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

104 Participants Needed

Trial Summary

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 data supports the effectiveness of the REASSURE treatment 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 unnecessary visits and providing psychosocial support, which may be components of the REASSURE treatment. ^{1 2 3 4 5}

How is the REASSURE treatment for breast cancer follow-up care different from other treatments?

The REASSURE treatment is unique because it focuses on a structured follow-up care program that may include nurse-led telephone follow-ups and educational group programs, aiming to maintain quality of life without frequent hospital visits. This approach contrasts with traditional follow-up care, which often involves regular hospital visits and mammography. ^{1 6 7 8 9}

What is the purpose of this trial?

This study tests a novel intervention designed to optimize needed survivorship care for low-risk breast cancer survivors while reducing burdensome care with limited health benefits. This study examines whether the intervention, titled REASSURE, improves survivors' preparedness for survivorship. Up to 110 participants will be on study for up to 18 months.

Research Team

Heather Neuman

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Canada pubmed.ncbi.nlm.nih.gov

Follow-up after treatment for breast cancer. The Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer. [2005]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Follow-up care for breast cancer survivors: improving patient outcomes. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Breast cancer follow-up: from the perspective of health professionals and patients. [2015]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Follow-up tests to detect recurrent disease: patient's reassurance or medical need? [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Feasibility of tailored follow-up for patients with early breast cancer. [2014]

6. England pubmed.ncbi.nlm.nih.gov

Safety and cost-effectiveness of shortening hospital follow-up after breast cancer treatment. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Nurse-led telephone follow-up and an educational group programme after breast cancer treatment: results of a 2 × 2 randomised controlled trial. [2022]

8. Italy pubmed.ncbi.nlm.nih.gov

Recommendations for the follow-up care of female breast cancer survivors: a guideline of the Spanish Society of Medical Oncology (SEOM), Spanish Society of General Medicine (SEMERGEN), Spanish Society for Family and Community Medicine (SEMFYC), Spanish Society for General and Family Physicians (SEMG), Spanish Society of Obstetrics and Gynecology (SEGO), Spanish Society of Radiation Oncology (SEOR), Spanish Society of Senology and Breast Pathology (SESPM), and Spanish Society of Cardiology (SEC). [2018]

9. Scotland pubmed.ncbi.nlm.nih.gov

Supportive care needs of breast cancer survivors with different levels of fear of cancer recurrence: A cross-sectional survey study. [2023]