Informing relatives about their cancer risk and preventive measures. A trial to assess the effectiveness of additional counseling.

The identification of a hereditary or familial breast or colon cancer risk has
not only implications for the counselee, but also for his or her relatives.
Relatives need to be informed about their possible risk so they can make an
informed decision about whether or not to pursue genetic counseling, testing
and/or preventive breast or colon screening. Generally, fewer relatives present
to genetic services for care than would be expected. Of first degree relatives,
an average of 40% present to genetic services for care. Percentages for 2nd and
3rd degree relatives are even lower. The limited uptake of genetic and
screening services raises the question whether and how at risk relatives are
informed by the counselee. Literature suggests that counselees may encounter
barriers in family disclosure which result from lack of knowledge (e.g. not
knowing who is at risk), not being motivated to inform (e.g. wanting to protect
relatives for negative emotions) and not being able to inform (e.g. loss of
contact).

The aim of this study is to evaluate an intervention aimed at improving family
disclosure of inherited cancer risks by 1) supporting counselees in what they
experience as a necessary, but at times difficult, task and, consequently 2)
provide more at risk relatives with the opportunity to make an autonomous, well
informed decision (not) to go for genetic counseling, testing and/or preventive
screening

More specifically, we will aim to answer the following research questions:
Does one additional counselling session, focused at counselees* disclosure of
genetic risk and preventive measures for cancer to relatives lead to
1. counselees feeling more knowledgeable, motivated and capable to disclose
genetic risk information to their at risk relatives, and
2. counselees informing more at risk relatives,
3. increased knowledge about hereditary cancer and preventive measures in
relatives,
4. increased intention among relatives to engage in genetic counseling, testing
and/or preventive screening?

To this end we propose a randomized clinical trial. Counselees in the control
group (n= 132) will receive standard care. Counselees in the intervention group
(n=132) will receive one additional counseling session, provided by one of five
psycho-social workers, aimed at whether and how best to inform at risk
relatives. This intervention will be based on the principles of Motivational
Interviewing. Assessments, consisting of questionnaires, will take place before
the final scheduled regular genetic counseling session (T1), immediately
following the intervention (T2) and at 4 months after the intervention (T3). A
part of the questionnaire at T2 will be completed together with the researcher
by telephone.
At the final assessment counselees are asked if they are willing to ask
relatives with whom they shared the hereditary risk information to participate
in the study. These relatives will receive one questionnaire.

(Index) patients in the intervention group will receive an additional
counseling session aimed at informing at risk relatives. This session will be
delivered by a psycho-social worker and will take place two weeks after they
received the summary letter from the department of Clinical Genetics. This will
allow counselees some time to reflect on the implications of the (test) result
for themselves and their relatives, and to anticipate possible obstacles in
informing at risk relatives. The intervention will be delivered by telephone.

The burden of the study will comprise the completion of three questionnaires by
all participating counselees. Completion in total will take 60 minutes.
Counselees in the intervention group will additionally receive a telephone
counselling session delivered by a psychosocial worker. This session will last
on average 30 minutes. Relatives complete one questionnaire.