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Acceptability and Feasibility of PSC Model of Serious Illness Communication

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07428655
Enrollment
28
Registered
2026-02-24
Start date
2025-08-25
Completion date
2026-03-30
Last updated
2026-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Breast Cancer

Keywords

Palliative care, Serious illness communication, Supportive listening, Patient support, Mixed methods, Psychosocial support

Brief summary

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.

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.

Interventions

OTHERPSC-facilitated supportive listening

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.

Sponsors

National Cancer Centre, Singapore
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

This is a single-arm, prospective, non-randomized pilot study designed to evaluate the feasibility and acceptability of a novel Patient Support Coordinator (PSC) model embedded within outpatient oncology. All enrolled participants are assigned to a single intervention group and receive a longitudinal series of supportive listening and values-based conversation sessions over a three-month period.

Eligibility

Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Intervention acceptability: Feeling Heard and Understood (FHU) ScaleAdministered 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

MeasureTime frameDescription
Participant enrolment rate (feasibility)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%.

Countries

Singapore

Contacts

STUDY_CHAIRDr Colin Phipps Diong, MB BCh BAO, MRCP, FRCPath

SingHealth Centralised Institutional Review Board F (Chairperson)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 6, 2026