The Signal-Trial: Evaluation of a Screening Tool for Psychosocial Problems in Cancer Genetics

This study has been completed.
Sponsor:
Collaborator:
UMC Utrecht
Information provided by (Responsible Party):
The Netherlands Cancer Institute
ClinicalTrials.gov Identifier:
NCT01562431
First received: December 20, 2011
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Psychosocial Issues
Cancer Genetics
Other: Feed-back

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: The Signal-Trial: Evaluation of a Screening Tool for Psychosocial Problems in Cancer Genetics

Resource links provided by NLM:


Further study details as provided by The Netherlands Cancer Institute:

Primary Outcome Measures:
  • Communication on psychosocial issues at the counseling session [ Time Frame: 3 weeks after randomization ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Initiation of discussed problems [ Time Frame: Counseling session (3 weeks after randomization) and telephone follow-up (up to 4 months after randomization) ] [ Designated as safety issue: No ]
  • Time spent on psychosocial problems [ Time Frame: Counseling session (3 weeks after randomization) and telephone follow-up (up to 4 months after randomization) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 246
Study Start Date: October 2011
Study Completion Date: June 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Control
Participants complete the Signal-checklist BUT counselors do not obtain the results of the checklist
Other: Feed-back
Counselors will receive the results of the completed Signal-checklist completed by participants in the intervention group
Intervention
Participants complete the Signal-checklist AND the counselor will get the results of the questionnaire
Other: Feed-back
Counselors will receive the results of the completed Signal-checklist completed by participants in the intervention group

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01562431

Locations
Netherlands
Netherlands Cancer Institute
Amsterdam, Noord-Holland, Netherlands, 1066 cx
Sponsors and Collaborators
The Netherlands Cancer Institute
UMC Utrecht
Investigators
Principal Investigator: E.M.A. Bleiker, PHd. The Netherlands Cancer Institute
Principal Investigator: N.K. Aaronson, PHd. The Netherlands Cancer Institute
Principal Investigator: D.E.E. Hahn, MSc. The Netherlands Cancer Institute
Principal Investigator: I Kluijt, MSc. The Netherlands Cancer Institute
  More Information

No publications provided by The Netherlands Cancer Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT01562431     History of Changes
Other Study ID Numbers: P11SIG, 2008-4016
Study First Received: December 20, 2011
Last Updated: January 23, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

ClinicalTrials.gov processed this record on October 29, 2014