Lung CancerNCT07049237
Evidence-Based Nursing for Fatigue and Quality of Life in Lung Cancer Chemotherapy
A study testing Evidence-Based Nursing Under Quantitative Assessment Strategy (EB-NQAS) 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 prospective randomized controlled trial investigated the effects of an evidence-based nursing intervention under a quantitative assessment strategy (EB-NQAS), utilizing the Edmonton Symptom Assessment Scale (ESAS), on cancer-related fatigue, self-management ability, and quality of life in lung cancer patients… 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 Under Quantitative Assessment Strategy (EB-NQAS) 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
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Jan 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
- Pathologically or radiologically confirmed lung cancer (World Health Organization [WHO] 2021 diagnostic criteria).
- Scheduled to receive first-line chemotherapy (platinum-based regimen).
- Karnofsky Performance Status (KPS) score ≥60.
- Estimated survival time >6 months (assessed by treating oncologist).
- Normal mental and cognitive function (Mini-Mental State Examination [MMSE] score ≥24).
- Voluntary participation and signed informed consent.
Who cannot join
- Concurrent severe organ dysfunction (Child-Pugh score ≥B for liver; estimated glomerular filtration rate [eGFR] <30 mL/min/1.73m² for kidney).
- Active neurological disorders (e.g., stroke, epilepsy) affecting symptom reporting.
- Acute infectious diseases (e.g., tuberculosis with sputum positivity).
- Known allergies to chemotherapy drugs (e.g., platinum agents).
- Acute illnesses requiring hospitalization (e.g., pneumonia, myocardial infarction).
- Secondary malignancies (pathologically confirmed).
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- Chemotherapy contraindications (e.g., uncontrolled heart failure).
- Inability to communicate in the local language (assessed via nurse interview).
- Concurrent radiotherapy or immunotherapy.
- Participation in other interventional clinical trials within 3 months.
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: Effects of Evidence-Based Nursing Under a Quantitative Assessment Strategy on Cancer-Related Fatigue, Self-Management Ability, and Quality of Life in Lung Cancer Patients Undergoing Chemotherapy
This prospective randomized controlled trial investigated the effects of an evidence-based nursing intervention under a quantitative assessment strategy (EB-NQAS), utilizing the Edmonton Symptom Assessment Scale (ESAS), on cancer-related fatigue, self-management ability, and quality of life in lung cancer patients undergoing chemotherapy. Outcomes were compared to a group receiving routine nursing care.
Read the detailed description
Lung cancer patients undergoing chemotherapy frequently experience significant cancer-related fatigue (CRF) and diminished quality of life (QoL), which may not be adequately addressed by conventional nursing approaches. This study aimed to evaluate the efficacy of an evidence-based nursing intervention guided by a quantitative assessment strategy (EB-NQAS). The EB-NQAS group (n=75) received personalized care plans developed by a dedicated nursing team. These plans were based on quantitative symptom assessment using the Edmonton Symptom Assessment Scale (ESAS) and incorporated evidence-based interventions for pain management (e.g., graded approach, music therapy, opioids), fatigue (e.g., activity plans, sleep optimization), nausea/vomiting prevention (e.g., prophylactic antiemetics, ginger, dietary advice), and psychological support (e.g., cognitive-behavioral therapy). Care plans were dynamically evaluated and adjusted based on daily and weekly ESAS monitoring. The control group (n=75) received routine nursing care, including standard health education, psychological support, dietary guidance, and adverse effect management. The study compared the effects of EB-NQAS versus routine nursing on CRF, self-management ability, QoL, and adverse events over a 3-month intervention period in 150 randomized lung cancer patients.
- Conditions
- Lung Cancer
- Being tested
- Evidence-Based Nursing Under Quantitative Assessment Strategy (EB-NQAS), Routine Nursing Care
- Keywords
- Chemotherapy, Cancer-Related Fatigue, CRF, Self-Management Ability, Quality of Life, QoL, Evidence-Based Nursing, Quantitative Assessment Strategy, Edmonton Symptom Assessment Scale
- 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 Under Quantitative Assessment Strategy (EB-NQAS)Behavioural
A multifaceted nursing program using the Edmonton Symptom Assessment Scale (ESAS) for quantitative symptom assessment to guide personalized, evidence-based care plans. Interventions included tailored strategies for pain management (graded, music therapy, heat, opioids), fatigue (supervised walking, sleep optimization), nausea/vomiting prevention (prophylactic antiemetics, ginger, dietary advice), and psychological support (cognitive-behavioral therapy). Care plans were dynamically monitored and adjusted.
