One of the aims of the renewed kConFab grant is to start annual review of families enrolled into kConFab. The main
aim of this annual review is to offer participation to individuals who have become eligible for kConFab since the family
collection was completed. This includes:
- children who have turned 18 since the family collection was ‘completed’
- first degree relatives of women how have become affected with breast or ovarian cancer in this period
- first degree relatives of men and women who have learnt (though attendance at a Family Cancer Clinic) that they carry a
BRCA1 or BRCA2 mutation. Note that this is a new direction for kConFab – until now first degree relatives of carriers
(who know they are carriers) have not formally been part of the recruitment criteria.
The annual review by kConFab RNs will need to link closely with the Clinical Follow Up (CFU) project to avoid contact of
the same people by the core RNs and CFU staff in a short period of time. In addition, transfer of information from the CFU
staff to kConFab RNs regarding new cases of breast and ovarian cancer in the family is necessary so that the RNs can approach
newly eligible family members.
The protocol for annual review will be as follows:
- The RNs to contact the Family Contact Person (FCP) to say that annual review is starting, and to
- if they know of newly affected cases which would therefore render their first degree relatives eligible for recruitment
into the study. No person can be approached by an RN unless they have first been approached by an enrolled family member. As with
the existing protocol, the RNs will ask the FCP to contact these newly eligible first degree relatives to determine if they
would like to receive information about the project. [Care must be taken not to overload the FCP by asking them to make
contact with extended family relatives etc.] However, if the “new” reported case of cancer is already a
consented kConFab participant, the RN can contact this person directly for an update.
If you have been in touch with
the FCP in the last 12 months and covered the issue of newly affected cases, then there is no need to call them again
for another 12 months.
- if the FCP knows of any new surgeries (including prophylactic). The same steps can followed as in point a) above for
unconsented and consented participants
- The RNs to try to recruit first degree relatives of newly affected cases of breast and ovarian cancer.
The approach could be via the FCP (see above). Alternatively, if the cancer is self reported (to the kConFab
RNs or to the CFU Study) then the RNs can ask the newly affected case for permission to approach their first degree
relatives. If the cancer is not reported by any member of the family (e.g. determined through Cancer Councils) then there
is no ethical way that the RNs can approach the first degree relatives and so this cannot be done.
- The RNs to try to recruit those who turned 18 since last contact . They should only do this by getting
permission from a parent who is enrolled in kConFab. If both parents have previously refused participation in kConFab, the
RNs should not consider an approach to the offspring at all. If no parent is alive to request
permission to contact the children, then we will need to reconsider if/how we can approach the children on a case-by-case
basis, perhaps with the advice of another family participant.
- The RNs to try to recruit first degree relatives of BRCA1/2 carriers. In reality this is usually
impossible to do because the RN does not know who the carriers are, and even if they did should not impart this information
to the carrier either directly, or indirectly by approaching their relatives. Therefore, at the moment this can only be
done if the carrier tells the RN of their carrier status, or if the FCC informs the RN that the results have been obtained
and they can now approach the carrier for contact with their relatives. In future we might try to have a regular link to
the FCCs to determine which carriers have received their results.
The source of the information regarding new affection or carrier status (self report, family member, FCC etc)
should be recorded to document compliance with Privacy Guidelines.
In the grant application we said that we would complete annual review of all the ‘completed’ kConFab
families in 2003. This was clearly overly ambitious since we need recruitment of new families to continue at almost the
same pace as previously. We have therefore revised the aim for 2003 to be annual review of all families whose collection
started between 1997-mid 1999. Once these have been completed we can move on to families recruited in late 1999, and early
2000 but first the RN should contact Prue Weideman to see how recently the Clinical Follow Up study has approached
them. It is likely that in fact ‘annual review’ will become biannual review, with the aim being in 2004 to
review all families down loaded in 2001 and 2002, and in 2005 to review families down loaded in 2003.
The annual review will need to be initiated as soon as possible but monitored mid-year to determine how much time it
is occupying, and how much it is impacting on the collection of new families. While clearly it will affect the number of
new families down loaded, it may not impact much on the numbers of bloods collected, as the intention is for the annual
review to recruit new family members (with blood samples) from previously ‘completed’ families.
(Updated July 2005)