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.
| Status | Completed |
| Enrollment | 246 |
| Est. completion date | June 2013 |
| Est. primary completion date | January 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 18 years of age or older - Sufficient command of the Dutch language to be able to complete questionnaires - Attendees of a second visit at the family cancer clinic because of increased risk of developing cancer due to a hereditary predisposition Exclusion Criteria: - Those who do not fulfill the inclusion criteria |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Netherlands Cancer Institute | Amsterdam | Noord-Holland |
| Lead Sponsor | Collaborator |
|---|---|
| The Netherlands Cancer Institute | UMC Utrecht |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Communication on psychosocial issues at the counseling session | The counseling session at the clinic will be audio taped, and content analyzed to evaluate counselor- counselee communication. A study-specific checklist will be used to rate whether psychosocial problems are discussed during the counseling session. | 3 weeks after randomization | No |
| Primary | Counselors awareness of psychosocial problems of the counselee at the counseling session | After each consult with a counselee, the counselor will have to complete a short form regarding their awareness of psychosocial problems of the counselee. The level of agreement between the counselor and the counselee will be assessed | 3 weeks after randomization | No |
| Primary | Management of these psychosocial problems of the counselee during the counseling session | Management of the psychosocial problems will be measured using the audio-taped sessions. The study-specific checklist will be used to rate whether problems are being counseled during the session and/or counselees are being referred to extra psychosocial services. | 3 weeks after randomization | No |
| Primary | Communication on psychosocial issues at telephone follow-up | The telephone follow-up will be audio taped, and content analyzed to evaluate counselor- counselee communication. A study-specific checklist will be used to rate whether psychosocial problems are discussed during the counseling session. | up to 4 months after randomization | No |
| Primary | Counselors awareness of psychosocial problems of the counselee at follow-up | After each consult with a counselee, the counselor will have to complete a short form regarding their awareness of psychosocial problems of the counselee. The level of agreement between the counselor and the counselee will be assessed | Up to 4 months after randomization) | No |
| Primary | Management of these psychosocial problems of the counselee at follow-up | Management of the psychosocial problems will be measured using the audio-taped sessions. The study-specific checklist will be used to rate whether problems are being counseled during the session and/or counselees are being referred to extra psychosocial services. | Up to 4 months after randomization | No |
| Secondary | Initiation of discussed problems | Counseling session (3 weeks after randomization) and telephone follow-up (up to 4 months after randomization) | No | |
| Secondary | Time spent on psychosocial problems | Counseling session (3 weeks after randomization) and telephone follow-up (up to 4 months after randomization) | No | |
| Secondary | Counselee and counselor's level of satisfaction | 4 weeks after counseling session (7 weeks after randomization) and 4 months after telephone follow-up (up to 8 months after randomization) | No | |
| Secondary | Levels of counselee cancer worries | Before randomization (Baseline, 1 week before randomization), 4 weeks after counseling session (7 weeks after randomization) and 4 months after telephone follow-up (up to 8 months after randomization) | No | |
| Secondary | Number of psychosocial problems | Counseling session (3 weeks after randomization) and telephone follow-up (up to 4 months after randomization) and 4 months after telephone follow-up (up to 8 months after randomization) | No | |
| Secondary | Counselee and counselor evaluation of the intervention/ feasibility of the implementation of the intervention | 4 weeks after counseling session (7 weeks after randomization) and 4 months after telephone follow-up (up to 8 months after randomization) | No |
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