Polaris Oncology Survivor Transition (POST) System
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Changes in Quality of Life
研究概览
简要总结
The POST's public health impact is likely to be substantial because it will improve cancer survivorship planning, which is currently an important deficiency in cancer care recognized by the Institute of Medicine and the American College of Surgeons.
The POST may have many potential benefits for patients such as:
- improved long-term health outcomes;
- improved psychosocial outcomes and quality of life;
- smoother transitions back into old and new life roles; and
- improved continuity and coordination of care between providers.
Most importantly, the POST's influence may reach beyond the patients it directly serves as it could help scientists and health care providers understand the potential benefits of cancer survivorship planning and how to best design and implement survivorship planning when patients are ending treatment for cancer.
详细描述
By January 2015, oncology care providers will be expected to craft Survivorship Care Plans (SCPs) for all individuals ending active treatment for cancer; however, there is a lack of systematic study of the impact survivorship planning has on patients, providers, or healthcare systems. The Polaris Oncology Survivorship Transition (POST) program is a web-based system that incorporates recommendations from the Institute of Medicine (IOM) and American College of Surgeons (ACS) to assist with cancer survivorship planning. It is a patient-centered approach that integrates input from both the treating oncology team and the patient. Phase 1 built and iteratively modified (N=25) the POST system and Phase 2 will test whether the SCPs impact patient and provider outcomes using a single blind, randomized controlled trial (RCT). Breast cancer patients (n=230) transitioning out of active treatment will be recruited and randomly assigned to receive Treatment as Usual (n=115) or the POST (n=115). All participants will be assessed at 1, 3, and 6 months by a research assistant blind to baseline status and group assignment. Primary outcomes will include quality of life, mechanisms of action such as confidence in entering survivorship, and other outcomes such as (1) depression and anxiety, (2) adherence to medical and behavioral health recommendations, (3) health care utilization, and (4) patient and provider satisfaction with the POST system.The POST will innovate the clinical setting through being the first system to produce computer generated tailored survivorship plans fully reflecting IOM recommendations and the new ACS 2015 requirements; incorporating information from both the oncology provider and the patient; featuring readily available "plug in" for two-way electronic health record integration; providing dynamic, electronic referrals for specialized support services; and facilitating care coordination between the oncologist and PCP. This study's impact will be significant. If hypotheses are confirmed, clear scientific evidence will exist for supporting survivorship care planning into oncology clinical practice. If hypotheses are disconfirmed, important lessons will guide future directions for care planning, including whether failure to affect outcomes was due to failure to impact several hypothesized mechanisms of action.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years or older
- •Confirmed diagnosis of breast cancer (not metastatic)
- •A final active treatment appointment scheduled with oncology team
- •Able to read or understand English at a 6th grade level
排除标准
- •Altered mental status (e.g., psychosis, delirium, disorientation)
- •Visual problems preventing them from reading the assessment and reports
- •Severe illness that would preclude conversation or interface with a computer (e.g.,persistent nausea/vomiting, severe pain)
- •Unable to read or understand English at a 6th grade level
- •Characteristics that would prevent adequate follow-up (e.g., lack of a telephone)
结局指标
主要结局
Changes in Quality of Life
时间窗: 1,3, 6 months after entering the study
Quality of life will be measured at baseline and at the follow-ups using the City of Hope Quality of Life measure. Improvement in quality of life is the primary goal of survivorship planning.
次要结局
- Change in Health care utilization(6-months after entering the study)
- Changes in Anxiety(1,3,6 months after entering study)
- Changes in Confidence in Transitioning to Survivorship(1,3,6 months after entering the study)
- Changes in Depression(1,3,6 months after entering study)
- Change in Patient Satisfaction and Usefulness of SCP(1,3,6 months after entering the study)
- Change in Patient Satisfaction with the POST system(1,3,6 months after entering the study)
- Change in Provider Satisfaction with the POST system(1,3,6 months after entering the study)