An interventional study of Lifestyle in Non-Small Cell Lung Cancer (NSCLC), sponsored by Kai-Uwe Schmitt, PhD, MEng, ICID. Recruiting at 4 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-30.
Sponsored by Kai-Uwe Schmitt, PhD, MEng, ICID · Not applicable, Interventional, and Supportive care
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).
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 88 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
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Exclusion Criteria:
Self-management mobile application covering physical activity, nutrition, and breathing/relaxation
Behavioral: Lifestyle
Usual care (study participation does not interfere with or change any other planned treatments)
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.
Health-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)
Time 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
Usability (intervention group only)
mHealth App Usability Questionnaire (MAUQ)
Time frame: At 3 months follow-up (end of the intervention)
Acceptability, appropriateness, and feasibility (intervention group only)
Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) (4-item measures of implementation outcomes)
Time frame: At 3 months follow-up (end of the intervention)
Experiences and satisfaction with the digital lifestyle intervention (intervention group only)
Short semi-structured interview; outcomes will be qualitatively assessed (no scale is used)
Time frame: At 3 months follow-up (end of the intervention)
Treatments/support since baseline
Cancer treatments (e.g., chemotherapy) and therapies/support (e.g., physical therapy, self-help group) participants might have received during the last 3 months (2 items)
Time frame: At 3 months follow-up (end of the intervention)
Plan to share: Yes — Pseudonymized data will be made available upon reasonable request after the main results have been published. The privacy of each subject and confidentiality of their information will be preserved in reports and publication of data.
Supporting information: Study protocol, Icf
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