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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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).

Eligibility

Primary outcome measure(s)

• Communication Quality — Baseline, Week 6 after Baseline, and 3 months Post Enrolment.
  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.
• Quality of Life per FACT-G7 — Baseline, Week 6 after Baseline, and 3 months Post Enrolment.
  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.
• Health Utility — Baseline, Week 6 after Baseline, and 3 months Post Enrolment.
  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.
• Spiritual Well-Being — Baseline, Week 6 after Baseline, and 3 months Post Enrolment.
  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.
• Healthcare Utilization - Rate of Unplanned Acute Hospital Utilization — From Study Enrolment to 3 months Post Enrolment.
  The rate of unplanned acute hospital utilization through the emergency department during the study will be collected.
• Healthcare utilization - Length of hospital stay — From Study Enrolment until Date of Death, up to 3 years.
  Data on the length of stay in hospital (bed days) will be collected.
• Healthcare utilization - Hospital Bill — From Study Enrolment until Date of Death, up to 3 years.
  Data on hospital bill size will be collected.
• Healthcare utilization - Chemotherapy usage (type) — From Study Enrolment until Date of Death, up to 3 years.
  Data on the type of chemotherapy used will be collected.
• Healthcare utilization - Chemotherapy usage (line) — From Study Enrolment until Date of Death, up to 3 years.
  Data on the line of chemotherapy (first, second or third or subsequent (fourth and onwards)) will be collected.
• Healthcare utilization - Intensive care unit visit — From Study Enrolment until Date of Death, up to 3 years.
  Data on the number of intensive care unit visits will be collected.
• Healthcare utilization - Length of intensive care unit visit — From Study Enrolment until Date of Death, up to 3 years.
  Data on the length of intensive care unit visits will be collected.
• Healthcare utilization - Location of death — From Study Enrolment until Date of Death, up to 3 years.
  Data on the location of death will be collected.

Trial sites (1)

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