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

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.

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Key information

Conditions

Cancer Survivors Statin Use Among High Risk Survivors

Age range

25 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Usual Care

Behavioral

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

Behavioral

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.

Primary outcomes

number of patients who initiated statins after the office visit

Time frame: 1 year

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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2020
Study completion: 2020
First posted: Sep 12, 2016
Registry last updated: Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed