Online Pain Coping Skills Training for Joint Pain in Breast Cancer Survivors

Recruiting at 1 trial location

Overseen By Zahra Hosseinian

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Northwestern University

Must be taking: AI therapy

Disqualifiers: Metastatic disease, Active cancer, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 8-10 weeks

452 Participants Needed

Trial Summary

What is the purpose of this trial?

The main goal of this clinical trial is to test benefits of completing online pain coping skills training program in women who have been diagnosed with stage I-III breast cancer, who have completed their primary cancer treatment, who are taking an AI medication, and who have arthralgia. Arthralgia is a type of joint, bone, and muscle pain that is a common side effect of AI medications. The main questions it aims to answer are: 1. Whether online pain coping skills training reduces the severity of pain and the interference it causes in women's daily lives. 2. Whether online pain coping skills training improves emotional distress, quality of life, and adherence to AI medications. 3. Whether benefits of online pain coping skills training are at least partially caused by women's increased confidence that they can manage their pain and a reduction in unhelpful thinking patterns about pain. 4. Whether online pain coping skills training improves effects of AI medications on sleep problems and symptoms of menopause like hot flashes and night sweats. Participants can complete all parts of the study at home. They will: 1. Complete four sets of questionnaires throughout the study, which will take about 9 to 10 months. 2. Attend 3 meetings in the first month of the study, all of which can be held via a video conference. 3. Use an electronic pill bottle to track their use of their AI medication. 4. Be randomized (like flipping a coin) to one of two study arms: They will either receive education about AIs and arthralgia or they will receive this education along with access to an online pain coping skills training program. Research will compare the education group to the education plus online pain coping skills training group to see if online pain coping skills training has the benefits mentioned above.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications. However, if you are taking pain relievers, you need to be on a stable dose for at least 14 days before joining the study and should not plan to increase the dose during the study. You can discuss any changes with your doctor.

What data supports the effectiveness of this treatment for joint pain in breast cancer survivors?

Research shows that educational interventions for cancer pain can help reduce pain intensity and improve understanding of pain. These programs, which include teaching about pain and self-management strategies, have been found to be beneficial for cancer patients experiencing pain. ^{1 2 3 4 5}

Is online pain coping skills training safe for humans?

The studies suggest that online pain coping skills training is generally safe for humans, as they focus on its acceptability and satisfaction among participants, without reporting any significant safety concerns. ^{1 2 4 6 7}

How is the Online Pain Coping Skills Training treatment different from other treatments for joint pain in breast cancer survivors?

This treatment is unique because it is delivered online, making it more accessible to patients who may face barriers like travel or physical burden. It focuses on teaching pain coping skills, which is a behavioral approach, rather than relying on medication or in-person therapy sessions. ^{1 6 7 8 9}

Eligibility Criteria

This trial is for postmenopausal women over 18 with Stage I-III hormone receptor positive breast cancer, who've finished primary treatment and are on stable AI therapy experiencing joint pain. They must be English-speaking, able to use digital devices for online training, and likely to complete the study.

Inclusion Criteria

I am currently on AI therapy (letrozole, exemestane, or anastrozole).

My joint or muscle pain started or got worse after beginning AI therapy.

My pain medication dose has been stable for the last 2 weeks and I don't plan to increase it during the study.

Exclusion Criteria

Have diagnosed or suspected condition that would interfere with informed consent or completion of study activities (e.g., significant impairment in cognition or uncorrected hearing/vision)

I am postmenopausal because of medical treatment, not natural causes.

I had major surgery less than 8 weeks ago or minor surgery recently, as approved.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive education about AIs and arthralgia, with or without access to an online pain coping skills training program, completed over 8 to 10 weeks.

8-10 weeks

3 meetings (virtual) in the first month

Follow-up 1

Participants' medication adherence is monitored using electronic pill bottles.

10-14 weeks

Follow-up 2

Participants are monitored for changes in menopause-specific quality of life.

22-26 weeks

Follow-up 3

Participants are monitored for changes in pain, emotional distress, sleep disturbance, and medication adherence.

34-38 weeks

Treatment Details

Interventions

• Education
• Online Pain Coping Skills Training

Trial Overview The trial tests if an online pain coping skills program can reduce pain severity from AI medication in breast cancer survivors, improve their quality of life, emotional distress, sleep issues, menopause symptoms and adherence to AI medications.

Participant Groups

Group I: Education + Online Pain Coping Skill Training Experimental Treatment 2 Interventions

Participants will receive their usual medical care and an educational booklet with information about Aromatase Inhibitors (AIs), side effects they cause including painful arthralgia, methods for managing arthralgia, and tips for talking with doctors about arthralgia and other AI side effects. They will also be given access to an online pain coping skills training program and asked to complete it at home over 8 to 10 weeks. This interactive, web-based program teaches cognitive and behavioral skills that research has shown can reduce pain and pain-related interference with daily activities. The program includes eight sessions that participants will complete at a rate of about 1 per week. Each session takes 35-45 minutes. Participants will be shown how to use the program and can contact the study team if they have any problems with it. Participants who do not have a device capable of accessing the program will be loaned a tablet computer for the study.

Group II: Education Active Control 1 Intervention

Participants will receive their usual medical care and an educational booklet with information about Aromatase Inhibitors (AIs), side effects they cause including painful arthralgia, methods for managing arthralgia, and tips for talking with doctors about arthralgia and other AI side effects.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

The personalized eHealth intervention for female breast cancer survivors with persistent pain was well-received, being described as easy to use and helpful, indicating strong acceptability and satisfaction among participants.

