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Trial Title:
Breast Cancer Survivors Who Experience Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)
NCT ID:
NCT06106282
Condition:
Anatomic Stage 0 Breast Cancer AJCC v8
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Hormone Receptor-Positive Breast Carcinoma
Conditions: Official terms:
Breast Neoplasms
Breast Carcinoma In Situ
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Non-Interventional Study
Description:
Non-Interventional Study
Arm group label:
Observational
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).
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.
Criteria for eligibility:
Study pop:
Patients with stage 0-III HR+ breast cancer and AIMSS (Aromatase Inhibitor Associated
Musculoskeletal Symptoms) at Mayo Clinic.
Sampling method:
Non-Probability Sample
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Florida
Address:
City:
Jacksonville
Zip:
32224-9980
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Barbara K. Bruce, Ph.D., L.P.
Email:
Principal Investigator
Start date:
July 12, 2023
Completion date:
July 12, 2028
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06106282
https://www.mayo.edu/research/clinical-trials
