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Table 1 Study outcomes

From: Song of Life (SOL) study protocol: a multicenter, randomized trial on the emotional, spiritual, and psychobiological effects of music therapy in palliative care

  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)  
  1. FACIT-Sp Functional Assessment of Chronic Illness Therapy – Spiritual Well-being, MQOL-R McGill Quality of Life Questionnaire Revised, NCCN National Comprehensive Cancer Network, HPA hypothalamic-pituitary-adrenal, HRV heart rate variability, T0 baseline assessment, T1 post intervention assessment