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)

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Other: Home observations and interview

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.

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• Belgium
  • Limburg
    • Diepenbeek, Limburg, Belgium, 3590
      • Faculteit Revalidatiewetenschappen - Gebouw 7

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 …).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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).

Other: Home 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Socio-demographic information	Name, birth date, address, telephone number, smoking status	Visit 1 during week 1
Anthropometric information	Weight in kg, height in cm	Visit 1 during week 1
Medical history (from medical file)	Oncological history, pathological staging (TNM 8e edition), treatment type, medication, hospital admissions in the past year	Before visit 1
Lung function (from medical file)	Complete lung function after surgery	Before visit 1
Physical activity	Objectively measured physical activity: Mean steps per day, MVPA, daily walking time, movement intensity during walking, sedentary time (measured by Dynaport MoveMonitor and Actigraph)	One week between the third week and fourth week.
Activity related information	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	Visit 2 during week 2
Comorbidities	Self-Administered Comorbidity Questionnaire	Visit 2 during week 2
Symptoms of dyspnea	Modified Medical Research Council Dyspnoe vragenlijst (mMRC)	Visit 2 during week 2
Symptoms of fatigue	Multidimensional Fatigue Inventory (MFI-20)	Visit 2 during week 2
Symptoms of anxiety	Depression Anxiety Stress Scale (DASS-21)	Visit 3 during week 3
Health related Quality of Life	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)	Visit 3 during week 3
Quality of Life	36-Item Short Form Survey (SF-36) and 12-Item Short Form Survey (SF-12)	Visit 3 during week 3
Loneliness	Loneliness Scale	Visit 3 during week 3

Collaborators and Investigators

• Sponsor: Hasselt University
• Investigators: Principal Investigator: Chris Burtin, PhD, University Hasselt

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: February 14, 2024
• First Submitted That Met QC Criteria: July 31, 2024
• First Posted (Actual): August 2, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: Z-2023064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No