Digital Lifestyle Intervention for Lung Cancer Survivors After Inpatient Rehabilitation

Study Overview
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Brief Summary
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The aim of this study is to assess the efficacy of a digital lifestyle intervention in non-small cell lung cancer (NSCLC) survivors following inpatient rehabilitation on health-related quality of life (HRQoL) over three months.

Detailed Description
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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 inpatient rehabilitation 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).

Official Title
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Effect of a Digital Lifestyle Intervention on Health-Related Quality of Life in Non-Small Cell Lung Cancer Survivors After Inpatient Rehabilitation (QUALUCA): a Multicenter Randomized Controlled Trial

Conditions
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Non-Small Cell Lung Cancer (NSCLC)

Intervention / Treatment
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* Behavioral: Lifestyle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Diagnosis of non-small cell lung cancer (NSCLC) Estimated life expectancy of ≥ six months (judged by health professionals) Currently undergoing inpatient rehabilitation Knowledge of German to understand study material and assessments Access to a cell phone or tablet Written informed consent Exclusion Criteria: Inability to provide informed consent due to cognitive or linguistic impairments Inability to participate in the intervention because of physical, cognitive, or safety reasons (judged by local investigators/responsible health professionals)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital lifestyle intervention<br>Self-management mobile application covering physical activity, nutrition, and breathing/relaxation | Behavioral: Lifestyle<br>* 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.<br>|
| No Intervention: Control<br>Usual care (study participation does not interfere with or change any other planned treatments) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Change from baseline to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Change from baseline to 3 months | 
| 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) | Change from baseline to 3 months | 
| Body mass index [kg/m²] | Computed using self-reported body weight [kg] and height [m] | Change from baseline to 3 months | 
| Physical activity | Modified Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ) (physical activity before inpatient rehabilitation and physical activity over the last week) | Change from baseline to 3 months | 
| Functional exercise capacity | 1-Minute Sit-to-Stand Test (number of repetitions) | Change from baseline to 3 months | 
| Low protein intake | Protein Screener 55+ (Pro55+) (10 items) | Change from baseline to 3 months | 
| Appetite | Simplified Nutritional Appetite Questionnaire (SNAQ) (4 items; 5-point Likert-type scale) | Change from baseline to 3 months | 
| Psychological distress | Short form of the Patient Health Questionnaire (PHQ-4) (4 items) | Change from baseline to 3 months | 
| Cancer-related fatigue | Brief Fatigue Inventory (BFI) (9 items) | 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) | Change from baseline to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical activity, Exercise, Nutrition, Breathing, Relaxation, Mobile application, Rehabilitation aftercare