Educational Intervention for Patients Undergoing Surgery for Lung Cancer

NCT07614204 | Active Not Recruiting

• 1 other identifier: 678/21-12-2020
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (5)

• Disease Acceptance

  Disease acceptance is assessed using the validated Greek version of the Illness Cognition Questionnaire for Chronic Diseases. The questionnaire consists of 18 closed-ended items rated on a four-point scale and evaluates three domains: acceptance of the illness, perceived benefits of the illness, and helplessness related to the illness. The primary outcome focuses on changes in the illness acceptance domain between the intervention and control groups over the predefined study assessment time points. The total score for this domain ranges from 6 to 24, with higher scores indicating greater illness acceptance and a better outcome.

  Baseline preoperative assessment, first 3 postoperative days, 1 month, 6 months, 1 year, and up to 5 years after surgery

• Change in Global Health Status/Quality of Life Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

  Global health status/quality of life will be assessed using the validated Greek version of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30. The global health status/quality of life scale score ranges from 0 to 100. Higher scores indicate better global health status and better quality of life. Changes in scores will be compared between the intervention and control groups over the predefined study assessment time points.

  Baseline preoperative assessment, first 3 postoperative days, 1 month, 6 months, 1 year, and up to 5 years after surgery

• Change in Functional Status Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30

  Functional status will be assessed using the validated Greek version of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30. The questionnaire includes functional scales assessing physical, role, emotional, cognitive, and social functioning. Each functional scale score ranges from 0 to 100. Higher scores indicate better functioning and therefore a better outcome. Changes in functional scale scores will be compared between the intervention and control groups over the predefined study assessment time points.

  Baseline preoperative assessment, first 3 postoperative days, 1 month, 6 months, 1 year, and up to 5 years after surgery.

• Change in Cancer-Related Symptoms Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30

  Cancer-related symptoms will be assessed using the validated Greek version of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30. Symptom scales and single-item symptom measures assess symptoms such as fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. Each symptom scale or single-item score ranges from 0 to 100. Higher scores indicate greater symptom burden and therefore a worse outcome. Changes in symptom scores will be compared between the intervention and control groups over the predefined study assessment time points.

  Baseline preoperative assessment, first 3 postoperative days, 1 month, 6 months, 1 year, and up to 5 years after surgery.

• Change in Lung Cancer-Specific Symptoms Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13

  Lung cancer-specific symptoms will be assessed using the validated Greek version of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13. This lung cancer-specific module assesses symptoms and treatment-related problems, including coughing, hemoptysis, dyspnea, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm or shoulder pain, other pain, and pain medication use. Each scale or single-item score ranges from 0 to 100. Higher scores indicate greater symptom burden and therefore a worse outcome. Changes in lung cancer-specific symptom scores will be compared between the intervention and control groups over the predefined study assessment time points.

  Baseline preoperative assessment, first 3 postoperative days, 1 month, 6 months, 1 year, and up to 5 years after surgery.

Secondary Outcomes (5)

• Change in Pain Intensity Assessed by the British Pain Society Numerical Pain Rating Scale

  Baseline preoperative assessment, first 3 postoperative days, 1 month, 6 months, 1 year, and up to 5 years after surgery

• Change in Total Cholesterol Levels

  Baseline preoperative assessment, postoperative Day 1, postoperative Day 2, postoperative Day 3, 1 month, 6 months, 1 year, and annually up to 5 years after surgery.

• Change in Triglyceride Levels

  Baseline preoperative assessment, postoperative Day 1, postoperative Day 2, postoperative Day 3, 1 month, 6 months, 1 year, and annually up to 5 years after surgery.

• Change in Total Protein Levels

  Baseline preoperative assessment, postoperative Day 1, postoperative Day 2, postoperative Day 3, 1 month, 6 months, 1 year, and annually up to 5 years after surgery.

• Change in Albumin Levels

  Baseline preoperative assessment, postoperative Day 1, postoperative Day 2, postoperative Day 3, 1 month, 6 months, 1 year, and annually up to 5 years after surgery

Study Arms (2)

Structured Educational Intervention plus Usual Care

EXPERIMENTAL

Participants in this arm receive a structured educational intervention in addition to usual clinical care. The intervention includes printed educational material and individualized education about lung cancer, surgery, postoperative recovery, respiratory exercises, pain management, lifestyle modification, follow-up care, and self-care. A caregiver is required to participate in the educational session together with the patient.

Behavioral: Structured Educational Intervention

Usual Care

ACTIVE COMPARATOR

Participants in this arm receive usual clinical care according to the protocol of the Thoracic Surgery Department of the referral center. The same variables are assessed at the same time points as in the intervention group, but participants do not receive the structured educational intervention.

Other: Usual Care

Interventions

Structured Educational Intervention BEHAVIORAL

The structured educational intervention is delivered to patients undergoing surgery for lung cancer in addition to usual care. It includes printed educational material and individualized education about lung cancer, imaging-based staging, histological findings and final disease staging, possible adjuvant treatments, the surgical procedure, postoperative drains, surgical incisions and wound care, postoperative recovery, respiratory exercises, pain management, relaxation techniques, sleep, lifestyle modification, nutrition, smoking, alcohol use, physical activity, permitted weight limits, and follow-up care. A caregiver is required to participate in the educational session together with the patient.

Structured Educational Intervention plus Usual Care

Usual Care OTHER

Usual care consists of standard clinical care provided according to the protocol of the Thoracic Surgery Department of the referral center. Participants receiving usual care undergo the same study assessments as the intervention group but do not receive the structured educational intervention.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Attikon Hospital: collaborator
• National and Kapodistrian University of Athens: lead

Study Sites (1)

General University Hospital "ATTIKON"

Chaïdári, Attica, 124 61, Greece

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Anastasios Moysiadis

  Medical School, National and Kapodistrian University of Athens; General University Hospital "ATTIKON"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, MSc (NSPH), MSc (NKUA), PhD Candidate

Model Details: This study used a parallel-group design. Participants in the intervention group received a structured educational intervention in addition to usual care, whereas participants in the control group received usual care alone.

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 29, 2026
• Study Start: January 1, 2021
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)