REASSURE Program for Breast Cancer Follow-Up Care

Overseen By Cancer Connect

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Chemotherapy, Pregnancy, Cognitive impairment, 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 tests a new program called REASSURE, designed to improve follow-up care for low-risk breast cancer survivors. It aims to ensure survivors feel more prepared for life after cancer treatment. The study compares this new approach with usual care to determine which is more effective. Suitable participants include those diagnosed with stage I breast cancer (an early-stage cancer) 6-24 months ago and willing to use email for study tasks. As an unphased trial, this study offers a unique opportunity to enhance follow-up care for breast cancer survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What prior data suggests that the REASSURE intervention is safe for breast cancer follow-up care?

Research has shown that the REASSURE program offers a new approach to support low-risk breast cancer survivors in their follow-up care. This program aims to simplify care and reduce stress for patients. Although specific safety data from past studies on this program is unavailable, the "Not Applicable" phase label typically indicates that it does not involve testing a drug or treatment with potential side effects. Instead, it likely involves a change in care delivery, which is generally considered safe. For concerns, discussing them with a doctor can provide more insight into what to expect. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the REASSURE Program because it offers a fresh approach to breast cancer follow-up care. Unlike the usual follow-up care, which typically involves regular physical exams and imaging, the REASSURE Program aims to provide a more personalized and supportive follow-up experience for patients. This program could improve patient satisfaction and overall well-being by incorporating tailored support and communication strategies. Researchers hope to find out if this approach enhances patient outcomes and quality of life compared to standard care practices.

What evidence suggests that the REASSURE intervention is effective for breast cancer follow-up care?

Research shows that follow-up care, such as the REASSURE program studied in this trial, can greatly benefit breast cancer survivors. Participants in this trial will receive either the REASSURE Follow-Up Care or Usual Follow-Up Care. Studies indicate that personalized follow-up programs, especially those led by nurses, help manage life after cancer by reducing unnecessary treatments and focusing on what matters most. Effective follow-up care includes clear summaries of treatment, advice on healthy eating and exercise, and information on side effects and signs of cancer recurrence. These programs aim to improve quality of life and detect any return of cancer early. Overall, well-organized follow-up care is essential for supporting breast cancer survivors over the long term. ^{1 6 7 8 9}

Who Is on the Research Team?

Heather Neuman

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for low-risk breast cancer survivors who were diagnosed with stage I, ER and/or PR positive, her2neu negative breast cancer in the past 6-24 months. Participants must be able to use email and read/write in English without cognitive impairments. Pregnant individuals or those who received chemotherapy for their diagnosis are excluded.

Inclusion Criteria

Willing to complete study procedures using email

I was diagnosed with early-stage, hormone-positive, HER2-negative breast cancer in the last 6-24 months.

Exclusion Criteria

I am not pregnant or will not become pregnant during the study.

I received chemotherapy for early-stage, HER2 negative breast cancer in the last 6-24 months.

My breast cancer is either triple-negative or HER2 positive, diagnosed within the last 5 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the REASSURE intervention, which includes a PRO assessment, follow-up visit recommendations, and survivorship messaging

18 months

Follow-up

Participants are monitored for quality of follow-up care, healthcare utilization, and survivorship experiences

18 months

What Are the Treatments Tested in This Trial?

Interventions

• REASSURE

Trial Overview The REASSURE intervention is being tested to see if it can improve preparedness for survivorship care among low-risk breast cancer survivors by optimizing necessary care while reducing unnecessary treatments. The study will involve 100 participants over an 18-month period.

How Is the Trial Designed?

Group I: REASSURE Follow Up care Experimental Treatment 1 Intervention

Group II: Usual Follow Up Care Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. withpower.com withpower.com/trial/phase-breast-cancer-10-2022-f6638

REASSURE Program for Breast Cancer Follow-Up Care The research suggests that follow-up care, including nurse-led and tailored follow-up programs, can be effective in managing breast cancer survivors by reducing ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4156000/

Follow-up care for breast cancer survivors: improving patient ... Preferred follow-up care elements included treatment summary, information on nutrition/exercise, expected side effects, signs and symptoms of recurrence, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11090970/

a 12-month electronic patient-reported outcomes follow-up ... The study reveals moderate adherence to 12-month ePROs follow-up assessments in invasive early breast cancer and DCIS patients, with response rates ranging ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0305737224001609

Follow-up of early breast cancer in a public health system Overall survival, detection of breast cancer (BC) recurrence, and quality of life (QoL) are critical parameters for assessing the effectiveness of surveillance ...

5. nature.com nature.com/articles/s41416-025-03059-5

Systematic review of clinical practice guidelines for long- ... While hormone receptor-positive (HR+) breast cancer can recur decades after diagnosis, HR-negative tumours have a very low recurrence rate ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05047575

Study Details | Remote Electronic Assessment of Survivors ... This study tests a novel, risk-stratified approach for low risk breast cancer survivor follow-up care that reduces burden for survivors and their ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5063767/

Follow-up after treatment for breast cancer To offer FPs a summary of evidence-based recommendations to guide their follow-up survivorship care of women treated for breast cancer.

8. ascopubs.org ascopubs.org/doi/10.1200/EDBK_432564

Enhancing Early-Stage Breast Cancer Survivorship Park et al found that 90% of second breast cancers were detected with a 2-year surveillance interval and DeBruhl et al found no contralateral ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0305737222001037

Rethinking breast cancer follow-up based on individual risk ... Data from the Surveillance, Epidemiology, and End Results Program (SEER) program shows that the 5-year relative survival rate is 90.4% for luminal, 83.6 ...