Coaching in Palliative Surgical Oncology
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-99
SponsorSingapore General Hospital
About this trial
This study aims to evaluate the effectiveness of a serious illness coaching intervention (CONCORD) in improving quality of serious illness conversation (SIC), treatment decision-making, goal-concordant care delivery and quality of life in patients with advanced cancer considered for palliative interventions. CONCORD will be delivered by lay healthcare providers. We compare outcomes between participants receiving CONCORD vs usual care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 21 or above;
Diagnosis of advanced cancer, i.e. stage 3 or 4 solid organ
Consulted for palliative surgery or other interventions, i.e. procedures aimed at relieving symptoms and improving quality of life
Able to speak English or Mandarin;
Disqualifiers
Patient refusal,
Active mental illness or severe dementia, or being certified unfit to make medical decision by a specialist physician,
Pregnant Women
Self-reported severe mental illness, dementia, active suicidal ideation, uncorrected hearing loss;
Trial design
Design model
Parallel
Treatments tested in this trial
CONCORD coaching intervention
Other interventionThe care coach will focus on improving readiness and preparedness for components that will be discussed during serious illness conversations (SICs) - (disease understanding/prognosis, fear/worry, goals of care, treatment expectations, informational preferences, trade-offs, caregiver involvement). The coach will also equip patients with basic tools for treatment decision-making and advanced care planning (ACP). The session will be conducted in-person over 30-to-45 minutes. All coaching content is adapted from the serious illness care program developed by Ariadne Labs. This includes an adapted version of the advanced cancer and surgery question prompt list, elements of the serious illness conversations and the "What Matters to Me" serious illness care program booklet. The SICs are conducted at least 12 hours prior to palliative intervention and findings conveyed to surgical team. Coaching sessions would be focused on decision-making and future planning aspects of palliative care.
Treatment groups
220 Participants
are divided into 2 treatment groupsGroup A: Usual CareNo intervention 0 interventions
Group B: CONCORD Coaching InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Quality of serious illness conversations (SIC) with patients
We measured the quality of the SIC conducted based on number of components explored. The seven components explored were disease understanding/prognosis, fear/worry, goals of care, treatment expectations, informational preferences, trade-offs, caregiver involvement. The team will ask questions from Serious Illness Conversations Guide (Ariadne Labs), which enable Healthcare providers to understand patients' values and goals. This would be used as part of a palliative care delivery quality indicator. Team members will share with the caregivers of the patient's goals and palliative care needs when the patient is being coached by the care coach.
Time frame
Baseline 1 (pre-coaching), Baseline 2 (post-coaching), 1 month, 3 months, 6 months after Baseline 1 (pre-coaching)Secondary outcomes
1
Health-Related Quality of Life (HRQoL) in patients
We measured HRQoL in patients with the Functional Assessment of Cancer Therapy - General (FACT-G). FACT-G is a well-validated HRQoL questionnaire that covers 4 domains - physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items) and functional well-being (7 items). Each item has response choices in a 5-point Likert-type scale, with a maximum value of 4 (being, "Very much") and a minimum value of 0 (being "Not at all"). Higher scores indicate a better quality of life.
Time frame
Baseline 1 (pre-coaching), Baseline 2 (post-coaching), 1 month, 3 months, 6 months after Baseline 1 (pre-coaching)2
Health-Related Quality of Life (HRQoL) in patients
We also measured HRQoL in patients with the 5-level EuroQol-5 Dimension instrument (EQ-5D-5L). EQ-5D-5L is a HRQoL questionnaire with five domains (mobility, selfcare, usual activities, pain/discomfort, anxiety/depression) and has five levels for each domain. Scores from all five items will be used to derive a single utility score ranging from 0 to 1, with 0 representing the worst possible health to 1 representing perfect health. It also contains a health state component and a visual analog scale.
Time frame
Baseline 1 (pre-coaching), Baseline 2 (post-coaching), 1 month, 3 months, 6 months after Baseline 1 (pre-coaching)3
Decisional Conflict in patients
We measured decisional conflict in patients using the Traditional Decisional Conflict Scale (DCS). DCS is a validated 16-item instrument that measures personal perceptions of uncertainty in choosing among options, the factors contributing to uncertainty, and the quality of the decision made. Items are rated on a 5-point Likert scale (0 = Strongly agree to 4 = Strongly disagree). Scores are summed, divided by 16, and multiplied by 25 to produce a total score ranging from 0 (no decisional conflict) to 100 (extremely high decisional conflict). Lower scores indicate less decisional conflict and better decision support.
Time frame
Baseline 1 (pre-coaching), Baseline 2 (post-coaching), 1 month, 3 months, 6 months after Baseline 1 (pre-coaching)4
Goals of care and life priorities in patients
We determined the goals of care and life priorities in patients by using the Life Priorities Survey (LPS). LPS assesses patients' goals and priorities for their medical care across five domains: prolonging life, curing a disease, establishing a diagnosis, preserving function or independence, and relieving symptoms. This tool identifies patients' primary goals of care and will be used to assess concordance between patient-reported priorities and the treatments and interventions received. Changes in life priorities over the cancer and surgical journey will also be examined.
Time frame
Baseline 1 (pre-coaching), Baseline 2 (post-coaching), 1 month, 3 months, 6 months after Baseline 1 (pre-coaching)Sponsors and contacts
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Singapore General Hospital
Lead sponsor
Duke-NUS Graduate Medical School
Collaborator
Source ClinicalTrials.gov