- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07428655
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Singapore, Singapore, 168583
- National Cancer Centre Singapore
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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.
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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.
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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.
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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
Investigators
- Study Chair: Dr Colin Phipps Diong, MB BCh BAO, MRCP, FRCPath, SingHealth Centralised Institutional Review Board F (Chairperson)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2025-1184
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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