Understanding Patient Perspectives on the Risks of Ionizing Radiation Used for Medical Imaging

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01482741
First received: November 28, 2011
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Breast Cancer
Colon Cancer
Lung Cancer
Neuroblastoma
Testicular Cancer
Behavioral: Focus Group Sessions

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Understanding Patient Perspectives on the Risks of Ionizing Radiation Used for Medical Imaging

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • characterize participant knowledge, attitudes [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    about imaging radiation, information sources, and satisfaction with risk-benefit communication.


Estimated Enrollment: 60
Study Start Date: November 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Behavioral: Focus Group Sessions
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.
Behavioral: Focus Group Sessions
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.
Behavioral: Focus Group Sessions
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.
Behavioral: Focus Group Sessions
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.
Behavioral: Focus Group Sessions
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.
Behavioral: Focus Group Sessions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Outpatient clinical practices at MSKCC.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01482741

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Raymond Thornton, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01482741     History of Changes
Other Study ID Numbers: 11-185
Study First Received: November 28, 2011
Last Updated: July 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Quality of Life
Focus groups
Risks of Ionizing Radiation
Risk of medical imaging
11-185

Additional relevant MeSH terms:
Breast Neoplasms
Colonic Neoplasms
Lung Neoplasms
Neuroblastoma
Testicular Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on August 01, 2014