INTENT Pilot Study - Enhancing Adherence Intentions to Endocrine Therapy

Breast Cancer Clinical Trial

Official title:

INTENT Pilot Study - Enhancing Adherence Intentions to Endocrine Therapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06246084
• Other study ID #: 23-607
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Dana-Farber Cancer Institute
• Contact: Ann Partridge, MD, MPH
• Phone: 617-632-6800
• Email: ann_partridge[@]dfci.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Description:

This research study is a randomized pilot study to determine whether a brief-video based intervention program can improve experiences of Endocrine Therapy (ET). Participants will be randomized into one of two groups: Group A: Endocrine Therapy Education Intervention vs. Group B Wait-list Control Group. Randomization means a participant is placed into a study group by chance.

The research study procedures include screening for eligibility, in-clinic visits, and survey questionnaires.

Participation in this research study is expected to last 3 months.

It is expected that about 60 people will take part in this research study.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 76
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Biologically female

• About to begin or just started (within four weeks of starting) an oral form of ET (either tamoxifen or AI)

• 18 years of age or older

• English fluency for reading and writing.

• Computer literacy (ability to watch videos and fill out questionnaires online)

Exclusion Criteria:

• Adults unable to consent

• Individuals with metastatic cancer

• Individuals who are not yet adults (infants, children, teenagers)

• Pregnant women

• Prisoners

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Female
• Breast Carcinoma
• Breast Neoplasms

Intervention

Behavioral:
• Endocrine Therapy Education Program
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.

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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