Adjuvant endocrine therapy (AET; e.g., tamoxifen, anastrozole, letrozole) is prescribed to patients with hormone sensitive breast cancer for five-to-10-year courses of treatment because it reduces recurrence and mortality by 50% and 29%, respectively. Per self-reported and objective adherence measures, non-initiation rates range from 12%-19% to 30%, respectively. Patients from diverse racial and ethnic backgrounds are more apprehensive about initiating treatment, with Black and Hispanic/Latina breast cancer survivors being less likely to initiate AET than non-Hispanic Whites despite facing a 1.4-2.4 fold greater risk of breast cancer specific mortality. Although adherence to AET can be attributed to modifiable factors–(1) low perceived social support and poor communication with clinicians, (2) negative beliefs about treatment efficacy, and (3) fear of menopause-like toxicities–interventions targeting AET initiation are nonexistent and current interventions targeting AET adherence are not culturally sensitive. The primary objective of phase 1 of this two-phase mixed-methods study was to develop a brief, nurse-led, evidence-based intervention (INITIATE) to coach a diverse sample of minority breast cancer survivors through AET initiation.

INITIATE was informed by the Adapt Guidance (4 Steps) and Typology of Adaptation Model (TAM; 6 Steps). Per Adapt Step 1, literature was reviewed to assess the rationale for a culturally sensitive intervention targeting AET initiation and to evaluate the intervention-context fit (or lack thereof) of current AET interventions. Confirming the need for intervention adaptation, we proceeded to Step 1 of TAM: collaborative working. Qualitative interviews were conducted with 10 hormone breast cancer survivors who had delayed initiation of AET or expressed significant hesitancy about initiating AET. Semi-structured interviews lasted approximately 30 minutes and participants were asked questions about their perceptions of AET, barriers and motivators to taking AET, support around initiating and taking AET, and study feasibility.

Emergent themes were categorized as 1. Concerns about Side Effects and Recurrence; 2. Frustrations about AET; 3. Racial and Cultural Considerations among Breast Cancer Survivors; and 4. Support Systems for Breast Cancer Survivors. Subcategories under theme one detail patient concern over medication toxicities (e.g., hot flashes, weight gain, sexual dysfunction; cognitive impairment, increased risk of stroke and uterine cancers) and fear of recurrence. Per theme two, patients expressed frustration over having to continue cancer treatment post chemotherapy and/or radiotherapy; frustration over the lack of alternative treatment options; and frustration over opposing clinician advice on AET initiation and insufficient opportunities to thoroughly discuss endocrine therapy before prescription. Beyond that, minority patients identified the burden of being the sole person of color in predominantly White medical institutions and revealed how the pressure of respecting authority hindered self-advocacy. Patients also stressed that resources for breast cancer survivors of racial and ethnic backgrounds are limited and urged clinicians to address race-related stressors for relevant, personalized care. Expanding upon this conversation, participants recognized social media platforms as unreliable: though sometimes a haven, social media platforms can be overcrowded by negative experiences. Per theme four and unlike social media, familial support is a clear influential factor of AET initiation. 

Per Adapt Step 2, the intervention was adapted from a feasible and acceptable intervention for AET adherence and symptom management (STRIDE) and an oncology nurse practitioner was recruited to deliver the intervention. And per TAM Step 3, stakeholder feedback about intervention content and feasibility in minority populations was sought.

Whereas Session 1 focuses on Understanding Your Hormonal Therapy; Exploring Thoughts and Beliefs About Hormonal Therapy; Making a Plan for Taking Hormonal Therapy; and Practicing Relaxation Using Diaphragmatic Breathing, Session 2 focuses on Exploring Ways to Cope With Worry and Unhelpful Thoughts; Learning How to Manage Symptoms and Side Effects; and Practicing Relaxation Using Progressive Muscle Relaxation.

To diversify the participant pool for phase 2–a single-arm pilot study (n = 30) to assess the feasibility and acceptability of INITIATE under Adapt Step 3–TAM Steps 4 and 5 were followed: recruitment flyers and Rally portal advertisements were translated into Spanish while considering appropriate vocabulary and population reading levels, and the intervention manual was edited to incorporate ethnic-specific messaging about breast cancer disparities and to reflect the prospective population’s cultural values. For instance, Session 2 recommends participants incorporate parts of their cultural background (e.g., Qigong and sound bath meditation) in Progressive Muscle Relaxation. Appendix resources also include organizations that cater to ethnic and racial minorities.

Delivery methods were refined following TAM Step Three: the INITIATE manual was translated into Spanish and interventions sessions were scheduled biweekly.

Per Adapt Step 4, future work will entail an efficacy trial to examine the sustainability of intervention implementation and maintenance at scale. Beyond identifying resources necessary for maintenance if applicable, responsive adaptations will be made as necessary to reflect changes in context over time.