Breast Cancer, Breast Cancer Female, Breast Carcinoma
Conditions
Keywords
Breast Cancer, Breast Cancer Female, Breast Carcinoma
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)
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.
Interventions
BEHAVIORALEndocrine 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.
Sponsors
Dana-Farber Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Engagement Rate of Intervention | 6 weeks | Adequate engagement of the intervention is defined as a click-to-open rate of 60% or over for the intervention group. |
| Intervention Satisfaction Questionnaire Mean Score Group A | At 6 weeks | 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. |
| Intervention Satisfaction Questionnaire Mean Score Group B | At 14 weeks | 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. |
Countries
United States
Outcome results
None listed