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

NCT07498972 | Completed

• 1 other identifier: IIT-2025-162
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Lung Cancer; Cancer-related Fatigue

Keywords

Evidence-Based Nursing; Progressive Exercise; Exercise Rehabilitation; Chemotherapy; Quality of Life; Treatment Adherence; Randomized Controlled Trial; 6-Minute Walk Test; Brief Fatigue Inventory

Outcome Measures

Primary Outcomes (2)

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

  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.

  Baseline; Week 8

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

  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).

  Baseline; Week 8

Secondary Outcomes (5)

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

  Baseline; Week 8

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

  Baseline; Week 8

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

  Baseline; Week 8

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

  Baseline; Week 8

• Incidence of Adverse Events

  Baseline through Week 8

Study Arms (2)

Intervention Group: Evidence-Based Nursing Plus Progressive Exercise

EXPERIMENTAL

Participants in the intervention group received routine nursing care combined with evidence-based nursing and a structured progressive exercise training program for 8 weeks. Evidence-based nursing included individualized health education, psychological support, symptom management, and family involvement based on current best evidence. The exercise program consisted of aerobic and resistance training with gradually increasing intensity, tailored to each patient's physical condition and tolerance, and supervised by rehabilitation specialists and nursing staff.

Behavioral: Evidence-Based Nursing; Behavioral: Progressive Exercise Training; Other: Routine Nursing Care

Control Group: Routine Nursing Care

ACTIVE COMPARATOR

Participants in the control group received routine nursing care, including standard health education, dietary guidance, symptom monitoring, and general psychological support. No structured exercise rehabilitation program or evidence-based nursing protocol was provided.

Other: Routine Nursing Care

Interventions

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.

Intervention Group: Evidence-Based Nursing Plus Progressive Exercise

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.

Intervention Group: Evidence-Based Nursing Plus Progressive Exercise

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.

Control Group: Routine Nursing Care; Intervention Group: Evidence-Based Nursing Plus Progressive Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanxi Province Cancer Hospital: lead

Study Sites (1)

Shanxi Province Cancer Hospital

Taiyuan, Shanxi, 030013, China

Location

MeSH Terms

Conditions

Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Qingjuan Li, MD

  Shanxi Province Cancer Hospital, Taiyuan, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, participants and care providers were not blinded. Outcome assessors and data analysts were blinded to group allocation to reduce assessment and analysis bias.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were randomly assigned in a 1:1 ratio to either the intervention group or the control 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. The two groups received different interventions concurrently over the same study period.

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 27, 2026
• Study Start: January 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: August 30, 2024
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

CN (1)