The development and evaluation of two decision aids for individuals considering genetic testing for hereditary cancer.

Recruiting

• Conditions: Hereditary breast/ovarian cancer; Hereditary non-polyposis colorectal cancer (HNPCC).; Cancer - Breast; Cancer - Ovarian and primary peritoneal; Cancer - Bowel - Back passage (rectum) or large bowel (colon)

• Registration Number: ACTRN12605000573651
• Lead Sponsor: Dr. Bettina Meiser

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-10-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

To be eligible to participate in the study, patients must meet all the following criteria: (i) be at potentially high risk of breast/ovarian cancer (family history consistent with hereditary breast/ovarian cancer syndrome [National Breast Cancer Centre Category 3]) or HNPCC (family history consistent with HNPCC according to the revised Amsterdam criteria); (ii) be eligible for genetic testing, that is either be affected with cancer or, if unaffected, have a living, affected relative for whom mutation search would be appropriate; (iii) be able to give informed consent; (iv) be able to read English proficiently.
Men from HNPCC families will be included because the larger number of them (compared to breast/ovarian cancer families) will enable meaningful statistical analysis of their responses.

Exclusion Criteria

Men from breast cancer families will not be invited to participate because of the low number of men attending familial cancer clinics and because of the substantial differences in the needs of men attending these clinics compared to women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome for the study is decisional conflict (measured by the Decisional Conflict Scale). This scale measures uncertainty about choosing among alternatives; modifiable factors contributing to uncertainty, such as being uninformed and unclear about values and feeling unsupported in decision-making, and perceptions of effectiveness of decision-making[Assessed immediately after reading the information materials provided, and in the 6-month follow up questionnaire.]

Secondary Outcome Measures

Name	Time	Method
1: Knowledge of the genetic testing process and the pros and cons of genetic testing. Six true-false items were purposively designed for this study and assess knowledge about the testing process and the pros and cons of genetic testing.[This is assessed immediately after reading the information materials provided, and in the 6 month follow up questionnaire.];2: Informed Choice (measured by the Multidimensional Measure of Informed Choice). This scale classifies patients as having made an informed or uninformed choice. An informed choice is defined as one based on relevant knowledge, consistent with the decision-makers values and behaviourally implemented.[This is assessed immediately after reading the information materials provided, and in the 6 month follow up questionnaire.<br>]