Cancer Genetics Clinical Trial
Official title:
The Signal-Trial: Evaluation of a Screening Tool for Psychosocial Problems in Cancer Genetics
Background
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 the investigators 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.
Aim
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.
Method
This study is a collaboration between the family cancer clinics of the NKI-AVL and the UMCU.
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=264) 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.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
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