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New nurse-led program aims to help breast cancer survivors overcome hormone therapy hesitation

NCT ID NCT05465408

Symptom relief Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a brief, nurse-led videoconference program designed to help breast cancer survivors who were hesitant or delayed in starting recommended hormone therapy. The program aimed to address cultural and personal concerns. Researchers measured how many people enrolled, completed sessions, and reported satisfaction. The goal was to see if this approach is feasible and acceptable, not yet to prove it works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Culturally aware behavioral intervention (nurse-led videoconference sessions)
What this could lead to
If successful, this approach could help more breast cancer survivors start and stick with hormone therapy, potentially improving long-term outcomes.
What could go wrong
This is a small, early feasibility study with only 35 participants. It does not prove the intervention works on a large scale or improves survival.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

35 people

The number who actually took part.

Started

Jul 2022

Finished

Nov 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone receptor-positive breast cancer Patient Compliance Treatment Adherence and Compliance Treatment Refusal

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer Survivorship Treatment adherence Treatment compliance Treatment refusal

Contacts and locations

Locations

  • Dana-Farber Brigham Cancer Center - Foxborough

    Foxborough, Massachusetts, 02035, United States

  • Dana-Farber Brigham Cancer Center at Milford Regional Medical Center

    Milford, Massachusetts, 01757, United States

  • Dana-Farber Brigham Cancer Center with South Shore Hospital

    Weymouth, Massachusetts, 02190, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Dana-Farber Cancer Institute - Merrimack Valley

    Methuen, Massachusetts, 01844, United States

  • Dana-Farber Cancer Institute at St Elizabeth's Medical Center

    Brighton, Massachusetts, 02135, United States

  • Dana-Farber/New Hampshire Onoclogy-Hematology

    Londonderry, New Hampshire, 03053, United States

  • Emerson Hospital/MGH Cancer Center

    Concord, Massachusetts, 01742, United States

  • Mass General at Newton Wellesley Hospital

    Newton, Massachusetts, 02462, United States

  • Mass General at North Shore Cancer Center

    Danvers, Massachusetts, 01923, United States

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114, United States

More trials for these conditions

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