Psychosocial IssuesNCT01562431
The Signal-Trial: Evaluation of a Screening Tool for Psychosocial Problems in Cancer Genetics
A study testing Feed-back in people with Psychosocial Issues and Cancer Genetics, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychosocial Issues, Cancer Genetics
- What is being tested?
- Feed-back
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2011to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Those who do not fulfill the inclusion criteria
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Netherlands Cancer Institute
Amsterdam, North Holland, 1066 cx
About this study
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.
Read more
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.
- Conditions
- Psychosocial Issues, Cancer Genetics
- Being tested
- Feed-back
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feed-backOther
Counselors will receive the results of the completed Signal-checklist completed by participants in the intervention group
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Participants complete the Signal-checklist BUT counselors do not obtain the results of the checklist Receives: Other: Feed-back |
| Intervention | Other | Participants complete the Signal-checklist AND the counselor will get the results of the questionnaire Receives: Other: Feed-back |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks after randomization
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
Measured: 3 weeks after randomization
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.
Measured: 3 weeks after randomization
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.
Measured: up to 4 months after randomization
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
Measured: Up to 4 months after randomization)
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.
Measured: Up to 4 months after randomization
Secondary outcomes (6)
Initiation of discussed problems
Measured: Counseling session (3 weeks after randomization) and telephone follow-up (up to 4 months after randomization)
Time spent on psychosocial problems
Measured: Counseling session (3 weeks after randomization) and telephone follow-up (up to 4 months after randomization)
Counselee and counselor's level of satisfaction
Measured: 4 weeks after counseling session (7 weeks after randomization) and 4 months after telephone follow-up (up to 8 months after randomization)
Levels of counselee cancer worries
Measured: 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)
Number of psychosocial problems
Measured: 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)
Counselee and counselor evaluation of the intervention/ feasibility of the implementation of the intervention
Measured: 4 weeks after counseling session (7 weeks after randomization) and 4 months after telephone follow-up (up to 8 months after randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startOct 2011
- Primary completionJan 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychosocial IssuesStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- UMC Utrecht
- Responsible party
- Sponsor
- Investigators
- E.M.A. Bleiker, PHd., Principal investigator, The Netherlands Cancer InstituteN.K. Aaronson, PHd., Principal investigator, The Netherlands Cancer InstituteD.E.E. Hahn, MSc., Principal investigator, The Netherlands Cancer InstituteI Kluijt, MSc., Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01562431
- Sponsor's protocol ID
- P11SIG
- Other IDs
- 2008-4016
- Status last verified
- Jan 2014
- First submitted
- 20 Dec 2011
- Last updated
- 24 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Eijzenga W, Aaronson NK, Kluijt I, Sidharta GN, Hahn DE, Ausems MG, Bleiker EM. The efficacy of a standardized questionnaire in facilitating personalized communication about problems encountered in cancer genetic counseling: design of a randomized controlled trial. BMC Cancer. 2014 Jan 15;14:26. doi: 10.1186/1471-2407-14-26.
PubMed 24428912
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Signal-Trial: Evaluation of a Screening Tool for Psychosocial Problems in Cancer Genetics
- ClinicalTrials.gov ID
- NCT01562431
- Acronym / sponsor ID
- P11SIG
- Conditions
- Psychosocial Issues, Cancer Genetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Collaborators
- UMC Utrecht
- Study start
- Oct 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 23 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: Feed-backParticipants complete the Signal-checklist BUT counselors do not obtain the results of the checklist |
| Intervention | Other | Other: Feed-backParticipants complete the Signal-checklist AND the counselor will get the results of the questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Those who do not fulfill the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feed-backCounselors will receive the results of the completed Signal-checklist completed by participants in the intervention group | Other | Control, Intervention |
Primary outcome
Communication on psychosocial issues at the counseling session
Time frame: 3 weeks after randomization
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.
Counselors awareness of psychosocial problems of the counselee at the counseling session
Time frame: 3 weeks after randomization
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
Management of these psychosocial problems of the counselee during the counseling session
Time frame: 3 weeks after randomization
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.
Communication on psychosocial issues at telephone follow-up
Time frame: up to 4 months after randomization
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.
Counselors awareness of psychosocial problems of the counselee at follow-up
Time frame: Up to 4 months after randomization)
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
Management of these psychosocial problems of the counselee at follow-up
Time frame: Up to 4 months after randomization
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.
6 secondary outcomes
Initiation of discussed problems
Time frame: Counseling session (3 weeks after randomization) and telephone follow-up (up to 4 months after randomization)
Time spent on psychosocial problems
Time frame: Counseling session (3 weeks after randomization) and telephone follow-up (up to 4 months after randomization)
Counselee and counselor's level of satisfaction
Time frame: 4 weeks after counseling session (7 weeks after randomization) and 4 months after telephone follow-up (up to 8 months after randomization)
Levels of counselee cancer worries
Time frame: 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)
Number of psychosocial problems
Time frame: 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)
Counselee and counselor evaluation of the intervention/ feasibility of the implementation of the intervention
Time frame: 4 weeks after counseling session (7 weeks after randomization) and 4 months after telephone follow-up (up to 8 months after randomization)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2014.
- Derived from this study: PubMed 24428912Eijzenga W, Aaronson NK, Kluijt I, Sidharta GN, Hahn DE, Ausems MG, Bleiker EM. The efficacy of a standardized questionnaire in facilitating personalized communication about problems encountered in cancer genetic counseling: design of a randomized controlled trial. BMC Cancer. 2014 Jan 15;14:26. doi: 10.1186/1471-2407-14-26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
E.M.A. Bleiker, PHd. principal investigator
The Netherlands Cancer Institute
N.K. Aaronson, PHd. principal investigator
The Netherlands Cancer Institute
D.E.E. Hahn, MSc. principal investigator
The Netherlands Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feed-back in people with Psychosocial Issues and Cancer Genetics, run by The Netherlands Cancer Institute at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Communication on psychosocial issues at the counseling session (time frame: 3 weeks after randomization). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01562431, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2014.