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New treatment option for Breast Cancer Survivor
Official title Enhanced Pain Coping in Cancer (EPIC): A Study of Managing Treatment-Related Joint Pain in Breast Cancer Survivors
ClinicalTrials.gov ID: NCT06728579
What this study is testing
- What it's testing
- The researchers are doing this study to compare two different types of group therapy and find out whether they are effective approaches for helping breast cancer survivors manage joint pain caused by aromatase inhibitors (AI). This type of joint pain is called AI-associated arthralgia, or AIA, and it is common in people taking AIs.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Age ≥18 years
- English-proficient women with a history of stage I, II, or III breast cancer
- Free of oncologic disease by clinical examination and history;
- Receiving third-generation AI therapy (anastrozole, letrozole, or exemestane) for at least 28 days prior to consent with plan to continue for at...
- Worst joint pain rated at least 4 or greater on a 0-10 numeric rating scale in the preceding week prior to consent;
You likely can't join if
- Metastatic breast cancer (stage IV);
- Completed chemotherapy, surgery, or radiation therapy less than 4 weeks prior to enrollment;
- Pain attributed to inflammatory arthritis (i.e. rheumatoid arthritis, gout, pseudogout);
- Surgery or joint injection involving the affected joints within the last month or planned within the next six months;
- Active suicidality or psychosis as determined by the Mini-International Neuropsychiatric Interview.
See the full eligibility criteria
- Age ≥18 years
- English-proficient women with a history of stage I, II, or III breast cancer
- Free of oncologic disease by clinical examination and history;
- Receiving third-generation AI therapy (anastrozole, letrozole, or exemestane) for at least 28 days prior to consent with plan to continue for at least another 12 months;
- Worst joint pain rated at least 4 or greater on a 0-10 numeric rating scale in the preceding week prior to consent;
- Reporting at least 15 days with pain in the preceding 30 days prior to consent;
- Experiencing joint pain for at least one month;
- Pain attributed to AI therapy;
- Willing to adhere to all study-related procedures, including randomization to one of two treatment arms: Mindfulness-Oriented Recovery Enhancement (MORE) or Supportive Group Psychotherapy (SG);
- Able to attend video-call sessions in a quiet/private location.
- Metastatic breast cancer (stage IV);
- Completed chemotherapy, surgery, or radiation therapy less than 4 weeks prior to enrollment;
- Pain attributed to inflammatory arthritis (i.e. rheumatoid arthritis, gout, pseudogout);
- Surgery or joint injection involving the affected joints within the last month or planned within the next six months;
- Active suicidality or psychosis as determined by the Mini-International Neuropsychiatric Interview.
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
- Tallahassee, Florida, United States
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, United States; Tallahassee, Florida, United States; Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.