Lung NeoplasmsNCT07525908
Efficacy of a Self-Efficacy Nursing Model in CyberKnife-Treated Lung Cancer Patients
A study testing Self-Efficacy Theory-Based Nursing Model and Routine Nursing Care in people with Lung Neoplasms and Anxiety, run by The First Hospital of Hebei Medical University at 1 site in China.
Trial summary
This study evaluates whether a multi-component nursing model based on self-efficacy theory can alleviate psychological distress, mitigate pain, and improve the quality of life (QoL) in lung cancer patients undergoing CyberKnife stereotactic radiosurgery compared to routine nursing care. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Lung Neoplasms, Anxiety
- What is being tested?
- Self-Efficacy Theory-Based Nursing Model 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
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 31 Oct 2024
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 40 and 80 years, inclusive.
- Histologically or cytologically confirmed diagnosis of primary lung cancer (suitable for CyberKnife treatment).
- Scheduled to receive CyberKnife stereotactic radiosurgery as a primary or palliative treatment.
- Karnofsky Performance Status (KPS) score of 80-100.
- Patient-Generated Subjective Global Assessment (PG-SGA) score ≤ 5.
- Estimated life expectancy of at least 6 months.
- Able to understand, speak, and read Mandarin Chinese.
- Willing and able to provide written informed consent.
Who cannot join
- Presence of severe, uncontrolled cardiovascular, cerebrovascular, respiratory, hepatic, or renal diseases.
- Known history of severe psychiatric disorders or cognitive impairment.
- Presence of other active malignancies requiring systemic treatment.
- Known severe, uncontrolled endocrine or metabolic diseases.
- Significant coagulation disorders.
- Previous radiotherapy to the planned CyberKnife treatment field.
- Participation in another interventional clinical trial concurrently or within 30 days prior to enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site
First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
About this study
Official title: Clinical Study on the Impact of a Self-Efficacy Theory-Based Nursing Model on Psychological Distress, Pain Level, and Quality of Life in Lung Cancer Patients Treated With CyberKnife
This study evaluates whether a multi-component nursing model based on self-efficacy theory can alleviate psychological distress, mitigate pain, and improve the quality of life (QoL) in lung cancer patients undergoing CyberKnife stereotactic radiosurgery compared to routine nursing care.
Read the detailed description
Lung cancer patients undergoing CyberKnife stereotactic radiosurgery often experience significant psychological distress, including profound fear and anxiety, as well as pain, which negatively impacts their quality of life. This single-center, prospective, randomized controlled trial investigated a structured nursing intervention based on Albert Bandura's self-efficacy theory. A total of 300 lung cancer patients scheduled for CyberKnife treatment were randomly assigned (1:1 ratio) to an intervention group or a control group. The control group received standard medical and routine nursing care. The intervention group received a multi-component nursing model in addition to routine care. The intervention included cognitive-behavioral strategies, psychological support, role model encouragement, functional exercise guidance, social support system enhancement, and self-management training, which was initiated upon admission and continued for 4 weeks. The primary hypothesis is that this theory-based approach will significantly improve general self-efficacy, reduce symptom burden (anxiety and pain), and enhance overall quality of life compared to standard care.
- Conditions
- Lung Neoplasms, Anxiety
- Being tested
- Self-Efficacy Theory-Based Nursing Model, Routine Nursing Care
- Medical subject headings
- Lung Neoplasms, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Efficacy Theory-Based Nursing ModelBehavioural
Patients received routine nursing care plus a structured, multi-component nursing intervention based on self-efficacy theory. The core components delivered over 4 weeks included: cognitive-behavioral education (to correct misconceptions and set realistic goals), psychological support (active listening and guided relaxation), role-model encouragement (sharing experiences of successful patients), functional exercise guidance (gentle breathing and physical activity), reinforcement of social support systems, and self-management skill training (symptom monitoring and action plans).
Routine Nursing CareBehavioural
Patients received standard medical care and routine nursing care. This included standard pre-treatment education regarding the CyberKnife procedure, basic symptom monitoring and management, general psychological support during routine interactions, and standard discharge planning.
| Study group | Role | What they receive |
|---|---|---|
| Self-Efficacy Nursing Group | Experimental | Patients received routine nursing care plus a structured, multi-component nursing intervention based on self-efficacy theory. The core components delivered over 4 weeks included: cognitive-behavioral education (to correct misconceptions and set realistic goals), psychological support (active listening and guided relaxation), role-model encouragement (sharing experiences of successful patients), functional exercise guidance (gentle breathing and physical activity), reinforcement of social support systems, and self-management skill training (symptom monitoring and action plans). Receives: Behavioral: Self-Efficacy Theory-Based Nursing Model |
| Control Group | Active comparator | Patients received standard medical care and routine nursing care. This included standard pre-treatment education regarding the CyberKnife procedure, basic symptom monitoring and management, general psychological support during routine interactions, and standard discharge planning. Receives: Behavioral: Routine Nursing Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in General Self-Efficacy
Change in general self-efficacy was assessed using the General Self-Efficacy Scale (GSES). The GSES is a 10-item psychometric scale where each item is rated on a 4-point Likert scale. Total scores range from 10 to 40, with higher scores indicating greater perceived self-efficacy to cope with difficulties.
Measured: Baseline and 4 weeks
Secondary outcomes (4)
Change in Anxiety Level
Change in anxiety level was measured using the Zung Self-Rating Anxiety Scale (SAS). The SAS is a 20-item self-report questionnaire with a standardized index score ranging from 25 to 100. Higher scores indicate greater anxiety levels.
Measured: Baseline and 4 weeks
Change in Pain Intensity
Change in pain intensity was measured using a 10cm Visual Analogue Scale (VAS). Scores range from 0 ("no pain") to 10 ("worst imaginable pain").
