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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

Must not have

Postmenopausal due to ovarian suppression rather than natural menopause

Evidence of metastatic disease

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

No Placebo-Only Group

Pivotal Trial

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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My cancer has spread to other parts of my body.

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I do not have any active cancer except for non-melanoma skin cancer.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 / 13Eligibility criteria met