Symptom Monitoring for Breast Cancer

(SyMPTOM Trial)

Enrolling by invitation 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 Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help women with hormone-positive breast cancer adhere to their hormone therapy. Participants will report symptoms monthly, and specialist pharmacists will provide advice to manage these symptoms and any medication-related issues. The trial consists of two parts: one group will begin with their usual care and then switch to pharmacist-delivered symptom monitoring and management, while the other group will follow the opposite sequence. The trial seeks women with stage 1-3 hormone receptor-positive breast cancer who have been on hormone therapy and are at risk of non-adherence. Participants should be fluent in English or Spanish and able to understand and consent to participate in the study. As an unphased trial, this study offers participants the chance to contribute to innovative research aimed at improving adherence to hormone therapy.

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 prior data suggests that this symptom monitoring and management protocol is safe?

Research has shown that pharmacist involvement in monitoring and managing symptoms is generally safe and appreciated by patients receiving cancer treatment. Studies have found that these services can reduce symptoms and offer better support for patients. One study found that even when provided remotely, these services effectively reduce the risk of serious medication side effects. This approach to treatment is promising and well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to managing breast cancer symptoms through pharmacist-delivered monitoring and management. Unlike the standard care that typically involves follow-ups with oncology teams, this method emphasizes consistent symptom tracking and proactive management by pharmacists. This could lead to more personalized and timely interventions, potentially improving patients' quality of life. By comparing this approach to usual care, researchers hope to find out if this enhanced monitoring can offer better outcomes in managing symptoms over time.

What evidence suggests that pharmacist delivered symptom monitoring and management is effective for improving adherence to endocrine therapy in breast cancer patients?

This trial will compare two approaches: one where patients receive usual care first, followed by pharmacist-delivered symptom monitoring and management, and another where patients receive symptom monitoring and management first, followed by usual care. Research has shown that pharmacist involvement in symptom monitoring and management can improve breast cancer treatment outcomes. In one study, patients with pharmacist support reported better symptom control and felt more supported. Another study found that pharmacist interventions reduced symptoms and helped patients adhere to their cancer treatments more easily. Patients generally find this approach safe and helpful. Overall, pharmacist involvement significantly improves symptom management and treatment adherence. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Usual Care first, Then Symptom Monitoring and Management Experimental Treatment 1 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 Care Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11352950/

Clinical Pharmacist-Led Interventions for Improving Breast ... This study aims to evaluate the impact of pharmacist-led interventions on breast cancer management and health outcomes.

2. withpower.com withpower.com/trial/symptom-monitoring-for-breast-cancer-0de6a

Symptom Monitoring for Breast Cancer · Info for Participants Research shows that pharmacist-delivered symptom monitoring and management is generally safe and well-received by patients undergoing cancer treatment. Patients ...

3. japha.org japha.org/article/S1544-3191(22)00073-5/abstract

Feasibility of a pharmacist-led symptom monitoring and ... An intervention using pharmacists in an oncology practice to systematically monitor and manage symptoms shows promise to reduce symptoms, enhance support and ...

4. ascopubs.org ascopubs.org/doi/10.1200/OP.24.00050

Electronic Patient-Reported Outcome-Driven Symptom ... We developed and implemented an electronic patient-reported outcome (ePRO)–driven symptom management tool led by oncology pharmacists in a majority-minority ...

5. mdpi.com mdpi.com/2226-4787/13/4/97

The Role of Pharmacists in Delivering Pharmaceutical ... This study aims to summarize and explore the provision and utilization of pharmaceutical services for breast cancer patients by pharmacists.

6. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2025.1640727/full

Pharmacist-led remote follow-up service for non-metastatic ... Conclusion: Remote pharmaceutical services delivered via a follow-up app effectively reduce the incidence of severe adverse drug reactions and ...