35 Participants Needed

Culturally Aware Support for Hormone Therapy in Breast Cancer Survivors

Recruiting at 10 trial locations
JM
Overseen ByJamie M Jacobs, PhD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
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 information does not specify whether you need to stop taking your current medications. It focuses on supporting those who are hesitant to start hormonal therapy for breast cancer.

What data supports the effectiveness of the Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention treatment?

Research suggests that factors like education, strong personal reasons for using the therapy, preparation for side effects, and good communication with healthcare providers can support adherence to hormone therapy in breast cancer survivors. These elements are important for improving the use of hormone therapy, especially in diverse populations.12345

How is the culturally aware support for hormone therapy in breast cancer survivors different from other treatments?

This treatment is unique because it focuses on providing culturally tailored support to improve adherence to hormone therapy in breast cancer survivors, using a personalized smartphone app and patient navigator to enhance communication and self-management, which is not typically part of standard care.14567

What is the purpose of this trial?

The purpose of this study is to examine the feasibility and acceptability of a brief, nurse-led intervention to support breast cancer survivors who have delayed initiation of hormonal therapy or who have concerns about starting hormonal therapy.

Research Team

JM

Jamie M Jacobs, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for female breast cancer survivors, aged 21 or older, with early-stage hormone receptor-positive breast cancer. They must be recommended to start AET but have either delayed it or are hesitant to begin treatment. Participants should be able to communicate in English or Spanish and have a stable physical condition (ECOG ≤ 2). Women from minority communities are especially encouraged to join.

Inclusion Criteria

I am female.
At least 10 participants should be from a racial or ethnic minority group based on their own reporting.
I am recommended to start or have hesitations about starting hormone therapy for my cancer.
See 4 more

Exclusion Criteria

I do not have cognitive issues that prevent me from joining the study.
You are currently receiving treatment for another type of cancer.
You are currently in another clinical trial that involves AET.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants receive two individual sessions with a nurse practitioner to encourage initiation of adjuvant endocrine therapy

12 weeks
2 sessions (in-person or via telephone)

Follow-up

Participants complete follow-up questionnaires to assess program feasibility and acceptability

12 weeks
3 questionnaires (at enrollment, 1-month, and 3-months post-baseline)

Treatment Details

Interventions

  • Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention
Trial Overview The study is testing a nurse-led intervention designed to help women who are reluctant or have postponed starting their prescribed hormonal therapy after surviving breast cancer. The focus is on the cultural awareness aspect of the intervention's effectiveness and its overall acceptability among patients.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation InterventionExperimental Treatment1 Intervention
Participants will have two (2), 60 minute, individual sessions with a nurse practitioner via videoconferencing (in person or via telephone) and complete three (3) questionnaires at the time of enrollment, 1-month post-baseline, and 3-months post-baseline.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Findings from Research

A qualitative study involving 23 women who continued adjuvant endocrine therapy (AET) and 15 who discontinued, along with 9 healthcare providers, identified key factors that support AET adherence, including preparedness for side effects, strong personal rationale for treatment, and supportive healthcare provider relationships.
Women who discontinued AET often felt overwhelmed by side effects and lacked sufficient information, highlighting the need for better communication and resources to manage side effects and improve adherence to AET.
Both "Vitamin L for Life" and "One Milligram of Satan": A Multi-Perspective Qualitative Exploration of Adjuvant Endocrine Therapy Use after Breast Cancer.Toivonen, KI., Oberoi, D., King-Shier, K., et al.[2021]
In a study of 3382 women with hormone receptor-positive breast cancer, those with low personal or clinical social support were more likely to not start or adhere to adjuvant endocrine therapy (AET), highlighting the importance of social support in treatment compliance.
Women with moderate or low personal social support had a significantly higher risk of discontinuing AET or being non-adherent, suggesting that healthcare teams should address these support gaps to improve treatment outcomes.
Personal and clinical social support and adherence to adjuvant endocrine therapy among hormone receptor-positive breast cancer patients in an integrated health care system.Kroenke, CH., Hershman, DL., Gomez, SL., et al.[2019]
Adjuvant endocrine hormonal therapy (EHT) is crucial for nearly all breast cancer patients with hormone receptor-positive tumors, significantly reducing recurrence rates and the risk of death, yet about 33% of patients do not adhere to their prescribed medication.
This study aims to improve adherence to EHT through a bilingual, culturally tailored smartphone app and support from a patient navigator, with the goal of enhancing patient education, self-management, and ultimately improving survival and quality of life for breast cancer patients.
Improving adherence to endocrine hormonal therapy among breast cancer patients: Study protocol for a randomized controlled trial.Chalela, P., Munoz, E., Inupakutika, D., et al.[2020]

References

Both "Vitamin L for Life" and "One Milligram of Satan": A Multi-Perspective Qualitative Exploration of Adjuvant Endocrine Therapy Use after Breast Cancer. [2021]
Racial/Ethnic and socioeconomic disparities in endocrine therapy adherence in breast cancer: a systematic review. [2021]
Personal and clinical social support and adherence to adjuvant endocrine therapy among hormone receptor-positive breast cancer patients in an integrated health care system. [2019]
Initiation of Adjuvant Endocrine Therapy in Black and White Women With Breast Cancer. [2022]
Behavioral Interventions to Enhance Adherence to Hormone Therapy in Breast Cancer Survivors: A Systematic Literature Review. [2022]
Improving adherence to endocrine hormonal therapy among breast cancer patients: Study protocol for a randomized controlled trial. [2020]
Increasing Adherence to Adjuvant Hormone Therapy Among Patients With Breast Cancer: A Smart Phone App-Based Pilot Study. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security