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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06536140
Acronym
LEILA
Enrollment
16
Registered
2024-08-02
Start date
2023-12-01
Completion date
2024-10-01
Last updated
2025-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Brief 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.

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.

Interventions

OTHERHome observations and interview

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.

Sponsors

Hasselt University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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 …).

Design outcomes

Primary

MeasureTime frameDescription
Barriers and facilitators for exercise and physical activityVisit 1 during week 1Self-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)
Motivation and self-efficacyVisit 1 during week 1Exercise Self-Efficacy Scale (ESES), Tampa Scale for Kinesiophobia (TSK), Perceived physical activity questionnaire (LIVAS), SRQ-E (Exercise self-regulation questionnaire)

Secondary

MeasureTime frameDescription
Medical history (from medical file)Before visit 1Oncological history, pathological staging (TNM 8e edition), treatment type, medication, hospital admissions in the past year
Lung function (from medical file)Before visit 1Complete lung function after surgery
Physical activityOne 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)
Activity related informationVisit 2 during week 2Previous 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
ComorbiditiesVisit 2 during week 2Self-Administered Comorbidity Questionnaire
Socio-demographic informationVisit 1 during week 1Name, birth date, address, telephone number, smoking status
Symptoms of fatigueVisit 2 during week 2Multidimensional Fatigue Inventory (MFI-20)
Symptoms of anxietyVisit 3 during week 3Depression Anxiety Stress Scale (DASS-21)
Health related Quality of LifeVisit 3 during week 3European 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)
Quality of LifeVisit 3 during week 336-Item Short Form Survey (SF-36) and 12-Item Short Form Survey (SF-12)
LonelinessVisit 3 during week 3Loneliness Scale
Symptoms of dyspneaVisit 2 during week 2Modified Medical Research Council Dyspnoe vragenlijst (mMRC)
Anthropometric informationVisit 1 during week 1Weight in kg, height in cm

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026