Effectiveness, Acceptability and Feasibility of a Communication and Care Coordinator (CCC) Model in Facilitating Serious Illness Communication (SIC) and Care in Patients With Cancer

NCT07733973 | Not Yet Recruiting

• 1 other identifier: 2026-1239
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the communication and care coordinator (CCC) model in a national cancer institute and assess the utility of the model in facilitating serious illness communication (SIC) and care for patients with cancer. The study aims are:

• To assess the effectiveness of the CCC model in improving patient outcomes.
• To assess the effectiveness of the CCC model in increasing rates of SIC and advance care planning (ACP) record documentation.
• To assess the acceptability of the CCC model to patients and clinicians.
• To evaluate the feasibility of implementing a CCC model in oncology care. Researchers will compare results from the CCC intervention arm and usual care arm, to see if the CCC model can help improve patient outcomes and facilitate SIC between patients and clinicians. Patient participants will:
• Follow the assignment of their clinician, who will be assigned randomly to either the usual care group or the intervention group.
• Be assigned a CCC and receive 6 CCC sessions over the course of 3 months (if assigned to CCC intervention arm).
• Complete 3 study assessment visits at baseline, Week 6, and 3 months
• Be invited to a one-time interview to share their study experience (optional, if selected and if in CCC intervention arm).

Conditions

Cancer

Keywords

Communication and Care Coordinators; Serious Illness Communication; Healthcare Communication; Cancer Care; Oncology

Outcome Measures

Primary Outcomes (12)

• Communication Quality

  Feeling Heard and Understood Survey (FHU) is a validated 4-item scale that has been used in palliative care to measure effectiveness of the SIC conversations and the value of the therapeutic relationship between the care team and the patient. The lowest possible score is 0 and the highest possible score is 16, with a higher score indicating that the care team listens well, respects patient's needs, and provides clear communication.

  Baseline, Week 6 after Baseline, and 3 months Post Enrolment.

• Quality of Life per FACT-G7

  Functional Assessment of Cancer Therapy-General-7 Item version (FACT-G7) is a 7-item questionnaire designed to quickly and effectively capture the most relevant issues to cancer. FACT-G7 scores could potentially range from 0-28, with a higher score indicating a better quality of life.

  Baseline, Week 6 after Baseline, and 3 months Post Enrolment.

• Health Utility

  EuroQOL Group 5-Dimension (EQ-5D-5L) contains a 5-item descriptive system measuring 5 dimensions: mobility, self-care, usual activities, pain/ discomfort, anxiety/ depression; a visual analogue scale (VAS) measuring overall health status. EQ-5D Index Value (Utility Score) ranges from 0 to 1.0 with higher value indicating better health-related quality of life. The VAS ranges from 0 to 100, with higher scores reflecting better self-rated health.

  Baseline, Week 6 after Baseline, and 3 months Post Enrolment.

• Spiritual Well-Being

  Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-Sp-12) is a validated 12-item survey that is commonly used in the palliative care setting. It has 3 subscales (meaning, peace and faith). Scores in each subscale can potentially range from 0-16 and the total scores can range from 0-48. A higher score indicates greater spiritual well-being, better ability to find purpose in life and drawing comfort from spiritual resources.

  Baseline, Week 6 after Baseline, and 3 months Post Enrolment.

• Healthcare Utilization - Rate of Unplanned Acute Hospital Utilization

  The rate of unplanned acute hospital utilization through the emergency department during the study will be collected.

  From Study Enrolment to 3 months Post Enrolment.

• Healthcare utilization - Length of hospital stay

  Data on the length of stay in hospital (bed days) will be collected.

  From Study Enrolment until Date of Death, up to 3 years.

• Healthcare utilization - Hospital Bill

  Data on hospital bill size will be collected.

  From Study Enrolment until Date of Death, up to 3 years.

• Healthcare utilization - Chemotherapy usage (type)

  Data on the type of chemotherapy used will be collected.

  From Study Enrolment until Date of Death, up to 3 years.

• Healthcare utilization - Chemotherapy usage (line)

  Data on the line of chemotherapy (first, second or third or subsequent (fourth and onwards)) will be collected.

  From Study Enrolment until Date of Death, up to 3 years.

• Healthcare utilization - Intensive care unit visit

  Data on the number of intensive care unit visits will be collected.

  From Study Enrolment until Date of Death, up to 3 years.

• Healthcare utilization - Length of intensive care unit visit

  Data on the length of intensive care unit visits will be collected.

  From Study Enrolment until Date of Death, up to 3 years.

• Healthcare utilization - Location of death

  Data on the location of death will be collected.

  From Study Enrolment until Date of Death, up to 3 years.

Secondary Outcomes (6)

• Acceptability - Satisfaction

  3 months Post Enrolment.

• Feasibility - Approach-to-Enrolment Rates

  From Commencement of Study Recruitment till the End of Recruitment, up to 24 months.

• Feasibility - Patient Retention Rate

  Baseline through Study Completion, estimated as up to 3 years.

• Effectiveness - SIC and ACP documentation

  From Commencement of Study Enrollment through Study Completion, estimated as up to 3 years

• Effectiveness - Time spent

  From Commencement of Study Enrollment through Study Completion, estimated as up to 3 years

Study Arms (2)

CCC Intervention Arm

EXPERIMENTAL

Each participant will be assigned a CCC and receive 6 CCC sessions over the course of 3 months.

Other: CCC Intervention

Usual Care Arm

NO INTERVENTION

Each participant will continue to be followed by the oncologist and receive usual care but will not receive CCC intervention.

Interventions

CCC Intervention OTHER

CCC sessions will be on exploring participant's illness journey thus far, their concerns, values and priorities.

CCC Intervention Arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient Participants
• Aged 21 and above
• Diagnosed with (a) advanced cancer (stage 3 or 4) or (b) non-advanced cancer, but at high risk of recurrence
• Able to speak English or Chinese, irrespective of race
• Clinicians
• Oncologists who are at least of designation of associate consultant and above in NCCS

You may not qualify if:

• Patient Participants
• Confused/not able to sign informed consent
• Diagnosed with untreated hearing or visual loss or psychiatric illness
• Clinicians
• Overseas/not practising in Singapore for a significant amount of time

Sponsors & Collaborators

• National Cancer Centre, Singapore: lead

Study Sites (1)

National Cancer Center, Singapore

Singapore, 168583, Singapore

Location

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MeSH Terms

Conditions

Neoplasms; Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Shirlyn NEO Hui Shan, MD, PhD

  National Cancer Centre, Singapore

  STUDY CHAIR

Central Study Contacts

Shirlyn NEO Hui Shan, MD, PhD

CONTACT

63065838; shirlyn.neo.h.s@singhealth.com.sg

Benton PT TAM, MSc

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will employ a stepped wedge cluster randomized trial design.

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 29, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)