Toward an Integrated Approach to Assessing and Addressing Follow-Up Care Needs That Will Facilitate Care Transitions for Cancer Survivors: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- SHAREDCare's Qualitative Acceptability
研究概览
简要总结
This clinical trial evaluates whether a shared response plan (SHAREDCare) improves follow-up care for lung cancer survivors. As the number of cancer survivors increases, there is a new need for high-quality chronic illness care. High-quality chronic illness care can be difficult to deliver and involves working with the patient to be certain they have what they need to be actively involved with their care to meet their needs. SHAREDCare allows the patient to work with a navigator to review identified distress and social needs. The patient and navigator discuss the needs and develop a shared response plan to address the needs in ways that consider the patient's current behaviors, beliefs, and motivation. The plan also establishes specific patient goals, anticipates barriers, and establishes how the navigator will follow-up on the needs and adjust care and assistance when needed. Using a shared response plan may improve follow-up care for lung cancer survivors.
详细描述
Primary Objective: Pilot and qualitatively assess the acceptability of SHAREDCare through semi- structured interviews
Secondary Objectives:
- Describe quantitative assessments of intervention acceptability, appropriateness, and feasibility.
- Describe survivor level of unmet needs13 using a validated measure to collect data before and/or after completion of the SHAREDCare intervention.
- Track clinical referrals and other actions made as a result of patient responses on the Electronic Distress Screening (EDS) and the percentage of referrals that have been "completed" (i.e. those referrals where a patient completed the relevant medical or social needs-related visit).
- Track recruitment, assessment completion, and any related adverse events.
OUTLINE:
Patients receive a SHAREDCare call with a navigator to discuss identified distress and social needs and develop/deploy a shared response plan to address identified needs on study. Patients also receive standard of care automated referrals on study. Two weeks following the initial call, patients receive a second SHAREDCare call with a navigator to follow-up on the shared response plan.
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
- 否
入选标准
- •Patients must have histologically or cytologically confirmed study disease. A pathology report should be referenced/available (stages I-IV lung cancer)
- •Ability to understand and the willingness to sign an institutional review board (IRB)-approved informed consent document
- •≥ 18 years of age
- •Within two years of lung cancer diagnosis
- •Able to understand, read and write English
排除标准
- •Does not meet the above inclusion criteria
研究组 & 干预措施
SHAREDCare Supportive care arm
Patients receive a SHAREDCare call with a navigator to discuss identified distress and social needs and develop/deploy a shared response plan to address identified needs on study. Patients also receive standard of care automated referrals on study. Two weeks following the initial call, patients receive a second SHAREDCare call with a navigator to follow-up on the shared response plan.
干预措施: Telephone based interview (Behavioral)
SHAREDCare Supportive care arm
Patients receive a SHAREDCare call with a navigator to discuss identified distress and social needs and develop/deploy a shared response plan to address identified needs on study. Patients also receive standard of care automated referrals on study. Two weeks following the initial call, patients receive a second SHAREDCare call with a navigator to follow-up on the shared response plan.
干预措施: Survey using a questionnaire. (Other)
SHAREDCare Supportive care arm
Patients receive a SHAREDCare call with a navigator to discuss identified distress and social needs and develop/deploy a shared response plan to address identified needs on study. Patients also receive standard of care automated referrals on study. Two weeks following the initial call, patients receive a second SHAREDCare call with a navigator to follow-up on the shared response plan.
干预措施: Electronic health record review (Other)
SHAREDCare Supportive care arm
Patients receive a SHAREDCare call with a navigator to discuss identified distress and social needs and develop/deploy a shared response plan to address identified needs on study. Patients also receive standard of care automated referrals on study. Two weeks following the initial call, patients receive a second SHAREDCare call with a navigator to follow-up on the shared response plan.
干预措施: Referral (Other)
结局指标
主要结局
SHAREDCare's Qualitative Acceptability
时间窗: At 4 weeks post-initial call
Will be assessed with semi-structured interviews. These methods will be guided by Grounded Theory, a process using inductive coding to develop theory from data (e.g., themes relating to components, timing, or delivery of the intervention).
次要结局
- SHAREDCare's Quantitative Acceptability(At 4 weeks post-initial call)
- SHAREDCare's Quantitative Appropriateness(At 4 weeks post-initial call)
- SHAREDCare's Quantitative Feasibility(At 4 weeks post-initial call)
- Number of Survivors With Unmet Needs(At baseline and at 4 weeks post-initial call)
- Number of Clinical Referrals Made(At 4 weeks post-initial call)
- Percentage of Referrals Completed(At 4 weeks post-initial call)
- Number of Participants Enrolled/Eligible(At 4 weeks post-initial call)
- Percentage of Assessments Completed(At 4 weeks post-initial call)
- Number of Adverse Events Reported(At baseline (initial call) up to 4 weeks post-initial call)