Navigated Early Survivorship Transition in Improving Survivorship Care Planning in Patients With Newly Diagnosed Cancer and Their Caregivers (NEST)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 67
- 试验地点
- 4
- 主要终点
- Patient and caregiver engagement, measured by the PHQ, IES-R, Distress Thermometer, & Effective Consumer Scale-17 & Psychosocial well-being, measured by the Patient Health Questionnaire (PHQ), Impact of Event Scale-Revised (IES-R), & Distress Thermometer
研究概览
简要总结
This pilot clinical trial studies the Navigated Early Survivorship Transition (NEST) intervention in improving survivorship care planning in patients with newly diagnosed cancer and their caregivers. A survivorship care planning session (SCPS) delivered to survivors and their primary caregivers may improve psychosocial well-being, patient and caregiver engagement, and adherence to treatment and follow-up recommendations. It is not yet known whether a NEST intervention or usual care is better in improving survivorship care planning in patients with newly diagnosed cancer.
详细描述
PRIMARY OBJECTIVES:
I. In a new model of survivorship care planning, planning started within the first two months of therapy, followed by additional survivorship care planning at the end of therapy or 6 months post diagnosis, evaluate the proportion of eligible survivors and participating caregivers who complete the survivorship care planning.
II. In a feasibility study of survivors and their identified support caregivers (70 survivors with or with a participating caregiver at VICC and 70 survivors with or without a participating caregiver at MMC), evaluate psychosocial well-being, engagement, resource utilization and adherence to recommended treatment and follow-up guidelines.
III. Assess the outcomes of survivors and participating caregivers treated at VICC and MMC to further individualize survivorship planning that will incorporate the optimal timing and content together with socioeconomic and cultural considerations. The pillars of this novel intervention (i.e., survivorship care planning, psychosocial assessment and patient engagement) are responsive to the recommendations of the IOM. The project proposed herein will build directly upon our work in the P20 grant and will set the stage for the planned R01 RCT, which would be directly responsive to NCI PAR 12-275. The ultimate aim is to inform best practices in survivorship planning in community and academic cancer centers, serving diverse, including underserved minority populations, with sufficient power to detect differences between treatment groups.
OUTLINE: Patients and their caregivers participate in an upfront survivorship care planning session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Newly diagnosed adult cancer patients from VICC and MMC
- •Caregiver of enrolled newly diagnosed adult cancer patients from VICC and MMC
- •No prior history of malignancy other than non-melanoma skin cancer
- •Planned treatment for stages I - III cancer
- •Treatment expected to be completed within 12 months
- •English speaking
排除标准
- •Prior history of malignancy other than non-melanoma skin cancer
- •Patients treated with surgery alone will not be included
- •Patients whose treatment is expected to last more than 12 months
- •Non-English speaking
研究组 & 干预措施
NEST Intervention
Patients (PTs) and their caregivers (CGs) receive educational intervention, follow-up care, psychosocial assessment and care, and questionnaire administration interventions by completing psychosocial questionnaires and meeting with a nurse practitioner (NP) or nurse navigator (NN) for an initial survivorship care planning session to review the expected course of therapy and recovery, identify resources that may be needed and provide recommendations for follow-up. At the end of their treatment EOT), PTs and their CGs complete a 2nd set of questionnaires and meet with the NP/NN for a booster survivorship care planning session. They will receive an individualized final survivorship care plan and related materials. 2 months after EOT, PTs and their CGs complete a final set of questionnaires.
干预措施: Educational Intervention (Other)
NEST Intervention
Patients (PTs) and their caregivers (CGs) receive educational intervention, follow-up care, psychosocial assessment and care, and questionnaire administration interventions by completing psychosocial questionnaires and meeting with a nurse practitioner (NP) or nurse navigator (NN) for an initial survivorship care planning session to review the expected course of therapy and recovery, identify resources that may be needed and provide recommendations for follow-up. At the end of their treatment EOT), PTs and their CGs complete a 2nd set of questionnaires and meet with the NP/NN for a booster survivorship care planning session. They will receive an individualized final survivorship care plan and related materials. 2 months after EOT, PTs and their CGs complete a final set of questionnaires.
干预措施: Follow-Up Care (Other)
NEST Intervention
Patients (PTs) and their caregivers (CGs) receive educational intervention, follow-up care, psychosocial assessment and care, and questionnaire administration interventions by completing psychosocial questionnaires and meeting with a nurse practitioner (NP) or nurse navigator (NN) for an initial survivorship care planning session to review the expected course of therapy and recovery, identify resources that may be needed and provide recommendations for follow-up. At the end of their treatment EOT), PTs and their CGs complete a 2nd set of questionnaires and meet with the NP/NN for a booster survivorship care planning session. They will receive an individualized final survivorship care plan and related materials. 2 months after EOT, PTs and their CGs complete a final set of questionnaires.
干预措施: Psychosocial Assessment and Care (Procedure)
NEST Intervention
Patients (PTs) and their caregivers (CGs) receive educational intervention, follow-up care, psychosocial assessment and care, and questionnaire administration interventions by completing psychosocial questionnaires and meeting with a nurse practitioner (NP) or nurse navigator (NN) for an initial survivorship care planning session to review the expected course of therapy and recovery, identify resources that may be needed and provide recommendations for follow-up. At the end of their treatment EOT), PTs and their CGs complete a 2nd set of questionnaires and meet with the NP/NN for a booster survivorship care planning session. They will receive an individualized final survivorship care plan and related materials. 2 months after EOT, PTs and their CGs complete a final set of questionnaires.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Patient and caregiver engagement, measured by the PHQ, IES-R, Distress Thermometer, & Effective Consumer Scale-17 & Psychosocial well-being, measured by the Patient Health Questionnaire (PHQ), Impact of Event Scale-Revised (IES-R), & Distress Thermometer
时间窗: Up to 2 months following the end of therapy
Will be compared between participants (patients and caregivers) and between those treated at VICC and MMC. Will use continuous scores on the depression, anxiety, and somatic symptom scales for the primary analyses; supplemental analyses will examine the percentage of patients above and below the recommended clinical cut-offs on these scales before and after the interventions. Will develop a regression model with the treatment group as the primary variable of interest.
次要结局
- Resource utilization, as measured by the Effectiveness in Obtaining Resources Scale and the Cancer Resource Survey(Up to 2 months following the end of therapy)
- Usefulness of navigation, as measured by the Usefulness of Navigator instrument(Up to 2 months following the end of therapy)
- Referral to subspecialists(Up to 2 months following the end of therapy)
- Adherence to National Comprehensive Cancer Network (NCCN) guidelines, as measured by chart review (patients only)(Up to 2 months following the end of therapy)
研究者
Debra Friedman
Principal Investigator
Vanderbilt-Ingram Cancer Center