- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01482741
Understanding Patient Perspectives on the Risks of Ionizing Radiation Used for Medical Imaging
Risks from imaging-related radiation exposure have become a popular topic in the media. Because these tests are commonly applied to patients at a cancer center, it is important to understand what patients know, how they feel about what they know, where they get their information, and how satisfied they are with available risk-benefit communication on this topic.
The purpose of this study is to understand how cancer patients perceive risks and benefits of diagnostic radiation and their satisfaction with healthcare communication on this topic.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- English-language fluent
- 18 years of age, or older
- Provide informed consent
- Group 1: Patients undergoing chemotherapy for Stage IV colorectal carcinoma.
- Group 2: Parents of pediatric patients who have undergone treatment for stage 1-3 neuroblastoma.
- Group 3: Women who have undergone treatment for early stage breast cancer within the preceding 6 months.
- Group 4: Men undergoing surveillance imaging after treatment for testicular cancer.
- Group 5: Patients currently or previously enrolled in the MSKCC lung cancer screening program.
- Group 6: Patients enrolled in or eligible for the thoracic survivorship program.
Exclusion Criteria:
- Participants who don't speak English
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Pts undergoing chemotherapy for Stage IV colorectal carcinoma
Six focus groups of 7-9 participants each will be conducted for approximately 90 minutes according to the established methodology of Krueger and Casey.
Focus group sessions are semi-structured group interviews in which previously chosen, open-ended questions about topics of interest are posed to participants by a trained moderator.
|
Participants will complete a pre-focus group demographic questionnaire.
Focus group participants will be asked to report the following: current age; gender; race/ethnicity; income; highest education attained; occupation; and cancer stage if participant has a cancer history.
Participants who are parents of pediatric patients will also report their child's current age, gender, and cancer stage.
Ten questions will be developed by the investigators and posed to each group by the moderator to solicit the desired information.
The objective for the focus groups will be to systematically explore three domains: 1) what participants know about radiation as it relates to medical imaging; 2) how what they know or believe about radiation shapes their attitudes about it; 3) and participant perceptions regarding the availability and adequacy of their sources, including risk-benefit communication with health care providers
|
|
Parents of pediatric patients stage 1-3 neuroblastoma
within the preceding 6 months.
Six focus groups of 7-9 participants each will be conducted for approximately 90 minutes according to the established methodology of Krueger and Casey.
Focus group sessions are semi-structured group interviews in which previously chosen, open-ended questions about topics of interest are posed to participants by a trained moderator.
|
Participants will complete a pre-focus group demographic questionnaire.
Focus group participants will be asked to report the following: current age; gender; race/ethnicity; income; highest education attained; occupation; and cancer stage if participant has a cancer history.
Participants who are parents of pediatric patients will also report their child's current age, gender, and cancer stage.
Ten questions will be developed by the investigators and posed to each group by the moderator to solicit the desired information.
The objective for the focus groups will be to systematically explore three domains: 1) what participants know about radiation as it relates to medical imaging; 2) how what they know or believe about radiation shapes their attitudes about it; 3) and participant perceptions regarding the availability and adequacy of their sources, including risk-benefit communication with health care providers
|
|
Women who have undergone tx for early stage breast cancer
within the preceding 6 months.
Six focus groups of 7-9 participants each will be conducted for approximately 90 minutes according to the established methodology of Krueger and Casey.
Focus group sessions are semi-structured group interviews in which previously chosen, open-ended questions about topics of interest are posed to participants by a trained moderator.
|
Participants will complete a pre-focus group demographic questionnaire.
Focus group participants will be asked to report the following: current age; gender; race/ethnicity; income; highest education attained; occupation; and cancer stage if participant has a cancer history.
Participants who are parents of pediatric patients will also report their child's current age, gender, and cancer stage.
Ten questions will be developed by the investigators and posed to each group by the moderator to solicit the desired information.
The objective for the focus groups will be to systematically explore three domains: 1) what participants know about radiation as it relates to medical imaging; 2) how what they know or believe about radiation shapes their attitudes about it; 3) and participant perceptions regarding the availability and adequacy of their sources, including risk-benefit communication with health care providers
|
|
Men undergoing surveillance imaging after tx for testicular ca
Six focus groups of 7-9 participants each will be conducted for approximately 90 minutes according to the established methodology of Krueger and Casey.
Focus group sessions are semi-structured group interviews in which previously chosen, open-ended questions about topics of interest are posed to participants by a trained moderator.
|
Participants will complete a pre-focus group demographic questionnaire.
Focus group participants will be asked to report the following: current age; gender; race/ethnicity; income; highest education attained; occupation; and cancer stage if participant has a cancer history.
Participants who are parents of pediatric patients will also report their child's current age, gender, and cancer stage.
Ten questions will be developed by the investigators and posed to each group by the moderator to solicit the desired information.
The objective for the focus groups will be to systematically explore three domains: 1) what participants know about radiation as it relates to medical imaging; 2) how what they know or believe about radiation shapes their attitudes about it; 3) and participant perceptions regarding the availability and adequacy of their sources, including risk-benefit communication with health care providers
|
|
Men & women enrolled in the MSKCC lung ca screening program
Six focus groups of 7-9 participants each will be conducted for approximately 90 minutes according to the established methodology of Krueger and Casey.
Focus group sessions are semi-structured group interviews in which previously chosen, open-ended questions about topics of interest are posed to participants by a trained moderator.
|
Participants will complete a pre-focus group demographic questionnaire.
Focus group participants will be asked to report the following: current age; gender; race/ethnicity; income; highest education attained; occupation; and cancer stage if participant has a cancer history.
Participants who are parents of pediatric patients will also report their child's current age, gender, and cancer stage.
Ten questions will be developed by the investigators and posed to each group by the moderator to solicit the desired information.
The objective for the focus groups will be to systematically explore three domains: 1) what participants know about radiation as it relates to medical imaging; 2) how what they know or believe about radiation shapes their attitudes about it; 3) and participant perceptions regarding the availability and adequacy of their sources, including risk-benefit communication with health care providers
|
|
Men and women enrolled in the thoracic survivorship
Six focus groups of 7-9 participants each will be conducted for approximately 90 minutes according to the established methodology of Krueger and Casey.
Focus group sessions are semi-structured group interviews in which previously chosen, open-ended questions about topics of interest are posed to participants by a trained moderator.
|
Participants will complete a pre-focus group demographic questionnaire.
Focus group participants will be asked to report the following: current age; gender; race/ethnicity; income; highest education attained; occupation; and cancer stage if participant has a cancer history.
Participants who are parents of pediatric patients will also report their child's current age, gender, and cancer stage.
Ten questions will be developed by the investigators and posed to each group by the moderator to solicit the desired information.
The objective for the focus groups will be to systematically explore three domains: 1) what participants know about radiation as it relates to medical imaging; 2) how what they know or believe about radiation shapes their attitudes about it; 3) and participant perceptions regarding the availability and adequacy of their sources, including risk-benefit communication with health care providers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
characterize participant knowledge, attitudes
Time Frame: 2 years
|
about imaging radiation, information sources, and satisfaction with risk-benefit communication.
|
2 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Raymond Thornton, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Genital Neoplasms, Male
- Testicular Diseases
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroectodermal Tumors, Primitive
- Neuroectodermal Tumors, Primitive, Peripheral
- Testicular Neoplasms
- Neuroblastoma
Other Study ID Numbers
- 11-185
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