Table 3.
Outcome measures, assessment instruments, and assessment time points
| Measures | Assessment instruments | Baseline Assessment T0 | Pre-Intervention Assessment T1 | Weekly assessments after group BPT | Pre/Post smartphone-triggered intervention | Post-Intervention Assessment T2 |
|---|---|---|---|---|---|---|
| Social demographics | Sociodemographic variables (sex, age, marital status, educational level, and job-related situation) | X | ||||
| Psychosocial health | Basic Documentation for Psycho-Oncology (PO-Bado) | X | ||||
| Performance status | Performance status score of the Eastern Cooperative Oncology Group (ECOG) | X | ||||
| Bodily disturbances | Body Image Scale (BIS) | X | X | X | X | |
| Awareness of bodily changes due to the diagnosis and treatment | single item; VAS-A patient-assessed (range 0–10) | X | X | X | ||
| Distress caused by bodily changes | single item; VAS-B patient-assessed (range 0–10) | X | X | X | ||
| Body mindfulness | Body Mindfulness Questionnaire (BMQ) | X | X | X | X | |
| Distress | National Comprehensive Cancer Network Distress Thermometer (DT) | X | X | X | X | |
| Somatic Symptoms | Somatic Symptom Disorder-B Criteria Scale (SSD-12) | X | X | X | ||
| Quality of life | EORTC QLQ-C30 | X | X | X | ||
| Vitality | 36-Item Short Form Health Survey (SF-36) – Scale Vitality | X | X | X | ||
| Mental health | 36-Item Short Form Health Survey (SF-36) – Scale Mental Health | X | X | X | ||
| Anxiety and depression | Hospital Anxiety and Depression Scale (HADS) | X | X | X | ||
| Suicidal tendency | Beck Depression Inventory (BDI-II), Item I: Suicidal tendency | X | X | X | ||
| Group cohesion | Group Climate Questionnaire – Short Form (GCQ-S) | X | X | |||
| Mood | Multidimensional Mood Questionnaire (MDMQ) | X | ||||
| Experience of presence | single item; VAS (range 0–10) | X | ||||
| Experience of vitality | single item; VAS (range 0–10) | X | ||||
| Therapist’s rating of patient’s bodily changes due to the diagnosis and treatment | Semi-standardized Interview single item; VAS-A therapist-assessed (range 0–10) | X | ||||
| Therapist’s rating of patient’s distress caused by bodily changes | Semi-standardized Interview single item; VAS-B therapist-assessed (range, 0–10) | X | ||||
| Motivation, previous experience, eligibility | Semi-standardized Interview | X | ||||
| Acceptance, treatment effect, potential for improvement, safety aspects | Semi-standardized Interview | X | ||||
| Therapist’s adherence to the manual | Adapted checklist to session content (see Table 2.) | X |
BPT Body Psychotherapy, EORTC QLQ-C30 European Organization for Research and Treatment of Cancer QLQ-C30, VAS Visual Analog Scale