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Completed

NCT Number: NCT06536140

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculteit Revalidatiewetenschappen - Gebouw 7

Diepenbeek, Limburg, 3590, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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 …).

Treatment and study plan

Home observations and interview

Other

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.

Primary outcomes

  1. Barriers and facilitators for exercise and physical activity

    Time frame: Visit 1 during week 1

    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)

  2. Motivation and self-efficacy

    Time frame: Visit 1 during week 1

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

Secondary outcomes

  1. Socio-demographic information

    Time frame: Visit 1 during week 1

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

  2. Anthropometric information

    Time frame: Visit 1 during week 1

    Weight in kg, height in cm

  3. Medical history (from medical file)

    Time frame: Before visit 1

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

  4. Lung function (from medical file)

    Time frame: Before visit 1

    Complete lung function after surgery

  5. Physical activity

    Time frame: One week between the third week and fourth week.

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

  6. Activity related information

    Time frame: Visit 2 during week 2

    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

  7. Comorbidities

    Time frame: Visit 2 during week 2

    Self-Administered Comorbidity Questionnaire

  8. Symptoms of dyspnea

    Time frame: Visit 2 during week 2

    Modified Medical Research Council Dyspnoe vragenlijst (mMRC)

  9. Symptoms of fatigue

    Time frame: Visit 2 during week 2

    Multidimensional Fatigue Inventory (MFI-20)

  10. Symptoms of anxiety

    Time frame: Visit 3 during week 3

    Depression Anxiety Stress Scale (DASS-21)

  11. Health related Quality of Life

    Time frame: Visit 3 during week 3

    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)

  12. Quality of Life

    Time frame: Visit 3 during week 3

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

  13. Loneliness

    Time frame: Visit 3 during week 3

    Loneliness Scale

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Registry information

Acronym: LEILA

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 2, 2024
Registry last updated
Mar 12, 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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