Evidence-Based Nursing for Fatigue and Quality of Life in Lung Cancer Chemotherapy (NCT07049237) | Clinical Trial Compass
CompletedNot Applicable
Evidence-Based Nursing for Fatigue and Quality of Life in Lung Cancer Chemotherapy
China150 participantsStarted 2024-01-01
Plain-language 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 undergoing chemotherapy. Outcomes were compared to a group receiving routine nursing care.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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).
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Cancer-Related Fatigue (CRF)
Timeframe: Baseline, 1 month, and 3 months post-intervention.
Trial details
NCT IDNCT07049237
SponsorThe First Hospital of Hebei Medical University