Breast CancerNCT06831838
A Randomized Controlled Trial (RCT) to Determine the Efficacy of a Multidisciplinary CBT Based Pain Management Program for the Treatment of Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS) in Breast Cancer Survivors
A study testing Cognitive Behavioral Therapy based Pain Management Program in people with Breast Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to evaluate the effectiveness of a multidisciplinary pain management program for AIMSS in reducing pain, subjective cognitive complaints, psychological distress, and impaired functional status resulting in improved adherence to Aromatase Inhibitor medications compared to usual care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Cognitive Behavioral Therapy based Pain Management Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old
- ECOG ≤ 2
- Stage 0-III HR+ breast cancer in need of strategies to reduce symptoms and improve quality of life
Who cannot join
- Less than 18 years of age.
- Stage 4 HR+ breast cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Alejandra Cuartas-Abril, M.S., 904-956-8885
Barbara K Bruce
About this study
The purpose of this research is to evaluate the effectiveness of a multidisciplinary pain management program for AIMSS in reducing pain, subjective cognitive complaints, psychological distress, and impaired functional status resulting in improved adherence to Aromatase Inhibitor medications compared to usual care. We want to identify predictors of improvement in pain, functional status, subjective cognition and mood following participation in the program.
- Conditions
- Breast Cancer
- Being tested
- Cognitive Behavioral Therapy based Pain Management Program
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy based Pain Management ProgramBehavioural
Subjects will participate in a two-day structured class that will focus on Cognitive-Behavioral skills and strategies to improve pain control, fatigue, sleep disturbance, cognitive symptoms, and stress while educating patients on the efficacy of Aromatase Inhibitors in prolonging cancer-free survival with the goal of eliminating non-adherence.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Subjects randomized to the treatment group will participate in a multicomponent pain treatment program in addition to standard of care treatment. Receives: Behavioral: Cognitive Behavioral Therapy based Pain Management Program |
| Control Group | No intervention | Subjects randomized to the control group will continue to receive standard of care treatment. At the end of the study, the control group participants will be offered the multicomponent pain treatment program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Aromatase Inhibitors (AIs)
Adherence to Aromatase Inhibitors (AIs) medications will be collected as a self-reported question asking the patients if they have taken their medications as prescribed during the past month (yes vs. no).
Measured: Baseline, 3 months, 6 months
AIMSS Follow-up Questionnaire
Subjects will complete the study follow-up questionnaire with study staff to indicate whether they are adhering to medications and to report symptoms.
Measured: Baseline, 3 months, 6 months
Secondary outcomes (8)
Brief Pain Inventory
The Brief Pain Inventory (BPI) allows participants to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function. Possible scores range from 0 to 10 with higher scores indicating a worse outcome/more severe pain and interference.
Measured: Baseline, 3 months, 6 months
Center for Epidemiologic Studies of Depression - Revised Questionnaire
The Center for Epidemiologic Studies Depression Scale-Revised (CESD-R) is a 20-item, self-reported questionnaire, that measures symptoms of depression. Each item is rated on a Likert scale, with 0 = 'Not at all or less than one day", and 3 = "Nearly every day for 2 weeks". Scores range from 0-60, with a score of 16 or higher indicating a risk of clinical depression.
Measured: Baseline, 3 months, 6 months
Pain Catastrophizing Scale
he Pain Catastrophizing Scale (PCS) is a 13-item self-report measure designed to assess catastrophic thinking related to pain. Items are rated on 5-point Likert scale, with 0 = "Not at all" and 4 = "All the time" Higher score indicates higher level of catastrophizing.
Measured: Baseline, 3 months, 6 months
Brief Resilience Scale
The Brief Resilience Scale is a 6 item, self-reported questionnaire, measuring how well a person recovers from stress. Each item is rated on a Likert scale, with 1 = "Strongly Disagree" and 5 = "Strongly Agree". The Brief Resilience Scale is scored by adding the value of all responses and dividing by 6. Higher scores indicate higher resilience to stress.
Measured: Baseline, 3 months, 6 months
Social Support Survey
The Social Support Survey is a 4 item, self-reported questionnaire, assessing the availability of support. Items are rated on a 4 point Likert scale, with 0 = "None of the time" and 4 = "All of the time". Higher scores indicate a greater level of support.
