Faculteit Revalidatiewetenschappen - Gebouw 7
Diepenbeek, Limburg, 3590, Belgium
NCT Number: NCT06536140
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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Observational
Diepenbeek, Limburg, 3590, Belgium
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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)
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)
Time frame: Visit 1 during week 1
Name, birth date, address, telephone number, smoking status
Time frame: Visit 1 during week 1
Weight in kg, height in cm
Time frame: Before visit 1
Oncological history, pathological staging (TNM 8e edition), treatment type, medication, hospital admissions in the past year
Time frame: Before visit 1
Complete lung function after surgery
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)
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
Time frame: Visit 2 during week 2
Self-Administered Comorbidity Questionnaire
Time frame: Visit 2 during week 2
Modified Medical Research Council Dyspnoe vragenlijst (mMRC)
Time frame: Visit 2 during week 2
Multidimensional Fatigue Inventory (MFI-20)
Time frame: Visit 3 during week 3
Depression Anxiety Stress Scale (DASS-21)
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)
Time frame: Visit 3 during week 3
36-Item Short Form Survey (SF-36) and 12-Item Short Form Survey (SF-12)
Time frame: Visit 3 during week 3
Loneliness Scale
Hasselt University
Other
Acronym: LEILA
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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