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AzTrials

Non-Small Cell Lung Cancer (NSCLC)QUALUCANCT05819346

Digital Lifestyle Intervention for Lung Cancer Survivors

A study testing Lifestyle in people with Non-Small Cell Lung Cancer (NSCLC), run by Kai-Uwe Schmitt, PhD, MEng, ICID at 4 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer (NSCLC)
What is being tested?
Lifestyle
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
4 sitesSwitzerland
Study dates
1 Aug 2023to 1 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

4 sites in 1 country.

Switzerland4 sites

  • Klinik Barmelweid AG

    Barmelweid, 5017

  • Zürcher RehaZentren | Klinik Davos

    Davos, 7272

  • Berner Reha Zentrum AG

    Heiligenschwendi, 3625

  • Zürcher RehaZentren | Klinik Wald

    Wald, 8636

Other trials in Switzerland

About this study

Official 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

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.

Read the 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).

Being tested
Lifestyle
Keywords
Physical activity, Exercise, Nutrition, Breathing, Relaxation, Mobile application, Rehabilitation aftercare
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Motor Activity, Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LifestyleBehavioural

    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.

Study groups in NCT05819346
Study groupRoleWhat they receive
Digital lifestyle interventionExperimentalSelf-management mobile application covering physical activity, nutrition, and breathing/relaxation
Receives: Behavioral: Lifestyle
ControlNo interventionUsual care (study participation does not interfere with or change any other planned treatments)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Change from baseline to 3 months

Secondary outcomes (11)

  1. 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)

    Measured: Change from baseline to 3 months

  2. 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)

    Measured: Change from baseline to 3 months

  3. Body mass index [kg/m²]

    Computed using self-reported body weight [kg] and height [m]

    Measured: Change from baseline to 3 months

  4. 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)

    Measured: Change from baseline to 3 months

  5. Functional exercise capacity

    1-Minute Sit-to-Stand Test (number of repetitions)

    Measured: Change from baseline to 3 months

  6. Risk for low protein intake

    Protein Screener 55+ (Pro55+) (10 items)

    Measured: Change from baseline to 3 months

  7. Appetite

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

    Measured: Change from baseline to 3 months

  8. Psychological distress

    Short form of the Patient Health Questionnaire (PHQ-4) (4 items)

    Measured: Change from baseline to 3 months

  9. Cancer-related fatigue

    Brief Fatigue Inventory (BFI) (9 items)

    Measured: Change from baseline to 3 months

  10. Enablement

    Shortened version of the Patient Enablement Scale-13 (PEN-13) (5 out of 13 items; 5-point Likert-type scale)

    Measured: Change from baseline to 3 months

  11. 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)

    Measured: Weekly for 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2023
  2. Study start1 Aug 2023
  3. Primary completion1 Dec 2025
  4. Study completion1 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05819346
Sponsor's protocol ID
0
Acronym
QUALUCA
Status last verified
Oct 2026
First submitted
6 Apr 2023
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Weber M, Raab AM, Schmitt KU, Busching G, Marcin T, Spielmanns M, Puhan MA, Frei A. Efficacy of a digital lifestyle intervention on health-related QUAlity of life in non-small cell LUng CAncer survivors following inpatient rehabilitation: protocol of the QUALUCA Swiss multicentre randomised controlled trial. BMJ Open. 2024 Mar 7;14(3):e081397. doi: 10.1136/bmjopen-2023-081397.

    PubMed 38453202

  • Weber M, Raab AM, Schmitt KU, Busching G, Marcin T, Riegler TF, Spielmanns M, Spielmanns S, Lauber E, Gioutsos K, Papasotiropoulos T, Wicki A, Puhan MA, Frei A. Insights from a randomized controlled trial on a digital lifestyle intervention in non-small cell lung cancer survivors following inpatient rehabilitation. Lung Cancer. 2026 Jul;217:109433. doi: 10.1016/j.lungcan.2026.109433. Epub 2026 May 5.

    PubMed 42127533

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle in people with Non-Small Cell Lung Cancer (NSCLC), run by Kai-Uwe Schmitt, PhD, MEng, ICID at 4 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health-related quality of life (Scale-Global health status) (time frame: Change from baseline to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05819346, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

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