A Risk Assessment Tool to Increase Statin Use Among High Risk Cancer Survivors: Development and Pilot Testing

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect initial data on what survivors of childhood, adolescent, and young adult cancer think of how information about statins is communicated. Statins are medications that lower cholesterol. The results of this study will be used to improve the communication about statins. This is to aid patients and their providers in making health care decisions together, also known as shared decision making.

Official Title
-----------------
A Risk Assessment Tool to Increase Statin Use Among High Risk Cancer Survivors: Development and Pilot Testing

Conditions
-----------------
Cancer Survivors, Statin Use Among High Risk Survivors

Intervention / Treatment
-----------------
* Behavioral: usual care
* Behavioral: statin communication tool


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English speaking A personal history of cancer, tumor, or a related illness Followed in the Adult Long Term Follow Up Program Received ≥ 2000 cGy radiation to the heart/chest ≥Ten years post-radiation therapy to the heart/chest Age ≥ 25 years old Exclusion Criteria: Evidence of active progression of disease or recurrence Neurocognitive deficits that impair ability to give informed consent Current use of a statin Diagnosis of another primary cancer for which the patient is currently undergoing radiation therapy chemotherapy, or bone marrow transplant Diagnosis of CVD with or without current statin use

Ages Eligible for Study
-----------------
Minimum Age: 25 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| usual care<br>first 25 participants will receive usual care (i.e. no risk communication tool) | Behavioral: usual care<br>* In order to characterize the content of and variation in usual care, the first 25 patients enrolled in the study will complete a post-visit questionnaire that asks what their doctor told them (if anything) about their risk of cardiovascular disease, risk reduction and statins specifically, and how this information was presented<br>|
| risk communication tool<br>next 25 participants, clinicians will use the risk communication tool in their discussion about statins and cardiovascular risk reduction | Behavioral: statin communication tool<br>* The Statin Choice decision aid uses icon arrays to communicate the expected benefits of statins. This modified risk communication tool will maintain the components of the validated original. The adapted paper-based risk communication tool will describe modified risk profiles applicable to the survivors at increased risk for cardiac disease due to chest irradiation.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients who initiated statins after the office visit | This data will allow validation of the adapted tool in the cancer survivor population. Acceptability will be estimated using the tool describe which will be transformed to a 0 to 100 scale and summarized separately in the two populations using means and standard deviations.These preliminary statistics in both populations (intervention and usual care) will be utilized to design a future larger scale study powered to detect a difference between the two groups. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Communication Tool, Cancer Survivors, Increase Statin, 16-1128