Program to help breast cancer survivors with pain from treatment
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.
This study is testing a special program to help breast cancer survivors manage pain and improve their mood and daily activities after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT06106282 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates a cognitive behavioral multicomponent treatment program aimed at improving pain, mood, and functioning in breast cancer survivors experiencing Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS). Participants will attend a 2-day treatment program and complete questionnaires, while their medical records will be reviewed to assess the program's effectiveness. The study also aims to identify predictors of improvement in pain and functional status following participation in the program.
Who should consider this trial
Good fit: Ideal candidates are breast cancer survivors aged 18 or older, who are hormone receptor-positive and have been on aromatase inhibitors for at least 6 months but no more than 7 years.
Not a fit: Patients who are asymptomatic, not on aromatase inhibitors, or have stage IV breast carcinoma will not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly enhance the quality of life for breast cancer survivors by alleviating pain and improving medication adherence.
How similar studies have performed: Other studies have shown promise in using multidisciplinary approaches for managing treatment-related symptoms in cancer survivors, suggesting potential success for this program.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Jacksonville, Florida
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Barbara K. Bruce, Ph.D., L.P. — Mayo Clinic
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.