Evidence-Based Nursing Plus Progressive Exercise for Cancer-Related Fatigue in Advanced Lung Cancer (NCT07498972) | Clinical Trial Compass
CompletedNot Applicable
Evidence-Based Nursing Plus Progressive Exercise for Cancer-Related Fatigue in Advanced Lung Cancer
China100 participantsStarted 2023-01-01
Plain-language summary
This study aims to evaluate the effectiveness and safety of evidence-based nursing combined with progressive exercise training in patients with advanced lung cancer undergoing chemotherapy. Cancer-related fatigue (CRF) is a common and distressing symptom in this population and is associated with poor quality of life and reduced treatment adherence.
In this single-center, prospective randomized controlled trial, 100 patients with stage III-IV lung cancer receiving platinum-based chemotherapy were randomly assigned to either a control group or an intervention group. The control group received routine nursing care, while the intervention group received evidence-based nursing combined with a structured progressive exercise program for 8 weeks.
The primary outcomes are cancer-related fatigue assessed by the Brief Fatigue Inventory (BFI) and functional exercise capacity assessed by the 6-minute walk test (6MWT). Secondary outcomes include quality of life (EORTC QLQ-C30), treatment adherence (MMAS-8), psychological status (HADS), sleep quality (PSQI), and safety outcomes.
The study is designed to determine whether a combined intervention approach integrating nursing care and exercise rehabilitation can provide greater benefits than routine care alone in improving both physical and psychological outcomes in patients with advanced lung cancer.
Who can participate
Age range
18 Years
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 confirmed advanced lung cancer (stage III-IV)
* Currently receiving platinum-based chemotherapy (first to fourth cycle)
* Age ≥18 years
* Karnofsky Performance Status (KPS) score ≥60
* Presence of moderate or more severe cancer-related fatigue, defined as a Brief Fatigue Inventory (BFI) score ≥4
* Expected survival time of more than 6 months
* Ability to understand the study procedures and provide written informed consent
Exclusion Criteria:
* Severe cardiopulmonary insufficiency or other conditions that contraindicate exercise intervention
* Cognitive impairment or mental disorders affecting compliance with the intervention
* Musculoskeletal disorders that limit physical activity or exercise participation
* Presence of other advanced malignant tumors
* Rapid disease progression during the study period requiring discontinuation of the intervention
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 Assessed by the Brief Fatigue Inventory (BFI)
Timeframe: Baseline; Week 8
2
Change in Functional Exercise Capacity Assessed by the 6-Minute Walk Test (6MWT)