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

Phase 3

Recruiting

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Currently taking AI therapy (letrozole, exemestane, or anastrozole)

Reporting musculoskeletal pain that developed or worsened since starting AI therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in hads score from baseline to 34-38 weeks post-baseline (follow up 3)

Awards & highlights

Study Summary

This trial tests the benefits of an online pain coping skills program to reduce arthralgia (joint pain) in women with breast cancer taking AI medications. Participants complete questionnaires and use an electronic pill bottle to track AI use. They may be randomized to an education or education+online program group.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

There may not be direct side effects from participating in this study since it involves education and skill training. However, participants will continue their usual AI therapy which can cause joint pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I have experienced pain on most days in the past month.

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I am 18 years old or older.

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I am female.

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I have Stage I-III breast cancer that is hormone receptor positive.

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I have finished all my initial cancer treatments.

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I have gone through menopause.

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I can take care of myself and am up and about more than half of my waking hours.

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My worst pain in the past week was 4 or more on a scale of 0 to 10.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in hads score from baseline to 34-38 weeks post-baseline (follow up 3)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in hads score from baseline to 34-38 weeks post-baseline (follow up 3)

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in hads score from baseline to 34-38 weeks post-baseline (follow up 3) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Change in Brief Pain Inventory pain interference subscale

Change in Brief Pain Inventory pain severity subscale

Change in Functional Assessment of Cancer Therapy-Lymphedema (FACT-B)

+4 more

Other outcome measures

Change in Chronic Pain Self-Efficacy Scale Pain Management Subscale

Change in Menopause Specific quality of Life Questionnaire (MENQOL) Vasomotor Subscale

Change in PROMIS 8-item Sleep-Related Impairment

+2 more

Trial Design

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

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,586 Previous Clinical Trials

916,799 Total Patients Enrolled

Duke UniversityOTHER

2,363 Previous Clinical Trials

3,420,054 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,663 Previous Clinical Trials

40,925,453 Total Patients Enrolled

1 Trials studying Joint Pain

42 Patients Enrolled for Joint Pain

Media Library

Education Clinical Trial Eligibility Overview. Trial Name: NCT05703178 — Phase 3

Joint Pain Research Study Groups: Education + Online Pain Coping Skill Training, Education

Joint Pain Clinical Trial 2023: Education Highlights & Side Effects. Trial Name: NCT05703178 — Phase 3

Education 2023 Treatment Timeline for Medical Study. Trial Name: NCT05703178 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining vacancies in this medical trial?

"Clinicaltrials.gov demonstrates that this medical investigation is currently recruiting participants. It was first advertised on the 21st of January 2023 and underwent a recent overhaul on the 19th of the same month."

Answered by AI

Are there any potential hazards associated with Education + Online Pain Coping Skill Training?

"Our internal evaluation has assigned Education + Online Pain Coping Skill Training a score of 3 due to the prior clinical research displaying both efficacy and safety."

Answered by AI

What is the maximum participant capacity for this research project?

"Affirmative. According to the information located on clinicaltrials.gov, this research is actively seeking participants; it was originally posted in January of 2021 and recently updated in early January of 2022. The study requires 452 people from two sites for full enrolment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Web-based Pain Coping Skills Training for Breast Cancer Survivors With AI-Associated Arthralgia

Christine Rini, PhD 2023. "Web-based Pain Coping Skills Training for Breast Cancer Survivors With AI-Associated Arthralgia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05703178.

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