Table 3.
Study measures and clinical assessments for the SJLIFE cohort
| Evaluation | Domain | Measures |
|---|---|---|
| Comprehensive health questionnairea | Health outcomes and status | Medical service utilization, medication use, current and past health problems, reproductive status and pregnancies |
| Social and demographic factors | Marital status, living arrangements, academic achievement, employment status, insurance access, income and financial hardship | |
| Health behaviours | Tobacco use, alcohol intake, substance use, physical activity, sedentary behaviour, sun exposure behaviours, participation in health screening, and use of complementary and alternative medicine | |
| Psychosocial constructs | Health perceptions, motivation for behaviour change, body image/weight concerns, perceived stress, cancer impact, post-traumatic distress, social desirability, depression, anxiety and somatization | |
| Men’s/women’s health | Fertility, onset of puberty, sexual development, relationship/marital satisfaction and sexual health/functioning. History of testosterone therapy, sperm banking and erectile dysfunction for male survivors and controls | |
| Quality of life | Pediatric Quality of Life Inventory (PedsQL) for children/parents22; Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) for adults23,24 | |
| Dietary intake | Block Food Frequency Questionnaire25 | |
| Neurocognitive assessment | Global intelligence | Wechsler Abbreviated Scale of Intelligence-Second Edition26 |
| Reading and mathematical academic skills | Woodcock Johnson Tests of Achievement27 | |
| Processing speed | Wechsler Intelligence Scale for Children,28 Wechsler Adult Intelligence Scale29 | |
| Sustained attention | Conner’s Continuous Performance Test30 | |
| Memory | California Verbal Learning Test31 | |
| Executive functions | Cognitive flexibility, fluency, planning and organization; Delis–Kaplan Executive Function System32 | |
| Patient report | Executive function using the Behavior Rating Inventory of Executive Function;33,34 attention and memory skills using the Childhood Cancer Survivor Study Neurocognitive Questionnaire35 for adults and the Behavioral Assessment Scale for Children36 | |
| Patient-reported fatigue | Multidimensional Fatigue Scale22 for children and parents or the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale37 for adults | |
| Blood analysis | General organ function | Complete blood count w/differential, comprehensive metabolic panel, lipid panel, c-reactive protein high sensitivity, haemoglobin A1c, insulin level, 25 hydroxy-vitamin D, insulin-like growth factor-1, thyroxine free, thyroid stimulating hormone, oestradiol level, testosterone total, follicle stimulating hormone assay, luteinizing hormone, cortisol, ferritin, cystatin C assay, urinalysis, random urine creatinine, random urine protein, random urine calcium, hepatitis B core antibody IgG and IgM, hepatitis B surface antigen, hepatitis B surface antibody, hepatitis C antibody, human immunodeficiency virus 1/2 antibody/antigen with positive reflex testing |
| Echocardiogram | Cardiac function | Left ventricular volume, mass, ejection fraction, E velocity, A velocity, E/A ratio, isovolumetric relaxation time (IVRT), deceleration time, medial annulus velocity, E/Em, estimation of filling pressures, and evaluation of the pulmonary veins, right atrial pressure and estimation of right ventricular systolic pressure |
| Pulmonary function testing | Respiratory muscle strength and gas exchange | Forced vital capacity, forced expiratory volume, and peak expiratory flow |
| Cardiac biomarker testing | Diagnosis/prognosis of heart failure | N-Terminal pro-brain natriuretic peptide (NT pro-BNP), troponin-T |
| Neuromuscular functional assessment | Muscle strength and flexibility | Knee extension and dorsiflexion strength, hand-grip strength, ankle dorsiflexion active and passive range of motion, sit and reach test |
| Exercise stress test | Cardio-respiratory fitness using a modified Bruce protocol | |
| Aerobic capacity | Peak VO2 estimated with the Duke Activity Status Index (DASI),38 six-minute walk test39 | |
| Mobility | Timed Up and Go40 | |
| Anthropometrics | Height, weight, body mass index, waist and hip circumference | |
| Body composition | Percent body fat, lean body mass, skeletal muscle mass and bone mineral content from dual X-ray absorptiometry (DXA) scans, lumbar bone mineral density using quantitative computed tomography (QCT) | |
| Balance | Berg Balance Measure41 | |
| Overall physical performance | Physical performance test (PPT)42 | |
| Fertility | Semen analysis for male participants | |
| Vision | Ophthalmology exam | Visual acuity testing, refraction testing, retinoscopy, ocular pressure, examination under mydriasis, fundus photography to screen for hypertensive retinopathy |
| Hearing | Audiology exam | Speech audiometry, tympanometry, otoacoustic emissions testing |
| Cancer screening | Subsequent neoplasms | Colonoscopy, breast mammogram and magnetic resonance imaging |
| Psychosocial assessment | Social adjustment | Comprehensive assessment by licensed social worker, assistance with referrals to community providers and resources for ongoing care as needed |
| Medical record abstraction | Cancer-related treatment exposures | Cumulative doses for 22 specific chemotherapeutic agents [actinomycin-D, carmustine, bleomycin, busulfan, carboplatin, chlorambucil, cis-platinum, lomustine, cyclophosphamide (oral, intravenous), cytosine arabinoside (intravenous, intramuscular, intrathecal, subcutaneous), daunorubicin, doxorubicin, idarubicin, ifosfamide, melphalan, methotrexate (intravenous, intramuscular, intrathecal), busulfan, nitrogen mustard, procarbazine, thiotepa, etoposide (oral, intravenous), tenopiside], surgical procedures, and radiation treatment fields, dose and energy source |
| Radiation dosimetry | Site-specific radiation dose reconstruction | Cranial, neck, chest, abdomen, pelvis, arm and leg |
| Chronic condition assessment | Morbidity | Assessed using modified CTCAE21 |
| DNA collection | Genetics | Whole genome and exome sequencing |
| Mortality | Mortality | Linkage to the NDI, all cause and cause-specific mortality |
a
Modified versions of questionnaires are administered to participants who are <18 years of age; for participants 11–18 years of age, parents and participants complete the questionnaires; for participants <11 years of age, parents answer the questions on behalf of the child.