Measured: Baseline, 3 months, 6 months
World Health Organization (WHO) Disability Assessment Schedule
The WHO Disability Assessment Schedule is a 36-item, self-reported questionnaire, assessing health and disability. The questionnaire cover 6 domains: cognition, mobility, self-care, getting along, life activities, and participation. Each item is rated on a 5 point Likert scale, with 0 = "None" and 4 = "Extreme or Cannot do". Higher scores indicate greater disability.
Measured: Baseline, 3 months, 6 months
State-Trait Inventory
The State-Trait Inventory is a self-reported questionnaire, used to assess anxiety. Participants respond to 40 questions about how they are currently feeling on a scale of 1 "Not at all" to 4 "Very much so". Total possible scores range from 40 to 160. Higher scores indicate higher anxiety (a worse outcome) and lower scores indicate less anxiety (a better outcome).
Measured: Baseline, 3 months, 6 months
Cognitive Functioning Index (CFI)
The Cognitive Function Index (CFI) is a 14-item, self-reported questionnaire, used to assess cognitive status. Total scores range from 0-29, with higher scores indicating an increased perception about cognitive difficulties.
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start6 Feb 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara Bruce, Ph.D., LP, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831838
- Sponsor's protocol ID
- 24-011941
- Status last verified
- Jul 2026
- First submitted
- 11 Feb 2025
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial (RCT) to Determine the Efficacy of a Multidisciplinary CBT Based Pain Management Program for the Treatment of Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS) in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT06831838
- Acronym / sponsor ID
- 24-011941
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Feb 2025 (actual)
- 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 research is to evaluate the effectiveness of a multidisciplinary pain management program for AIMSS in reducing pain, subjective cognitive complaints, psychological distress, and impaired functional status resulting in improved adherence to Aromatase Inhibitor medications compared to usual care. We want to identify predictors of improvement in pain, functional status, subjective cognition and mood following participation in the program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Behavioral: Cognitive Behavioral Therapy based Pain Management ProgramSubjects randomized to the treatment group will participate in a multicomponent pain treatment program in addition to standard of care treatment. |
| Control Group | No intervention | –Subjects randomized to the control group will continue to receive standard of care treatment. At the end of the study, the control group participants will be offered the multicomponent pain treatment program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years old
- ECOG ≤ 2
- Stage 0-III HR+ breast cancer in need of strategies to reduce symptoms and improve quality of life
Key exclusion criteria (2 listed)
- Less than 18 years of age.
- Stage 4 HR+ breast cancer
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 |
|---|---|---|
| Cognitive Behavioral Therapy based Pain Management ProgramSubjects will participate in a two-day structured class that will focus on Cognitive-Behavioral skills and strategies to improve pain control, fatigue, sleep disturbance, cognitive symptoms, and stress while educating patients on the efficacy of Aromatase Inhibitors in prolonging cancer-free survival with the goal of eliminating non-adherence. | Behavioural | Treatment Group |
Primary outcome
Adherence to Aromatase Inhibitors (AIs)
Time frame: Baseline, 3 months, 6 months
Adherence to Aromatase Inhibitors (AIs) medications will be collected as a self-reported question asking the patients if they have taken their medications as prescribed during the past month (yes vs. no).
AIMSS Follow-up Questionnaire
Time frame: Baseline, 3 months, 6 months
Subjects will complete the study follow-up questionnaire with study staff to indicate whether they are adhering to medications and to report symptoms.
8 secondary outcomes
Brief Pain Inventory
Time frame: Baseline, 3 months, 6 months
Center for Epidemiologic Studies of Depression - Revised Questionnaire
Time frame: Baseline, 3 months, 6 months
Pain Catastrophizing Scale
Time frame: Baseline, 3 months, 6 months
Brief Resilience Scale
Time frame: Baseline, 3 months, 6 months
Social Support Survey
Time frame: Baseline, 3 months, 6 months
World Health Organization (WHO) Disability Assessment Schedule
Time frame: Baseline, 3 months, 6 months
State-Trait Inventory
Time frame: Baseline, 3 months, 6 months
Cognitive Functioning Index (CFI)
Time frame: Baseline, 3 months, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Barbara Bruce, Ph.D., LP principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy based Pain Management Program in people with Breast Cancer, run by Mayo Clinic 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 4 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alejandra Cuartas-Abril, M.S. (904-956-8885, Cuartas-Abril.Alejandra@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to Aromatase Inhibitors (AIs) (time frame: Baseline, 3 months, 6 months). The study lists 2 primary outcomes in all. 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 4 Aug 2026.