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Completed

NCT Number: NCT05465408

Culturally Aware AET Non-Initiation Intervention

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

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About this study

This is a single-arm pilot trial to examine the feasibility and acceptability of a patient-centered, evidence-based, culturally competent, nurse-led intervention to encourage breast cancer survivors who have not started their adjuvant endocrine therapy (AET) to initiate the medication.

The research study procedures include:

  • screening for eligibility
  • two individual study intervention sessions
  • study assessment follow-up questionnaires

This research study involves two individual sessions with a nurse practitioner, which will take place via videoconferencing, in person, or by telephone. Participants will also complete three brief questionnaire packets over the 12-week study period.

It is expected that up to 35 people will take part in this research study. The investigators plan to enrich the study sample with patients from racial and/or ethnic minority groups to ensure the generalizability of the study findings.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention

Behavioral

One-to-One virtual (videoconference) behavioral intervention.

Primary outcomes

  1. Program Feasibility

    Time frame: Up to 3 months

    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).

  2. Program Acceptability

    Time frame: Up to 3 months

    Acceptability will be demonstrated by >75% of participants reporting average satisfaction scores greater than the mid-point of the Client Satisfaction Questionnaire. The total score range is 3-12, with higher scores indicating a better outcome.

Secondary outcomes

  1. Adjuvant Endocrine Therapy (AET) Initiation

    Time frame: Up to 3 months

    Following the intervention, participants will be more likely to have started their AET. AET initiation will be measured by self-reported questionnaire.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Addressing Non-Initiation of Recommended Adjuvant Endocrine Therapy With a Culturally Informed-Intervention

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 19, 2022
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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