The Lived Experiences of Persons With Early Stage Non-small Cell Lung Cancer and Their Significant Other(s) Following Surgery: a Rapid Ethnographic Approach
LEILA
1 other identifier
observational
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2023
CompletedFirst Submitted
Initial submission to the registry
February 14, 2024
CompletedFirst Posted
Study publicly available on registry
August 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2024
CompletedMarch 12, 2025
October 1, 2024
9 months
February 14, 2024
March 10, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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)
Visit 1 during week 1
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)
Visit 1 during week 1
Secondary Outcomes (13)
Socio-demographic information
Visit 1 during week 1
Anthropometric information
Visit 1 during week 1
Medical history (from medical file)
Before visit 1
Lung function (from medical file)
Before visit 1
Physical activity
One week between the third week and fourth week.
- +8 more secondary outcomes
Study Arms (1)
NSCLC patients 1-3 months after lung resection surgery with or without (neo-)adjuvant therapy
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).
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- Adults (18+ year);
- Ability to give informed consent.
You may not qualify if:
- 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 …).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculteit Revalidatiewetenschappen - Gebouw 7
Diepenbeek, Limburg, 3590, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chris Burtin, PhD
University Hasselt
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 10 Weeks
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 14, 2024
First Posted
August 2, 2024
Study Start
December 1, 2023
Primary Completion
September 1, 2024
Study Completion
October 1, 2024
Last Updated
March 12, 2025
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share