Routine Nursing CareBehavioural
Standard hospital oncology nursing care including health education, general psychological support (weekly 15-minute sessions), dietary guidance based on nutritional risk screening, and verbal instructions for managing common adverse effects.
| Study group | Role | What they receive |
|---|---|---|
| Evidence-Based Nursing Under Quantitative Assessment Strategy (EB-NQAS) Group | Experimental | Participants (n=75) received evidence-based nursing under a quantitative assessment strategy. This involved baseline assessment with ESAS; tailored care planning for pain, fatigue, nausea/vomiting, and psychological distress (including CBT, activity/sleep plans, prophylactic antiemetics); and dynamic daily/weekly evaluation and adjustment of care based on ESAS scores. Receives: Behavioral: Evidence-Based Nursing Under Quantitative Assessment Strategy (EB-NQAS) |
| Routine Nursing Care Group | Active comparator | Participants (n=75) received standard nursing care as per hospital guidelines, including health education on lung cancer and chemotherapy, weekly 15-minute psychological support sessions, individualized dietary guidance, and verbal instructions on managing adverse effects. Receives: Behavioral: Routine Nursing Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cancer-Related Fatigue (CRF)
Assessed using the Piper Fatigue Scale (PFS). The PFS consists of 22 items covering 4 domains (behavioral, emotional, cognitive, physical), with each item scored from 0 to 10. The total score ranges from 0 to 220, where higher scores indicate more severe fatigue.
Measured: Baseline, 1 month, and 3 months post-intervention.
Secondary outcomes (3)
Change in Self-Management Ability
Evaluated using the Adult Health Self-Management Scale (AHSMSRS). This 38-item scale assesses 3 domains (environment, behavior, cognition), with items scored from 1 to 5. The total score ranges from 38 to 190, with higher scores indicating better self-management ability.
Measured: Baseline, 1 month, and 3 months post-intervention.
Change in Quality of Life (QoL)
Measured using the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC-QLQ-C30). This questionnaire assesses 4 functioning domains and 5 symptom domains. Scores are normalized to a 0-100 scale; higher scores represent better functioning/QoL for functioning scales and more severe symptoms for symptom scales.
Measured: Baseline, 1 month, and 3 months post-intervention.
Incidence of Chemotherapy-Related Adverse Events
Occurrence of chemotherapy-related adverse effects, including gastrointestinal reactions (nausea/vomiting ≥CTCAE grade 2), hepatic dysfunction (AST/ALT >2 times Upper Limit of Normal), myelosuppression (neutrophils <1.5×10⁹/L), neurotoxicity (peripheral numbness ≥grade 2), and alopecia. Adverse events were recorded daily using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: Assessed daily during the intervention period (up to 3 months).
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 Jan 2024
- Primary completion1 Jan 2025
- Study completion1 Jan 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
- 150 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
- NCT07049237
- Sponsor's protocol ID
- 2023S00501
- 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
- Effects of Evidence-Based Nursing Under a Quantitative Assessment Strategy on Cancer-Related Fatigue, Self-Management Ability, and Quality of Life in Lung Cancer Patients Undergoing Chemotherapy
- ClinicalTrials.gov ID
- NCT07049237
- Acronym / sponsor ID
- 2023S00501
- Conditions
- Lung Cancer
- Keywords
- Chemotherapy, Cancer-Related Fatigue, CRF, Self-Management Ability, Quality of Life, QoL, Evidence-Based Nursing, Quantitative Assessment Strategy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- The First Hospital of Hebei Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 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 prospective randomized controlled trial investigated the effects of an evidence-based nursing intervention under a quantitative assessment strategy (EB-NQAS), utilizing the Edmonton Symptom Assessment Scale (ESAS), on cancer-related fatigue, self-management ability, and quality of life in lung cancer patients undergoing chemotherapy. Outcomes were compared to a group receiving routine nursing care.
