Clinical trial 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
Official title: The Lived Experiences of Persons With Early Stage Non-small Cell Lung Cancer and Their Significant Other(s) Following Surgery: a Rapid Ethnographic Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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 ...).

Primary outcomes:
measure: Barriers and facilitators for exercise and physical activity
timeFrame: Visit 1 during week 1
measure: Motivation and self-efficacy
timeFrame: Visit 1 during week 1
Secondary outcomes:
measure: Socio-demographic information
timeFrame: Visit 1 during week 1
measure: Anthropometric information
timeFrame: Visit 1 during week 1
measure: Medical history (from medical file)
timeFrame: Before visit 1
measure: Lung function (from medical file)
timeFrame: Before visit 1
measure: Physical activity
timeFrame: One week between the third week and fourth week.
measure: Activity related information
timeFrame: Visit 2 during week 2
measure: Comorbidities
timeFrame: Visit 2 during week 2
measure: Symptoms of dyspnea
timeFrame: Visit 2 during week 2
measure: Symptoms of fatigue
timeFrame: Visit 2 during week 2
measure: Symptoms of anxiety
timeFrame: Visit 3 during week 3
measure: Health related Quality of Life
timeFrame: Visit 3 during week 3
measure: Quality of Life
timeFrame: Visit 3 during week 3
measure: Loneliness
timeFrame: Visit 3 during week 3
Other outcomes:
Locations:
city: Diepenbeek
country: Belgium
facility: Faculteit Revalidatiewetenschappen - Gebouw 7
state: Limburg
Study officials:
affiliation: University Hasselt
name: Chris Burtin, PhD
role: PRINCIPAL_INVESTIGATOR
References: