Lung CancerNCT04826835
A Prehabilitation Program to Boost Postoperative Functional Capacity in Surgical Lung Cancer Patients
A study testing Prehabilitation intervention in people with Lung Cancer, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This research study is evaluating a prehabiliation intervention designed to improve postoperative functional capacity (measured by 6-minure walking distance) in individuals undergoing lung resection for cancer. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Prehabilitation intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteHong Kong
- Study dates
- 14 May 2021to 1 Jun 2025
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are diagnosed of stage I, II, or IIIA Non-small-cell lung carcinoma (NSCLC) diagnosis, with or without pre-operative histologic confirmation
- Patients scheduled to undergo lung resection surgery at least two weeks from recruitment
- Patients with a Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 at recruitment
- Patients with no evidence of recurrent or progressive disease
- Patients aged 45-80 years
- Patients able to communicate in Cantonese, Mandarin, or English
Show all 9Show fewer
- Patients is absence of any cognitive impairment
- Patients with a score of 6 minutes walking test (6MWT) ≤ 500 meters at baseline. [rationale: a threshold value of 500 meters preoperative 6MWT predicts a higher risk of postoperative complications and prolonged LOS after lung resection]
- Engagement in less than 150 minutes of moderate aerobic activity per week in the past 3 months
Who cannot join
- Patients who had engaged in at least 150 minutes of moderate aerobic activity or 75 minutes of vigorous aerobic activity per week in the past three months
- Presence of another concurrent, actively treated malignancy
- Presence of chronic obstructive pulmonary disease
- Presence of significant comorbidities that impede ability to engage in exercise, such as congestive heart failure, orthopedic disorders of the lower limbs, respiratory failure, or the need for portable oxygen therapy for activities of daily living
- Not having a smart device to receive WhatsApp messages
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prehabilitation Program to Boost Postoperative Functional Capacity in Surgical Lung Cancer Patients: a Randomized Controlled Trial
This research study is evaluating a prehabiliation intervention designed to improve postoperative functional capacity (measured by 6-minure walking distance) in individuals undergoing lung resection for cancer.
- Conditions
- Lung Cancer
- Being tested
- Prehabilitation intervention, Health education control
- Keywords
- Prehabilitation, Physical activity, Lung resection, Functional capacity
- Medical subject headings
- Lung Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation interventionBehavioural
Participants will:
- Receive four supervised exercise classes (twice per week for two weeks) one-to-one by an exercise specialist;
- Practice six sessions of home-based exercise (three times per week for two weeks);
- Practice unsupervised respiratory muscle training at home (twice daily for two weeks);
- Receive usual care.
Health education controlBehavioural
Participants will:
- Receive four recorded health education talks (twice per week for two weeks)
- Receive a brief health education booklet on dietary education for chronic lung conditions, preoperative preparation, and postoperative recovery
- Receive usual care.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation intervention | Experimental | Participants in the intervention group will follow a 2-week prehabilitation program before lung resection. Receives: Behavioral: Prehabilitation intervention |
| Health education control | Active comparator | Participants in the control group will receive health education classes during 2 weeks before lung resection. Receives: Behavioral: Health education control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline 6-minute walking distance from baseline to 3-month post-surgery
Measured: Baseline; 3-month post-surgery
Secondary outcomes (18)
Change from baseline 6-minute walking distance at post-intervention
Measured: Baseline; 2 weeks (post-intervention)
Change from baseline 6-minute walking distance at 1-month post-surgery
Measured: Baseline; 1-months post-surgery
Length of postoperative hospital stay
Measured: 1-month post-surgery
Postoperative complication
Measured: 1-month post-surgery
Change from baseline functional assessment of cancer treatment - Lung (FACT-L) at post-intervention
Measured: Baseline; 2 weeks (post-intervention)
Change from baseline functional assessment of cancer treatment - Lung (FACT-L) at 1-month post-surgery
Measured: Baseline; 2 weeks (post-intervention); 1-month post-surgery
Change from baseline functional assessment of cancer treatment - Lung (FACT-L) at 3-months post-surgery
Measured: Baseline; 3-month post-surgery
Change from baseline international physical activity questionnaire (IPAQ) at post-intervention
Measured: Baseline; 2 weeks (post-intervention)
Change from baseline international physical activity questionnaire (IPAQ) at 1-month post-surgery
Measured: Baseline; 1-month post-surgery
Change from baseline international physical activity questionnaire (IPAQ) at 3-month post-surgery
Measured: Baseline; 3-month post-surgery
Change from baseline daily step count measured by pedometer at post-intervention
Measured: Baseline; 2 weeks (post-intervention)
Change from baseline daily step count measured by pedometer at 1-month post-surgery
Measured: Baseline; 1-month post-surgery
Change from baseline daily step count measured by pedometer at 3-month post-surgery
Measured: Baseline; 3-month post-surgery
Health-related quality of life for the cost-effectiveness analysis (EuroQol- 5 Dimension, EQ-5D-5L)
Measured: Baseline; 2 weeks (post-intervention); 1-month post-surgery; 3-month post-surgery
Health-related quality of life for the cost-effectiveness analysis (EuroQol-Visual Analog Score, EQ-VAS)
Measured: Baseline; 2 weeks (post-intervention); 1-month post-surgery; 3-month post-surgery
Physical activity self-efficacy (9-item Self-Efficacy for Exercise, SEE)
Measured: Baseline; 2 weeks (post-intervention); 1-month post-surgery; 3-month post-surgery
Financial toxicity (COmprehensive Score for financial Toxicity, COST questionnaire)
Measured: Baseline; 3-month post-surgery
Return to work (investigator-designed questionnaire)
Measured: 3-month post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start14 May 2021
