Hypnosis to Reduce Aromatase Inhibitor Pain and Improve Adherence

Breast Neoplasms Clinical Trial

Official title:

Hypnosis to Reduce Aromatase Inhibitor (AI) Associated Musculoskeletal Pain and to Improve AI Adherence: An RCT to Explore Efficacy and Cost Effects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02657993
• Other study ID #: GCO 14-1344
• Secondary ID: R01AT008762-01
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: March 18, 2021

Study information

• Verified date: June 2021
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The primary purpose of this study is to evaluate the efficacy of hypnosis for reducing musculoskeletal pain (MSP) in women taking aromatase inhibitors (AIs) for breast cancer. Research indicates that AIs are associated with musculoskeletal pain in up to 61% of breast cancer survivors. AI-associated MSP can include joint pain in the wrists, hands, and knees; carpal tunnel syndrome and trigger finger; and decreased grip strength, morning stiffness, and general muscle pain. MSP can lead to difficulty performing daily activities and can reduce quality of life in breast cancer survivors. This pain is not only aversive in and of itself, but also is associated with non-adherence to prescribed, daily AI regimens. In some studies, AI non-adherence estimates were as high as 50%.

At the present time, there is no "gold standard" treatment for AI-associated MSP. What is needed is an intervention that: reduces breast cancer survivors' MSP and helps them be more adherent to their prescribed AI regimen, does not have side-effects of its own, does not place a large time or financial burden on survivors, and which can be taught to survivors to practice on their own.

Hypnosis, a mind-body intervention, has been widely demonstrated to reduce pain. In fact, analgesia is perhaps the best known effect of hypnosis. Meta-analyses have consistently supported the efficacy of hypnosis for pain control, including chronic pain. Hypnosis also has a long tradition in cancer symptom management, especially for pain reduction. Hypnosis has been defined as an agreement between a person designated as the hypnotist (e.g., health care professional) and a person designated as the client or patient to participate in a psychotherapeutic technique based on the hypnotist providing suggestions for changes in sensation, perception, cognition, affect, mood, or behavior.

This study will examine whether or not hypnosis is helpful in reducing breast cancer survivors' AI-related MSP and in improving their adherence to their prescribed AI regimen. This study will also examine whether the hypnosis intervention is cost effective. To answer these questions, this randomized clinical trial will compare hypnosis (three sessions) to a non-hypnosis, attention control, empathic listening condition (three sessions). For each intervention, the first session will be approximately 40 minutes, and sessions 2 and 3 will be approximately 30 minutes each. Both interventions will be delivered face-to-face, by a doctoral-level psychology professional.

All participants will be taking AIs for breast cancer, will be experiencing some musculoskeletal pain since starting AIs (≥3 on a 10 point scale), and will be randomized to one of the two intervention groups. Study participants will be asked to complete measures of pain, AI adherence, and other behavioral and psychosocial measures over the course of 12-month period. The follow-up assessments will evaluate the clinical efficacy and cost-effectiveness of hypnosis versus professional attention.

Overall, this project is a critical step towards reducing the struggles of breast cancer survivors experiencing AI-related MSP, and associated non-adherence. By reducing MSP and improving AI adherence, the hypnosis intervention tested here has the potential to improve quality of life and well-being.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: March 18, 2021
• Est. primary completion date: March 18, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Neoplasms
• Musculoskeletal Pain

Intervention

Behavioral:
• Hypnosis
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.
• Attention Control
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.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	eCap measure	Adherence to aromatase inhibitors as measured by the eCap system. The eCap system is a medication event monitoring system that tracks medication usage without active patient input. eCaps record the date and time whenever the cap is opened to remove a pill.	12 months
Secondary	The Australian/Canadian Osteoarthritis Hand Index (AUSCAN)	AUSCAN is a self-report measure of musculoskeletal pain.	12 months
Secondary	The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	WOMAC is a self-report measure of musculoskeletal pain.	12 months
Secondary	The Breast Cancer Prevention Trial-Musculoskeletal Symptom (BCPT-MS)	BCPT-MS is a self-report measure of musculoskeletal pain.	12 months
Secondary	The Medication Adherence Report Scale (MARS)	MARS is a self-reported measure of AI adherence.	12 months
Secondary	The Healthcare Consumption, Illness and Work Questionnaire (Adapted TiC-P)	Adapted TiC-P is a self-report measure to calculate costs associated with AI-related musculoskeletal pain.	12 months