NCT07498972

Evidence-Based Nursing Plus Progressive Exercise for Cancer-Related Fatigue in Advanced Lung Cancer

Effect of Evidence-Based Nursing Combined With Progressive Gymnastics Training on Cancer-Related Fatigue, Quality of Life, and Treatment Adherence in Patients With Advanced Lung Cancer Undergoing Chemotherapy: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Shanxi Province Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a single-center, prospective, randomized controlled trial designed to evaluate the effectiveness and safety of evidence-based nursing combined with progressive exercise training in patients with advanced lung cancer undergoing chemotherapy. Eligible patients with stage III-IV lung cancer receiving platinum-based chemotherapy were consecutively recruited and randomly assigned in a 1:1 ratio to either the control group or the intervention group using a random number table. Stratified randomization was performed according to age, sex, and Karnofsky Performance Status (KPS). Allocation was implemented using sealed opaque envelopes. Due to the nature of the intervention, participants and intervention providers were not blinded; however, outcome assessment and statistical analysis were conducted by independent personnel blinded to group allocation. The control group received routine nursing care, including health education, symptom monitoring, dietary guidance, and general psychological support. The intervention group received, in addition to routine care, a comprehensive intervention consisting of evidence-based nursing and progressive exercise training. Evidence-based nursing included individualized health education, psychological support, symptom management, and family involvement strategies developed based on current best evidence. The progressive exercise program was supervised by rehabilitation specialists and included aerobic and resistance training with gradually increasing intensity, tailored to individual patient tolerance. The intervention duration was 8 weeks. Patients were followed throughout the intervention period with regular monitoring of symptoms, adherence, and safety. Primary outcomes included changes in cancer-related fatigue assessed by the Brief Fatigue Inventory (BFI) and functional exercise capacity assessed by the 6-minute walk test (6MWT). Secondary outcomes included quality of life measured by the EORTC QLQ-C30, treatment adherence measured by the MMAS-8, psychological status assessed by the Hospital Anxiety and Depression Scale (HADS), sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI), and the incidence of adverse events. The study aims to provide evidence for a multidimensional supportive care model integrating nursing interventions and exercise rehabilitation to improve clinical outcomes in patients with advanced lung cancer.

Conditions

• Advanced Lung Cancer
• Cancer-related Fatigue

Interventions

Type	Name	Description
BEHAVIORAL	Evidence-Based Nursing	Evidence-based nursing included individualized health education, psychological support, symptom management, and family involvement strategies based on current best available evidence. Nursing interventions were tailored to patients' clinical conditions and aimed to improve symptom control, treatment adherence, and overall quality of life.
BEHAVIORAL	Progressive Exercise Training	Progressive exercise training consisted of aerobic and resistance exercises with gradually increasing intensity over an 8-week period. The program was individualized based on patients' physical condition and tolerance, and included activities such as walking, Tai Chi, and light resistance training. Exercise sessions were supervised by rehabilitation specialists and nursing staff.
OTHER	Routine Nursing Care	Routine nursing care included standard health education, dietary guidance, symptom monitoring, and general psychological support provided during chemotherapy, without a structured evidence-based nursing protocol or exercise program.

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-06-30
• Completion: 2024-08-30
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: China