Lung CancerNCT07049250
Evidence-Based Nursing for Psychological Resilience in Lung Cancer Chemotherapy Patients
A study testing Evidence-Based Nursing Intervention under Quantitative Evaluation Strategy and Routine Nursing Care in people with Lung Cancer, run by The First Hospital of Hebei Medical University at 1 site in China.
Trial summary
This study investigates the effect of an evidence-based nursing intervention, guided by a quantitative evaluation strategy, on psychological resilience and illness perception in lung cancer patients undergoing chemotherapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Evidence-Based Nursing Intervention under Quantitative Evaluation Strategy and Routine Nursing Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of lung cancer confirmed according to the Chinese Quality Control Indicators for Standardized Diagnosis and Treatment of Primary Lung Cancer (2022) through both imaging and histopathological examination.
- TNM staging determined using the 8th edition AJCC/UICC classification system.
- Scheduled to receive chemotherapy with an expected survival exceeding one year.
- Demonstrated normal cognitive and communication abilities as assessed by standardized neuropsychological tests.
- Provided written informed consent prior to enrollment.
Who cannot join
- Pre-existing neurological disorders.
- Significant organ dysfunction (defined as Child-Pugh class B/C for liver function or eGFR <30 mL/min/1.73m² for renal function).
- Active infectious diseases.
- Contraindications to chemotherapy.
- Concurrent radiotherapy.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
About this study
Official title: Effect of Evidence-Based Nursing Intervention Under Quantitative Evaluation Strategy on Psychological Resilience and Illness Perception in Lung Cancer Patients Undergoing Chemotherapy
This study investigates the effect of an evidence-based nursing intervention, guided by a quantitative evaluation strategy, on psychological resilience and illness perception in lung cancer patients undergoing chemotherapy. Patients were randomized to receive either the specialized nursing intervention or routine nursing care, with outcomes assessed at baseline and 3 months post-intervention.
Read the detailed description
Lung cancer patients undergoing chemotherapy often experience significant physical and psychological distress. Conventional nursing may not adequately address these multifaceted needs. Evidence-based nursing (EBN) integrates research evidence, clinical expertise, and patient preferences. This study evaluated an EBN intervention model guided by a quantitative evaluation strategy, which involves multidisciplinary risk assessment, tailored interventions including psychological support, cognitive restructuring, and complication prevention. The study aimed to determine if this model could improve psychological resilience, illness perception, coping styles, and reduce chemotherapy-related complications in lung cancer patients compared to routine nursing care. A total of 142 patients were randomized. The intervention group received a comprehensive EBN program including risk stratification, psychological/cognitive interventions (e.g., cognitive-behavioral techniques, peer mentoring, family counseling), systematic complication prevention (e.g., prophylactic antiemetics, dietary guidance, infection control), and sleep optimization. The control group received standard disease education, exercise guidance, and medication adherence counseling. Outcomes were measured at baseline and 3 months post-intervention.
- Conditions
- Lung Cancer
- Being tested
- Evidence-Based Nursing Intervention under Quantitative Evaluation Strategy, Routine Nursing Care
- Keywords
- Chemotherapy, Psychological Resilience, Illness Perception, Evidence-Based Nursing, Quantitative Evaluation Strategy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evidence-Based Nursing Intervention under Quantitative Evaluation StrategyBehavioural
A multifaceted nursing program incorporating comprehensive risk assessment, dynamic risk stratification, psychological and cognitive interventions (including cognitive-behavioral techniques, peer mentoring, family counseling), systematic complication prevention strategies (including prophylactic antiemetics, dietary guidance, infection control), and sleep optimization protocols.
Routine Nursing CareBehavioural
Standard disease education on chemotherapy side effects and self-management, personalized exercise guidance, and medication adherence counseling. Delivered in 30-minute sessions twice weekly for two months.
| Study group | Role | What they receive |
|---|---|---|
| Evidence-Based Nursing Intervention Group | Experimental | Participants (n=71) received evidence-based nursing intervention guided by quantitative evaluation strategy. This included: 1) comprehensive risk assessments by a multidisciplinary team; 2) dynamic risk stratification for care intensity; 3) psychological and cognitive interventions (cognitive-behavioral techniques, peer mentoring, family counseling); 4) systematic complication prevention strategies (prophylactic antiemetics, dietary guidance, infection control); 5) sleep optimization protocols. Receives: Behavioral: Evidence-Based Nursing Intervention under Quantitative Evaluation Strategy |
| Routine Nursing Care Group | Active comparator | Participants (n=71) received routine nursing care. This consisted of standard disease education covering chemotherapy side effects and self-management strategies, personalized exercise guidance focusing on maintaining physical function, and medication adherence counseling, delivered in 30-minute sessions twice weekly for a duration of two months. Receives: Behavioral: Routine Nursing Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Psychological Resilience Score
Psychological resilience assessed using the 25-item Resilience Scale. Scores range from 0 to 100, with higher scores indicating better psychological resilience. The scale measures optimism, resilience, and strength subdomains.
Measured: Baseline and 3 months post-intervention.
Secondary outcomes (3)
Change in Illness Perception
Illness perception assessed using the Brief Illness Perception Questionnaire (B-IPQ). This evaluates emotional, cognitive, and comprehension domains, with each item scored from 0 to 10. Higher scores in relevant domains indicate more positive or accurate illness perception.
Measured: Baseline and 3 months post-intervention.
Change in Coping Styles
Coping styles measured by the Simplified Coping Style Questionnaire (SCSQ) to distinguish between active and passive coping strategies. Higher scores for active coping and lower scores for passive coping are generally considered favorable.
