Non-Small Cell Lung Cancer (NSCLC)
Conditions
Keywords
Physical activity, Exercise, Nutrition, Breathing, Relaxation, Mobile application, Rehabilitation aftercare
Brief summary
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.
Detailed description
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).
Interventions
BEHAVIORALLifestyle
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.
Sponsors
Kai-Uwe Schmitt, PhD, MEng, ICID
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Diagnosis of non-small cell lung cancer (NSCLC) * Estimated life expectancy of ≥ six months (judged by local investigators/responsible health professionals) * Undergoing inpatient or outpatient rehabilitation OR completion of planned surgery, chemotherapy, or radiation therapy for NSCLC within the past 24 weeks * 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 * Inability to participate in the intervention because of physical, cognitive, or safety reasons (judged by local investigators/responsible health professionals)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health-related quality of life (Scale-Global health status) | 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
| Measure | Time frame | Description |
|---|---|---|
| Functional exercise capacity | Change from baseline to 3 months | 1-Minute Sit-to-Stand Test (number of repetitions) |
| Psychological distress | Change from baseline to 3 months | Short form of the Patient Health Questionnaire (PHQ-4) (4 items) |
| Cancer-related fatigue | Change from baseline to 3 months | Brief Fatigue Inventory (BFI) (9 items) |
| Enablement | 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) |
| Self-rated health | 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) |
| Health-related quality of life (5 functional scales, 9 symptom scales/items) | 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) |
| Lung cancer-specific health-related quality of life (10 symptom scales/items) | 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) |
| Body mass index [kg/m²] | Change from baseline to 3 months | Computed using self-reported body weight \[kg\] and height \[m\] |
| Physical activity (self-reported) | Change from baseline to 3 months | Modified Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ) (physical activity before rehabilitation/treatment and physical activity over the last week) |
| Risk for low protein intake | Change from baseline to 3 months | Protein Screener 55+ (Pro55+) (10 items) |
| Appetite | Change from baseline to 3 months | Simplified Nutritional Appetite Questionnaire (SNAQ) (4 items; 5-point Likert-type scale) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Experiences and satisfaction with the digital lifestyle intervention (intervention group only) | At 3 months follow-up (end of the intervention) | Short semi-structured interview; outcomes will be qualitatively assessed (no scale is used) |
| Treatments/support since baseline | At 3 months follow-up (end of the intervention) | 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) |
| Usability (intervention group only) | At 3 months follow-up (end of the intervention) | mHealth App Usability Questionnaire (MAUQ) |
| Acceptability, appropriateness, and feasibility (intervention group only) | At 3 months follow-up (end of the intervention) | Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) (4-item measures of implementation outcomes) |
Countries
Switzerland
Contacts
Primary ContactAnja Frei, PhD
Outcome results
None listed