This clinical trial studies how well hypnotherapy works in reducing musculoskeletal pain and improving aromatase inhibitor adherence in patients with hormone receptor positive stage 0-III breast cancer. Hypnotherapy may help women who are taking aromatase inhibitors as part of their breast cancer treatment, and may help to manage musculoskeletal pain associated with these aromatase inhibitors.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02657993.
PRIMARY OBJECTIVES:
I. To investigate the clinical efficacy of a “live” hypnosis intervention to reduce musculoskeletal pain (MSP) in breast cancer survivors taking aromatase inhibitor (AI)s.
II. To explore the cost-effectiveness of a “live” hypnosis intervention to reduce MSP in breast cancer survivors taking AIs (exploratory outcome).
III. To investigate the clinical efficacy of a “live” hypnosis intervention to increase AI adherence in breast cancer survivors.
IV. To explore the cost-effectiveness of a “live” hypnosis intervention to increase AI adherence in breast cancer survivors.
V. To test the hypothesized mediational model: Hypnosis exerts its effects on AI adherence through MSP reduction.
OUTLINE: Patients are randomized into 1 of 2 arms.
ARM I: Patients attend 1 hypnosis session over 40 minutes within 2 weeks after baseline. Patients also attend another 2 hypnosis sessions over 30 minutes of each after 1 week and after 1 month.
ARM II: Patients attend 1 attention control session over 40 minutes within 2 weeks after baseline. Patients also attend another 2 attention control sessions over 30 minutes of each after 1 week and after 1 month.
After completion of study, patients are followed up at 3, 6, 9, and 12 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationIcahn School of Medicine at Mount Sinai
Principal InvestigatorGuy H Montgomery