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

Cancer Survivors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02895880
• Other study ID #: 16-1128
• Status: Completed
• Start date: August 2016
• Est. completion date: June 11, 2020

Study information

• Verified date: June 2020
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: June 11, 2020
• Est. primary completion date: June 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Survivors
• Statin Use Among High Risk Survivors

Intervention

Behavioral:
• usual care
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
• statin communication tool
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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center