Trial Information

A Pilot Study: Psychosocial and Socio-Demographic Determinants of Accepting Breast Cancer Risk Assessment

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