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

ConditionCancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorNational Cancer Centre, Singapore

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Oncologists who are at least of designation of associate consultant and above in NCCS

Disqualifiers

Confused/not able to sign informed consent

Diagnosed with untreated hearing or visual loss or psychiatric illness

Overseas/not practising in Singapore for a significant amount of time

Trial design

Design model

Parallel

Treatments tested in this trial

  • CCC Intervention

    Other intervention

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

Treatment groups

560 Participants
are divided into 2 treatment groups
Group A: CCC Intervention ArmExperimental treatment 1 intervention
Group B: Usual Care ArmNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, Week 6 after Baseline, and 3 months Post Enrolment.
2

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.

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

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.

Time frame
Baseline, Week 6 after Baseline, and 3 months Post Enrolment.
4

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.

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

Secondary outcomes

1

Acceptability - Satisfaction

Client satisfaction survey is a 4-item, 4-point scale survey in which patients provide ratings on their satisfaction with the intervention, and their views on its relevance, timeliness, and impact. It has been validated in research studies in the outpatient setting around mental health support. Score can range from 4-16, with a higher score indicating greater client satisfaction.

Time frame
3 months Post Enrolment.
2

Feasibility - Approach-to-Enrolment Rates

Approach-to-enrolment rates - where feasibility is defined that at least 60% of those patients approached could be enrolled into the study.

Time frame
From Commencement of Study Recruitment till the End of Recruitment, up to 24 months.
3

Feasibility - Patient Retention Rate

Patient retention rate - where feasibility is defined that at least 80% of enrolled patients will be able to participate in the study for the planned study duration (3 months).

Time frame
Baseline through Study Completion, estimated as up to 3 years.
4

Effectiveness - SIC and ACP documentation

The number of SIC and ACP documentation per clinician per enrolled patient during the study duration will be tracked during the intervention period(s) and during the control period(s). Clinical notes will also be read to evaluate if there was relevant documentation by clinician on SIC related issues.

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

Other outcomes

Sponsors and contacts

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