After 6 weeks of using the program, participants showed significant improvements in pain-related functioning, physical functioning, and quality of life, suggesting the intervention's preliminary efficacy in managing post-surgery pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and pilot testing of a personalized eHealth intervention for pain science education and self-management for breast cancer survivors with persistent pain: a mixed-method study. De Groef, A., Evenepoel, M., Van Dijck, S., et al.[2023]

Educational interventions for healthcare professionals improve their knowledge and attitudes towards cancer pain management, but this does not always lead to better patient outcomes.

Targeted educational programs for patients have been shown to improve their outcomes, suggesting that patient education is crucial, although the exact mechanisms of these improvements are still unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Education in cancer pain management. Bennett, MI., Flemming, K., Closs, SJ.[2021]

Educational interventions for cancer pain management can lead to small to moderate reductions in pain intensity for patients, based on a review of 34 randomized controlled trials.

These interventions often include key components such as improving knowledge about cancer pain, enhancing communication, and teaching non-pharmacological pain management strategies, indicating a multifaceted approach is effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Educational interventions for cancer pain. A systematic review of systematic reviews with nested narrative review of randomized controlled trials. Adam, R., Bond, C., Murchie, P.[2022]

Providing psychosocial support and education to patients and caregivers is essential for effectively managing cancer pain, leading to significant clinical benefits.

The review emphasizes the importance of tailoring educational programs to meet the diverse needs of cancer patients, particularly those with limited health literacy, to enhance their understanding and management of pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing effective cancer pain education programs. Martin, MY., Pisu, M., Kvale, EA., et al.[2022]

Pain education programs that include information about the neurophysiology of pain can lead to reduced pain intensity and lower levels of catastrophizing in cancer patients, based on a systematic review of 12 studies.

Despite these benefits, the review found no significant improvement in the overall quality of life for patients, indicating that further research is necessary to fully understand the impact of pain education in oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Therapeutic Education in Patients with Cancer Pain: Systematic Review and Meta-Analysis. González-Martín, AM., Aguilera-García, I., Castellote-Caballero, Y., et al.[2023]

An 8-week web-based pain coping skills training (PCST) program was found to be highly acceptable to cancer patients, providing both emotional and physical benefits, which could improve pain management for those with cancer-related bone pain.

Healthcare providers expressed support for the web-based PCST program, suggesting that it could be effectively integrated into clinical care if barriers such as provider familiarity and patient workload are addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A qualitative study of patient and provider perspectives on using web-based pain coping skills training to treat persistent cancer pain. Rini, C., Vu, MB., Lerner, H., et al.[2020]

A brief pain coping skills training (PCST) intervention delivered via mobile health technology was found to be feasible and acceptable for 25 cancer patients, with an impressive session completion rate of 84%.

Participants experienced significant improvements in pain, physical symptoms, psychological distress, and pain catastrophizing after the intervention, suggesting that mHealth delivery can effectively enhance access to pain management resources for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study of a Mobile Health Pain Coping Skills Training Protocol for Patients With Persistent Cancer Pain. Somers, TJ., Abernethy, AP., Edmond, SN., et al.[2018]

Mobile health pain coping skills training (mPCST) is significantly more feasible than traditional in-person pain coping skills training (PCST-traditional), making it easier for cancer patients to access and complete the program.

Both mPCST and PCST-traditional showed similar effectiveness in reducing pain severity and interference, indicating that mPCST is a viable alternative to traditional methods for managing cancer-related pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A behavioral cancer pain intervention: A randomized noninferiority trial comparing in-person with videoconference delivery. Kelleher, SA., Winger, JG., Dorfman, CS., et al.[2023]

The Meaning-Centered Pain Coping Skills Training (MCPC) intervention was found to be feasible and acceptable for 30 participants with stage IV cancer, with a high completion rate of 90% for intervention sessions and 87% for post-intervention assessments.

Participants reported significant improvements in pain severity, pain interference, and spiritual well-being after the intervention, along with high satisfaction levels, indicating that MCPC could be a beneficial approach for managing pain in advanced cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meaning-Centered Pain Coping Skills Training: A Pilot Feasibility Trial of a Psychosocial Pain Management Intervention for Patients with Advanced Cancer. Winger, JG., Ramos, K., Kelleher, SA., et al.[2023]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Feasibility and pilot testing of a personalized eHealth intervention for pain science education and self-management for breast cancer survivors with persistent pain: a mixed-method study. [2023]

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

Education in cancer pain management. [2021]

3. Ireland pubmed.ncbi.nlm.nih.gov

Educational interventions for cancer pain. A systematic review of systematic reviews with nested narrative review of randomized controlled trials. [2022]

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

Developing effective cancer pain education programs. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of Therapeutic Education in Patients with Cancer Pain: Systematic Review and Meta-Analysis. [2023]

6. England pubmed.ncbi.nlm.nih.gov

A qualitative study of patient and provider perspectives on using web-based pain coping skills training to treat persistent cancer pain. [2020]

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

A Pilot Study of a Mobile Health Pain Coping Skills Training Protocol for Patients With Persistent Cancer Pain. [2018]

8. England pubmed.ncbi.nlm.nih.gov

A behavioral cancer pain intervention: A randomized noninferiority trial comparing in-person with videoconference delivery. [2023]

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

Meaning-Centered Pain Coping Skills Training: A Pilot Feasibility Trial of a Psychosocial Pain Management Intervention for Patients with Advanced Cancer. [2023]