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Table 1 Primary, secondary, and exploratory outcomes

From: Statistical analysis plan for the Surgery for Cancer with Option of Palliative Care Expert (SCOPE) trial: a randomized controlled trial of a specialist palliative care intervention for patients undergoing surgery for cancer

Variable

Description

Time frame

Primary outcome

Physical and functional well-being measured by the FACT-G TOI

Sum of physical and functional well-being subscales of the FACT-G. Higher scores indicate better outcome.

90 days

Secondary outcomes

Quality of life measured by the total FACT-G score

Total score of all subscales (physical well-being, social/family well-being, emotional well-being, functional well-being) of the FACT-G. Higher scores indicate better outcome.

90 days

Days alive at home without an emergency room visit

Days alive without an emergency room visit and without being an inpatient of a hospital or other healthcare facility.

90 days

All-cause mortality

Time to death (in days).

1 year

Exploratory outcomes

Anxiety measured by PROMIS Anxiety T-score

T-score calculated from the PROMIS Emotional Distress-Anxiety 6a Short Form. Higher scores indicate more anxiety.

90 days

Depression measured by PROMIS Depression T-score

T-score calculated from the PROMIS Depression 6a Short Form. Higher scores indicate more symptoms of depression.

90 days

Time to initiation of adjuvant therapy

Time to initiation of adjuvant chemotherapy or radiation (in days). Death will be a competing risk.

90 days

Caregiver burden measured by the Short Form Zarit Burden Interview score

Short Form Zarit Burden Interview (ZBI-12) score. Higher scores indicate more caregiver burden.

90 days

Size of life space measured by the Life-Space Assessment Questionnaire

Life-Space Assessment Questionnaire score. Higher scores indicate larger life space.

90 days

  1. FACT-G Functional Assessment of Cancer Therapy-General, TOI Trial Outcome Index, PROMIS Patient-Reported Outcomes Measurement Information System