Breast NeoplasmsNCT02657993
Hypnosis to Reduce Aromatase Inhibitor Pain and Improve Adherence
A study testing Hypnosis in people with Breast Neoplasms and Musculoskeletal Pain, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Musculoskeletal Pain
- What is being tested?
- Hypnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 191 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 18 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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).
Who cannot join
- 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.
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Hypnosis to Reduce Aromatase Inhibitor (AI) Associated Musculoskeletal Pain and to Improve AI Adherence: An RCT to Explore Efficacy and Cost Effects
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.
Read the detailed 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.
- Conditions
- Breast Neoplasms, Musculoskeletal Pain
- Being tested
- Hypnosis, Attention Control
- Keywords
- Breast Neoplasms, Aromatase Inhibitors, Musculoskeletal Pain, Hypnosis, Medication Adherence, Cost-Benefit Analysis, Treatment Outcomes
- Medical subject headings
- Breast Neoplasms, Musculoskeletal Pain, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosisBehavioural
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 ControlBehavioural
Also called Non-Hypnosis
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.
| Study group | Role | What they receive |
|---|---|---|
| Hypnosis | Experimental | The hypnosis intervention involves three, face-to-face, hypnosis sessions delivered by doctoral-level psychology professionals Receives: 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. Receives: Behavioral: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (6)
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.
Measured: 12 months
The Australian/Canadian Osteoarthritis Hand Index (AUSCAN)
AUSCAN is a self-report measure of musculoskeletal pain.
Measured: 12 months
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
WOMAC is a self-report measure of musculoskeletal pain.
Measured: 12 months
The Breast Cancer Prevention Trial-Musculoskeletal Symptom (BCPT-MS)
BCPT-MS is a self-report measure of musculoskeletal pain.
Measured: 12 months
The Medication Adherence Report Scale (MARS)
MARS is a self-reported measure of AI adherence.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2016 (estimated)
- Study startMar 2016
- Primary completion18 Mar 2021
- Study completion18 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Guy Montgomery, Icahn School of Medicine at Mount Sinai
- Investigators
- Guy H Montgomery, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657993
- Sponsor's protocol ID
- GCO 14-1344
- Other IDs
- R01AT008762-01
- Status last verified
- Jun 2021
- First submitted
- 14 Jan 2016
- Last updated
- 22 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypnosis to Reduce Aromatase Inhibitor (AI) Associated Musculoskeletal Pain and to Improve AI Adherence: An RCT to Explore Efficacy and Cost Effects
- ClinicalTrials.gov ID
- NCT02657993
- Acronym / sponsor ID
- GCO 14-1344
- Conditions
- Breast Neoplasms, Musculoskeletal Pain
- Keywords
- Breast Neoplasms, Aromatase Inhibitors, Musculoskeletal Pain, Hypnosis, Medication Adherence, Cost-Benefit Analysis, Treatment Outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Mar 2016
- Primary completion
- 18 Mar 2021 (actual)
- Study completion
- 18 Mar 2021 (actual)
- First posted
- 18 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypnosis | Experimental | Behavioral: HypnosisThe hypnosis intervention involves three, face-to-face, hypnosis sessions delivered by doctoral-level psychology professionals |
| Attention Control (Non-Hypnosis) | Active comparator | Behavioral: Attention ControlThe attention control intervention is matched to the hypnosis intervention in terms of the amount of professional time received by patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HypnosisThe 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. | Behavioural | Hypnosis |
| Attention ControlAlso: Non-HypnosisThe 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. | Behavioural | Attention Control (Non-Hypnosis) |
Primary outcome
Patient-reported musculoskeletal pain (MSP) as measured by the Brief Pain Inventory-Short Form (BPI-SF)
Time frame: 12 months
The Brief Pain Inventory-Short Form (BPI-SF) is a self-report questionnaire assessing pain.
6 secondary outcomes
eCap measure
Time frame: 12 months
The Australian/Canadian Osteoarthritis Hand Index (AUSCAN)
Time frame: 12 months
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 12 months
The Breast Cancer Prevention Trial-Musculoskeletal Symptom (BCPT-MS)
Time frame: 12 months
The Medication Adherence Report Scale (MARS)
Time frame: 12 months
The Healthcare Consumption, Illness and Work Questionnaire (Adapted TiC-P)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guy H Montgomery, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis in people with Breast Neoplasms and Musculoskeletal Pain, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported musculoskeletal pain (MSP) as measured by the Brief Pain Inventory-Short Form (BPI-SF) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2021.