Table 4.
SA1 (months 1–36) | All outcomes measured at approximately: | Patients | (1) Quality of life—Functional Assessment of Chronic Illness Therapy—Palliative Care (FACIT-Pal)a65 |
Five days after surgery | Subscales: (i) Functional Assessment of Cancer Therapy-General (FACT-G) | ||
One month after surgery | (ii) Trial Outcome Index (TOI) | ||
(2) Demographics | |||
Three months after surgery | (3) Edmonton Symptom Assessment Score (ESAS)b,69 | ||
(4) Functional Assessment of Chronic Illness Therapy—Spiritual Well-being (FACIT-Sp-12)b,68 | |||
Six months after surgery | |||
(5) Mood symptoms including anxiety and depression subscales—PROMIS-2966,67 | |||
(6) Health care utilizationb (No. of postoperative hospitalizations and/or emergency room visits) | |||
(7) Presence of advance care planningb | |||
(8) Prognostic understandingb,70 | |||
(9) Mortalityb | |||
Caregivers | (1) Demographics | ||
(2) Zarit Caregiver Burden Scale (ZBI-12)b,71 | |||
(3) Mood symptoms including anxiety and depression subscales—PROMIS-2967,68 | |||
(3) Functional Assessment of Chronic Illness Therapy—Spiritual Well-being (FACIT-Sp-12) family/companion measureb,68 | |||
(5) Prognostic understandingb | |||
SA2 (months 8–16) | In-depth interviews (approx., n = 20 in each arm) | Patients | Patient experiences and beliefs regarding management of symptoms, prognostic clarity, and advance care planning practices and beliefs |
In-depth interviews (approx., n = 20 in each arm) | Caregivers | Family member experiences and beliefs regarding prognostic clarity, caregiver experience, and patient experience of symptoms and advance care planning practices and beliefs | |
In-depth interviews (approx., n = 8; all surgeons involved in the trial) | Surgeons | Surgeon experiences and beliefs regarding surgeon-alone vs. surgeon-palliative care team co-management of perioperative cancer patients and their families. | |
In-depth interviews (approx., n = 10–15) | Palliative care clinicians | Palliative care team experiences and beliefs regarding surgeon-alone vs. surgeon-palliative care team co-management of perioperative cancer patients and their families. |
Primary outcome.
Secondary outcome.