Acceptability and Feasibility of PSC Model of Serious Illness Communication

February 19, 2026 updated by: National Cancer Centre, Singapore

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

Study Overview

Status

Active, not recruiting

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Singapore, Singapore, 168583
        • National Cancer Centre Singapore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

Administered post-intervention, within two weeks following the completion of the three-month intervention phase.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Dr Colin Phipps Diong, MB BCh BAO, MRCP, FRCPath, SingHealth Centralised Institutional Review Board F (Chairperson)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2025

Primary Completion (Actual)

January 12, 2026

Study Completion (Estimated)

March 30, 2026

Study Registration Dates

First Submitted

February 19, 2026

First Submitted That Met QC Criteria

February 19, 2026

First Posted (Actual)

February 24, 2026

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 19, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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