The patient will be asked to come in to the Counseling Center at MSKCC (641 Lexington Avenue, 7th Floor) and participate in an individual interview at their convenience.

The patient will be asked to come in to the Counseling Center at MSKCC (641 Lexington Avenue, 7th Floor) and participate in a focus group at their convenience.

The patient will be asked to participate in three 60-90 minute telephone interviews scheduled at their convenience.

The doctor and/or one of her trained research study staff will ask the patient about their experience as an adolescent/young adult cancer survivor, their health and quality of life. It should take (approximately 1-1 ½ hours)to complete. Interviews will be audiotaped and transcribed by a professional transcription service.

interview

The patient will participate with 6-8 other adolescent/young adult cancer survivors. The doctor and/or her trained research study staff will ask about their experience as an adolescent/young adult cancer survivor, their health and quality of life. It should take about one-and-a-half hour to complete. Focus groups will be audio taped and transcribed by a professional transcription service.

Focus groups

The patient will be asked to participate in three 60-90 minute telephone interviews conducted by the doctor and/or her trained research study staff scheduled at the patient's convenience, the second interview approximately 6-8 months after the first and the last interview approximately 12-16 months after the first. The questionnaire will ask about their experience as an adolescent/young adult cancer survivor, their health and quality of life.

Questionnaire

Marie Barnett, PhD

The purpose of this study is to better understand how the illness has affected the identity and what needs the survivor may have. We hope that this information will help us provide better care to future adolescent and young adult cancer survivors.

Adolescent and Young Adult Cancer Survivors: Identity Development

Memorial Sloan Kettering Cancer Center

Herbal and Botanical

All Drugs and Chemicals

Grape

After 4 week run-in period, drink 6 ounces of purple grape juice twice daily, then 4 week washout, week 12 drink 6 ounces of clear apple juice for 4 weeks twice daily

After 4 week run-in period, drink 6 ounces of clear apple juice twice daily, then 4 week washout, week 12 drink 6 ounces of purple grape juice for 4 weeks twice daily

6 ounces of purple grape juice consumed twice daily either during first or second 4 week supplementation period, depending on sequence randomization

Purple Grape Juice

6 ounces of clear apple juice consumed twice daily either during first or second 4 week supplementation period, depending on sequence randomization

Apple Juice

Cindy K Blair, MPH

Rationale: Survivors of childhood cancer are at an increased risk of developing cardiovascular risk factors as well as early cardiovascular disease, likely due to the intensive therapeutic regimen used to treat their cancer. Purple grape juice (PGJ) is a rich source of flavonoids and a powerful antioxidant. Clinical studies in both diseased and healthy adults suggest that daily consumption of PGJ contributes to increased antioxidant capacity, reduced low-density lipoprotein (LDL) oxidation, and improved vasodilation.

Purpose: This randomized clinical trial is evaluating whether purple grape juice can reduce oxidative stress and improve the vascular health of survivors of childhood cancer in the early stages of cardiovascular disease.

Primary Objective:

* To evaluate the effect of PGJ on endothelial function, a key measure of vascular health and considered a barometer for cardiovascular disease risk.

Secondary Objective:

* To evaluate the effect of PGJ on biomarkers of vascular and systemic oxidative stress.

Outline:

Patients undergo a 4-week washout period and refrain from consuming any type of juice, juice drink (less than 100% juice), wine or grapes. Patients are then randomized to 1 of 2 arms.

Arm 1: Beginning in week 4, patients consume 6 ounces of purple grape juice (PGJ) twice daily for 4 weeks. Beginning in week 12, after a 4 week washout period, patients crossover to consume apple juice (AJ) as in Arm 2.

Arm 2: Beginning in week 4, patients consume 6 ounces of AJ twice daily for 4 weeks. Beginning in week 12, after a 4 week washout period, patients crossover to consume PGJ as in Arm 1.

Purple Grape Juice in Improving Vascular Health in Childhood Cancer Survivors

A Pilot Study to Evaluate the Effects of Purple Grape Juice on the Vascular Health of Childhood Cancer Survivors

Difference of least square means (95% Confidence Interval) in RH-PAT Index Scores between juice groups. Higher RH-PAT scores indicate better endothelial function; a positive difference of least square means is suggestive of an improvement in endothelial function.

