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Trial 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
NCT ID:
NCT06536140
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Other
Intervention name:
Home observations and interview
Description:
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.
Arm group label:
NSCLC patients 1-3 months after lung resection surgery with or without (neo-)adjuvant therapy
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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 ...).
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Faculteit Revalidatiewetenschappen - Gebouw 7
Address:
City:
Diepenbeek
Zip:
3590
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Chris Burtin, PhD
Email:
chris.burtin@uhasselt.be
Investigator:
Last name:
Maarten Criel, PhD
Email:
Principal Investigator
Investigator:
Last name:
Sarah Haesevoets, MSc
Email:
Sub-Investigator
Start date:
December 1, 2023
Completion date:
September 1, 2024
Lead sponsor:
Agency:
Hasselt University
Agency class:
Other
Source:
Hasselt University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06536140