Detailed description
Lung cancer patients undergoing chemotherapy frequently experience significant cancer-related fatigue (CRF) and diminished quality of life (QoL), which may not be adequately addressed by conventional nursing approaches. This study aimed to evaluate the efficacy of an evidence-based nursing intervention guided by a quantitative assessment strategy (EB-NQAS). The EB-NQAS group (n=75) received personalized care plans developed by a dedicated nursing team. These plans were based on quantitative symptom assessment using the Edmonton Symptom Assessment Scale (ESAS) and incorporated evidence-based interventions for pain management (e.g., graded approach, music therapy, opioids), fatigue (e.g., activity plans, sleep optimization), nausea/vomiting prevention (e.g., prophylactic antiemetics, ginger, dietary advice), and psychological support (e.g., cognitive-behavioral therapy). Care plans were dynamically evaluated and adjusted based on daily and weekly ESAS monitoring. The control group (n=75) received routine nursing care, including standard health education, psychological support, dietary guidance, and adverse effect management. The study compared the effects of EB-NQAS versus routine nursing on CRF, self-management ability, QoL, and adverse events over a 3-month intervention period in 150 randomized lung cancer patients.
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 Under Quantitative Assessment Strategy (EB-NQAS) Group | Experimental | Behavioral: Evidence-Based Nursing Under Quantitative Assessment Strategy (EB-NQAS)Participants (n=75) received evidence-based nursing under a quantitative assessment strategy. This involved baseline assessment with ESAS; tailored care planning for pain, fatigue, nausea/vomiting, and psychological distress (including CBT, activity/sleep plans, prophylactic antiemetics); and dynamic daily/weekly evaluation and adjustment of care based on ESAS scores. |
| Routine Nursing Care Group | Active comparator | Behavioral: Routine Nursing CareParticipants (n=75) received standard nursing care as per hospital guidelines, including health education on lung cancer and chemotherapy, weekly 15-minute psychological support sessions, individualized dietary guidance, and verbal instructions on managing adverse effects. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Pathologically or radiologically confirmed lung cancer (World Health Organization [WHO] 2021 diagnostic criteria).
- Scheduled to receive first-line chemotherapy (platinum-based regimen).
- Karnofsky Performance Status (KPS) score ≥60.
- Estimated survival time >6 months (assessed by treating oncologist).
- Normal mental and cognitive function (Mini-Mental State Examination [MMSE] score ≥24).
Key exclusion criteria (10 listed)
- Concurrent severe organ dysfunction (Child-Pugh score ≥B for liver; estimated glomerular filtration rate [eGFR] <30 mL/min/1.73m² for kidney).
- Active neurological disorders (e.g., stroke, epilepsy) affecting symptom reporting.
- Acute infectious diseases (e.g., tuberculosis with sputum positivity).
- Known allergies to chemotherapy drugs (e.g., platinum agents).
- Acute illnesses requiring hospitalization (e.g., pneumonia, myocardial infarction).
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 Under Quantitative Assessment Strategy (EB-NQAS)A multifaceted nursing program using the Edmonton Symptom Assessment Scale (ESAS) for quantitative symptom assessment to guide personalized, evidence-based care plans. Interventions included tailored strategies for pain management (graded, music therapy, heat, opioids), fatigue (supervised walking, sleep optimization), nausea/vomiting prevention (prophylactic antiemetics, ginger, dietary advice), and psychological support (cognitive-behavioral therapy). Care plans were dynamically monitored and adjusted. | Behavioural | Evidence-Based Nursing Under Quantitative Assessment Strategy (EB-NQAS) Group |
| Routine Nursing CareStandard hospital oncology nursing care including health education, general psychological support (weekly 15-minute sessions), dietary guidance based on nutritional risk screening, and verbal instructions for managing common adverse effects. | Behavioural | Routine Nursing Care Group |
Primary outcome
Change in Cancer-Related Fatigue (CRF)
Time frame: Baseline, 1 month, and 3 months post-intervention.
Assessed using the Piper Fatigue Scale (PFS). The PFS consists of 22 items covering 4 domains (behavioral, emotional, cognitive, physical), with each item scored from 0 to 10. The total score ranges from 0 to 220, where higher scores indicate more severe fatigue.
3 secondary outcomes
Change in Self-Management Ability
Time frame: Baseline, 1 month, and 3 months post-intervention.
Change in Quality of Life (QoL)
Time frame: Baseline, 1 month, and 3 months post-intervention.
Incidence of Chemotherapy-Related Adverse Events
Time frame: Assessed daily during the intervention period (up to 3 months).
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 Under Quantitative Assessment Strategy (EB-NQAS) 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 6 inclusion and 10 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 Cancer-Related Fatigue (CRF) (time frame: Baseline, 1 month, 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.