Clinical trial · Interventional
Culturally Aware AET Non-Initiation Intervention
Addressing Non-Initiation of Recommended Adjuvant Endocrine Therapy With a Culturally Informed-Intervention
NCT05465408CI-TRIAL-00103957completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Survivorship | — | UNRESOLVED | — |
| Treatment Adherence | — | UNRESOLVED | — |
| Treatment Compliance | — | UNRESOLVED | — |
| Treatment Refusal | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention
- description
- 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.
- interventionNames
- Behavioral: Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention
Primary outcomes (2)
- measure
- Program Feasibility
- timeFrame
- Up to 3 months
- description
- Feasibility will be demonstrated by enrollment (\>50% of eligible and approached patients will enroll), retention (\>70% of enrolled participants will complete the two intervention sessions) and attendance (≥70% of participants completing at least one session).
- measure
- Program Acceptability
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female * Age 21 or older * Diagnosis of early-stage (Stage I-IIIB), hormone receptor-positive breast cancer * Recommended to start AET at least 3 weeks prior and not currently taking AET OR recommended to start AET in the future, and reports hesitations to start AET as determined by a score of \>/= 4 (range =0-10) when asked "How hesitant are you about starting your recommended hormonal therapy? (0=Not at all hesitant and 10 = Extremely hesitant)" * Ability to read and respond in English or Spanish * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * For at least 10 participants, identify as a member of a racial or ethnic minority community per self-report Exclusion Criteria: * Uncontrolled psychosis, active suicidal ideation, psychiatric hospitalization within the past year * Cognitive impairment that prohibits participation in the study * Undergoing primary treatment for another cancer (i.e., advanced-stage cancer) * Participating in a clinical trial involving AET
References
Publications (1)
- DERIVEDPost KE, Dunderdale L, Datta S, Gutierrez N, Varella L, Horick N, Traeger L, Greer JA, Moy B, Temel JS, Jacobs JM. Development and refinement of a nurse-led, culturally sensitive intervention for adjuvant endocrine therapy initiation among patients with breast cancer. Eur J Oncol Nurs. 2025 Dec;79:103010. doi: 10.1016/j.ejon.2025.103010. Epub 2025 Oct 15. PMID 41172636