Advanced Lung CancerENPE-CRFNCT07498972
Evidence-Based Nursing Plus Progressive Exercise for Cancer-Related Fatigue in Advanced Lung Cancer
A study testing Evidence-Based Nursing, Progressive Exercise Training and Routine Nursing Care in people with Advanced Lung Cancer and Cancer-related Fatigue, run by Shanxi Province Cancer Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Lung Cancer, Cancer-related Fatigue
- What is being tested?
- Evidence-Based Nursing, Progressive Exercise Training and Routine Nursing Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read more
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.
Read the 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
- Being tested
- Evidence-Based Nursing, Progressive Exercise Training, Routine Nursing Care
- Keywords
- Evidence-Based Nursing, Progressive Exercise, Exercise Rehabilitation, Chemotherapy, Quality of Life, Treatment Adherence, Randomized Controlled Trial, 6-Minute Walk Test, Brief Fatigue Inventory
- Medical subject headings
- Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evidence-Based NursingBehavioural
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 TrainingBehavioural
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Routine Nursing Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Baseline; Week 8
Secondary outcomes (5)
Change in Quality of Life Assessed by the EORTC QLQ-C30
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.
Measured: Baseline; Week 8
Change in Treatment Adherence Assessed by the Morisky Medication Adherence Scale (MMAS-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.
Measured: Baseline; Week 8
Change in Psychological Status Assessed by the Hospital Anxiety and Depression Scale (HADS)
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.
Measured: Baseline; Week 8
Change in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)
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.
Measured: Baseline; Week 8
Incidence of Adverse Events
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.
Measured: Baseline through Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Jan 2023
- Primary completion30 Jun 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanxi Province Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qingjuan Li, MD, Principal investigator, Shanxi Province Cancer Hospital, Taiyuan, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07498972
- Sponsor's protocol ID
- IIT-2025-162
- Acronym
- ENPE-CRF
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data will be considered for sharing upon reasonable request to the corresponding author, subject to institutional policies and data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07498972
- Acronym / sponsor ID
- ENPE-CRF / IIT-2025-162
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Shanxi Province Cancer HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group: Evidence-Based Nursing Plus Progressive Exercise | Experimental | Behavioral: Evidence-Based Nursing, Behavioral: Progressive Exercise Training, Other: Routine Nursing CareParticipants 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. |
| Control Group: Routine Nursing Care | Active comparator | Other: Routine Nursing CareParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evidence-Based NursingEvidence-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. | Behavioural | Intervention Group: Evidence-Based Nursing Plus Progressive Exercise |
| Progressive Exercise TrainingProgressive 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. | Behavioural | Intervention Group: Evidence-Based Nursing Plus Progressive Exercise |
| Routine Nursing CareRoutine 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. | Other | Control Group: Routine Nursing Care, Intervention Group: Evidence-Based Nursing Plus Progressive Exercise |
Primary outcome
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.
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).
5 secondary outcomes
Change in Quality of Life Assessed by the EORTC QLQ-C30
Time frame: Baseline; Week 8
Change in Treatment Adherence Assessed by the Morisky Medication Adherence Scale (MMAS-8)
Time frame: Baseline; Week 8
Change in Psychological Status Assessed by the Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline; Week 8
Change in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline; Week 8
Incidence of Adverse Events
Time frame: Baseline through Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data will be considered for sharing upon reasonable request to the corresponding author, subject to institutional policies and data protection regulations.
Related trials for Advanced Lung Cancer
RecruitingPhase 2
Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors
Advanced Lung Neuroendocrine Tumor, Functioning Lung Neuroendocrine Tumor
RecruitingPhase 3
Chemotherapy Combined With Immunotherapy Versus Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial
Advanced Lung Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor
Recruiting
Multi-site Trial of a Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer
Advanced Lung Cancer, Dyspnea
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qingjuan Li, MD principal investigator
Shanxi Province Cancer Hospital, Taiyuan, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evidence-Based Nursing, Progressive Exercise Training and Routine Nursing Care in people with Advanced Lung Cancer and Cancer-related Fatigue, run by Shanxi Province Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cancer-Related Fatigue Assessed by the Brief Fatigue Inventory (BFI) (time frame: Baseline; Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.