Culturally Aware Support for Hormone Therapy in Breast Cancer Survivors

No longer recruiting at 11 trial locations

Overseen By Jamie M Jacobs, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Uncontrolled psychosis, Suicidal ideation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a nurse-led support program designed to assist breast cancer survivors hesitant to start hormone therapy. The program includes two one-hour sessions with a nurse practitioner, conducted online or by phone, to address concerns and enhance comfort with the treatment. Women with early-stage breast cancer who have been recommended hormone therapy but have not started it, and who feel hesitant about beginning it, may be suitable candidates. The study particularly seeks participants from racial or ethnic minority communities. As an unphased trial, it offers a unique opportunity for participants to receive personalized support and contribute to research that may benefit others in similar situations.

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 prior data suggests that this intervention is safe for breast cancer survivors?

Research has shown that adjuvant endocrine therapy (AET) can significantly aid breast cancer survivors by reducing the chance of cancer recurrence by 40% and lowering the risk of death by 30%. This makes AET a highly effective treatment option. However, starting and continuing AET can be challenging for some, particularly those from minority communities. The Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention assists in these cases.

The intervention supports patients with concerns about beginning this therapy. Although specific safety data for this cultural intervention is unavailable, it aims to promote the safe start of AET through personalized support in nurse-led sessions. This approach focuses on making the experience more comfortable for those considering AET, without introducing new medications or medical risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention because it offers a personalized approach to hormone therapy support for breast cancer survivors. Unlike traditional hormone therapies that focus solely on the medical aspects, this intervention incorporates cultural awareness, which can help address personal and cultural barriers to starting and sticking with treatment. By providing individualized support through videoconferencing with nurse practitioners, this method aims to improve patient engagement and outcomes, making it a promising complement to existing endocrine therapies like tamoxifen or aromatase inhibitors.

What evidence suggests that this intervention is effective for supporting breast cancer survivors with hormone therapy concerns?

Research has shown that many breast cancer survivors, particularly those from racial or ethnic minority groups, face difficulties in starting hormone therapy. This treatment is crucial because it reduces the chance of cancer returning. Studies have found that failing to start this therapy can lead to worse health outcomes. The culturally aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention, provided to participants in this trial, aims to offer personalized support. This approach has shown promise in helping more people begin and continue their therapy, which is vital for better health. Early results suggest that this support can assist more survivors in starting and adhering to their hormone therapy. ^{2 4 6 7 8}

Who Is on the Research Team?

Jamie M Jacobs, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

A text-based intervention using daily reminders and interactive surveys significantly improved medication adherence among post-menopausal breast cancer survivors, with 69.2% of participants completing the study requirements.

The intervention not only enhanced self-reported adherence but also led to measurable decreases in hormone levels, confirming the effectiveness of the treatment, while participants and physicians found the intervention beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing Adherence to Adjuvant Hormone Therapy Among Patients With Breast Cancer: A Smart Phone App-Based Pilot Study. Krok-Schoen, JL., Naughton, MJ., Young, GS., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1462388925002340

Development and Refinement of a Nurse-Led, Culturally ... Patients from racial or ethnic minority communities are less likely to initiate AET and are at greater risk for poor breast cancer outcomes.

2. withpower.com withpower.com/trial/phase-compliance-treatment-11-2022-baad8

Culturally Aware Support for Hormone Therapy in Breast ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10553065/

A Systematic Review and Meta-Analysis of Interventions to ... Adjuvant endocrine therapy (AET) adherence among breast cancer survivors is often suboptimal, leading to higher cancer recurrence and mortality.

4. formative.jmir.org formative.jmir.org/2021/6/e23884/

Perceptions of Endocrine Therapy in African-American Breast ... We recruited 20 African-American women diagnosed with estrogen-positive breast cancer and currently prescribed endocrine therapy.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5499377/

Racial disparities in initiation of adjuvant endocrine therapy ... We used multivariate Poisson regression to examine the effect of race on likelihood of initiating ET. 14 % of women did not initiate ET within 12 months of ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05465408?cond=breast+cancer&aggFilters=status%3A

Culturally Aware AET Non-Initiation Intervention A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8191495/

Initiation and adherence to adjuvant endocrine therapy among ... AET markedly reduces the risks of breast cancer recurrence (by 40%) and mortality (by 30%) among HR+ breast cancers. Despite its striking efficacy, previous ...

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/ecc.13722

Adherence to adjuvant endocrine therapy among White ... This study compared AET adherences rates in White British women and women from minority ethnic groups in the United Kingdom.