Clinical trial · Interventional
Hypnosis to Reduce Aromatase Inhibitor Pain and Improve Adherence
Hypnosis to Reduce Aromatase Inhibitor (AI) Associated Musculoskeletal Pain and to Improve AI Adherence: An RCT to Explore Efficacy and Cost Effects
NCT02657993CI-TRIAL-00052387completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Musculoskeletal Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Attention Control | Behavioral | — | UNRESOLVED |
| Hypnosis | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hypnosis
- description
- The hypnosis intervention involves three, face-to-face, hypnosis sessions delivered by doctoral-level psychology professionals
- interventionNames
- Behavioral: Hypnosis
- type
- ACTIVE_COMPARATOR
- label
- Attention Control (Non-Hypnosis)
- description
- The attention control intervention is matched to the hypnosis intervention in terms of the amount of professional time received by patients.
- interventionNames
- Behavioral: Attention Control
Primary outcomes (1)
- measure
- Patient-reported musculoskeletal pain (MSP) as measured by the Brief Pain Inventory-Short Form (BPI-SF)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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). Exclusion Criteria: * 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)
References
Publications (0)
Data not yet available
No reference posted for this study.