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

(WB ABCs Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different educational programs can assist people with persistent pain after breast cancer surgery. Participants will engage in either a new coping skills training focused on managing pain (CST-PSP) or general health education, which may be self-guided or involve a coach. The trial aims to determine if these approaches improve well-being by reducing pain and enhancing understanding of mental and physical factors in ongoing pain. Individuals who underwent surgery for Stage 0 to III breast cancer at least three months ago and experience moderate to severe breast pain may be suitable candidates. As an unphased trial, this study provides an opportunity to contribute to valuable research that could improve pain management strategies for future patients.

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 prior data suggests that these interventions are safe for managing postoperative pain?

Research shows that both CST-PSP (Coping Skills Training for Persistent Post-Surgical Pain) and Targeted-PCST (Pain Coping Skills Training) have been evaluated for safety and effectiveness. Participants using CST-PSP reported better pain management and coping skills, with no major side effects, suggesting the treatment is generally well-tolerated.

For Targeted-PCST, research indicates that ongoing pain is common after breast cancer surgery, affecting up to 50% of patients. However, no specific safety issues with Targeted-PCST have been noted, suggesting it is generally safe.

Overall, both programs aim to teach skills for better pain management, and studies have not found harmful side effects. This suggests they are likely safe options for managing long-term pain after breast surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for postoperative pain after breast cancer surgery because they focus on developing coping skills tailored for persistent pain. Unlike standard medical treatments that often rely on medications like opioids or NSAIDs to manage pain, the Coping Skills Training for Persistent Post-Surgical Pain (CST-PSP) aims to empower patients with strategies to manage their pain mentally and emotionally. This approach is unique because it targets the psychological aspects of pain management, offering patients tools to potentially reduce reliance on medications and improve their overall quality of life. Additionally, the combination of general health education with a coach provides personalized guidance that can enhance the effectiveness of these coping strategies.

What evidence suggests that this trial's treatments could be effective for persistent pain after breast cancer surgery?

Research has shown that learning coping skills for ongoing pain after surgery (CST-PSP), a treatment in this trial, can reduce pain following breast cancer surgery. CST-PSP combines health education with techniques to manage pain physically and emotionally. Studies have found that patients who participated in CST-PSP reported less severe pain and required pain medication for fewer days. Meanwhile, targeted pain coping skills training (PCST) is another treatment option in this trial, specifically designed for women dealing with persistent pain after surgery. Both methods aim to improve well-being by teaching effective ways to handle pain and stress. ^{1 2 6 7 8}

Who Is on the Research Team?

Rebecca Shelby, PhD

Principal Investigator

Duke University

Dana Bovbjerg, PhD

Principal Investigator

University of Pittsburgh Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10001426/

Improving Well-Being for Individuals with Persistent Pain after ... CST-PSP sessions are delivered by study-trained interventionists (e.g., master's or PhD-level psychologists). Each session incorporates a review of home ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04225585

NCT04225585 | Well-Being After Breast Cancer Surgery We have developed, manualized, and pilot tested a pain coping skills training intervention that specifically targets the needs of women with persistent pain ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714422002609

Improving well-being for individuals with persistent pain ... The randomized trial described here will compare the benefits of three manualized behavioral interventions for individuals with PSP.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10330043/

Effect of Pain Coping Skills Training on Pain and Pain ... We hypothesized that women assigned to 5-session PCST would report less pain severity and days with pain medication use at post-intervention, and that these ...

5. withpower.com withpower.com/trial/phase-5-2021-f1f93

Health Education & Coping Skills Training for ... CST-PSP is unique because it combines health education with coping skills training to address postoperative pain, focusing on both the physical and emotional ...

6. jpsmjournal.com jpsmjournal.com/article/S0885-3924(23)00445-1/fulltext

Effect of Pain Coping Skills Training on ... Both conditions led to improvements in pain, pain medication use, pain self-efficacy, and coping skills use, and 5-session PCST showed the greatest benefits.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0885392423004451

Effect of Pain Coping Skills Training on Pain and ... Both conditions led to improvements in pain, pain medication use, pain self-efficacy, and coping skills use, and 5-session PCST showed the greatest benefits.

8. heal.nih.gov heal.nih.gov/funding/awarded?combine=&goal=All&grant=All&institutions1=&institutions=&items_per_page=25&locations1=&locations=&research_program=166&rfa=All&select_location=All&year=&order=field_investigators&sort=asc

Funded Projects | NIH HEAL Initiative Approximately 20% of patients who undergo surgery develop chronic pain, or Chronic Postsurgical Pain (CPSP). CPSP is highly associated with impaired functional ...