Assessing the Impact of Cancer Care Ontario's Psychosocial Oncology & Palliative Care Pathway in Ambulatory Head and Neck Cancer Clinics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Increased documentation of response to symptoms (ESAS), PPS, illness understanding and advanced care planning (ACP)
研究概览
简要总结
Rates of depression and anxiety in cancer patients are much higher compared to the general population. 40% of head and neck cancer patients will develop significant distress along the cancer journey. Less than half of these patients are able to access support, with factors such as age, social difficulty, cancer stage and site affecting referral. In 2016, 78,000 Canadians died of cancer, yet there is limited implementation of routine and integrated advanced care planning in cancer care.
An upcoming deliverable of all cancer centres in Ontario is the integration of Cancer Care Ontario's Psychosocial and Palliative Care (PSOPC) pathway into all disease pathways. Successful widespread implementation of this pathway at Odette Cancer Centre (OCC) will impact >16,000 patients/year. If effective, it will reduce suffering, unnecessary healthcare utilization, improve treatment decisions and compliance, enable a better quality of life in survivorship and improve quality at end of life. There is a need for better developed, standardized response pathways to address PSO and PC needs throughout the patient's journey.
详细描述
Head and neck cancer (HNC) is the sixth most commonly diagnosed cancer worldwide. Individuals with HNC experience a high burden of symptom-related distress (e.g. emotional, physical, psychological, spiritual etc.). Additionally, HNC patients may experience facial disfigurement, communication barriers, social stigma, lack of social support, and/or self-imposed or experienced disease stigma. The presence of depression, anxiety or social difficulty is relatively common in HNC patients yet less than half of those with significant distress access psychosocial (PSO) and palliative care (PC). Few studies have examined a systematic response to reducing distress, integrating a routine psychosocial and palliative care approach to oncology, with planning for future care for this population.
Most cancer centres do not have a systematic model of practice geared towards distress screening, PC and PSO approach to care. Therefore, determining how to best incorporate PSO and PC (PSOPC) into the interprofessional oncology clinic management of patients with HNC remains an important and unanswered question. The question remains of how to proactively identify those at higher risk for distress and greater need for specialized psychosocial or palliative care. Some oncologists consider the provision of PSOPC as an integral part of their professional role. Yet increasing the delivery of quality primary PSOPC by busy oncologists may require targeted training, the use of algorithms to prompt PC and PSO assessment, incorporating response to distress screening / advanced care planning tools into routine clinical processes, prompts to document conversations about illness understanding and consideration of individual factors influencing treatment decisions.
The primary goal of this study is to integrate quality primary level PSO and PC into clinic care by developing and evaluating a routine response to screening in hopes of increasing documentation of the following: discussion of response to ESAS, illness understanding, advanced care planning or goals of care conversations.
Specifically, this study will examine the impact of Cancer Care Ontario's (CCO) PSOPC Pathway, an expert panel recommended algorithm for assessing and managing symptoms and initiating a PSOPC approach and timely specialized referral, when necessary.
Phase Two: Randomized Controlled Trial
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consenting ambulatory OCC HNC patients, with baseline ESAS scores of >2 (emotional) or >3 (physical symptoms) with no active suicidal ideation, cognitive impairment or significant debilitation such that participation would be burdensome for participants and/or safety concerns as determined by a research assistant.
排除标准
- •If participants endorse thoughts of dying at baseline, they will be asked to complete semi-structured questions to assess suicidal ideation (SI). If there is any active SI or intent, the oncology team will be informed, a record kept and the participant will be withdrawn from the study.
结局指标
主要结局
Increased documentation of response to symptoms (ESAS), PPS, illness understanding and advanced care planning (ACP)
时间窗: baseline
Documented high ESAS scores (\>6) and of all PPS scores, symptom management and conversations about PSO-either distress/management/referral/resources, PC needs, and ACP, illness understanding
次要结局
- Princess Margaret Hospital Satisfaction with Doctor Questionnaire (PMH-PSQ 24)(baseline, 1, 3, and 6 months)
- General Anxiety Disorder (GAD-7)(baseline, 1, 3, and 6 months)
- Patient and, if participating, Caregiver Semi-structured interview(1 and 3 months)
- The European Organization for Research and Treatment of Cancer Quality of Life (EORTC-QOL 30)(baseline, 1, 3, and 6 months)
- Illness Understanding Questionnaire(1, 3, and 6 months)
- Mixed-methods interviews(1 and 3 months)
- Patient Health Questionnaire (PHQ-9)(baseline, 1, 3, and 6 months)
- Beck Anxiety Inventory (BAI)(baseline, 1, 3, and 6 months)
- Edmonton Symptom Assessment System(baseline, 1 and 3 months)
- Palliative Performance Scale(baseline)
- Beck Depression Inventory (BDI-II)(baseline, 1, 3, and 6 mnths)
- Experiences in Close Relationships Inventory(baseline, 1, 3, and 6 months)