Apply to Trial

Compensation: Varies

Number of Visits: Unknown

225 Participants Needed

Symptom Monitoring for Breast Cancer
(SyMPTOM Trial)

Recruiting at 2 trial locations

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Must be taking: Endocrine therapy

Disqualifiers: Metastatic disease, Pregnancy, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require you to continue taking your endocrine therapy medications.

What data supports the effectiveness of pharmacist-delivered symptom monitoring and management for breast cancer?

Research shows that pharmacists successfully monitor patients on oral cancer treatments, improving outcomes. Additionally, pharmacist interventions in outpatient cancer care have been effective in enhancing patient understanding and quality of life.¹ ² ³ ⁴ ⁵

Is pharmacist-delivered symptom monitoring and management safe for humans?

Research shows that pharmacist-delivered symptom monitoring and management is generally safe and well-received by patients undergoing cancer treatment. Patients reported high satisfaction and improved understanding of their medication and side-effect management, indicating that this approach is beneficial and safe in a clinical setting.¹ ² ⁵ ⁶ ⁷

How does pharmacist-delivered symptom monitoring and management differ from other breast cancer treatments?

This treatment is unique because it involves pharmacists actively monitoring and managing symptoms for breast cancer patients, which can improve medication adherence and patient outcomes. Unlike traditional treatments that focus solely on medication, this approach integrates pharmacists into the care team to provide ongoing support and symptom management.² ⁷ ⁸ ⁹ ¹⁰

What is the purpose of this trial?

This is an intervention targeting patients at risk for non-adherence to endocrine therapy after primary treatments for hormone-positive breast cancer. In a randomized study, the study team will collect patient-reported symptoms monthly from participants through surveys. Pharmacists who specialize in cancer at the patients' hospital will give patients recommendations to help improve their symptoms and address other barriers so they can continue daily endocrine therapy medications.

Eligibility Criteria

This trial is for individuals with hormone-positive breast cancer who have completed primary treatments and are currently on endocrine therapy. Participants must be at risk of not sticking to their medication regimen. The study excludes those who don't meet the inclusion criteria set by the researchers.

Inclusion Criteria

I am advised to continue hormone therapy for 2 more years.

Ability to understand informed consent and the willingness to sign it

I have filled my prescriptions less than 80% of the time in the last 2 years.

See 4 more

Exclusion Criteria

I can understand and make decisions about the study.

Pregnant or trying to get pregnant

My cancer treatment was stopped by my doctor.

See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Symptom Monitoring and Management

Participants report symptoms monthly and receive pharmacist-led management based on patient-reported outcomes

12 months

Monthly visits (virtual or in-person)

Usual Care

Participants receive usual care with follow-up every six months

12 months

Biannual visits (in-person)

Follow-up

Participants are monitored for adherence durability and symptom management effectiveness

12 months

Treatment Details

Interventions

Pharmacist delivered symptom monitoring and management

Trial Overview The trial tests a pharmacist-led symptom monitoring program where patients report symptoms monthly via surveys. Pharmacists then provide personalized advice to manage these symptoms, aiming to help participants adhere to daily endocrine therapy medications.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Usual Care first, Then Symptom Monitoring and ManagementExperimental Treatment1 Intervention

Patients first receive care as usual which includes follow-up with their oncology team first 12 months of the study. Following data collection at 12 months they will then receive symptom monitoring and management for the second 12 months of the study.

Group II: Symptom Monitoring and Management first, Then Usual CareExperimental Treatment1 Intervention

Patients first receive symptom monitoring and management for the first 12 months of the study. After data collection at 12 months they will then receive care as usual which includes follow-up with their oncology for the second 12 months of the study.