INTENT Pilot Study - Enhancing Adherence Intentions to Endocrine Therapy
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Dana-Farber Cancer Institute
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- Engagement Rate of Intervention
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Ann H. Partridge, MD, MPH
Principal Investigator
Dana-Farber Cancer Institute
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
Outcomes
Primary Outcomes
Engagement Rate of Intervention
Time Frame: 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
Time Frame: 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
Time Frame: 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.