Measured: Baseline and 3 months post-intervention.
Incidence of Chemotherapy-Related Complications
Occurrence of chemotherapy-related complications including gastrointestinal reactions, pulmonary infections, hepatorenal toxicity, bone marrow suppression, and phlebitis. Assessed as percentage of patients experiencing each complication.
Measured: Assessed throughout the 3-month post-intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start1 Mar 2024
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feifei Wang, The First Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049250
- Sponsor's protocol ID
- 2024S00040
- Status last verified
- Jun 2025
- First submitted
- 25 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Evidence-Based Nursing Intervention Under Quantitative Evaluation Strategy on Psychological Resilience and Illness Perception in Lung Cancer Patients Undergoing Chemotherapy
- ClinicalTrials.gov ID
- NCT07049250
- Acronym / sponsor ID
- 2024S00040
- Conditions
- Lung Cancer
- Keywords
- Chemotherapy, Psychological Resilience, Illness Perception, Evidence-Based Nursing, Quantitative Evaluation Strategy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- The First Hospital of Hebei Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the effect of an evidence-based nursing intervention, guided by a quantitative evaluation strategy, on psychological resilience and illness perception in lung cancer patients undergoing chemotherapy. Patients were randomized to receive either the specialized nursing intervention or routine nursing care, with outcomes assessed at baseline and 3 months post-intervention.
Detailed description
Lung cancer patients undergoing chemotherapy often experience significant physical and psychological distress. Conventional nursing may not adequately address these multifaceted needs. Evidence-based nursing (EBN) integrates research evidence, clinical expertise, and patient preferences. This study evaluated an EBN intervention model guided by a quantitative evaluation strategy, which involves multidisciplinary risk assessment, tailored interventions including psychological support, cognitive restructuring, and complication prevention. The study aimed to determine if this model could improve psychological resilience, illness perception, coping styles, and reduce chemotherapy-related complications in lung cancer patients compared to routine nursing care. A total of 142 patients were randomized. The intervention group received a comprehensive EBN program including risk stratification, psychological/cognitive interventions (e.g., cognitive-behavioral techniques, peer mentoring, family counseling), systematic complication prevention (e.g., prophylactic antiemetics, dietary guidance, infection control), and sleep optimization. The control group received standard disease education, exercise guidance, and medication adherence counseling. Outcomes were measured at baseline and 3 months post-intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Evidence-Based Nursing Intervention Group | Experimental | Behavioral: Evidence-Based Nursing Intervention under Quantitative Evaluation StrategyParticipants (n=71) received evidence-based nursing intervention guided by quantitative evaluation strategy. This included: 1) comprehensive risk assessments by a multidisciplinary team; 2) dynamic risk stratification for care intensity; 3) psychological and cognitive interventions (cognitive-behavioral techniques, peer mentoring, family counseling); 4) systematic complication prevention strategies (prophylactic antiemetics, dietary guidance, infection control); 5) sleep optimization protocols. |
| Routine Nursing Care Group | Active comparator | Behavioral: Routine Nursing CareParticipants (n=71) received routine nursing care. This consisted of standard disease education covering chemotherapy side effects and self-management strategies, personalized exercise guidance focusing on maintaining physical function, and medication adherence counseling, delivered in 30-minute sessions twice weekly for a duration of two months. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of lung cancer confirmed according to the Chinese Quality Control Indicators for Standardized Diagnosis and Treatment of Primary Lung Cancer (2022) through both imaging and histopathological examination.
- TNM staging determined using the 8th edition AJCC/UICC classification system.
- Scheduled to receive chemotherapy with an expected survival exceeding one year.
- Demonstrated normal cognitive and communication abilities as assessed by standardized neuropsychological tests.
- Provided written informed consent prior to enrollment.
Key exclusion criteria (5 listed)
- Pre-existing neurological disorders.
- Significant organ dysfunction (defined as Child-Pugh class B/C for liver function or eGFR <30 mL/min/1.73m² for renal function).
- Active infectious diseases.
- Contraindications to chemotherapy.
- Concurrent radiotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evidence-Based Nursing Intervention under Quantitative Evaluation StrategyA multifaceted nursing program incorporating comprehensive risk assessment, dynamic risk stratification, psychological and cognitive interventions (including cognitive-behavioral techniques, peer mentoring, family counseling), systematic complication prevention strategies (including prophylactic antiemetics, dietary guidance, infection control), and sleep optimization protocols. | Behavioural | Evidence-Based Nursing Intervention Group |
| Routine Nursing CareStandard disease education on chemotherapy side effects and self-management, personalized exercise guidance, and medication adherence counseling. Delivered in 30-minute sessions twice weekly for two months. | Behavioural | Routine Nursing Care Group |
Primary outcome
Change in Psychological Resilience Score
Time frame: Baseline and 3 months post-intervention.
Psychological resilience assessed using the 25-item Resilience Scale. Scores range from 0 to 100, with higher scores indicating better psychological resilience. The scale measures optimism, resilience, and strength subdomains.
3 secondary outcomes
Change in Illness Perception
Time frame: Baseline and 3 months post-intervention.
Change in Coping Styles
Time frame: Baseline and 3 months post-intervention.
Incidence of Chemotherapy-Related Complications
Time frame: Assessed throughout the 3-month post-intervention period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evidence-Based Nursing Intervention under Quantitative Evaluation Strategy and Routine Nursing Care in people with Lung Cancer, run by The First Hospital of Hebei Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Psychological Resilience Score (time frame: Baseline and 3 months post-intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.