Table 1 Study outcomes
Primary outcome | Secondary outcomes | Exploratory analyses | |
|---|---|---|---|
Patient | • a1: Quality of life – psychological (MQOL-R, 4 items, T0-T1) | • b1: Spiritual well-being – meaning/peace (FACIT-Sp, 8 items, T0-T1) • b2: Ego-integrity (Brief Measure of Generativity and Ego-Integrity, 5 items, T0-T1) • b3: Quality of life - global (MQOL-R, 1 item, T0-T1) • b4: Distress (NCCN Distress Thermometer, 1 item, pre-post each session) • b5: Retrospective evaluation (Feedback Questionnaire, 8 Items, T1 only) | • c1: Biomarkers of stress: ▪ HPA-axis (cortisol) ▪ Sympathetic nervous system (salivary α-amylase, peripheral blood flow) ▪ Parasympathetic nervous system (HRV) • c2: Strengths and weaknesses of the intervention; Beliefs about working mechanisms (qualitative interview) |
Caregiver | • d1: Retrospective evaluation (Feedback Questionnaire, 12 items, T1-T2) |