1. Health-related quality of life (Scale-Global health status) (Time Frame - Change from baseline to 3 months): European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) (2 items; 7-point Likert-type scale; the score ranges from 0 to 100; a high score for the global health status represents a high HRQoL)
Secondary outcome:
1. Health-related quality of life (5 functional scales, 9 symptom scales/items) (Time Frame - Change from baseline to 3 months): European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) (28 items; 4-point Likert-type scale; 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning), 3 symptom scales (fatigue, nausea and vomiting, pain), 6 single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea, financial difficulties); all scales and single-item measures range in score from 0 to 100)
2. Lung cancer-specific health-related quality of life (10 symptom scales/items) (Time Frame - Change from baseline to 3 months): European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 29 (lung cancer-specific module) (EORTC QLQ-LC29) (29 items; 4-point Likert-type scale / 5 multi-item scales and 5 single items; all scales and single-item measures range in score from 0 to 100)
3. Body mass index [kg/m²] (Time Frame - Change from baseline to 3 months): Computed using self-reported body weight [kg] and height [m]
4. Physical activity (self-reported) (Time Frame - Change from baseline to 3 months): Modified Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ) (physical activity before inpatient rehabilitation and physical activity over the last week)
5. Functional exercise capacity (Time Frame - Change from baseline to 3 months): 1-Minute Sit-to-Stand Test (number of repetitions)
6. Risk for low protein intake (Time Frame - Change from baseline to 3 months): Protein Screener 55+ (Pro55+) (10 items)
8. Psychological distress (Time Frame - Change from baseline to 3 months): Short form of the Patient Health Questionnaire (PHQ-4) (4 items)
9. Cancer-related fatigue (Time Frame - Change from baseline to 3 months): Brief Fatigue Inventory (BFI) (9 items)
10. Enablement (Time Frame - Change from baseline to 3 months): Shortened version of the Patient Enablement Scale-13 (PEN-13) (5 out of 13 items; 5-point Likert-type scale)
11. Self-rated health (Time Frame - Weekly for 3 months): EuroQol Group Visual Analogue Scale (EQ VAS) (vertical visual analog scale that takes values between 100 [best imaginable health] and 0 [worst imaginable health], on which respondents provide a global assessment of their health)
Lifestyle: Participants assigned to the intervention group receive access to a lifestyle mobile application for three months after inpatient rehabilitation has finished. The digital program is target group-specific and includes personalization and interactive elements without face-to-face appointments during the intervention. One virtual appointment at the beginning of the intervention (about one week post-rehabilitation) with the study staff ensures that participants familiarize themselves with the mobile application and that they are assigned to a suitable program level. The intervention is mainly based on the following behavior change technique (BCT) clusters: goals and planning, feedback and monitoring, shaping knowledge, and comparison of behavior.
Quelle: ClinicalTrials.gov
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"Digital Lifestyle Intervention for Lung Cancer Survivors After Inpatient Rehabilitation"
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