Optimalisation of genetic counseling for patients with breast cancer, by also making use of other ways to provide information than the personal consultation.
ID
Source
Brief title
Condition
- Chromosomal abnormalities, gene alterations and gene variants
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Satisfaction of the patient regarding genetic testing and counseling
Psychological / psychosocial burden of the patient regarding genetic testing
and counseling
Secondary outcome
Factors that determine the patient*s choice for or against the DNA-direct
procedure
Waiting and processing times
Family characteristics of detected families with a mutation or a so-called
unclassified variant type 3 (UV-III) in the BRCA1 or BRCA2 gene
Background summary
It is customary for breast cancer patients who are referred to Human Genetics
for genetic advice, to receive a consultation with a genetic counselor both
prior to as following the results of DNA-testing. In this first consultation,
information regarding the chances and (im)possibilities of DNA-testing is
discussed, before DNA-testing for a mutation in the BRCA1 or BRCA2 genes is
started. This information is for the most part generic. A consultation prior to
DNA-testing is sometimes perceived as a delaying factor by breast cancer
patients and/or their referring doctors, due to the result of DNA-testing being
required for personal genetic advice. It is also known that patient recall for
oral medical information is generally low.
We want to evaluate the effects of replacing the first consultation by
information provided by telephone plus written and digital form with a movie
and website (DNA-direct procedure) on the experience and psychosocial burden of
breast cancer patients, as well as the speed and quality of genetic advice.
This will be compared to the current procedure where oral information is
provided during a consultation before DNA-testing (DNA-intake procedure).
Study objective
Optimalisation of genetic counseling for patients with breast cancer, by also
making use of other ways to provide information than the personal consultation.
Study design
150 patients who are or have been in treatment for breast cancer and were
referred for genetic counseling, may choose whether to have a personal
consultation or information by telephone and written/digital form, prior to DNA
testing. All patients receive the same questionnaires when included (baseline)
and after the result of genetic counseling (outcome). A small selection of
these patients, namely 1) those who carry a mutation in the BRCA1 or BRCA2
gene, or 2) patients who report problems with the procedure, as well as 3)
patients chosen by random selection (n=10), then receive an invitation for a 30
minute long semistructured interview by telephone. The expected total of
interviewees is 30 of 150 patients.
Study burden and risks
Time investment in order to fill in 2 questionnaires (20 minutes per
questionnaire) and for 30 of 150 patients (20%) to be interviewed once (30
minutes).
postbus 9101
6500HB
NL
postbus 9101
6500HB
NL
Listed location countries
Age
Inclusion criteria
All female breast cancer patients (recently diagnosed or in the past) referred to Human Genetics of the Radboud University Medical Centre Nijmegen for genetic counseling.
Exclusion criteria
For the DNA-direct procedure: problems with (large amounts of) written Dutch text, current psychological / psychiatric treatment (including medication), problems with family communication about cancer as estimated by the patient.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL36219.091.11 |
| OMON | NL-OMON22096 |