Breast CancerNCT01482741
Understanding Patient Perspectives on the Risks of Ionizing Radiation Used for Medical Imaging
An observational study of Breast Cancer and Colon Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Colon Cancer, Lung Cancer
- What is being tested?
- Focus Group Sessions
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatient clinical practices at MSKCC.
Who may be able to join
- 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.
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- 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.
Who cannot join
- Participants who don't speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
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.
- Conditions
- Breast Cancer, Colon Cancer, Lung Cancer, Neuroblastoma, Testicular Cancer
- Being tested
- Focus Group Sessions
- Keywords
- Quality of Life, Focus groups, Risks of Ionizing Radiation, Risk of medical imaging, 11-185
- Medical subject headings
- Breast Neoplasms, Colonic Neoplasms, Lung Neoplasms, Neuroblastoma, Testicular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus Group SessionsBehavioural
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
Focus Group SessionsBehavioural
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
Focus Group SessionsBehavioural
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
Focus Group SessionsBehavioural
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
Focus Group SessionsBehavioural
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
Focus Group SessionsBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Focus Group Sessions | |
| 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. Receives: Behavioral: Focus Group Sessions | |
| 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. Receives: Behavioral: Focus Group Sessions | |
| 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. Receives: Behavioral: Focus Group Sessions | |
| 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. Receives: Behavioral: Focus Group Sessions | |
| 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. Receives: Behavioral: Focus Group Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
characterize participant knowledge, attitudes
about imaging radiation, information sources, and satisfaction with risk-benefit communication.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raymond Thornton, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482741
- Sponsor's protocol ID
- 11-185
- Status last verified
- Jun 2015
- First submitted
- 28 Nov 2011
- Last updated
- 25 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Patient Perspectives on the Risks of Ionizing Radiation Used for Medical Imaging
- ClinicalTrials.gov ID
- NCT01482741
- Acronym / sponsor ID
- 11-185
- Conditions
- Breast Cancer, Colon Cancer, Lung Cancer, Neuroblastoma, Testicular Cancer
- Keywords
- Quality of Life, Focus groups, Risks of Ionizing Radiation, Risk of medical imaging, 11-185
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 1 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Pts undergoing chemotherapy for Stage IV colorectal carcinoma | – | Behavioral: Focus Group SessionsSix 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. |
| Parents of pediatric patients stage 1-3 neuroblastoma | – | Behavioral: Focus Group Sessionswithin 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. |
| Women who have undergone tx for early stage breast cancer | – | Behavioral: Focus Group Sessionswithin 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. |
| Men undergoing surveillance imaging after tx for testicular ca | – | Behavioral: Focus Group SessionsSix 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. |
| Men & women enrolled in the MSKCC lung ca screening program | – | Behavioral: Focus Group SessionsSix 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. |
| Men and women enrolled in the thoracic survivorship | – | Behavioral: Focus Group SessionsSix 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient clinical practices at MSKCC.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (1 listed)
- Participants who don't speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus Group SessionsParticipants 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 | Behavioural | Pts undergoing chemotherapy for Stage IV colorectal carcinoma |
| Focus Group SessionsParticipants 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 | Behavioural | Parents of pediatric patients stage 1-3 neuroblastoma |
| Focus Group SessionsParticipants 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 | Behavioural | Women who have undergone tx for early stage breast cancer |
| Focus Group SessionsParticipants 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 | Behavioural | Men undergoing surveillance imaging after tx for testicular ca |
| Focus Group SessionsParticipants 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 | Behavioural | Men & women enrolled in the MSKCC lung ca screening program |
| Focus Group SessionsParticipants 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 | Behavioural | Men and women enrolled in the thoracic survivorship |
Primary outcome
characterize participant knowledge, attitudes
Time frame: 2 years
about imaging radiation, information sources, and satisfaction with risk-benefit communication.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2015.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond Thornton, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Colon Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
characterize participant knowledge, attitudes (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2015.