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NCT Number: NCT07498972

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

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.

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Key information

Conditions

Advanced Lung Cancer Behavior Cancer-related Fatigue Health Behavior Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanxi Province Cancer Hospital

Taiyuan, Shanxi, 030013, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evidence-Based Nursing

Behavioral

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.

Progressive Exercise Training

Behavioral

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.

Routine Nursing Care

Other

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.

Primary outcomes

  1. Change in Cancer-Related Fatigue Assessed by the Brief Fatigue Inventory (BFI)

    Time frame: Baseline; Week 8

    Cancer-related fatigue is assessed using the Brief Fatigue Inventory (BFI), a validated scale ranging from 0 to 10, with higher scores indicating more severe fatigue. The outcome measure is the change in total BFI score.

  2. Change in Functional Exercise Capacity Assessed by the 6-Minute Walk Test (6MWT)

    Time frame: Baseline; Week 8

    Functional exercise capacity is assessed using the 6-minute walk test (6MWT), which measures the distance a participant can walk in 6 minutes. The outcome measure is the change in walking distance (meters).

Secondary outcomes

  1. Change in Quality of Life Assessed by the EORTC QLQ-C30

    Time frame: Baseline; Week 8

    Quality of life was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Scores were linearly transformed to a 0-100 scale, with higher scores on functional scales indicating better quality of life. The outcome measure was the change in functional domain scores from baseline to the end of the intervention.

  2. Change in Treatment Adherence Assessed by the Morisky Medication Adherence Scale (MMAS-8)

    Time frame: Baseline; Week 8

    Treatment adherence was assessed using the 8-item Morisky Medication Adherence Scale (MMAS-8), with total scores ranging from 0 to 8 and higher scores indicating better adherence. The outcome measure was the change in MMAS-8 score from baseline to the end of the intervention.

  3. Change in Psychological Status Assessed by the Hospital Anxiety and Depression Scale (HADS)

    Time frame: Baseline; Week 8

    Psychological status was evaluated using the Hospital Anxiety and Depression Scale (HADS), which includes subscales for anxiety and depression. Higher scores indicate more severe symptoms. The outcome measure was the change in total HADS score from baseline to the end of the intervention.

  4. Change in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline; Week 8

    Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), with total scores ranging from 0 to 21 and higher scores indicating poorer sleep quality. The outcome measure was the change in PSQI score from baseline to the end of the intervention.

  5. Incidence of Adverse Events

    Time frame: Baseline through Week 8

    All adverse events occurring during the study period were recorded, including exercise-related adverse events and chemotherapy-related complications such as myelosuppression and infection. The outcome measure was the incidence and type of adverse events observed during the intervention period.

Sponsors and collaborators

Lead sponsor

Shanxi Province Cancer Hospital

Other

Registry information

Official study title

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

Acronym: ENPE-CRF

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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