomised Controlled Trial on the Effect of Pain Neuroscience Education. [2023]