To develop and evaluate a screening questionnaire as an aid in identifying individuals experiencing significant psychosocial problems associated with cancer genetic counseling. The questionnaire will be multidimensional and will be developed…
ID
Source
Brief title
Condition
- Chromosomal abnormalities, gene alterations and gene variants
- Family issues
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameters are the screening questionnaire and the results of
the interview between the social worker and the counselee.
The following information will be extracted from the medical records:
demographic data, number of affected relatives, age at which (s)he was first
confronted with cancer in the family, types of cancer in the family, age at
genetic testing, genetic test results, and whether (s)he has ever been treated
for cancer. Additionally, information will be collected on previous
professional psychosocial treatment and history.
Secondary outcome
not applicable
Background summary
Approximately 20% of individuals undergoing genetic counseling and/or testing
for cancer experience significant psychosocial problems and worries during or
after this process. These problems (i.e., generalized distress, decisional
conflict, cancer worries, family communication, cancer-related grief, concerns
about insurance, etc.) can be addressed effectively with professional support.
However, without appropriate screening tools, 30% of counselees with
psychosocial problems remain undetected in daily practice. Therefore, the
development of a screening instrument in cancer genetics is warranted.
Study objective
To develop and evaluate a screening questionnaire as an aid in identifying
individuals experiencing significant psychosocial problems associated with
cancer genetic counseling. The questionnaire will be multidimensional and will
be developed according to standardized procedures. It will be evaluated for its
reliability, validity, sensitivity, specificity and positive predictive value
for detecting psychosocial problems and psychosocial support needs.
Study design
The questionnaire is expected to cover three broad domains of psychosocial
problems: a) general psychological problems such as anxiety and depression, b)
cancer-specific problems such as fear of developing cancer (recurrence) and
unresolved grief over one*s own cancer/ cancer of a close relative and c)
genetic-specific problems such as decisional conflict regarding genetic testing
or risk reducing options, problems in informing children and relatives about
cancer risk and practical concerns (e.g. insurances). The questionnaire
development process will consist of four phases according to EORTC guidelines
for questionnaire module development: 1) generation of relevant issues, 2)
operationalization of these issues into a set of items, 3) pre-testing the
questionnaire (the first 20 participants) and 4) field testing of the resulting
questionnaire*s psychometric and screening properties. The study sample will
consist of new counselees (N=180) who attend the NKI-AVL family cancer clinic.
During the fourth phase of the study all counselees will be invited to complete
the screening questionnaire just prior to their second visit at the family
cancer clinic (thus after an informative intake session), and at follow-up
(three weeks after their final counseling). At both assessment points, the
counselees will also be interviewed by a trained psychosocial worker who will
use a semi-structured interview (*gold standard*) to determine the problem
areas that warrant further services. The properties of the screening
questionnaire will be evaluated with a standard set of psychometric procedures.
Study burden and risks
Study participants are invited to complete the screening questionnaire and an
interview with a social worker, which will take approximately 60 minutes in
total. This will take place prior to their second visit at the family cancer
clinic.
Three weeks after receiving their test result, participants will be asked to
complete the screening questionnare again. After filling in they will be
contacted by phone to have an interview with a social worker. This will take
approximately 60 minutes in total. There is no specific benefit or burden for
the participant because of their participation in the study.
The screening instrument developed during this study will facilitate efficient
and timely identification of individuals undergoing cancer genetic counseling
who are in need of psychosocial services or suffer from specific psychosocial
problems that may require additional professional support. This, in turn, can
facilitate appropriate planning and provision of psychosocial services within
the family cancer clinic context. The availability of this screening instrument
will set stage for future intervention studies aimed at decreasing onco-genetic
related psychosocial problems or to investigate the effectiveness of the
instrument measuring communication between counsellors and clients, the
awareness of clients* problems, appropriate counseling behaviour and correct
referrals which should lead to an increase in health related quality of life.
Plesmanlaan 121
1066 CX Amsterdam
NL
Plesmanlaan 121
1066 CX Amsterdam
NL
Listed location countries
Age
Inclusion criteria
1) between 18 and 70 years of age
2) in sufficient command of the Dutch language to complete the questionnaires
3) attendees of a second visit at the family cancer clinic because of increased risk of developing cancer due to hereditary predisposition
Exclusion criteria
Those who not fulfill the inclusion criteria
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL29969.031.09 |