The Impact of Systematic Financial Navigation in Acute Myeloid Leukemia "SF-NAV"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Self-reported financial toxicity as assessed by the total score of the COmprehensive Score Financial Toxicity (COST) assessment tool at 6 months after enrollment.
研究概览
简要总结
The purpose of this research is to see how personal financial burden (financial toxicity) related to cancer affects the overall health and quality of life by evaluating the impact of systematic financial navigation in addition to standard financial distress interventions during cancer treatment.
详细描述
Financial navigation (FN) has been increasingly recognized as an important interventional tool with the potential to significantly mitigate the onset, severity, and duration of financial toxicity (FT). There have been several recent pilot studies in this area demonstrating the feasibility and effectiveness of this approach. With the suddenness of onset and high healthcare utilization of an acute leukemia diagnosis, financial navigation early in the disease course may represent an opportunity to reduce the financial distress burden of this disease and improve outcomes.
The investigators have chosen to conduct this as a randomized, controlled trial (RCT) evaluating the effect of financial navigation (FN) on the patient reported objective measurement of financial toxicity (FT) using the Comprehensive Score for Financial Toxicity (COST) measure. This 12-question measure has become the standard for financial toxicity (FT) quantification in the research setting and will allow for direct comparison between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand and willingness to sign an IRB-approved informed consent.
- •Age 18-64 years at the time of consent
- •Initial diagnosis of Acute Myeloid Leukemia (AML) per investigator Note: Date of initial diagnosis is the date of the bone marrow biopsy
- •Planned intensive induction chemotherapy Note: It is acceptable if chemotherapy has been initiated at the time of enrollment as long as it is within 30 days of therapy initiation
- •Ability to read and understand the English and/or Spanish language(s)
- •As determined by the enrolling investigator, ability of the participant to understand and comply with study procedures for the entire length of the study.
排除标准
- •Diagnosis of Acute Promyelocytic Leukemia
- •Unwilling to receive induction chemotherapy for AML
- •Previous treatment for hematologic malignancy
- •Prior allogeneic hematopoietic stem cell transplant
研究组 & 干预措施
Systematic Financial Navigation
Participants randomized to Arm A will initiate navigation as soon as feasibly possible after randomization but no later than 4 weeks from enrollment.
The intervention will consist of systematic financial navigation with consistent screening and intervention on any financial related issues. The clinical trials staff will refer the participant to the appropriate services for personalized recommendations and assistance provided by Atrium Health personnel including financial navigators, nurse navigators. All the resources provided to the patient, including counseling, will be free of charge. Assessment will be performed once per month for 6 months.
干预措施: Arm A (Other)
Standard of Care Financial Distress Intervention
Participants randomized to Arm B will receive standard of care financial distress treatment including nurse navigation and pharmacy resources as soon as feasibly possible after randomization but no later than 4 weeks from enrollment.
All patients randomized to the Standard of Care arm will have access to the financial distress resources (Financial Navigation and Nurse Navigation) as per current clinical policy which is per patient or clinician request. All the resources provided to the patient, including counseling, will be free of charge as per institutional policy.
干预措施: Arm B (Other)
结局指标
主要结局
Self-reported financial toxicity as assessed by the total score of the COmprehensive Score Financial Toxicity (COST) assessment tool at 6 months after enrollment.
时间窗: From the date of randomization up until six months
For each participant, the total score of the COST at the 6-month assessment will be calculated. The total score is informed by 11 questions, each assessed on a 5-point scale of numerical values ranging 0 to 4, and the total score may range from 0 to 44 (where the lower score, the worse the financial well-being of the participant). Data of COST assessments from all randomized participants will inform this intent-to-treat analysis comparing scores between the arms.
次要结局
- Self-reported financial toxicity as assessed by the total score of the COmprehensive Score Financial Toxicity (COST) assessment tool at 3 months after enrollment.(From the date of randomization up until three months)
- Self-reported financial toxicity as assessed by the total score of the COmprehensive Score Financial Toxicity (COST) assessment tool at 12 months after enrollment.(From the date of randomization up until twelve months)
- Self-reported physical health as assessed by the total score of the Global Physical Health (GPH) as part of the Patient-Reported Outcomes Measurement Information System (PROMIS) at 3 months after enrollment(From the date of randomization up until three months)
- Self-reported physical health as assessed by the total score of the Global Physical Health (GPH) as part of the Patient-Reported Outcomes Measurement Information System (PROMIS) at 6 months after enrollment(From the date of randomization up until six months)
- Self-reported physical health as assessed by the total score of the Global Physical Health (GPH) as part of the Patient-Reported Outcomes Measurement Information System (PROMIS) at 12 months after enrollment(From the date of randomization up until twelve months)
- Self-reported physical health as assessed by the total score of the Global Mental Health (GMH) as part of the Patient-Reported Outcomes Measurement Information System (PROMIS) at 3 months after enrollment(From the date of randomization up until three months)
- Self-reported physical health as assessed by the total score of the Global Mental Health (GMH) as part of the Patient-Reported Outcomes Measurement Information System (PROMIS) at 6 months after enrollment(From the date of randomization up until six months)
- Self-reported physical health as assessed by the total score of the Global Mental Health (GMH) as part of the Patient-Reported Outcomes Measurement Information System (PROMIS) at 12 months after enrollment(From the date of randomization up until twelve months)
- Self-reported gaps in care as assessed by the number of gaps of care reported in the Financial Navigation Intervention Compliance/Coping Survey at 3 months after enrollment(From the date of randomization up until three months)
- Self-reported gaps in care as assessed by the number of gaps of care reported in the Financial Navigation Intervention Compliance/Coping Survey at 6 months after enrollment(From the date of randomization up until six months)
- Self-reported gaps in care as assessed by the number of gaps of care reported in the Financial Navigation Intervention Compliance/Coping Survey at 12 months after enrollment(From the date of randomization up until twelve months)
- Overall survival(From the date of randomization up until date of death or last known follow-up, assessed over 3 years.)
- Comparison of relapse-free survival All randomized participants will inform this analysis.(From the date of randomization up until date of relapse, death or last known follow-up, assessed over 3 years.)
- Annualized count of acute care visits(From the date of randomization up until twelve months)