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Lung CancerLEILANCT06536140

The Lived Experiences of Persons With Early Stage Non-small Cell Lung Cancer and Their Significant Other(s) Following Surgery: a Rapid Ethnographic Approach

An observational study of Lung Cancer, run by Hasselt University at 1 site in Belgium.

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

To understand the lived experiences, thoughts and habits about exercise and PA of persons with early stage non-small cell lung cancer and their significant other(s) following surgery. Read more about this study

Who is it for?
Any age
Conditions the study is for
Lung Cancer
What is being tested?
Home observations and interview
How many people
16 participants
Where
1 siteBelgium
Study dates
1 Dec 2023to 1 Oct 2024
How long will I take part?
10 Weeks
Phase
Observational
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: This study will include twenty persons who underwent surgery for early stage I-IIIA NSCLC (with or without (neo-) adjuvant chemotherapy/radiotherapy/immunotherapy) one to three months before inclusion and their carers significant other(s). This can be one person or multiple persons (e.g. partner, parent, child, brother, sister). In case the person doesn't have a significant other, this person will not be excluded from the study. Purposive sampling will be applied. The study will aim to recruit persons with a wide range of characteristics including age, sex and ethnic cultural background as it is important to recruit a diverse sample. We will not have access to the socio-economic background of persons during the screening process.

Who may be able to join

  • Persons who got surgery for early stage I-IIIA NSCLC, one to three months before inclusion;
  • If persons received adjuvant chemotherapy/radiotherapy, the inclusion window is one to three months after the end of adjuvant chemotherapy/radiotherapy. If persons receive adjuvant immunotherapy after the end of adjuvant chemotherapy, persons can be included during the immunotherapy;
  • Adults (18+ year);
  • Ability to give informed consent.

Who cannot join

  • Persons having progressive or recurrent lung cancer;
  • Persons who had other malignancies in the last 2 years;
  • Persons who do systematically perform or plan to perform structured exercise;
  • Persons not living independently at home (e.g. care home, psychiatric institution);
  • Psychiatric or cognitive disorders;
  • Not understanding and speaking Dutch;
  • Not living at home (e.g. nursing home, prison …).

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Faculteit Revalidatiewetenschappen - Gebouw 7

    Diepenbeek, Limburg, 3590

Other trials in Belgium

About this study

To understand the lived experiences, thoughts and habits about exercise and PA of persons with early stage non-small cell lung cancer and their significant other(s) following surgery.

Read the detailed description

It is important to gather information on the lived lives of persons and their significant other(s) following surgery for early stage non-small cell lung cancer (NSCLC). The adaptations these persons make, the challenges they face and their personal experiences need to be investigated so their thoughts and habits about exercise and physical activity (PA) can be better understood. In this way, rehabilitation programs focused on exercise and PA can be better individualized. The individualization of such programs is heavily influenced by the person's experiences, including beliefs and expectations regarding exercise and PA. Observations of and informal conversations with persons with early stage NSCLC and their significant other(s) following surgery will offer insight into the challenges faced by these individuals and the opportunities for exercise and PA, how this does and could fit, within their everyday lives so this can be enhanced. It is important to align exercise and PA to everyday activities, to make it meaningful to individuals (more likely to engage) and to obtain sustained effects in the long term. The investigators expect this study to show the highly personal views and behaviour of these persons, warranting an equally personal communication approach to discuss these issues with these persons in light of developing individualized rehabilitation programs.

Conditions
Lung Cancer
Being tested
Home observations and interview
Medical subject headings
Lung Neoplasms

What participants receive

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

  • Home observations and interviewOther

    If persons want to participate, the person will be invited one week before the first observation for a 'warm-up' phone call (W1) as a preparation for the three observations and follow-up interview.

    During the observations, SH will be an active participant, offering to help with activities of daily life with the person, so opportunities are created to observe and ask questions (sensory ethnography). The person will be asked to take pictures or make drawings of important things in the house as the observer will be able to better understand how they feel about exercise and PA (visual ethnography). Six weeks after the last observation (W10), formal follow-up interviews (30-60 min) with questions based on the observations that took place, will be held to explore specific issues in-depth.

