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

Completed

• Conditions: Statin Use Among High Risk Survivors; Cancer Survivors
• Interventions: Behavioral: statin communication tool; Behavioral: usual care

• Registration Number: NCT02895880
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-31
• Study First Submitted QC: 2016-09-06
• Study First Posted: 2016-09-12
• Status Verified: 2020-06
• Primary Completion: 2020-06-11
• Study Completion: 2020-06-11
• Last Update Submitted: 2020-06-12
• Last Update Posted: 2020-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
risk communication tool	statin communication tool	next 25 participants, clinicians will use the risk communication tool in their discussion about statins and cardiovascular risk reduction
usual care	usual care	first 25 participants will receive usual care (i.e. no risk communication tool)

Primary Outcome Measures

Name	Time	Method
number of patients who initiated statins after the office visit	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.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States