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

June 12, 2020 updated by: Memorial Sloan Kettering Cancer Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Survivorship clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Nirupa Raghunathan, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

June 11, 2020

Study Completion (Actual)

June 11, 2020

Study Registration Dates

First Submitted

August 31, 2016

First Submitted That Met QC Criteria

September 6, 2016

First Posted (Estimate)

September 12, 2016

Study Record Updates

Last Update Posted (Actual)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 12, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 16-1128

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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