Online Pain Coping Skills Training for Joint Pain in Breast Cancer Survivors
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Northwestern University
Must be taking: AI therapy
Disqualifiers: Metastatic disease, Active cancer, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
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.
12345Is 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.
12467How 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.
16789Eligibility 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.
+11 more
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.
+3 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Education + Online Pain Coping Skill TrainingExperimental Treatment2 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: EducationActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Duke UniversityDurham, NC
Northwestern UniversityChicago, IL
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Who Is Running the Clinical Trial?
Northwestern UniversityLead Sponsor
Duke UniversityCollaborator
National Cancer Institute (NCI)Collaborator
References
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]Here, we describe the development and pilot study of a personalized eHealth intervention containing a pain science education program and self-management support strategies regarding pain and pain-related functioning in female survivors of breast cancer. First, we aimed to evaluate the eHealth intervention's acceptability, comprehensibility, and satisfaction; second, we aimed to assess its preliminary efficacy.
Education in cancer pain management. [2021]To describe the current position of educational interventions within the context of cancer pain management.
Educational interventions for cancer pain. A systematic review of systematic reviews with nested narrative review of randomized controlled trials. [2022]Educational interventions are one approach to improving cancer pain management. This review aims to determine whether educational interventions can improve cancer pain management and to characterize components of cancer pain educational interventions.
Developing effective cancer pain education programs. [2022]Pain is prevalent, burdensome, and undertreated in individuals with cancer across the disease trajectory. Providing patients and family caregivers with psychosocial support and education to manage cancer pain is a core component of quality care that can result in significant clinical benefit. In this review, we: (1) outline an approach for developing and assessing the effectiveness of education programs for adults with cancer pain; (2) discuss considerations for tailoring programs to the needs of diverse populations and those with limited health literacy skills; (3) describe the resource needs and costs of developing a program; (4) highlight innovative approaches to cancer pain education. We conclude with recommendations for future research and the next generation of educational interventions.
Effectiveness of Therapeutic Education in Patients with Cancer Pain: Systematic Review and Meta-Analysis. [2023](1) Objective: To review the existing evidence on pain education in patients with pain derived from an oncological process. (2) Methods: A systematic review was conducted using the databases Pubmed, Web of Science, PEDro, and Scopus. The selected studies had to incorporate instruction about the neurophysiology of pain into their educational program. The target population was cancer patients who had suffered pain for at least one month. The methodological quality of the articles collected was assessed using the PEDro scale. (3) Results: Some 698 studies were initially identified, of which 12 were included in this review. Four different models of pain education programs were found in the studies' interventions. Pain intensity, pain experience, quality of life, pain tolerance, and catastrophism were the variables that appeared most frequently. (4) Conclusions: This review demonstrates that pain education in patients with cancer pain may produce effects such as decreased pain intensity and catastrophism. Knowledge about pain also seems to increase. However, no benefit was reported for patients' overall quality of life. Therefore, more research is needed to clarify the effects of these interventions on the oncology population.
A qualitative study of patient and provider perspectives on using web-based pain coping skills training to treat persistent cancer pain. [2020]Persistent pain is common and inadequately treated in cancer patients. Behavioral pain interventions are a recommended part of multimodal pain treatments, but they are underused in clinical care due to barriers such as a lack of the resources needed to deliver them in person and difficulties coordinating their use with clinical care. Pain coping skills training (PCST) is an evidence-based behavioral pain intervention traditionally delivered in person. Delivering this training via the web would increase access to it by addressing barriers that currently limit its use. We conducted a patient pilot study of an 8-week web-based PCST program to determine the acceptability of this approach to patients and the program features needed to meet their needs. Focus groups with healthcare providers identified strategies for coordinating the use of web-based PCST in clinical care.
A Pilot Study of a Mobile Health Pain Coping Skills Training Protocol for Patients With Persistent Cancer Pain. [2018]Pain coping skills training (PCST) interventions have shown efficacy for reducing pain and providing other benefits in patients with cancer. However, their reach is often limited because of a variety of barriers (e.g., travel, physical burden, cost, time).
A behavioral cancer pain intervention: A randomized noninferiority trial comparing in-person with videoconference delivery. [2023]Behavioral cancer pain interventions are efficacious for improving important pain outcomes; yet, traditional in-person delivery limits patient access. This study compared videoconference-delivered mobile health pain coping skills training (mPCST) to in-person pain coping skills training (PCST-traditional).
Meaning-Centered Pain Coping Skills Training: A Pilot Feasibility Trial of a Psychosocial Pain Management Intervention for Patients with Advanced Cancer. [2023]Background: Pain from advanced cancer can greatly reduce patients' physical, emotional, and spiritual well-being. Objective: To examine the feasibility and acceptability of a behavioral pain management intervention, Meaning-Centered Pain Coping Skills Training (MCPC). Design: This trial used a single-arm feasibility design. Setting/Subjects: Thirty participants with stage IV solid tumor cancer, moderate-to-severe pain, and clinically elevated distress were enrolled from a tertiary cancer center in the United States. The manualized protocol was delivered across four 45- to 60-minute videoconference sessions. Measurements: Feasibility and acceptability were assessed through accrual, session/assessment completion, intervention satisfaction, and coping skills usage. Participants completed validated measures of primary outcomes (i.e., pain severity, pain interference, and spiritual well-being) and secondary outcomes at baseline, post-intervention, and four-week follow-up. Results: Eighty-eight percent (38/43) of patients who completed screening met inclusion criteria, and 79% (30/38) consented and completed baseline assessment. Sixty-seven percent (20/30) of participants were female (mean age = 57). Most participants were White/Caucasian (77%; 23/30) or Black/African American (17%; 5/30) with at least some college education (90%; 27/30). Completion rates for intervention sessions and both post-intervention assessments were 90% (27/30), 87% (26/30), and 77% (23/30), respectively. At the post-intervention assessment, participants reported a high degree of intervention satisfaction (mean = 3.53/4.00; SD = 0.46), and 81% (21/26) reported weekly use of coping skills that they learned. Participants also showed improvement from baseline on all primary outcomes and nearly all secondary outcomes at both post-intervention assessments. Conclusions: MCPC demonstrated strong feasibility and acceptability. Findings warrant further evaluation of MCPC in a randomized controlled trial. ClinicalTrials.gov Identifier: NCT03207360.