Probes were placed on the index fingers of both hands and a blood pressure cuff was placed on one arm. The cuff was inflated to suprasystolic pressure and the digital pulse volume was recorded before, during \& after a 5 minute occlusion period. The ratio of the hyperemic and the baseline pulse amplitude (corrected for the same ratio on the control finger) was calculated and expressed as the RH-PAT index score. Lower scores reflect worse endothelial function.

Change from baseline in Oxidized LDL at 4 weeks, a biomarker of oxidative stress

Change from baseline in Myeloperoxidase (MPO) at 4 weeks, a biomarker of oxidative stress

Change from baseline in high sensitivity C-Reactive Protein (hs-CRP) at 4 weeks, a biomarker of inflammation

University of Minnesota

6 ounces of grape juice consumed twice daily in either the first or second intervention period

6 ounces of clear apple juice consumed twice daily in either the first or second intervention period

Includes groups randomized to receive purple grape juice first and apple juice first

Entire Study Population

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Measured in kilograms at beginning of study.

Weight

Measured in centimeters are beginning of study.

Height

Measured in kilograms/m\^2 at beginning of study.

Body Mass Index

Systolic blood pressure

Diastolic blood pressure

Fasting glucose

Fasting insulin

Low-density lipoprotein (LDL) Cholesterol

High-density lipoprotein (HDL) Cholesterol

Triglycerides

Cindy K. Blair, MPH

Change in Endothelial Function (Reactive Hyperemia Peripheral Arterial Tonometry (RH-PAT) Index Score)

Change in Oxidized LDL

Arm 2 Apple Juice Then Purple Grape Juice

Change in Myeloperoxidase (MPO)

Change in High Sensitivity C-Reactive Protein (Hs-CRP)

Arm 1: 6 ounces of grape juice twice daily during first 4 weeks of intervention (intervention period 1) followed by a 4 week washout period followed by 6 ounces of clear apple juice twice daily during 4 weeks (intervention period 2).

Arm 1 Purple Grape Juice Then Apple Juice

Arm 2: 6 ounces of clear apple juice twice daily during first 4 weeks of intervention (intervention period 1) followed by a 4 week washout period followed by 6 ounces of purple grape juice twice daily during 4 weeks (intervention period 2).

First Intervention

Washout Period

Second Intervention

adult survivors of childhood malignancies

Yiu-fai Cheung, MD

Anthracyclines have been used commonly to treat children with solid tumours and haematological malignancies and have led to their increased survival. Nonetheless, anthracycline has the side effect of cardiotoxicity. The purpose of this study is to assess the impact of anthracycline therapy on heart deformation and fibrosis, heart-vessel interaction, usefulness of circulating biomarkers in the assessment of heart function and potential genetic predisposition to heart failure in adult survivors of childhood cancers.

Incorporation of anthracyclines into chemotherapy protocols has improved the survival of children with solid tumours and haematological malignancies. Nonetheless, longitudinal studies have implicated the absence of a safe anthracycline dose that is free of cardiotoxicity. Substantial risk for cardiovascular disease has been shown recently in large cohorts of adult survivors of childhood and adolescent survivors. Serial monitoring of cardiac function is hence of paramount importance in childhood cancer survivors for early detection of myocardial damage and timely institution of interventions. The optimal monitoring of cardiac function in the long term in these at-risk patients remains to be established. Novel noninvasive imaging modalities including echocardiography and cardiac magnetic resonance allow interrogation of myocardial deformation and fibrosis, while circulating biomarkers are increasingly used to monitor the cardiac status in heart failure patients. Additionally, genetics of heart failure are increasingly unveiled.

Cardiovascular Function in Adult Survivors of Childhood Malignancies

Novel Imaging and Circulation Biomarkers for Comprehensive Evaluation of Cardiovascular Function in Adult Survivors of Childhood Malignancies

The University of Hong Kong

Professor

Neoplasms

All Conditions

Musculoskeletal Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Sarcoma

Osteosarcoma

Sarcoma, Ewing

Bone Neoplasms

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Soft Tissue Sarcoma

Ewing Sarcoma

Patients will have dynamic contrast-enhanced (DCE), diffusion-weighted (DW), magnetization transfer (MT), and chemical exchange saturation transfer (CEST) magnetic resonance imaging (MRI) performed before and after 1 cycle of chemotherapy.

