Trial Information

Establishment of a Lifetime of Cohort of Adults Surviving Childhood Cancer

SJLIFE will be implemented in progressive stages with specific objectives to permit
knowledge gained in each phase to inform content/format/study design of subsequent stages.
The planned stages of the study include 1) Pre-Recruitment Study, 2) Barriers to
Participation Survey, 3) Pilot Study of Recruitment Strategies, 4) Pilot Studies of
High-Risk Survivor Cohorts, 5) Cross-Sectional Study of 10-year survivors, and 6)
Prospective Lifetime Cohort Study.

Stage I entails telephone interviews with a random sampling of potentially eligible
survivors to obtain subjective feedback regarding barriers and facilitators to SJLIFE
recruitment and participation. The random sample will include thirty alumnus survivors
representing a broad representation of race, gender, attained age, years from diagnosis and
primary diagnostic groups. The interview content comprised assessment of interest,
decision-making factors, and barriers to participation, current

In Stage 2, the Barriers to Participation Survey will be distributed to a random sampling of
500 patients representative of the potentially eligible cohort by age, race, sex, geographic
distribution, primary diagnosis and time from diagnosis; 200 patients will be randomly
selected up front to receive follow-up communication by telephone if they fail to return
completed surveys. Information obtained from responses to the questionnaire will inform a
subsequent randomized recruitment trial and provide insight regarding retention procedures.

In Stage 3, a pilot study will be undertaken to assess feasibility and potential pitfalls in
recruitment for the Lifetime Cohort. Introductory letters will be sent to 300 alumni
survivors, with a broad representation across targeted diagnostic groups, to invite their
participation in the Lifetime Cohort. Recruitment approaches will be informed by the
findings of the Barriers to Participation Survey. Parameters that will be assessed related
to feasibility include 1) accuracy of contact information in hospital system (need for
tracing of potentially eligible research participants); 2) number of eligible participants
actively or passively declining study participation; and 3) reasons for declining
participation. The pilot study will provide insight regarding the need for implementing
procedures to track potential study participants who are "lost to follow-up" or incentives
to recruit and retain study participants.

In Stage 4, a pilot study will be undertaken in 20 groups of 20 survivors identified by
SJLIFE investigators to be at high risk for cancer-related morbidity based on specific
demographic, diagnostic, therapeutic, or genetic/familiar factors. In addition to
utilizing data collected from the risk-based evaluations performed in the Cross-Sectional
study these individuals will undergo more extensive assessment beyond the screening
recommendations outlined in the COG Guidelines to determine the frequency and more
thoroughly characterize the extent specific treatment complications, as well as define the
need for further study. Knowledge gained in this pilot study will provide important
preliminary results that will be used to develop proposals for extramural funding for
further study of the identified vulnerable populations.

In Stage 5, a cross-sectional study of the cohort of 10 or more year alumnus survivors will
be undertaken using a risk-based assessment as recommended by the COG Guidelines. The first
year of the study will target accrual of survivors with a diagnosis of acute lymphoblastic
leukemia, Hodgkin lymphoma, and acute myeloid leukemia who are 30 years or older. The
second year will target enrollment of survivors of central nervous system tumors, Wilms'
tumor and other bone/soft tissue sarcomas. The third year will target accrual of the
remaining diagnostic subtypes. The prevalence of late treatment complications detected by
risk-based screening will provide important information regarding the appropriateness of the
COG Guidelines recommendations in at risk survivor populations after specific therapeutic
exposures.

In Stage 6, information gained from the evaluations of survivors in the cross-sectional
cohort will inform the final composition of the "high priority" cohort that will be invited
to continue with periodic onsite evaluations in the prospective study. Evaluations will be
undertaken using the same risk-based assessment as recommended by the COG Guidelines. The
frequency of follow-up of the specific diagnostic subtypes will vary according to the
prevalence of treatment complications determined during the cross-sectional study. In
general, most survivors will have evaluations scheduled every 2 to 5 years. Survivors not
targeted as high priority for onsite outcomes investigation will continue with follow-up
through mail questionnaires and the St. Jude Cancer Registry.

Several activities are planned to optimize communication with participating survivors about
research activities involving the Lifetime Cohort. A newsletter will be distributed on a
semi-annual basis for the purpose of 1) maintaining contact through periodic mailings (which
include an address correction request from the post-office that can identify individuals who
have moved from their last known address and may require additional tracing to re-establish
contact); 2) providing an update on the status of the project; and 3) maintaining and
enhancing the relationship with participants and 4) educating survivors about selected
topics of health-related importance. In addition, a website will be developed that will
serve as a resource that updates the progress of Lifetime Cohort activities.

Adults who are siblings, parents, other relatives or friends of St. Jude patients or former
St. Jude patients will be invited to participate as a control in this study during the time
of the child's St. Jude clinic visit. Employees who request to be in the study may volunteer
if they are not a SJLIFE study team member or not supervised by a SJLIFE study team member.
Flyers will also be placed in the clinic areas and elevators on the SJCRH campus. In
addition, recruitment drives may be held periodically in various locations on the St. Jude
Children's Research Hospital (SJCRH) campus. An announcement of the drive may be made by
email and placed in St. Jude Today. Their participation in the study involves the storage
of biological samples. Controls will be recruited by, and should discuss their desire to
participate with, a member of the St. Jude Life clinical staff. The individual will then be
registered as a "Research Participant" by a member of the study team and informed consent
will be obtained using the SJLIFE Banking Control consent document. The individual will then
be registered as a "Research Participant" by a member of the study team and informed consent
will be obtained. Participants will be compensated with a $25 gift card for their
participation.

Control enrollment to this protocol is expected to average 200-300 participants in the first
year; with an estimated targeted accrual of 1200.