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NCT Number: NCT07428655

Acceptability and Feasibility of PSC Model of Serious Illness Communication

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.

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Key information

Conditions

Advanced Breast Cancer

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer Centre Singapore

Singapore, 168583

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Cognitive impairment preventing provision of informed consent
  • Poorly controlled mental health conditions

Treatment and study plan

PSC-facilitated supportive listening

Other

The intervention is a longitudinal, non-clinical supportive care model delivered over a three-month period. The intervention is designed to provide a dedicated space for supportive listening and biographical reflection that complements routine medical consultations. Each session begins with a standardised distress screening using the Distress Thermometer and Problem List (DTPL) to systematically identify participant concerns and provide basic symptom management or lifestyle improvement advice. This is followed by facilitated self-expression sessions focused on emotional grounding and/or collaborative goal-setting, allowing participants to explore and articulate their values at their own pace. Questions relating to goals of care may be explored opportunistically and spontaneously during these sessions, with key insights documented and communicated to the treating oncologist to ensure care alignment and strengthen patient-clinician communication.

Primary outcomes

  1. Intervention acceptability: Feeling Heard and Understood (FHU) Scale

    Time frame: 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.

Secondary outcomes

  1. Participant enrolment rate (feasibility)

    Time frame: From initiation of recruitment through to conclusion of enrolment phase (approximately 3 months).

    Measurement: Percentage of eligible patients who consent to study enrolment. Specific definition: Number of participants who provide written informed consent divided by the total number of eligible patients approached during the recruitment period.

    Predefined target: ≥60%.

Sponsors and collaborators

Lead sponsor

National Cancer Centre, Singapore

Other

Registry information

Official study title

Pilot Study to Evaluate the Acceptability, Feasibility, and Potential Effectiveness of a Patient Support Coordinator (PSC)-Facilitated Model of Serious Illness Communication

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 24, 2026
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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