Table 1.
Schedule of the study procedures and assessments
Study contacts | Screening/information | Inclusion | T0: baseline assessments | Intervention or standard care | T1: follow-up assessments |
Time | Inpatient rehabilitation | Inpatient rehabilitation | 7–14 days after rehabilitation | 12 weeks | 14 weeks±7 days after baseline assessments |
Oral and written study information | ✓ | ||||
Inclusion/exclusion criteria | ✓ | ✓ | |||
Written informed consent | ✓ | ||||
Participant characteristics | ✓ | ✓ | |||
Clinical data | ✓ | ||||
Primary outcome | |||||
HRQoL (Global Health Status) (EORTC QLQ-C30) | ✓ | ✓ | |||
Secondary outcomes | |||||
HRQoL (functional and symptom scales) (EORTC QLQ-C30) | ✓ | ✓ | |||
Lung cancer-specific HRQoL (EORTC QLQ-LC29) | ✓ | ✓ | |||
BMI (self-reported height and weight) | ✓ | ✓ | |||
Self-reported PA (modified GSLTPAQ) | ✓ | ✓ | |||
Exercise capacity (1 min STS test) | ✓ | ✓ | |||
Risk of low protein intake (Pro55+) | ✓ | ✓ | |||
Appetite (SNAQ) | ✓ | ✓ | |||
Psychological distress (PHQ-4) | ✓ | ✓ | |||
Cancer-related fatigue (BFI) | ✓ | ✓ | |||
Enablement (shortened PEN-13) | ✓ | ✓ | |||
Self-rated health (EQ VAS) | ✓ | ✓ (weekly) | ✓ | ||
Explanatory outcomes | |||||
Treatments/support since discharge | ✓ | ||||
App usability (MAUQ) | ✓ (IG only) | ||||
Acceptability, appropriateness and feasibility (AIM, IAM, FIM) | ✓ (IG only) | ||||
Short semistructured interview | ✓ (IG only) | ||||
Mobile app tracking | ✓ (IG only) |
AIM, Acceptability of Intervention Measure; BFI, Brief Fatigue Inventory; BMI, body mass index; EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30; EORTC QLQ-LC29, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 29; EQ VAS, EuroQol Visual Analogue Scale; FIM, Feasibility of Intervention Measure; GSLTPAQ, Godin-Shephard Leisure-Time Physical Activity Questionnaire; HRQoL, health-related quality of life; IAM, Intervention Appropriateness Measure; IG, intervention group; MAUQ, mHealth App Usability Questionnaire; 1 min STS, 1-minute Sit-to-Stand; PA, physical activity; PEN-13, Patient Enablement Scale-13; PHQ-4, Patient Health Questionnaire-4; Pro55+, Protein Screener 55+; SNAQ, Simplified Nutritional Appetite Questionnaire.