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 entailed 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 included 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 groups of 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 10-year survivors enrolled in the
cohort provided compelling support for the potential benefits and knowledge to be gained by
prospective and systematic evaluations of all cohort members. In addition, evaluation of
participants earlier in survivorship (i.e., before 10 years from diagnosis) was perceived to
enhance opportunities to characterize the pathophysiology of emerging late onset
treatment-related toxicities. Therefore, the cohort will be expanded by changing the
eligibility from +10 years of survival and +18 years of age to 5+ years from cancer diagnosis
regardless of age. As part of the expansion of the SJLIFE study, participants will now
undergo systematic organ function evaluations (e.g., echocardiography, pulmonary function
testing, audiological testing, ophthalmologic evaluation, bone mineral density testing). In
addition, all participants will undergo a comprehensive psychosocial assessment by a licensed
social worker and receive, as needed, assistance with referrals to community providers and
resources for ongoing care. In general, most survivors will have evaluations scheduled to
occur within a 4 to 5 year interval.

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 non-first degree 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.

As part of SJLIFE initiative a group of study subjects who are not survivors of childhood
cancer (community controls) will be recruited. These controls will serve as a comparative
group to the aging survivors in SJLIFE cohort for assessing health-related, psychosocial, and
quality of life outcomes.

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

Inclusion Criteria:

- Patient will have a diagnosis of childhood malignancy (or neoplasm requiring similar
therapy) that was treated or followed at St. Jude Children's Research Hospital.

- Patient will be at least five years from diagnosis.

- Patient is willing to participate at any level of study

- Patient is willing to comply with the guidelines of St. Jude domiciliary care
facilities

- Patient or legally authorized representative must sign informed consent for study
participation.

Control Participant:

- ≥5 years of age

- Non-first degree relatives or friends of St. Jude patients or former patients or SJCRH
employees/affiliates who are not SJLIFE study team members, or family members of
SJLIFE study team, or supervised by a SJLIFE study team members, or any volunteer not
associated with St. Jude.

- Participant does not have a diagnosis of childhood malignancy or childhood neoplasm
requiring similar therapy (i.e., diagnosed <21 years of age).

- Participant is not currently pregnant or lactating.

- Patient is willing to comply with the guidelines of St. Jude domiciliary care
facilities.

- Patient must sign informed consent for study participation.

Exclusion Criteria:

- Patient or control subject refuses to participate at any level of study