Hypnosis to Reduce Aromatase Inhibitor Pain and Improve Adherence

Completed · Not applicable

Conditions studied: Breast Neoplasms, Musculoskeletal Pain

In brief

The purpose of this study is to determine whether hypnosis is efficacious in reducing musculoskeletal pain in breast cancer survivors taking aromatase inhibitors, and by doing so, whether hypnosis can help survivors to be more adherent to their medication regimen.

Key facts

Study ID

NCT02657993

Run by

Icahn School of Medicine at Mount Sinai

People needed

191

Starts

2016-03-01

Expected to finish

2021-03-18

Last updated by the study team

2021-06-22

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female
• Diagnosed with Stage 0-III hormone-receptor positive breast cancer
• Taking a third-generation aromatase inhibitor (AI) (e.g., anastrozole (Arimidex), letrozole (Femara), or exemestane (Aromasin)) for at least 3 months left in their AI prescription to complete all study assessments (e.g., at least one year left on AIs)
• Experiencing ongoing pain and/or stiffness in one or more joints, which started or worsened after initiation of AI therapy
• Having a baseline worst pain score over the past week on the Brief Pain Inventory-Short Form (BPI-SF) of ≥ 3 on a 0 to 10 scale
• Over age 18
• Able to speak and read English (to allow for participation in study intervention sessions)
• Consent to the study
• Be willing to be randomized to experimental conditions
• Willing to travel to Mount Sinai for study procedures (e.g., intervention sessions, follow-up appointments).

You may not qualify if…

• Inflammatory, metabolic or neuropathic arthropathies at the time of recruitment
• Fibromyalgia
• Past cancer. Patients will be excluded if they have ever been diagnosed with cancer (including DCIS/LCIS) prior to the breast cancer for which the present course of AIs is being prescribed. However, patients will be eligible if they have a history of non-metastatic, non-melanomatous skin cancer
• Metastatic (Stage IV) breast cancer, as their treatment and outcomes typically follow a different course
• Bone fracture/surgery of an extremity during the preceding 6 months
• Non-steroidal joint injection within the last 3 months.
• Current use of corticosteroids, defined as oral, intravenous (IV), or injections of corticosteroids in the past 4 weeks
• Regular use of narcotics.
• Patients will be excluded due to the presence of the following psychiatric conditions: dementia, psychosis, current mania or uncontrolled major depressive disorder, or addictive disorder or current intoxication.
• In the rare instance of the presence of a comorbidity that does not fall into any of the above mentioned exclusion criteria, but that is clinically determined to significantly interfere with the patient's ability to participate in the study (e.g., cognitive impairment)

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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