Breast CancerNCT00234715
Psychosocial Study on Breast Cancer Risk Assessment
An observational study of Breast Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The proposed pilot study is part of the design and development process of a final questionnaire that aims to gain insight on factors that influences acceptance and adoption of breast cancer risk assessment in women. Read more about this study
- Who is it for?
- Ages 25 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- How many people
- 62 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2005to Aug 2006
- 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 25 to 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cohort recruited from the University Health Network community.
Who may be able to join
- Are 25 - 74 years of age
- Are in good health
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Ontario Cancer Institute / Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
Official title: A Pilot Study: Psychosocial and Socio-Demographic Determinants of Accepting Breast Cancer Risk Assessment
The proposed pilot study is part of the design and development process of a final questionnaire that aims to gain insight on factors that influences acceptance and adoption of breast cancer risk assessment in women. Feedback on the questionnaire will help identify potential issues of clarity, comprehensibility, and reliability; and to identify possible biases that often accompany a designed questionnaire. Information gained from the large-scale study will provide directions for the development of educational strategies in the TIBS research program that could accompany increases in public awareness of risk factors, the availability of risk assessment tools and preventive lifestyle.
Read the detailed description
The development of risk assessment tools for preventive oncology aims to identify all members of a given at risk subpopulation to whom intervention strategies can be offered to reduce their risk. An ideal risk assessment tool should permit assessment of a woman's breast cancer risk in order to a) identify the needs for and potential benefits of risk reducing interventions; b) direct her to the most appropriate risk reducing interventions, and; c) monitor the efficacy of the intervention in actually reducing risk. Earlier implemented risk reduction interventions could potentially preclude needs for more drastic lifestyle and less desirable changes, such as chemoprevention and prophylactic surgeries, later in life. Currently, no such classification and monitoring technique has proven effective. Yet several candidate techniques are being investigated. While risk assessment tools may potentially provide future benefits, the effectiveness of current and new risk assessment tool developments certainly requires users to perceive these tools as potentially effective. It is this perception of potential effectiveness that would motivate them to adhere to risk assessment protocols the evaluation of which would help provide the evidence base for understanding true effectiveness. The investigators of this study are currently developing a Transillumination Breast Spectroscopy (TIBS) research program, consisting of ongoing studies of different types. As part of the technology assessment process for TIBS, and in part due to the further development of the research program, there is a need to address factors that may directly or indirectly influence willingness to participate in a breast cancer risk assessment. The primary goal of this pilot study is to determine the content validity of the investigator-designed draft questionnaire. The outcome measure of a final questionnaire is to assess general acceptability of breast cancer risk assessment and degree of acceptability based on a) knowledge and awareness of breast cancer, b) varying levels of involvement and invasiveness of a risk assessment procedure, and c) perceived potential effectiveness of risk reducing interventions. Acceptability of risk assessment, willingness to undergo therapy and follow through with recommendations is assessed independent of currently available and new developments of risk assessment procedures.The secondary goal of this study is to test the overall comprehensibility (e.g. language, clarity), question acceptability (e.g. appropriateness of response selection), and reliability of the questionnaire.Information gained from this pilot study will be considered in the development of a final questionnaire to be administered to a large population representative cohort. The results of the planned future study will provide directions for the development of educational strategies in the TIBS research program that should accompany increases in public awareness on risk factors, the availability of risk assessment tools and preventive lifestyle and insight into the extent of broad-based community education strategies required to initiate and sustain interest in assessment for breast cancer risk among women in the general public to facilitate informed decision-making related to breast health in these women. Critical gaps in knowledge of risk factors and preventive lifestyle changes identified in this subsequent study can provide a focus for the educational strategies, which may address: the costs of risk assessment (e.g. stress, financial, inconvenience) and the development of understandable and practical educational materials to ensure their accessibility to a broad range of audiences, including those women who may be candidates for risk reducing interventions but who are not yet aware of its availability. The ultimate hypothesis of a future large-scale study is:General knowledge and awareness of breast cancer, psychosocial factors such as perceived risk susceptibility and perceived costs of risk assessment (e.g. stress, financial, inconvenience), perceived effectiveness of intervention strategies, and socio-demographic position are determinants of accepting risk assessment.However, to help guide questionnaire design and development, a pilot study is required to identify issues of the questionnaire such as content validity, overall comprehensibility (e.g. language, clarity), question acceptability (e.g. appropriateness of response selection), and reliability. To achieve the goals of the pilot study, we intend to recruit 50 women between ages of 25 - 74 years (10 per age group, 25 - 34, 35 - 44, 45 - 54, 55 - 65, 65 - 74). A 26-item investigator-designed, self-administered questionnaire was designed with standard measures. The questionnaire consists of 7 sections covering the following topics: Breast Cancer Knowledge and Awareness, Susceptibility Perception, Likelihood of Undergoing Risk Assessment, Benefits and Barriers of Risk Assessment, Breast Cancer Risk Assessment, Risk Reduction Intervention, and Demographics
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Breast Cancer Risk, Breast Cancer Risk Assessment, Psychosocial, Acceptance
- Medical subject headings
- Breast Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2005 (estimated)
- Study startOct 2005
- Study completionAug 2006
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 University Health Network, TorontoThe 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
- Cross-sectional
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Investigators
- Lothar Lilge, PhD, Principal investigator, Ontario Cancer Institute, University Health Network, Toronto, Ontario, Canada M5G 2M9; Department of Biophysics and Bioimaging, University of Toronto, Toronto, Ontario, Canada M5G 2M9
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00234715
- Sponsor's protocol ID
- UHNREB#05-0601-CE
- Status last verified
- Nov 2007
- First submitted
- 5 Oct 2005
- Last updated
- 15 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study: Psychosocial and Socio-Demographic Determinants of Accepting Breast Cancer Risk Assessment
- ClinicalTrials.gov ID
- NCT00234715
- Acronym / sponsor ID
- UHNREB#05-0601-CE
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Breast Cancer Risk, Breast Cancer Risk Assessment, Psychosocial, Acceptance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Oct 2005
- Study completion
- Aug 2006 (actual)
- First posted
- 7 Oct 2005 (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.
