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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Endocrine Therapy Education Intervention | Experimental | Participants will complete:
|
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| Group B: Wait-List Control Group | No Intervention | Participants will complete:
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endocrine Therapy Education Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann Partridge, MD, MPH | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
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.
Data can be shared no earlier than 1 year following the date of publication
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| D017437 |
| Skin and Connective Tissue Diseases |