Imaging techniques using high-field MRI to make quantitative assessments in patients with osteosarcoma or Ewing sarcoma

DCE-MRI, DW-MRI, MT-MRI, and CEST-MRI

Vicki Keedy, MD

The objective of these studies is to use changes in 3 Tesla MRI measurements of tumor protein content, cell density, and microvessel perfusion, obtained before and after a single cycle of NAC, to predict eventual tumor response observed at the conclusion of NAC, within patients with osteosarcoma or Ewing Sarcoma.

Neoadjuvant chemotherapy (NAC) for osteosarcoma (OS) and Ewing sarcoma (ES) is associated with significant immediate and long-term complications, particularly difficult to endure in adolescent patients. Tumor response is assessed only at resection, often after the patient has received months of potentially toxic and ineffective therapy. Surgical approaches in this setting are extensive and life changing, with amputations not uncommon. Poor response to NAC is the single most important prognostic indicator in localized OS/ES. Early identification of those patients unlikely to benefit from the prescribed regimen could have significant clinical implications and allow for earlier adjustments in the patient's therapy. In patients with OS/ES there remains a compelling yet unmet need for more advanced quantitative, noninvasive imaging methods that can be deployed early after the initiation of treatment and which are capable of longitudinally measuring quantitative changes in relevant physiological, metabolic and/or biophysical parameters that can serve as reliable surrogates, or even predictors, of long-term tumor response to intervention, including pathological response at surgery. In this pilot study we will use multi-parametric 3 Tesla (3T) MRI, deployed before and after the first cycle of NAC, to correlate early changes in imaging biomarkers with the patient's eventual histopathological response at surgical resection. We will measure treatment-induced changes in: 1) protein content, measured via the amide proton transfer asymmetry (APTasym) using chemical exchange saturation transfer (CEST) MRI); 2) tumor fibrosis, measured via the magnetization transfer ratio (MTR) using magnetization transfer (MT) MRI); 3) tumor cellularity, measured via the apparent diffusion coefficient (ADC) using diffusion-weighted MRI); and 4) tumor perfusion, measured via the volume transfer coefficient (Ktrans) using dynamic contrast-enhanced DCE-MRI. The relevance and future clinical impact of each of these imaging biomarkers (alone or in combination) in OS/ES is potentially very high.

Quantitative Imaging Biomarkers of Treatment Response in Osteosarcoma and Ewing Sarcoma

Use 3T CEST-MRI, DW-MRI, and DCE-MRI to quantitatively measure protein content (APTasym), tumor cellularity (ADC), and tumor perfusion (Ktrans)and measure changes in these parameters from baseline to post 1 cycle of neoadjuvant chemotherapy.

Duration from first dose of neo-adjuvant chemotherapy to disease progression, date of last follow-up, or death for any reason

Percent of necrosis in the excised tumor specimen determined by the reading pathologist.

Standard of care imaging, either CT or MRI, will be performed prior to the initiation of neoadjuvant chemotherapy and at the end of cycle 2 using standard RECIST 1.1 guidelines summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), \>=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), \>=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR\>PR\>SD\>PD.

National Cancer Institute (NCI)

Vanderbilt-Ingram Cancer Center

Assistant Professor of Medicine; Clinical Director, Sarcoma Program; Medical Director, Clinical Trials Shared Resource; Medical Oncologist

Behaviors and Mental Disorders

Depression

Depressive Disorder

Arm I (Parent Social-Cognitive Intervention Program \[P-SCIP\]): Participants undergo five 60-minute behavioral intervention sessions once or twice weekly for 3 weeks to learn how to engage in effective social and cognitive processing to deal with fears and worries about the transplant and transplant-related concerns. Participants receive a laptop computer and a CD-ROM after the first session.

Arm II (Best-recommended Psychosocial Care \[BPC\]): Participants undergo usual care and receive a "Discovery to Recovery" DVD and pamphlet developed by the National Marrow Donor Program (NMDP) describing psychological issues associated with hematopoietic stem cell transplantation (HSCT), the booklet "Top Tips for Parent Caregivers During the BMT Process" published by National Marrow Donor Program-Link describing caregiver issues during HSCT and advice on how to handle them, 2 walkie-talkies, a laptop to view the DVD, and 5 hours of respite care from a child-life specialist once or twice weekly for 3 weeks.

Participants undergo five 60-minute behavioral intervention sessions once or twice weekly for 3 weeks to learn how to engage in effective social and cognitive processing to deal with fears and worries about the transplant and transplant-related concerns.