- Primary completion1 May 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Chia-Chin Lin, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826835
- Sponsor's protocol ID
- UW 19-214
- Status last verified
- Jan 2024
- First submitted
- 23 Mar 2021
- Last updated
- 8 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prehabilitation Program to Boost Postoperative Functional Capacity in Surgical Lung Cancer Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04826835
- Acronym / sponsor ID
- UW 19-214
- Conditions
- Lung Cancer
- Keywords
- Prehabilitation, Physical activity, Lung resection, Functional capacity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 14 May 2021 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 1 Apr 2021 (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 research study is evaluating a prehabiliation intervention designed to improve postoperative functional capacity (measured by 6-minure walking distance) in individuals undergoing lung resection for cancer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation intervention | Experimental | Behavioral: Prehabilitation interventionParticipants in the intervention group will follow a 2-week prehabilitation program before lung resection. |
| Health education control | Active comparator | Behavioral: Health education controlParticipants in the control group will receive health education classes during 2 weeks before lung resection. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients who are diagnosed of stage I, II, or IIIA Non-small-cell lung carcinoma (NSCLC) diagnosis, with or without pre-operative histologic confirmation
- Patients scheduled to undergo lung resection surgery at least two weeks from recruitment
- Patients with a Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 at recruitment
- Patients with no evidence of recurrent or progressive disease
- Patients aged 45-80 years
Key exclusion criteria (5 listed)
- Patients who had engaged in at least 150 minutes of moderate aerobic activity or 75 minutes of vigorous aerobic activity per week in the past three months
- Presence of another concurrent, actively treated malignancy
- Presence of chronic obstructive pulmonary disease
- Presence of significant comorbidities that impede ability to engage in exercise, such as congestive heart failure, orthopedic disorders of the lower limbs, respiratory failure, or the need for portable oxygen therapy for activities of daily living
- Not having a smart device to receive WhatsApp messages
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 |
|---|---|---|
| Prehabilitation interventionParticipants will: * Receive four supervised exercise classes (twice per week for two weeks) one-to-one by an exercise specialist; * Practice six sessions of home-based exercise (three times per week for two weeks); * Practice unsupervised respiratory muscle training at home (twice daily for two weeks); * Receive usual care. | Behavioural | Prehabilitation intervention |
| Health education controlParticipants will: * Receive four recorded health education talks (twice per week for two weeks) * Receive a brief health education booklet on dietary education for chronic lung conditions, preoperative preparation, and postoperative recovery * Receive usual care. | Behavioural | Health education control |
Primary outcome
Change from baseline 6-minute walking distance from baseline to 3-month post-surgery
Time frame: Baseline; 3-month post-surgery
18 secondary outcomes
Change from baseline 6-minute walking distance at post-intervention
Time frame: Baseline; 2 weeks (post-intervention)
Change from baseline 6-minute walking distance at 1-month post-surgery
Time frame: Baseline; 1-months post-surgery
Length of postoperative hospital stay
Time frame: 1-month post-surgery
Postoperative complication
Time frame: 1-month post-surgery
Change from baseline functional assessment of cancer treatment - Lung (FACT-L) at post-intervention
Time frame: Baseline; 2 weeks (post-intervention)
Change from baseline functional assessment of cancer treatment - Lung (FACT-L) at 1-month post-surgery
Time frame: Baseline; 2 weeks (post-intervention); 1-month post-surgery
Change from baseline functional assessment of cancer treatment - Lung (FACT-L) at 3-months post-surgery
Time frame: Baseline; 3-month post-surgery
Change from baseline international physical activity questionnaire (IPAQ) at post-intervention
Time frame: Baseline; 2 weeks (post-intervention)
Change from baseline international physical activity questionnaire (IPAQ) at 1-month post-surgery
Time frame: Baseline; 1-month post-surgery
Change from baseline international physical activity questionnaire (IPAQ) at 3-month post-surgery
Time frame: Baseline; 3-month post-surgery
Change from baseline daily step count measured by pedometer at post-intervention
Time frame: Baseline; 2 weeks (post-intervention)
Change from baseline daily step count measured by pedometer at 1-month post-surgery
Time frame: Baseline; 1-month post-surgery
Change from baseline daily step count measured by pedometer at 3-month post-surgery
Time frame: Baseline; 3-month post-surgery
Health-related quality of life for the cost-effectiveness analysis (EuroQol- 5 Dimension, EQ-5D-5L)
Time frame: Baseline; 2 weeks (post-intervention); 1-month post-surgery; 3-month post-surgery
Health-related quality of life for the cost-effectiveness analysis (EuroQol-Visual Analog Score, EQ-VAS)
Time frame: Baseline; 2 weeks (post-intervention); 1-month post-surgery; 3-month post-surgery
Physical activity self-efficacy (9-item Self-Efficacy for Exercise, SEE)
Time frame: Baseline; 2 weeks (post-intervention); 1-month post-surgery; 3-month post-surgery
Financial toxicity (COmprehensive Score for financial Toxicity, COST questionnaire)
Time frame: Baseline; 3-month post-surgery
Return to work (investigator-designed questionnaire)
Time frame: 3-month post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation intervention in people with Lung Cancer, run by The University of Hong Kong at 1 site in Hong Kong.
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 9 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: status not confirmed, as of the sponsor's last update on 8 Jan 2024. 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 Hong Kong. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chia-chin Lin, PhD (39176614, cclin@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline 6-minute walking distance from baseline to 3-month post-surgery (time frame: Baseline; 3-month post-surgery). 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 8 Jan 2024.