Measured: Baseline and 4 weeks
Change in Quality of Life (Physical Component Summary)
Change in the Physical Component Summary (PCS) of the Short Form-36 Health Survey (SF-36). Scores are transformed to a 0-100 scale, with higher scores indicating better physical health-related quality of life.
Measured: Baseline and 4 weeks
Change in Quality of Life (Mental Component Summary)
Change in the Mental Component Summary (MCS) of the Short Form-36 Health Survey (SF-36). Scores are transformed to a 0-100 scale, with higher scores indicating better mental health-related quality of life.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Oct 2023
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yusha Yan, The First Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07525908
- Sponsor's protocol ID
- 2023S00352
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 13 Apr 2026
- 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Impact of a Self-Efficacy Theory-Based Nursing Model on Psychological Distress, Pain Level, and Quality of Life in Lung Cancer Patients Treated With CyberKnife
- ClinicalTrials.gov ID
- NCT07525908
- Acronym / sponsor ID
- 2023S00352
- Conditions
- Lung Neoplasms, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- The First Hospital of Hebei Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 13 Apr 2026 (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 evaluates whether a multi-component nursing model based on self-efficacy theory can alleviate psychological distress, mitigate pain, and improve the quality of life (QoL) in lung cancer patients undergoing CyberKnife stereotactic radiosurgery compared to routine nursing care.
Detailed description
Lung cancer patients undergoing CyberKnife stereotactic radiosurgery often experience significant psychological distress, including profound fear and anxiety, as well as pain, which negatively impacts their quality of life. This single-center, prospective, randomized controlled trial investigated a structured nursing intervention based on Albert Bandura's self-efficacy theory. A total of 300 lung cancer patients scheduled for CyberKnife treatment were randomly assigned (1:1 ratio) to an intervention group or a control group. The control group received standard medical and routine nursing care. The intervention group received a multi-component nursing model in addition to routine care. The intervention included cognitive-behavioral strategies, psychological support, role model encouragement, functional exercise guidance, social support system enhancement, and self-management training, which was initiated upon admission and continued for 4 weeks. The primary hypothesis is that this theory-based approach will significantly improve general self-efficacy, reduce symptom burden (anxiety and pain), and enhance overall quality of life compared to standard care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-Efficacy Nursing Group | Experimental | Behavioral: Self-Efficacy Theory-Based Nursing ModelPatients received routine nursing care plus a structured, multi-component nursing intervention based on self-efficacy theory. The core components delivered over 4 weeks included: cognitive-behavioral education (to correct misconceptions and set realistic goals), psychological support (active listening and guided relaxation), role-model encouragement (sharing experiences of successful patients), functional exercise guidance (gentle breathing and physical activity), reinforcement of social support systems, and self-management skill training (symptom monitoring and action plans). |
| Control Group | Active comparator | Behavioral: Routine Nursing CarePatients received standard medical care and routine nursing care. This included standard pre-treatment education regarding the CyberKnife procedure, basic symptom monitoring and management, general psychological support during routine interactions, and standard discharge planning. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged between 40 and 80 years, inclusive.
- Histologically or cytologically confirmed diagnosis of primary lung cancer (suitable for CyberKnife treatment).
- Scheduled to receive CyberKnife stereotactic radiosurgery as a primary or palliative treatment.
- Karnofsky Performance Status (KPS) score of 80-100.
- Patient-Generated Subjective Global Assessment (PG-SGA) score ≤ 5.
Key exclusion criteria (7 listed)
- Presence of severe, uncontrolled cardiovascular, cerebrovascular, respiratory, hepatic, or renal diseases.
- Known history of severe psychiatric disorders or cognitive impairment.
- Presence of other active malignancies requiring systemic treatment.
- Known severe, uncontrolled endocrine or metabolic diseases.
- Significant coagulation disorders.
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 |
|---|---|---|
| Self-Efficacy Theory-Based Nursing ModelPatients received routine nursing care plus a structured, multi-component nursing intervention based on self-efficacy theory. The core components delivered over 4 weeks included: cognitive-behavioral education (to correct misconceptions and set realistic goals), psychological support (active listening and guided relaxation), role-model encouragement (sharing experiences of successful patients), functional exercise guidance (gentle breathing and physical activity), reinforcement of social support systems, and self-management skill training (symptom monitoring and action plans). | Behavioural | Self-Efficacy Nursing Group |
| Routine Nursing CarePatients received standard medical care and routine nursing care. This included standard pre-treatment education regarding the CyberKnife procedure, basic symptom monitoring and management, general psychological support during routine interactions, and standard discharge planning. | Behavioural | Control Group |
Primary outcome
Change in General Self-Efficacy
Time frame: Baseline and 4 weeks
Change in general self-efficacy was assessed using the General Self-Efficacy Scale (GSES). The GSES is a 10-item psychometric scale where each item is rated on a 4-point Likert scale. Total scores range from 10 to 40, with higher scores indicating greater perceived self-efficacy to cope with difficulties.
4 secondary outcomes
Change in Anxiety Level
Time frame: Baseline and 4 weeks
Change in Pain Intensity
Time frame: Baseline and 4 weeks
Change in Quality of Life (Physical Component Summary)
Time frame: Baseline and 4 weeks
Change in Quality of Life (Mental Component Summary)
Time frame: Baseline and 4 weeks
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 13 Apr 2026.
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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 Self-Efficacy Theory-Based Nursing Model and Routine Nursing Care in people with Lung Neoplasms and Anxiety, 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 8 inclusion and 7 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 13 Apr 2026. 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 General Self-Efficacy (time frame: Baseline and 4 weeks). 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 13 Apr 2026.