The proposed pilot study is part of the design and development process of a final questionnaire that aims to gain insight on factors that influences acceptance and adoption of breast cancer risk assessment in women. Feedback on the questionnaire will help identify potential issues of clarity, comprehensibility, and reliability; and to identify possible biases that often accompany a designed questionnaire. Information gained from the large-scale study will provide directions for the development of educational strategies in the TIBS research program that could accompany increases in public awareness of risk factors, the availability of risk assessment tools and preventive lifestyle.
Detailed description
The development of risk assessment tools for preventive oncology aims to identify all members of a given at risk subpopulation to whom intervention strategies can be offered to reduce their risk. An ideal risk assessment tool should permit assessment of a woman's breast cancer risk in order to a) identify the needs for and potential benefits of risk reducing interventions; b) direct her to the most appropriate risk reducing interventions, and; c) monitor the efficacy of the intervention in actually reducing risk. Earlier implemented risk reduction interventions could potentially preclude needs for more drastic lifestyle and less desirable changes, such as chemoprevention and prophylactic surgeries, later in life. Currently, no such classification and monitoring technique has proven effective. Yet several candidate techniques are being investigated. While risk assessment tools may potentially provide future benefits, the effectiveness of current and new risk assessment tool developments certainly requires users to perceive these tools as potentially effective. It is this perception of potential effectiveness that would motivate them to adhere to risk assessment protocols the evaluation of which would help provide the evidence base for understanding true effectiveness. The investigators of this study are currently developing a Transillumination Breast Spectroscopy (TIBS) research program, consisting of ongoing studies of different types. As part of the technology assessment process for TIBS, and in part due to the further development of the research program, there is a need to address factors that may directly or indirectly influence willingness to participate in a breast cancer risk assessment. The primary goal of this pilot study is to determine the content validity of the investigator-designed draft questionnaire. The outcome measure of a final questionnaire is to assess general acceptability of breast cancer risk assessment and degree of acceptability based on a) knowledge and awareness of breast cancer, b) varying levels of involvement and invasiveness of a risk assessment procedure, and c) perceived potential effectiveness of risk reducing interventions. Acceptability of risk assessment, willingness to undergo therapy and follow through with recommendations is assessed independent of currently available and new developments of risk assessment procedures.The secondary goal of this study is to test the overall comprehensibility (e.g. language, clarity), question acceptability (e.g. appropriateness of response selection), and reliability of the questionnaire.Information gained from this pilot study will be considered in the development of a final questionnaire to be administered to a large population representative cohort. The results of the planned future study will provide directions for the development of educational strategies in the TIBS research program that should accompany increases in public awareness on risk factors, the availability of risk assessment tools and preventive lifestyle and insight into the extent of broad-based community education strategies required to initiate and sustain interest in assessment for breast cancer risk among women in the general public to facilitate informed decision-making related to breast health in these women. Critical gaps in knowledge of risk factors and preventive lifestyle changes identified in this subsequent study can provide a focus for the educational strategies, which may address: the costs of risk assessment (e.g. stress, financial, inconvenience) and the development of understandable and practical educational materials to ensure their accessibility to a broad range of audiences, including those women who may be candidates for risk reducing interventions but who are not yet aware of its availability. The ultimate hypothesis of a future large-scale study is:General knowledge and awareness of breast cancer, psychosocial factors such as perceived risk susceptibility and perceived costs of risk assessment (e.g. stress, financial, inconvenience), perceived effectiveness of intervention strategies, and socio-demographic position are determinants of accepting risk assessment.However, to help guide questionnaire design and development, a pilot study is required to identify issues of the questionnaire such as content validity, overall comprehensibility (e.g. language, clarity), question acceptability (e.g. appropriateness of response selection), and reliability. To achieve the goals of the pilot study, we intend to recruit 50 women between ages of 25 - 74 years (10 per age group, 25 - 34, 35 - 44, 45 - 54, 55 - 65, 65 - 74). A 26-item investigator-designed, self-administered questionnaire was designed with standard measures. The questionnaire consists of 7 sections covering the following topics: Breast Cancer Knowledge and Awareness, Susceptibility Perception, Likelihood of Undergoing Risk Assessment, Benefits and Barriers of Risk Assessment, Breast Cancer Risk Assessment, Risk Reduction Intervention, and Demographics
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 25 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort recruited from the University Health Network community.
Key inclusion criteria (2 listed)
- Are 25 - 74 years of age
- Are in good health
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 15 Nov 2007.
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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.
Lothar Lilge, PhD principal investigator
Ontario Cancer Institute, University Health Network, Toronto, Ontario, Canada M5G 2M9; Department of Biophysics and Bioimaging, University of Toronto, Toronto, Ontario, Canada M5G 2M9
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, run by University Health Network, Toronto at 1 site in Canada.
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 2 inclusion and 0 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 15 Nov 2007. 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 Canada. 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.
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 15 Nov 2007.