Advanced Breast CancerNCT07428655
Acceptability and Feasibility of PSC Model of Serious Illness Communication
A study testing PSC-facilitated supportive listening in people with Advanced Breast Cancer, run by National Cancer Centre, Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- PSC-facilitated supportive listening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSingapore
- Study dates
- 25 Aug 2025to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cognitive impairment preventing provision of informed consent
- Poorly controlled mental health conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Advanced Breast Cancer
- Being tested
- PSC-facilitated supportive listening
- Keywords
- Palliative care, Serious illness communication, Supportive listening, Patient support, Mixed methods, Psychosocial support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSC-facilitated supportive listeningOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: PSC-facilitated supportive listening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Administered post-intervention, within two weeks following the completion of the three-month intervention phase.
Secondary outcomes (1)
Participant enrolment rate (feasibility)
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%.
Measured: From initiation of recruitment through to conclusion of enrolment phase (approximately 3 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start25 Aug 2025
- Primary completion12 Jan 2026
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Colin Phipps Diong, MB BCh BAO, MRCP, FRCPath, Study chair, SingHealth Centralised Institutional Review Board F (Chairperson)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07428655
- Sponsor's protocol ID
- 2025-1184
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ng A, Yeo SM, Tan WM, Chua B, Erina R, Neo SHS. Acceptability and feasibility of a Patient Support Coordinator (PSC) model to facilitate serious illness communication in outpatient oncology. BMC Palliat Care. 2026 Jun 4;25(1):221. doi: 10.1186/s12904-026-02180-3.
PubMed 42243766
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Acceptability, Feasibility, and Potential Effectiveness of a Patient Support Coordinator (PSC)-Facilitated Model of Serious Illness Communication
- ClinicalTrials.gov ID
- NCT07428655
- Acronym / sponsor ID
- 2025-1184
- Conditions
- Advanced Breast Cancer
- Keywords
- Palliative care, Serious illness communication, Supportive listening, Patient support, Mixed methods, Psychosocial support
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (actual)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 12 Jan 2026 (actual)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| PSC-facilitated supportive listening | Experimental | Other: PSC-facilitated supportive listeningThis 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Cognitive impairment preventing provision of informed consent
- Poorly controlled mental health conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSC-facilitated supportive listeningThe 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. | Other | PSC-facilitated supportive listening |
Primary outcome
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.
1 secondary outcome
Participant enrolment rate (feasibility)
Time frame: From initiation of recruitment through to conclusion of enrolment phase (approximately 3 months).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Derived from this study: PubMed 42243766Ng A, Yeo SM, Tan WM, Chua B, Erina R, Neo SHS. Acceptability and feasibility of a Patient Support Coordinator (PSC) model to facilitate serious illness communication in outpatient oncology. BMC Palliat Care. 2026 Jun 4;25(1):221. doi: 10.1186/s12904-026-02180-3.
- Individual participant dataSharing planned: No
Related trials for Advanced Breast Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
Active, not recruitingPhase 2
Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Colin Phipps Diong, MB BCh BAO, MRCP, FRCPath study chair
SingHealth Centralised Institutional Review Board F (Chairperson)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSC-facilitated supportive listening in people with Advanced Breast Cancer, run by National Cancer Centre, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07428655, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.