The Impact of an Educational Intervention on Disease Acceptance, Quality of Life, Pain Levels, and Postoperative Clinical and Biometric Outcomes Among Patients Undergoing Surgery for Lung Cancer.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 160
- Locations
- 1
Study Overview
Brief Summary
The goal of this interventional study is to learn about the effect of a structured educational intervention in patients undergoing surgery for lung cancer. The study will examine whether this intervention can improve patients' acceptance of the disease, quality of life, pain levels, and postoperative clinical and biometric outcomes.
The main question it aims to answer is: Does a structured educational intervention improve disease acceptance, quality of life, pain levels, and postoperative clinical and biometric outcomes in patients undergoing surgery for lung cancer? Participants are assigned to two groups. Participants in the intervention group receive a structured educational intervention in addition to usual care, while participants in the control group receive usual care only. Data are collected through questionnaires and clinical and biometric measurements after surgery, with follow-up assessments over a 5-year period.
Detailed Description
This is a two-arm parallel-group interventional study evaluating the impact of a structured educational intervention in patients undergoing surgery for lung cancer. The study is conducted at a referral center, where all interviews, educational sessions, follow-up assessments, and data collection procedures take place.
Before enrollment, all eligible patients receive written information about the study and provide written informed consent. By signing the consent form, participants give permission for the researcher to collect study-related data through personal interviews and from their medical records.
Baseline preoperative data are collected from all participants before the delivery of the educational intervention. These data are collected using specially designed questionnaires administered through personal interviews with the patient and include demographic characteristics, hospital admission information, biometric measurements, lifestyle-related factors such as smoking, physical activity, dietary habits and alcohol consumption, as well as personal and family medical history.
Participants are allocated to either an intervention group or a control group. Allocation is performed using a predefined alternating sequence according to the order of surgery. On the first surgical day of the study, the research team determines the initial group assignment for the first eligible participant undergoing the first scheduled surgery. Subsequently, eligible participants are allocated alternately to the intervention and control groups according to the order of surgery. On the next surgical day, the allocation sequence starts with the opposite group, and this alternating pattern continues throughout enrollment.
The intervention group receives usual care plus a structured educational intervention supported by printed educational material. Participation of a caregiver is required during the educational session together with the patient. The printed material includes the date of the educational intervention, the researcher-educator's contact details, and the scheduled follow-up appointment.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Care Provider)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients diagnosed with lung cancer.
- •Patients admitted to the referral hospital and undergoing surgical treatment for lung cancer.
- •Age older than 18 years.
- •Signed written informed consent.
- •Ability to speak, understand, and read the Greek language.
- •Undisturbed level of consciousness allowing cooperation with the researcher and the healthcare team.
- •Ability to participate in a personal interview and complete the study questionnaires.
- •Availability of a supportive psychosocial network/caregiver, where required for participation in the educational intervention.
Exclusion Criteria
- •Inability to provide written informed consent.
- •Inability to speak, understand, or read the Greek language.
- •Impaired level of consciousness that prevents cooperation.
- •Presence of a chronic condition affecting behavior or ability to cooperate with the study procedures.
- •Lack of a supportive psychosocial network.
- •Inability to cooperate with the medical and nursing staff.
- •Inability to participate in the interview process or complete the required study assessments.
Investigators
Anastasios Moysiadis
RN, MSc (NSPH), MSc (NKUA), PhD Candidate
National and Kapodistrian University of Athens