NCT06246084

Brief Summary

This research is being done to pilot an intervention which aims to improve participants' experiences on Endocrine Therapy. The name of the intervention used in this research study is: Endocrine Therapy Education Program (a brief, video-based intervention)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 7, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

February 15, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2024

Completed
Last Updated

January 22, 2025

Status Verified

September 1, 2024

Enrollment Period

6 months

First QC Date

January 30, 2024

Last Update Submit

January 20, 2025

Conditions

Breast CancerBreast Cancer FemaleBreast Carcinoma

Keywords

Breast CancerBreast Cancer FemaleBreast Carcinoma

Outcome Measures

Primary Outcomes (3)

  • Engagement Rate of Intervention

    Adequate engagement of the intervention is defined as a click-to-open rate of 60% or over for the intervention group.

    6 weeks

  • Intervention Satisfaction Questionnaire Mean Score Group A

    Responses will be analyzed to determine a mean score for each item for the intervention group. The Intervention Satisfaction Questionnaire includes 9 items rated on a 1 to 10 scale.

    At 6 weeks

  • Intervention Satisfaction Questionnaire Mean Score Group B

    Responses will be analyzed to determine a mean score for each item for the control group (following the release of the intervention educational videos). The Intervention Satisfaction Questionnaire includes 9 items rated on a 1 to 10 scale.

    At 14 weeks

Study Arms (2)

Group A: Endocrine Therapy Education Intervention

EXPERIMENTAL

Participants will complete: * Baseline visit. * Educational video once a week for 6 weeks. * 6-week survey. * 3-month survey.

Behavioral: Endocrine Therapy Education Program

Group B: Wait-List Control Group

NO INTERVENTION

Participants will complete: * Baseline visit. * 6-week survey. * 3-month survey. * Access to intervention educational videos. * 2-week post video survey.

Interventions

Endocrine Therapy Education ProgramBEHAVIORAL

Brief, video-based intervention program to improve endocrine therapy adherence and experiences and to provide detailed education to participants. The intervention is distributed and assessed via the MyEmma platform, a HIPAA-compliant, online communications platform.

Group A: Endocrine Therapy Education Intervention

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Biologically female
  • About to begin or just started (within four weeks of starting) an oral form of ET (either tamoxifen or AI)
  • years of age or older
  • English fluency for reading and writing.
  • Computer literacy (ability to watch videos and fill out questionnaires online)

You may not qualify if:

  • Adults unable to consent
  • Individuals with metastatic cancer
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ann Partridge, MD, MPH

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 30, 2024

First Posted

February 7, 2024

Study Start

February 15, 2024

Primary Completion

July 31, 2024

Study Completion

December 23, 2024

Last Updated

January 22, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data can be shared no earlier than 1 year following the date of publication
Access Criteria
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
More information

Locations

US(1)