The Signal - Trial: evaluation of a screening tool for psychosocial problems in cancer genetics

An important part of individuals undergoing genetic counseling and/or testing
for cancer experience psychosocial problems and worries during or after this
process. Approximately 20% of these individuals experience serious problems,
such as fear for cancer in themselves or their relatives, family communication
problems, unresolved grief, problems in coping with the DNA-test-results,
difficulties in choices with regard to DNA-testing, preventive surgeries, and
concerns about insurance or work. Research shows that these problems are
frequently undetected by the counselors. Within the limited available time of a
counseling session, a lot of information should be given to the counselee. This
information is mostly biomedical and provider driven. Therefore psychosocial
issues can be underexposed. The use of a brief questionnaire, completed by the
counselee prior to the counseling session, can serve as a tool for the
counselor to screen and address the relevant psychosocial issues in a
systematic manner. Therefore, in 2009-2010 we have developed and validated the
*Signal-checklist* to identify relevant psychosocial problems frequently
encountered in the cancer-genetics setting, and need for extra psychosocial
services. This *Signal-checklist* can serve as a tool in screening
systematically for psychosocial issues, addressing these issues and directing
appropriate referrals to extra psychosocial services. The Signal-Trial will be
performed to evaluate the use and effectiveness of the checklist.

The aim of the trial is to evaluate the implementation of a short,
self-developed cancer-genetics checklist; the *Signal-checklist*, as an aid in
1) facilitating communication on psychosocial issues during the genetic
counseling session, 2) increasing counselors awareness of psychosocial problems
of the counselee, and 3) improving the management of these psychosocial
problems during and after the process of genetic counselling.

This study is a collaboration between the family cancer clinics of the NKI-AVL
and the UMCN. Individuals requesting genetic counseling for the high incidence
of cancer in their family are invited to participate in the trial. Participants
will be asked to complete the *Signal checklist* prior to their counseling
visit. Participants (N=200) will be randomly assigned to one of the two study
arms. The intervention group will receive feed-back on the *Signal-checklist*,
whereas the control group will not receive feed-back. Three weeks after the
DNA-test disclosure session, participants will be asked to complete again the
*Signal-checklist* followed by a telephone call by their counselor. Again, the
results of the *Signal-checklist* will be available to the counselor for
participants in the intervention group, but not for the control group. Both the
genetic counseling session and telephone call will be audio taped. Furthermore,
all participants will be asked to complete three questionnaires on the Internet
(or by mail, if preferred); 1) before randomization (3 weeks prior to the
counseling session), 2) three weeks after the counseling session, and 3) four
months after the potential DNA-test result disclosure. These questionnaires
include items on communication during genetic counseling, the need for
professional psychosocial support, cancer worries, satisfaction with received
care, and experiences with the use of the *Signal-checklist*. The audio-tapes
and completed questionnaires will be used to measure psychosocial problems of
the counselees, the awareness of the counselors of these problems, and the
management of these problems. Secondary analysis will be conducted to assess
the need for extra psychosocial services, satisfaction with genetic counseling,
feasibility of implementing the *Signal-checklist* and decreasing psychosocial
problems over time.

The intervention will take place twice: during genetic counseling (usually the
3rd contact with the clinic), and at follow-up (four weeks after the disclosure
of the test result). The intervention comprises: 1) the completion of the
*Signal-checklist* by the counselee, and 2) providing feedback by the counselor
to the counselee, based on the scores at the *Signal-checklist*.

Participants will be asked to complete five questionnaires, and will have a
telephone call with their counselor. We expect this to take maximally 2 hours
to complete in total. With the use of the 'Signal-checklist', we expect
psychosocial issues to be recognized in an earlier stage and managed properly.