ClinicalTrials.gg
CompletedNCT00234715Updated Nov 15, 2007

Psychosocial Study on Breast Cancer Risk Assessment

An observational study in Breast Cancer, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to female participants aged 25 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-11-15.

Sponsored by University Health Network, Toronto · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
62
Ages
25 Years to 74 Years
Sex
Female
01

Study 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. 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

02

Conditions studied

  • Breast Cancer

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Keywords

  • Breast Cancer
  • Breast Cancer Risk
  • Breast Cancer Risk Assessment
  • Psychosocial
  • Acceptance
03

In context

Breast Neoplasms

12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

This study's enrollment of 62 is below the median of 184 across 2,711 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,432 studies on the registry; 292 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 74 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Cohort recruited from the University Health Network community.

Eligibility criteria

Inclusion Criteria:

  • Are 25 - 74 years of age
  • Are in good health
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
62 participants (actual)
06

Study locations

1 site
  • Ontario Cancer Institute / Princess Margaret Hospital
    Toronto, Ontario M5G 2M9, Canada
07

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2005 and a completion of Aug 2006. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 5, 2005
First posted
Oct 7, 2005
Start
Oct 2005
CompletionActual
Aug 2006
Last update
Nov 15, 2007
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 15, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00234715
First posted
Oct 7, 2005
Start date
Oct 2005
Completion
Aug 2006
Last update
Nov 15, 2007

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2007. You cannot join it, but the record below documents what was studied.

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