Ignite Creation Date:
2024-05-06 @ 12:23 AM
Last Modification Date:
2024-10-26 @ 10:49 AM
Study NCT ID:
NCT01562431
Status:
COMPLETED
Last Update Posted:
2014-01-24
First Post:
2011-12-20
Brief Title:
The Signal-Trial Evaluation of a Screening Tool for Psychosocial Problems in Cancer Genetics
Sponsor:
The Netherlands Cancer Institute
Organization:
The Netherlands Cancer Institute
Study Overview
Official Title:
The Signal-Trial Evaluation of a Screening Tool for Psychosocial Problems in Cancer Genetics
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
An important part of individuals undergoing genetic counseling andor 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 N264 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
An important part of individuals undergoing genetic counseling andor 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 N264 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2008-4016 | OTHER_GRANT | Dutch Cancer Society | None |