NCT02657993

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
191

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2021

Completed
Last Updated

June 22, 2021

Status Verified

June 1, 2021

Enrollment Period

5 years

First QC Date

January 14, 2016

Last Update Submit

June 15, 2021

Conditions

Breast NeoplasmsMusculoskeletal Pain

Keywords

Breast NeoplasmsAromatase InhibitorsMusculoskeletal PainHypnosisMedication AdherenceCost-Benefit AnalysisTreatment Outcomes

Outcome Measures

Primary Outcomes (1)

  • Patient-reported musculoskeletal pain (MSP) as measured by the Brief Pain Inventory-Short Form (BPI-SF)

    The Brief Pain Inventory-Short Form (BPI-SF) is a self-report questionnaire assessing pain.

    12 months

Secondary Outcomes (6)

  • eCap measure

    12 months

  • The Australian/Canadian Osteoarthritis Hand Index (AUSCAN)

    12 months

  • The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    12 months

  • The Breast Cancer Prevention Trial-Musculoskeletal Symptom (BCPT-MS)

    12 months

  • The Medication Adherence Report Scale (MARS)

    12 months

  • +1 more secondary outcomes

Study Arms (2)

Hypnosis

EXPERIMENTAL

The hypnosis intervention involves three, face-to-face, hypnosis sessions delivered by doctoral-level psychology professionals

Behavioral: Hypnosis

Attention Control (Non-Hypnosis)

ACTIVE COMPARATOR

The attention control intervention is matched to the hypnosis intervention in terms of the amount of professional time received by patients.

Behavioral: Attention Control

Interventions

HypnosisBEHAVIORAL

The hypnosis intervention involves three parts. First, participants will receive three, face-to-face hypnosis sessions delivered by doctoral-level psychology professionals. The sessions are based on materials developed by experienced psychologists in the Integrative Behavioral Medicine Program at the Icahn School of Medicine at Mount Sinai. Second, participants will be taught how to use hypnosis themselves (self-hypnosis) to help manage their pain. Third, participants will receive a hypnosis recording to listen to in-between sessions and throughout the course of the study. At home hypnosis practice will be recommended. Participants will be asked to complete questionnaires over a period of 12 months.

Hypnosis
Attention ControlBEHAVIORAL

The attention control intervention involves three face-to-face meetings with a doctoral-level psychology professional. During these sessions, participants will be asked to discuss with the interventionist their experience of taking aromatase inhibitors and associated musculoskeletal pain. The interventionist will not lead the patient in imagery, relaxation, evaluation of thought processes, or even simple discussion. Rather interventionists will allow the patient to direct the flow of the conversation and will provide support and empathy. Interventionist contact time in AC sessions will be identical to that in the hypnosis group. Overall, the attention control intervention will control for professional attention. Participants will be asked to complete questionnaires over a period of 12 months.

Also known as: Non-Hypnosis
Attention Control (Non-Hypnosis)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsMusculoskeletal PainMedication Adherence

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesMuscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Guy H Montgomery, PhD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 14, 2016

First Posted

January 18, 2016

Study Start

March 1, 2016

Primary Completion

March 18, 2021

Study Completion

March 18, 2021

Last Updated

June 22, 2021

Record last verified: 2021-06

Locations

US(1)