Behavioral intervention sessions

Participants receive a laptop computer and a CD-ROM after the first session of behavioral intervention.

CD-ROM

Participants receive a "Discovery to Recovery" DVD and pamphlet developed by the National Marrow Donor Program (NMDP) describing psychological issues associated with hematopoietic stem cell transplantation (HSCT), the booklet "Top Tips for Parent Caregivers During the BMT Process" published by National Marrow Donor Program-Link describing caregiver issues during HSCT and advice on how to handle them, 2 walkie-talkies, a laptop to view the DVD.

DVD and pamphlet

Participants receive 5 hours of respite care from a child-life specialist once or twice weekly for 3 weeks.

Respite care

Sharon L Manne, Ph.D.

The investigators have developed a parent social-cognitive processing intervention (P-SCIP) to help decrease distress among parent caregivers of children undergoing hematopoietic stem cell transplant (HSCT). The investigators will evaluate the efficacy of P-SCIP in reducing short- and long-term distress and parenting stress among 300 parents of children undergoing HSCT. P-SCIP will be delivered during the child's inpatient HSCT hospitalization and is specifically designed to improve parent social (e.g., sharing concerns) and cognitive (e.g., acceptance) processing of the transplant experience. The intervention includes five in-person sessions that are accompanied by an interactive CD-ROM. The CD-ROM complements the materials in the in-person sessions and provides parents with the opportunity to enhance and deepen their cognitive and social processing of the HSCT experience. The intervention will be tested against best-practices psychosocial care (BPC) available in four enriched pediatric HSCT settings across the United States. P-SCIP will be provided to both Spanish- and English-speaking parents. Participants will complete measures of psychological distress, well-being, and social and cognitive processing at the time of HSCT, two, six and twelve months after HSCT. Research questions will address the effects of P-SCIP versus BPC on parent psychological adaptation and social and cognitive processing, as well as evaluate parent personal resources as well as child medical course variables that contribute to intervention response. The investigators will also examine barriers to participation in the intervention by comparing barriers to participation among parents who refuse participation in the trial and parents who accept.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Adolescent and Young Adult Cancer Survivors: Identity Development	NCT00832325	Cancer	interview Focus groups Questionnaire	15 Years - 25 Years	Memorial Sloan Kettering Cancer Center
Adolescent and Young Adult Cancer Survivors: Identity Development	NCT00832325	Cancer	interview Focus groups Questionnaire	15 Years - 25 Years	Memorial Sloan Kettering Cancer Center
Purple Grape Juice in Improving Vascular Health in Childhood Cancer Survivors	NCT01043939	Cardiovascular ...	Purple Grape Ju... Apple Juice	10 Years - 30 Years	University of Minnesota
Cardiovascular Function in Adult Survivors of Childhood Malignancies	NCT01415999	Childhood Cance...		18 Years - 35 Years	The University of Hong Kong
Cardiovascular Function in Adult Survivors of Childhood Malignancies	NCT01415999	Childhood Cance...		18 Years - 35 Years	The University of Hong Kong
Quantitative Imaging Biomarkers of Treatment Response in Osteosarcoma and Ewing Sarcoma	NCT01882231	Osteosarcoma Paget's Disease Ewing Sarcoma	DCE-MRI, DW-MRI...	13 Years -	Vanderbilt-Ingram Cancer Center
Purple Grape Juice in Improving Vascular Health in Childhood Cancer Survivors	NCT01043939	Cardiovascular ...	Purple Grape Ju... Apple Juice	10 Years - 30 Years	University of Minnesota
Facilitating Parent Adaptation to Pediatric Transplant: The P-SCIP Trial	NCT00939380	Childhood Cance...	Behavioral inte... CD-ROM DVD and pamphle... Respite care	18 Years -	Rutgers, The State University of New Jersey
Adolescent and Young Adult Cancer Survivors: Identity Development	NCT00832325	Cancer	interview Focus groups Questionnaire	15 Years - 25 Years	Memorial Sloan Kettering Cancer Center
Facilitating Parent Adaptation to Pediatric Transplant: The P-SCIP Trial	NCT00939380	Childhood Cance...	Behavioral inte... CD-ROM DVD and pamphle... Respite care	18 Years -	Rutgers, The State University of New Jersey

Spots Global Cancer Trial Database for childhood cancers