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NCT06106282 | RECRUITING | Anatomic Stage 0 Breast Cancer AJCC v8

Breast Cancer Survivors Who Experience Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)
Sponsor:

Mayo Clinic

Brief Summary:

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).

Condition or disease

Anatomic Stage 0 Breast Cancer AJCC v8

Anatomic Stage I Breast Cancer AJCC v8

Anatomic Stage II Breast Cancer Ajc V8

Anatomic Stage III Breast Cancer AJCC v8

Hormone Receptor-Positive Breast Carcinoma

Intervention/treatment

Non-Interventional Study

Detailed Description:

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 500 participants
Official Title : Breast Cancer Survivors Who Experience Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS): A Multidisciplinary Pain Program Designed to Decrease Pain and Improve Functioning, Mood, and Medication Adherence.
Actual Study Start Date : 2023-07-12
Estimated Primary Completion Date : 2028-07-12
Estimated Study Completion Date : 2028-07-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Patients are 18 years old or more.
  • * A breast cancer survivor ECOG =\< 2, stage 0-III HR+ who is experiencing musculoskeletal symptoms associated with aromatase inhibitors intake
  • * Patients must be at least 6 months on aromatase inhibitors and for no more than 7 years
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.
  • * Asymptomatic patients
  • * Patients less than 18 years old
  • * Patient that are not being followed as a Mayo Clinic patient
  • * Patients with stage IV breast carcinoma
  • * Patients that are HR -
  • * Patients that are ECOG 3 or more
Breast Cancer Survivors Who Experience Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)

Location Details

NCT06106282

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Florida

Mayo Clinic in Florida

Jacksonville, Florida, United States, 32224-9980