Social Genomic Mechanisms of Health Disparities Among Adolescent and Young Adult (AYA) Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1,350
- 主要终点
- Disease free survival (DFS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Observational
Patients complete questionnaires and undergo collection of blood samples on study.
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
Disease free survival (DFS)
时间窗: Time interval after primary treatment for a cancer ends that the patient survives without any signs or symptoms of thatcancer, assessed up to 2 years
A gated hypothesis testing procedure will be used to ensure control of the family-wise error rate at 0.05 (two-sided). Cox regression will be used to assess the association of the social-environmental risk factors with the hazard of DFS.
Comorbidities (including symptoms, late effects)
时间窗: Up to 2 years
Will be assessed using Charlson Comorbidity Index (Patient version) National Cancer Institute Common Toxicity Criteria for Adverse Events.
Overall survival (OS)
时间窗: From participant registration to the date of death or censored at the date of data collection, assessed up to 2 years
A gated hypothesis testing procedure will be used to ensure control of the familywise error rate at 0.05 (two- sided). OS will be tested only if statistical significance is achieved for DFS. Cox regression will be used to assess the association of the social-environmental risk factors with the hazard of OS.
Impact of social-environmental risk factors on changes in Charlson Comorbidity Index (CCI)
时间窗: Through Study Completion, up to 2 years.
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.
次要结局
- Quality of life collected via PROMIS-29 v2(Up to 2 years)