Pilot Study to Evaluate the Acceptability, Feasibility, and Potential Effectiveness of a Patient Support Coordinator (PSC)-Facilitated Model of Serious Illness Communication
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Intervention acceptability: Feeling Heard and Understood (FHU) Scale
研究概览
简要总结
This prospective, single-arm pilot study evaluates the feasibility and acceptability of a novel Patient Support Coordinator (PSC) model for women with advanced or high-risk breast cancer in an outpatient oncology setting. The PSC model is designed to address gaps in serious illness communication by embedding a trained, non-clinical coordinator into routine care pathways to provide longitudinal psychosocial support and facilitate values-based discussions. The primary hypothesis posits that the PSC intervention will be perceived as acceptable by participants, defined by a population median score of ≥12 out of 16 on both the Client Satisfaction Questionnaire (CSQ-4) and the Feeling Heard and Understood (FHU) scale. Additionally, the study assesses feasibility through metrics such as enrollment and retention rates, as well as the successful integration of PSC-documented patient priorities into clinical workflows. By using a convergent parallel mixed-methods design, the study aims to generate a complete view of how this lay-led model complements existing supportive care infrastructure at the National Cancer Centre Singapore.
详细描述
The study employs a convergent parallel mixed-methods design to evaluate the implementation of the Patient Support Coordinator (PSC) model over a three-month intervention period. Eligible participants are women aged 21 and above with Stage III or IV breast cancer, or those at high risk of recurrence, who are proficient in English or Mandarin.
Following recruitment and informed consent, participants undergo a three-month intervention consisting of up to eight flexible sessions conducted in-person or via telephone. The intervention structure includes systematic distress screening using the Distress Thermometer and Problem List (DTPL) to identify immediate concerns, followed by facilitated self-expression and collaborative goal-setting. As rapport develops, the PSC progressively introduces values-based questions based on a locally adapted Serious Illness Conversation Guide (SICG). A critical component of the model involves the PSC documenting participant goals and priorities for communication to the treating oncologist, thereby fostering goal-concordant care.
Quantitative outcome measures, including the CSQ and FHU, are collected post-intervention to assess global satisfaction and the quality of the therapeutic alliance. Descriptive statistics are utilized for analysis, with the median score serving as the primary benchmark for acceptability. Simultaneously, qualitative data are gathered through semi-structured interviews with patients and clinicians to explore experiences of utility and barriers to engagement. These qualitative data are analysed using the framework method, involving systematic indexing and the construction of a coding matrix to facilitate cross-case comparison. During the final interpretation phase, quantitative descriptive results and qualitative themes are merged to identify areas of convergence and divergence, providing a robust basis for refining the PSC model for future large-scale trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of advanced cancer (Stage III or IV) or assessed to be at risk of recurrence by treating oncologist
- •Aware of cancer diagnosis
- •Proficiency in English or Mandarin
排除标准
- •Cognitive impairment preventing provision of informed consent
- •Poorly controlled mental health conditions
研究组 & 干预措施
PSC-facilitated supportive listening
This is a single-arm study where all participants are assigned to the Patient Support Coordinator (PSC) intervention. Enrolled participants engage in a longitudinal supportive care pathway ("PSC model"/ "PSC intervention") consisting of up to eight one-on-one sessions of supportive listening with the PSC delivered over a three-month period.
干预措施: PSC-facilitated supportive listening (Other)
结局指标
主要结局
Intervention acceptability: Feeling Heard and Understood (FHU) Scale
时间窗: Administered post-intervention, within two weeks following the completion of the three-month intervention phase.
Measurement: Total score on the four-item Feeling Heard and Understood (FHU) survey. Specific definition: A patient-reported outcome measure assessing the perceived quality of the therapeutic alliance. Scores range from 4 to 16, with a total score of ≥12 (equivalent to a mean of 3 out of 4 per item) defined as the threshold for intervention acceptability.
次要结局
- Participant enrolment rate (feasibility)(From initiation of recruitment through to conclusion of enrolment phase (approximately 3 months).)