Study groups in NCT06536140
Study groupRoleWhat they receive
NSCLC patients 1-3 months after lung resection surgery with or without (neo-)adjuvant therapyThis study will include twenty persons who underwent surgery for early stage I-IIIA NSCLC (with or without (neo-) adjuvant chemotherapy/radiotherapy/immunotherapy) one to three months before inclusion and their carers significant other(s). This can be one person or multiple persons (e.g. partner, parent, child, brother, sister).
Receives: Other: Home observations and interview

What is being measured

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

  1. Barriers and facilitators for exercise and physical activity

    Self-developed questionnaire to assess person's motivation and self-efficacy regarding exercise and PA based on Chan et al. (2022) and Rogers et al. (2006)

    Measured: Visit 1 during week 1

  2. Motivation and self-efficacy

    Exercise Self-Efficacy Scale (ESES), Tampa Scale for Kinesiophobia (TSK), Perceived physical activity questionnaire (LIVAS), SRQ-E (Exercise self-regulation questionnaire)

    Measured: Visit 1 during week 1

Secondary outcomes (13)

  1. Socio-demographic information

    Name, birth date, address, telephone number, smoking status

    Measured: Visit 1 during week 1

  2. Anthropometric information

    Weight in kg, height in cm

    Measured: Visit 1 during week 1

  3. Medical history (from medical file)

    Oncological history, pathological staging (TNM 8e edition), treatment type, medication, hospital admissions in the past year

    Measured: Before visit 1

  4. Lung function (from medical file)

    Complete lung function after surgery

    Measured: Before visit 1

  5. Physical activity

    Objectively measured physical activity: Mean steps per day, MVPA, daily walking time, movement intensity during walking, sedentary time (measured by Dynaport MoveMonitor and Actigraph)

    Measured: One week between the third week and fourth week.

  6. Activity related information

    Previous exercise/activity interventions. Marital status, living status, education level, last work experience, current work status, feeling of loneliness, having grandchildren and/or a pet(s), experience with step counters/activity trackers

    Measured: Visit 2 during week 2

  7. Comorbidities

    Self-Administered Comorbidity Questionnaire

    Measured: Visit 2 during week 2

  8. Symptoms of dyspnea

    Modified Medical Research Council Dyspnoe vragenlijst (mMRC)

    Measured: Visit 2 during week 2

  9. Symptoms of fatigue

    Multidimensional Fatigue Inventory (MFI-20)

    Measured: Visit 2 during week 2

  10. Symptoms of anxiety

    Depression Anxiety Stress Scale (DASS-21)

    Measured: Visit 3 during week 3

  11. Health related Quality of Life

    European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Core-30 item (EORTC QLQ-C30), European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire and Lung Cancer Module (EORTC QLQ-LC-13) and EuroQoL five-dimensional instrument (EQ-5D)

    Measured: Visit 3 during week 3

  12. Quality of Life

    36-Item Short Form Survey (SF-36) and 12-Item Short Form Survey (SF-12)

    Measured: Visit 3 during week 3

  13. Loneliness

    Loneliness Scale

    Measured: Visit 3 during week 3

Timeline

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

  1. First posted2 Aug 2024
  2. Study start1 Dec 2023
  3. Primary completion1 Sep 2024
  4. Study completion1 Oct 2024

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
16 participants (actual)
Target duration
10 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT06536140
Sponsor's protocol ID
Z-2023064
Acronym
LEILA
Status last verified
Oct 2024
First submitted
14 Feb 2024
Last updated
12 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Haesevoets S, Muijsenberg AJL, Cops D, Harrison SL, Criel M, Ruttens D, Daenen M, Spruit MA, Demeyer H, Burtin C. The lived experiences of individuals with early stage non-small cell lung cancer following lung surgery: A rapid ethnographic approach. Chron Respir Dis. 2026 Jan-Dec;23:14799731261438123. doi: 10.1177/14799731261438123. Epub 2026 May 15.

    PubMed 42139296

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Cancer, run by Hasselt University at 1 site in Belgium.

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 4 inclusion and 7 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 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. 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?

Barriers and facilitators for exercise and physical activity (time frame: Visit 1 during week 1). The study lists 2 primary outcomes in all. 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 NCT06536140, which also lists 1 linked publication.

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 12 Mar 2025.

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