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NCT Number: NCT05819346

Digital Lifestyle Intervention for Lung Cancer Survivors

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.

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Key information

Conditions

Non-small Cell Lung Cancer (NSCLC) Behavior Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Motor Activity Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinik Barmelweid AG, Barmelweid, Switzerland

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Lifestyle

Behavioral

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.

Primary outcomes

  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 outcomes

  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 rehabilitation/treatment 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)

  7. Appetite

    Time frame: Change from baseline to 3 months

    Simplified Nutritional Appetite Questionnaire (SNAQ) (4 items; 5-point Likert-type scale)

  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)

Other outcomes

  1. Usability (intervention group only)

    Time frame: At 3 months follow-up (end of the intervention)

    mHealth App Usability Questionnaire (MAUQ)

  2. Acceptability, appropriateness, and feasibility (intervention group only)

    Time frame: 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)

  3. Experiences and satisfaction with the digital lifestyle intervention (intervention group only)

    Time frame: At 3 months follow-up (end of the intervention)

    Short semi-structured interview; outcomes will be qualitatively assessed (no scale is used)

  4. Treatments/support since baseline

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Anja Frei, PhD

CONTACT

[email protected]

+41 44 634 43 60

Sponsors and collaborators

Lead sponsor

Kai-Uwe Schmitt, PhD, MEng, ICID

Other

Registry information

Official study title

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

Acronym: QUALUCA

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Apr 19, 2023
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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