Validation Study of Pediatric Patient-Reported Outcomes

A longitudinal framework was designed to collect data from childhood cancer survivors (8-18.9 years of age) and parents of participating cancer survivors (i.e., dyads) when they visit the After Completion of Therapy (ACT) clinic at St. Jude in three consecutive years (approximately 1 year apart; T1, T2, and T3).

Participants will complete pediatric patient-reported outcomes (PRO) survey/questionnaires, a neurocognitive assessment and physical performance evaluation will be completed, and parental surveys will be conducted. In addition, any data collected as part of the SJLIFE protocol may also be used as part of this study.

• The Pediatric PRO survey/questionnaires collection information on PROs. They include questions about general health, pain interference, fatigue, psychological stress experiences, stigma, sleep disturbance, sleep-related impairment, positive affect, meaning and purpose, depressive symptoms, anxiety, and physical function-mobility. Each cancer survivor will complete these during annual follow-up visits at three time points: years 1, 2 and 3. This process takes approximately 30-40 minutes.
• Neurocognitive evaluation is done by tests given by a licensed or certified psychological examiner to evaluate how the participant processes information. The tests evaluate how problems are solved, how well information is remembered, how well the participant pays attention, how quickly they understand information, and their assessment of quality of life. The tests are commonly used standardized tests that take about 2 hours to complete.
• Physical performance evaluation will measure heart and lung fitness, flexibility, mobility, muscle strength, endurance, balance and physical mobility. Testing takes about 2 hours to complete and includes six-minute walk test, walking speed test, muscle strength and flexibility, and balance.
• The parental survey is a parent-report form (PRF) to be completed by parents/legal guardians of participants. Information collected on the PRF includes demographic information, parental quality of life, social support, family dynamics, parenting behaviors, and the child's health care utilization data. The child and parent data will be compared. Parental questionnaires will be completed at one time point, year 1, 2, or 3, and will take approximately 40 minutes to complete.

Inclusion criteria

for Childhood Survivors:

• St. Jude childhood cancer survivors who have consented to SJLIFE;
• Age at assessment: 8-18.9 years at T1 (toward 20.9 years at T3);
• 2 years off therapy and > 5 years since diagnosis; and
• Agrees to complete three annual assessments during routinely scheduled ACT clinic appointments.

Exclusion criteria

for Childhood Survivors:

• Cancer-related or unrelated (e.g., genetic disorders) neurocognitive injuries that requires parents/proxies to complete the survey [e.g. intelligence quotient (IQ) <70];
• Inability to read and speak English; or
• Parent doesn't agree to participate in the parent part of the study.

Inclusion criteria

for Parents/Legal Guardians:

• Parent/legal guardian of St. Jude childhood cancer survivor aged 8-18.9 who is eligible to participate and has agreed to do so;
• Participant is not developmentally delayed, intellectually disabled or non-communicative; and
• Participant speaks and understands the English language.

Exclusion criteria

for Parents/Legal Guardians:

• Developmentally delayed, intellectually disabled or non-communicative;
• Unable to speak or understand the English language; and
• Child doesn't agree to participate in child part of the study.