NCT06536140

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2024

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 2, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

March 12, 2025

Status Verified

October 1, 2024

Enrollment Period

9 months

First QC Date

February 14, 2024

Last Update Submit

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).

Other: Home observations and interview

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.

NSCLC patients 1-3 months after lung resection surgery with or without (neo-)adjuvant therapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

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

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Chris Burtin, PhD

    University Hasselt

    PRINCIPAL INVESTIGATOR

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

Locations