NCT07428655

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 25, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 19, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 24, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

February 19, 2026

Last Update Submit

February 19, 2026

Conditions

Keywords

Palliative careSerious illness communicationSupportive listeningPatient supportMixed methodsPsychosocial support

Outcome Measures

Primary Outcomes (1)

  • Intervention acceptability: Feeling Heard and Understood (FHU) Scale

    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 Outcomes (1)

  • Participant enrolment rate (feasibility)

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

Study Arms (1)

PSC-facilitated supportive listening

EXPERIMENTAL

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.

Other: PSC-facilitated supportive listening

Interventions

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.

PSC-facilitated supportive listening

Eligibility Criteria

Age21 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Centre Singapore

Singapore, 168583, Singapore

Location

Study Officials

  • Dr Colin Phipps Diong, MB BCh BAO, MRCP, FRCPath

    SingHealth Centralised Institutional Review Board F (Chairperson)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2026

First Posted

February 24, 2026

Study Start

August 25, 2025

Primary Completion

January 12, 2026

Study Completion

March 30, 2026

Last Updated

February 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations