Adherence Intervention for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method to help women in Rwanda adhere to their breast cancer medication plan. It targets those with ER-positive breast cancer, which responds to hormone therapy. Participants will either receive additional support, such as educational videos and text reminders, or continue with standard care. This approach is part of the AET Pilot Intervention. Women who have been on hormone therapy for 6 to 36 months and can receive text messages are suitable candidates. The goal is to determine if these additional supports improve treatment adherence. As an unphased trial, this study allows participants to contribute to innovative strategies that may enhance treatment adherence and improve outcomes for future patients.
Do I need to stop my current medications for this trial?
The trial does not specify if you need to stop taking your current medications. However, since the study focuses on improving adherence to adjuvant endocrine therapy (AET), you will likely need to continue taking your AET medication.
What prior data suggests that this intervention is safe for improving adherence to AET?
A previous study tested a multi-part program to help women continue hormone therapy for breast cancer. This program included tools like text messages and symptom tracking cards. The research found the program to be generally safe and well-received by participants. Most women reported that the support tools were helpful and encouraged them to maintain their treatment.
Another review examined various programs designed to aid adherence to hormone therapy. While it primarily focused on program effectiveness, the review identified no major safety issues. Overall, participants tolerated the programs well.
These findings suggest that the treatment is likely safe for use in similar programs. However, individual experiences may vary, so discussing any concerns with the research team before joining a trial is important.12345Why are researchers excited about this trial?
Researchers are excited about the Adherence Intervention for Breast Cancer because it offers a fresh approach to improving medication adherence among patients. Unlike standard treatments that typically focus on the medication itself, this intervention emphasizes support through a light-touch, multi-modal package. Key features include a one-time educational video, a symptom monitoring card, and weekly text message reminders, all designed to help patients stick to their treatment plan. By addressing adherence in an engaging and supportive way, this intervention has the potential to enhance the effectiveness of existing breast cancer treatments.
What evidence suggests that this intervention is effective for improving adherence to AET in breast cancer patients?
Research has shown that adjuvant endocrine therapy (AET) is crucial for reducing the risk of breast cancer recurrence in patients with hormone receptor-positive breast cancers. This trial will evaluate an adherence intervention for AET. Participants in the intervention arm will receive a light-touch, multi-modal medication adherence support package, including a one-time educational video, a symptom monitoring card, and weekly one-way text message reminders. Studies have found that supporting patients in adhering to their AET treatment can significantly impact outcomes. For instance, a review of over 375,000 breast cancer survivors found that support methods like educational videos and text reminders improved adherence to treatment plans. Another study demonstrated that using various support types to address different challenges in taking AET enhanced patient adherence. Overall, these findings suggest that structured support can significantly aid patients in consistently taking their AET medication.12346
Who Is on the Research Team?
Temidayo Fadelu, MD
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
This trial is for women aged 18 or older in Rwanda with ER-positive breast cancer, who are within 6-36 months of starting hormone therapy (AET), have disease limited to the breast and nearby lymph nodes, can receive text messages, and are being treated at Butaro or its satellite clinics.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants receive a multi-modal medication adherence support package, including an educational video, a symptom monitoring card, and weekly text message reminders
Follow-up
Participants are monitored for adherence and quality of life using questionnaires and assessments
What Are the Treatments Tested in This Trial?
Interventions
- AET Pilot Intervention
Trial Overview
The study tests a combination of text reminders, an educational video, and a symptom monitoring card to help patients stick to their prescribed hormone therapy. The goal is to see if these tools improve medication adherence.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants randomized to the intervention arm will receive a light-touch, multi-modal medication adherence support package, including a one-time educational video, a symptom monitoring card, and weekly one-way text message reminders.
Participants will receive standard care.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dana-Farber Cancer Institute
Lead Sponsor
Citations
Study Details | NCT07562399 | AET Pilot Intervention
This study aims to evaluate a multi-modal intervention designed to improve adherence to adjuvant endocrine therapy (AET) among patients with ER- ...
A Systematic Review and Meta-Analysis of Interventions to ...
This systematic review includes adherence data from 375,951 breast cancer survivors prescribed AET across 33 studies. Thirty-four records are represented in ...
findings from the ROSETA pilot fractional factorial randomized ...
In this pilot trial of a multicomponent intervention to support AET adherence in women with breast cancer, predefined criteria were met to ...
Supporting endocrine therapy adherence in women with ...
We developed an intervention with 4 components to target key barriers to taking AET: text messages, information leaflet, guided self-help, and side effect self ...
A Systematic Review and Meta-Analysis of Interventions to ...
This systematic review includes adherence data from 375,951 breast cancer survivors prescribed AET across 33 studies. Thirty-four records are ...
6.
physiciansweekly.com
physiciansweekly.com/post/a-systematic-review-of-interventions-to-improve-aet-adherence-in-breast-cancer-survivorsA Systematic Review of Interventions to Improve AET ...
The study represented the first meta-analysis demonstrating a significant effect of interventions to promote AET adherence among breast cancer ...
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