An observational study in Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-31.
Sponsored by Mayo Clinic · Observational
This study evaluates the effectiveness of a cognitive behavioral multicomponent treatment program in improving pain, mood, and functioning while reducing medication non-adherence in breast cancer patients with Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS).
PRIMARY OBJECTIVES:
I. To evaluate the effectiveness of a Multidisciplinary Pain Program for AIMSS, specifically determine the impact of the program on level of pain, functional status, and adherence to prescribed medication.
II. To identify predictors of improvement in pain, functional status, and mood following participation in the program.
OUTLINE: This is an observational study.
Patients attend a 2-day treatment program and complete questionnaires on study. Patients also have their medical records reviewed on study.
142 studies on the registry are indexed under Breast Carcinoma In Situ; 26 are open to participants now.
This study's enrollment of 105 is below the median of 214 across 26 observational studies indexed under Breast Carcinoma In Situ.
Browse Breast Carcinoma In Situ studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with stage 0-III HR+ breast cancer and AIMSS (Aromatase Inhibitor Associated Musculoskeletal Symptoms) at Mayo Clinic.
Patients are 18 years old or more.
Exclusion Criteria:
Breast cancer survivor patients that are not in aromatase inhibitor treatment or have less than 6 months of treatment or more than 7 years of treatment.
Patient that are not being followed as a Mayo Clinic patient
Patients attend a 2-day treatment program and complete questionnaires on study. Patients also have their medical records reviewed on study.
Other: Non-Interventional Study
Non-Interventional Study
Adherence to Aromatase Inhibitor (AI) treatment regimen
Adherence to AI treatment regimen will be recorded based on self-report. Patient self-report will categorize each subject as adherent or non-adherent to AI medication. Baseline and follow-up data from each timepoint will be compared to evaluate treatment impact on outcomes.
Time frame: Baseline; up to 12 months post-treatment
Functional impairment (quality of life)
Functional impairment (quality of life) will be assessed using the Symptom Impact Questionnaire (SIQR), which has three domains: Function, Overall and Symptoms. Domain 1 (Function) consists of 9 questions answered on a scale where respondent choose a box between "No difficulty" and "Very difficult." Domain 2 (Overall) consists of 2 questions answered on a scale where respondent choose a box between "Never" and "Always." Domain 3 (Symptoms) consists of 10 questions answered on a scale where respondents choose a box between two extremes (e.g., No pain/Unbearable pain or Awoke rested/Awoke very tired). Baseline and follow-up data from each timepoint will be compared to evaluate treatment impact on outcomes.
Time frame: Baseline; up to 12 months post-treatment
Fatigue
Fatigue will be measured using the Brief Fatigue Inventory (BFI) from MD Anderson. The BFI is a nine-question scale in which respondents rate each item on a 0-10 numeric scale, with 0 meaning "no fatigue" and 10 meaning "fatigue as bad as you can imagine." Baseline and follow-up data from each timepoint will be compared to evaluate treatment impact on outcomes.
Time frame: Baseline; up to 12 months post-treatment
Level of pain
Level of pain will be assesses using the Pain Catastrophizing Scale (PCS). The PCS is a 13-item self-report questionnaire answered using a 5-point Likert scale ranging from 0 (never) to 4 (always). The final score is categorized as rumination, magnification, or helplessness.Baseline and follow-up data from each timepoint will be compared to evaluate treatment impact on outcomes.
Time frame: Baseline; up to 12 months post-treatment
Mood
Mood/depression will be assessed using the Center for Epidemiologic Studies Depression Scale Revised (CES-D-R). The CES-D-R is a 20-question survey with 4 available answers for each question: Rarely or none of the time (less than 1 day); Some or a little of the time (1-2 days); Occasionally or a moderate amount of time (3-4 days); or Most or all of the time (5-7 days). Baseline and follow-up data from each timepoint will be compared to evaluate treatment impact on outcomes.
Time frame: Baseline; up to 12 months post-treatment
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Mayo Clinic