The aim of this study is to assess the efficacy of a digital lifestyle intervention in non-small cell lung cancer (NSCLC) survivors on health-related quality of life (HRQoL) over three months.
Lung cancer survivors suffer from reduced physical and psychological functioning as well as decreased overall health-related quality of life (HRQoL) due to cancer symptoms, cancer treatments, and comorbidities. Experienced symptoms by lung cancer survivors, such as cancer-related fatigue or dyspnea, persist after active treatment ends. Therefore, lung cancer survivors should receive continuous attention regarding their health and HRQoL beyond the expected cancer cure. Physical activity, healthy nutrition, and breathing/relaxation exercises before, during, and after cancer treatments can increase physical as well as psychological functioning and HRQoL. Thus, the adhesion to an appropriate healthy lifestyle is crucial and represents an effective adjunctive strategy in the management of lung cancer survivors. Most lung cancer survivors, however, are sedentary and fail to meet official lifestyle recommendations, for instance, of the American Cancer Society or the World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR). The present project evaluates a mobile application for non-small cell lung cancer (NSCLC) survivors that will be used for three months after rehabilitation or treatment has finished. The main foci of the mobile application are physical activity, nutrition, and breathing/relaxation. The contents of the mobile application and the mobile application itself were developed in an iterative co-creation process involving software developers and potential users as well as researchers and clinicians from different disciplines (e.g., physical therapy and nutritional therapy).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
88
Participants assigned to the intervention group receive access to a lifestyle mobile application for three months after rehabilitation or treatment 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 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.
Klinik Barmelweid AG
Barmelweid, Switzerland
RECRUITINGZürcher RehaZentren | Klinik Davos
Davos, Switzerland
RECRUITINGBerner Reha Zentrum AG
Heiligenschwendi, Switzerland
RECRUITINGHealth-related quality of life (Scale-Global health status)
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)
Time frame: Change from baseline to 3 months
Health-related quality of life (5 functional scales, 9 symptom scales/items)
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)
Time frame: Change from baseline to 3 months
Lung cancer-specific health-related quality of life (10 symptom scales/items)
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)
Time frame: Change from baseline to 3 months
Body mass index [kg/m²]
Computed using self-reported body weight \[kg\] and height \[m\]
Time frame: Change from baseline to 3 months
Physical activity (self-reported)
Modified Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ) (physical activity before rehabilitation/treatment and physical activity over the last week)
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Zürcher RehaZentren | Klinik Wald
Wald, Switzerland
RECRUITINGTime frame: Change from baseline to 3 months
Functional exercise capacity
1-Minute Sit-to-Stand Test (number of repetitions)
Time frame: Change from baseline to 3 months
Risk for low protein intake
Protein Screener 55+ (Pro55+) (10 items)
Time frame: Change from baseline to 3 months
Appetite
Simplified Nutritional Appetite Questionnaire (SNAQ) (4 items; 5-point Likert-type scale)
Time frame: Change from baseline to 3 months
Psychological distress
Short form of the Patient Health Questionnaire (PHQ-4) (4 items)
Time frame: Change from baseline to 3 months
Cancer-related fatigue
Brief Fatigue Inventory (BFI) (9 items)
Time frame: Change from baseline to 3 months
Enablement
Shortened version of the Patient Enablement Scale-13 (PEN-13) (5 out of 13 items; 5-point Likert-type scale)
Time frame: Change from baseline to 3 months
Self-rated health
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)
Time frame: Weekly for 3 months