Evaluating the Impact of Social and Genetic Factors on Outcomes in Adolescent and Young Adult Cancer Survivors

Brief Summary
This study examines the impact of social and genetic factors on outcomes in adolescent and young adult (AYA) cancer survivors of Hodgkin or non-Hodgkin lymphoma or leukemia. Compared to both older adult and childhood cancer patients, AYAs with cancer experience different diagnoses and specific biological, clinical, psychological and social factors that affect their risks for post-treatment morbidity and premature death. Collecting samples of blood and health and treatment information from cancer survivors of Hodgkin or non-Hodgkin lymphoma or leukemia may help doctors identify conditions that increase the likelihood of AYAs getting sick and dying after treatment of cancer and better understand how to address the needs of adolescent and young adult cancer survivors.
Brief Title
Evaluating the Impact of Social and Genetic Factors on Outcomes in Adolescent and Young Adult Cancer Survivors
Detailed Description
PRIMARY OBJECTIVE:

I. To evaluate the impact of social-environmental risk factors on changes in Charlson Comorbidity Index over time for adolescent and young adult cancer survivors.

OUTLINE: This is an observational study.

Patients complete questionnaires and undergo collection of blood samples on study.
Completion Date
Completion Date Type
Estimated
Conditions
ACUTE LYMPHOBLASTIC LEUKEMIA
HODGKIN LYMPHOMA
NON-HODGKIN LYMPHOMA
Eligibility Criteria
Inclusion Criteria:

* Patient must be \>= 18 years of age at the time of registration
* Patient must have been between the ages of 15-39 at the time of their first primary cancer diagnosis of Hodgkin lymphoma or non-Hodgkin lymphoma (NHL) or leukemia (acute lymphoblastic leukemia \[ALL\] only)
* Patient must have completed therapy (with a complete response, per clinician determination) at the time of registration
* Patients last date of prior systemic therapy for first primary diagnosis for Hodgkin lymphoma or non-Hodgkin lymphoma or leukemia (ALL) must have been within 3 years prior to registration

* NOTE: Systemic therapy refers to all anti-cancer therapy, including but not limited to chemotherapy, intravenous (IV) or oral targeted medications, or radiation, and administered via a clinical trial or standard approach
* Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-3
* Patient must be English speaking in order to be able to complete the required QOL forms on this study

* NOTE: Sites cannot translate the associated QOL forms
* Patient must not be receiving active therapy for Hodgkin lymphoma or non-Hodgkin lymphoma or leukemia
* Patient must have internet access through computer, tablet, or smartphone
* Patient must have email address
* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
Inclusion Criteria
Inclusion Criteria:

* Patient must be \>= 18 years of age at the time of registration
* Patient must have been between the ages of 15-39 at the time of their first primary cancer diagnosis of Hodgkin lymphoma or non-Hodgkin lymphoma (NHL) or leukemia (acute lymphoblastic leukemia \[ALL\] only)
* Patient must have completed therapy (with a complete response, per clinician determination) at the time of registration
* Patients last date of prior systemic therapy for first primary diagnosis for Hodgkin lymphoma or non-Hodgkin lymphoma or leukemia (ALL) must have been within 3 years prior to registration

* NOTE: Systemic therapy refers to all anti-cancer therapy, including but not limited to chemotherapy, intravenous (IV) or oral targeted medications, or radiation, and administered via a clinical trial or standard approach
* Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-3
* Patient must be English speaking in order to be able to complete the required QOL forms on this study

* NOTE: Sites cannot translate the associated QOL forms
* Patient must not be receiving active therapy for Hodgkin lymphoma or non-Hodgkin lymphoma or leukemia
* Patient must have internet access through computer, tablet, or smartphone
* Patient must have email address
* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT06002828
Org Class
Network
Org Full Name
Eastern Cooperative Oncology Group
Org Study Id
EAQ211
Overall Status
Active, not recruiting
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Social Genomic Mechanisms of Health Disparities Among Adolescent and Young Adult (AYA) Cancer Survivors
Primary Outcomes
Outcome Description
Will fit Conway-Maxwell-Poisson mixed effects models with a log link to evaluate the impact of social-environmental risk factors on changes in CCI over time. Estimates will be reported as rate ratios (and 95% confidence intervals) on the link scale, with model-based marginal means by visit to aid interpretation on the count scale. Models will be fit by maximum likelihood using all observed visits; targeted diagnostics will assess dispersion, fit, and influence.
Outcome Measure
Impact of social-environmental risk factors on changes in Charlson Comorbidity Index (CCI)
Outcome Time Frame
Through Study Completion, up to 2 years.
Secondary Ids
Secondary Id
NCI-2022-05526
Secondary Id
EAQ211
Secondary Id
ECOG-ACRIN-EAQ211
Secondary Id
EAQ211
Secondary Id
UG1CA189828
Start Date
Start Date Type
Actual
Status Verified Date
First Submit Date
First Submit QC Date
Study Population
Patients with treated Hodgkin lymphoma or non-Hodgkin lymphoma or leukemia across the United States
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Noah Kornblum
Investigator Email
nkornblu@montefiore.org
Investigator Phone
718-920-4826
Investigator Department
Medicine
Investigator Division
Oncology
Investigator Sponsor Organization
External
Study Department
Oncology (Medical/Hematologic)
Study Division
Medical and Hematologic Oncology
Categories Mesh Debug
Blood & Bone Marrow Cancers --- PRECURSOR CELL LYMPHOBLASTIC LEUKEMIA-LYMPHOMA
Blood & Bone Marrow Cancers --- LEUKEMIA, LYMPHOID
Blood & Bone Marrow Cancers --- LEUKEMIA
Cancer --- LEUKEMIA
Cancer --- NEOPLASMS
Blood Disorders --- HEMATOLOGIC DISEASES
Immune System --- IMMUNE SYSTEM DISEASES
MeSH Terms
PRECURSOR CELL LYMPHOBLASTIC LEUKEMIA-LYMPHOMA
HODGKIN DISEASE
LYMPHOMA, NON-HODGKIN
LEUKEMIA, LYMPHOID
LEUKEMIA
NEOPLASMS BY HISTOLOGIC TYPE
NEOPLASMS
HEMATOLOGIC DISEASES
HEMIC AND LYMPHATIC DISEASES
LYMPHOPROLIFERATIVE DISORDERS
LYMPHATIC DISEASES
IMMUNOPROLIFERATIVE DISORDERS
IMMUNE SYSTEM DISEASES
LYMPHOMA