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Trial Title:
INTENT Pilot Study - Enhancing Adherence Intentions to Endocrine Therapy
NCT ID:
NCT06246084
Condition:
Breast Cancer
Breast Cancer Female
Breast Carcinoma
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Breast Cancer
Breast Cancer Female
Breast Carcinoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Endocrine Therapy Education Program
Description:
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.
Arm group label:
Group A: Endocrine Therapy Education Intervention
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)
Detailed 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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Start date:
February 15, 2024
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Dana-Farber Cancer Institute
Agency class:
Other
Source:
Dana-Farber Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06246084
