Educational Intervention for Patients Undergoing Surgery for Lung Cancer (LUNG-SURG-EDU)
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.
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.
調査の概要
詳細な説明
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.
The educational intervention includes detailed information about lung cancer and the patient's treatment pathway. Patients are informed about the disease, imaging-based staging, and the possible contribution of histological findings to final disease staging and further treatment planning. Information is also provided about potential adjuvant treatments, including chemotherapy, immunotherapy, and radiotherapy, when clinically indicated.
The intervention also covers the surgical procedure and the expected postoperative course. Patients receive information about postoperative drains, surgical incisions, wound care, mobilization, recovery after surgery, and orientation to the clinical setting. Education is provided on lifestyle modification, including smoking cessation, alcohol use, nutrition, physical activity, exercise after surgery, permitted weight limits, and general self-care during recovery.
In addition, patients are trained in preoperative respiratory exercises to support postoperative respiratory function. A dedicated section focuses on postoperative pain, including pain recognition, pain management strategies, relaxation techniques, and the importance of adequate sleep. Throughout the intervention, patients and their caregivers are encouraged to ask questions, express concerns, and discuss issues related to the disease, surgery, recovery, and follow-up care.
The control group consists of patients in whom the same variables are assessed without receiving the educational intervention. Participants in the control group receive usual clinical care according to the protocol of the Thoracic Surgery Department of the referral center. Interviews and data collection for the control group are also conducted at the referral center. Participants in the control group are reassessed at the same time points as participants in the intervention group.
The first interview and educational session for the intervention group are conducted during the patient's preoperative hospitalization. For both groups, baseline assessment is performed preoperatively. A second interview and educational session for the intervention group are conducted during the first three postoperative days and serve as the first postoperative reassessment. Participants in the control group are reassessed during the same postoperative period without receiving the educational intervention.
Additional follow-up assessments are conducted at the same time points for both groups: at 1 month and 6 months after surgery, after the first postoperative year, and during the planned long-term follow-up period of 5 years.
Patient-reported outcomes are assessed using validated Greek versions of standardized questionnaires. Illness perceptions and disease-related cognition are evaluated using the Illness Cognition Questionnaire for Chronic Diseases, which consists of 18 closed-ended items rated on a four-point scale. The questionnaire assesses three domains: illness acceptance, perceived benefits of the illness, and helplessness related to the illness.
Quality of life is assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and the lung cancer-specific module EORTC QLQ-LC13, both validated in the Greek language. These instruments assess physical, psychological, and social aspects of quality of life, as well as cancer-related and lung cancer-specific symptoms.
Pain intensity is assessed using the Pain Rating Scale of The British Pain Society. The scale is administered at the predefined study assessment time points in order to monitor postoperative pain and changes in pain levels during follow-up.
Clinical information and biometric measurements are also collected at the predefined assessment time points. Treating physicians and nursing staff are not informed of participants' group allocation.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Attica
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Chaïdári、Attica、ギリシャ、124 61
- General University Hospital "ATTIKON"
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Structured Educational Intervention plus Usual Care
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.
|
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.
|
|
アクティブコンパレータ：Usual Care
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.
|
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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Disease Acceptance
時間枠：Baseline preoperative assessment, first 3 postoperative days, 1 month, 6 months, 1 year, and up to 5 years after surgery
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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.
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Baseline preoperative assessment, first 3 postoperative days, 1 month, 6 months, 1 year, and up to 5 years after surgery
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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)
時間枠：Baseline preoperative assessment, first 3 postoperative days, 1 month, 6 months, 1 year, and up to 5 years after surgery
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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.
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Baseline preoperative assessment, first 3 postoperative days, 1 month, 6 months, 1 year, and up to 5 years after surgery
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Change in Functional Status Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30
時間枠：Baseline preoperative assessment, first 3 postoperative days, 1 month, 6 months, 1 year, and up to 5 years after surgery.
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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.
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Baseline preoperative assessment, first 3 postoperative days, 1 month, 6 months, 1 year, and up to 5 years after surgery.
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Change in Cancer-Related Symptoms Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30
時間枠：Baseline preoperative assessment, first 3 postoperative days, 1 month, 6 months, 1 year, and up to 5 years after surgery.
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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.
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Baseline preoperative assessment, first 3 postoperative days, 1 month, 6 months, 1 year, and up to 5 years after surgery.
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Change in Lung Cancer-Specific Symptoms Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13
時間枠：Baseline preoperative assessment, first 3 postoperative days, 1 month, 6 months, 1 year, and up to 5 years after surgery.
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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.
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Baseline preoperative assessment, first 3 postoperative days, 1 month, 6 months, 1 year, and up to 5 years after surgery.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Pain Intensity Assessed by the British Pain Society Numerical Pain Rating Scale
時間枠：Baseline preoperative assessment, first 3 postoperative days, 1 month, 6 months, 1 year, and up to 5 years after surgery
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Pain intensity will be assessed using the British Pain Society Numerical Pain Rating Scale.
This is an 11-point numerical scale used to evaluate patients' perceived pain intensity.
The score ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain.
Higher scores indicate greater pain intensity and therefore a worse outcome.
Changes in pain intensity scores will be compared between the intervention and control groups over the predefined study assessment time points.
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Baseline preoperative assessment, first 3 postoperative days, 1 month, 6 months, 1 year, and up to 5 years after surgery
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Change in Total Cholesterol Levels
時間枠：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.
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Total cholesterol levels will be assessed through blood biochemical analysis.
Total cholesterol will be reported in mg/dL.
Changes in total cholesterol levels will be compared between the intervention and control groups over the predefined study assessment time points.
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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.
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Change in Triglyceride Levels
時間枠：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.
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Triglyceride levels will be assessed through blood biochemical analysis.
Triglycerides will be reported in mg/dL.
Changes in triglyceride levels will be compared between the intervention and control groups over the predefined study assessment time points.
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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.
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Change in Total Protein Levels
時間枠：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.
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Total protein levels will be assessed through blood biochemical analysis.
Total proteins will be reported in g/dL.
Changes in total protein levels will be compared between the intervention and control groups over the predefined study assessment time points.
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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.
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Change in Albumin Levels
時間枠：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
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Serum albumin levels will be assessed through blood biochemical analysis.
Albumin will be reported in g/dL.
Changes in albumin levels will be compared between the intervention and control groups over the predefined study assessment time points.
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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
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協力者と研究者
協力者
捜査官
- 主任研究者：Anastasios Moysiadis、Medical School, National and Kapodistrian University of Athens; General University Hospital "ATTIKON"
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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