Lung Cancer Rehabilitation After Medical Treatment

April 1, 2020 updated by: Jun Ni, Nantong University

The Effectiveness of Rehabilitation for Patients With Lung Cancer in China: a Randomised Controlled Trial

Lung cancer is the leading cause of cancer death worldwide and associated with high disease burden, symptoms and poor health-related quality of life (HRQoL). Lung cancer is the most commonly diagnosed type of cancer in China (with rates rising due to the smoking incidence) and is the leading cause of cancer-related death. The burden is on patients, families, the healthcare system and society, and will continue to rise into the future. The full impact of this in China has not yet occurred. New strategies are urgently required to improve survivorship. This multi-site, assessor blinded, two-arm superiority randomised controlled trial, conducted at two hospitals in China, aims to test the effect of exercise rehabilitation, compared to usual care (no exercise rehabilitation) on HRQoL and functional outcomes in 150 patients treated for lung cancer. The primary hypothesis is that exercise rehabilitation will be superior to usual care, in improving HRQoL at 12-weeks (post program). Secondary aims include measuring the effectiveness of exercise rehabilitation, compared to usual care on function, physical activity, symptoms, mood, sleep and program costs. Faecal samples (500mg) will be collected before and after the intervention.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

Lung cancer is the leading cause of cancer death worldwide and associated with high disease burden, symptoms and poor health-related quality of life (HRQoL). Lung cancer is the most commonly diagnosed type of cancer in China (with rates rising due to the smoking incidence) and is the leading cause of cancer-related death. The burden is on patients, families, the healthcare system and society, and will continue to rise into the future. The full impact of this in China has not yet occurred. New strategies are urgently required to improve survivorship. This multi-site, assessor blinded, two-arm superiority randomized controlled trial, conducted at two hospitals in China, aims to test the effect of exercise rehabilitation, compared to usual care (no exercise rehabilitation) on HRQoL and outcomes including physical function in 150 patients treated for lung cancer. The primary hypothesis is that exercise rehabilitation will be superior to usual care, in improving HRQoL at 12-weeks (post program). Secondary aims include include measuring the effectiveness of exercise rehabilitation, compared to usual care on function, physical activity, symptoms, mood, sleep and program costs.

One hundred and fifty patients with stage I-IIIA non-small cell lung cancer (NSCLC) 4-12 weeks following completion of treatment (including surgery with or without adjuvant therapy) and life expectancy greater than 6 months will be recruited from the affiliated hospital of Nantong University and the first affiliated hospital of Nanjing Medical University. At recruitment participants provide written informed consent, complete baseline assessment and to ensure concealment of allocation participants will be randomly allocated off-site to one of two arms (1:1 ratio). The intervention programs start following randomization and will continue for 12 weeks duration. Trained physiotherapists will provide the intervention. Patients in both arms will receive usual medical, physiotherapy and nursing care according to usual protocols. This does not involve exercise rehabilitation or advice. Additionally patients in intervention group (exercise rehabilitation) will receive a multimodal program which includes a 90 minute program at the hospital gymnasium in a supervised environment a minimum of once but up to twice per week. Rehabilitation will include aerobic (brisk walking) and resistance training and 30 minutes of 8 style Tai Chi). Participants will be advised to walk on days of non-attendance - this will be individualized with the aim to have participants increase to 30 minutes walking per day. Assessments will be conducted at baseline and then by blinded assessors at 12 weeks and 6 months post-baseline. Survival will be followed-up and censored at 1 year. This important study brings together a strong collaborative research team spanning China and Australia, involving medical doctors, physiotherapists and academics. The topic is important, novel and will generate clinically meaningful research for an international audience, aiming to improve the survivorship quality of patients with lung cancer.

The gut microbiome is a source of potentially disease-modifying bioactive metabolites and has recently been suggested to contribute to the pathogenesis of a variety of disorders. Therefore, we will study the gut microbiota and metabolites of the participants in order to identify potential the biomarkers for the clinical outcomes. Fresh faecal samples will be collected from all individuals before group assignment and after the completion of the program. The written informed consent will be provided by the participants.

Specifically, faecal samples (500mg) will be collected from participants who are free from gastrointestinal conditions, with no antibiotic exposure in the 28 days prior to sample collection. 'Snap' frozen samples will be stored at -80°C until the time of DNA extractions, 16S rDNA sequencing, and mass spectrometry analysis of the faecal metabolites. The distribution of gut microbiota before and after exercise will be compared and analyzed to obtain the species of bacterial flora that changed significantly after exercise. Moreover, the gut metabolites that changed significantly before and after exercise will be used to explore the biomarkers for the curative effect of rehabilitation exercise, as well as their relationships with the differentially distributed gut microbiota.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • The First Affiliated Hospital with Nanjing Medical University
      • Nantong, Jiangsu, China, 226000
        • The Affiliated Hospital of Nantong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with non-small cell lung cancer (NSCLC) 4-12 weeks following completion of treatment (surgery, chemotherapy, radiotherapy, immunotherapy);
  2. Physician/doctor approval;
  3. Physician rated life expectancy greater than 6 months;
  4. Informed consent;
  5. Eastern Cooperate Oncology Group (ECOG) performance status of 0-2 at study entry;
  6. Not meeting physical activity/exercise guidelines.

Exclusion Criteria:

  1. Unstable psychiatric/cognitive disorder;
  2. Comorbidity preventing exercise;
  3. ECOG performance status of 3 or 4 at study entry.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual care(both arms)
Usual care (both arms): Patients in both arms will receive usual medical, physiotherapy and nursing care according to usual protocols. This does not involve exercise rehabilitation or advice.
Experimental: Intervention (exercise rehabilitation)
Patients in intervention group (exercise rehabilitation) will receive a multimodal program which includes a 90 minute program at the hospital gymnasium in a supervised environment a minimum of once but up to twice per week. Rehabilitation will include aerobic (brisk walking), resistance training and 30 minutes of 8 style Tai Chi. Participants will be advised to walk on days of non-attendance - this will be individualised with the aim to have participants increase to 30 minutes walking per day.
Other: Intervention (rehabilitation exercise)
Patients in intervention group (exercise rehabilitation) will receive a multimodal program which includes a 90 minute program at the hospital gymnasium in a supervised environment a minimum of once but up to twice per week. Rehabilitation will include aerobic (brisk walking), resistance training and 30 minutes of 8 style Tai Chi. Participants will be advised to walk on days of non-attendance - this will be individualised with the aim to have participants increase to 30 minutes walking per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
European Organization for the Research and Treatment of Cancer questionnaire (EORTC QLQ-C30-LC13)
Time Frame: The primary time point is the change from baseline to 12 weeks. This outcome will also be measured at 6 months post-baseline.
HRQoL will be assessed with the European Organization for the Research and Treatment of Cancer questionnaire (EORTC QLQ-C30-LC13) at baseline, 12 weeks and 6 months post-baseline. Score ranges from 0~100.For functional domains and global health status/quality of life scale, higher score means better status. While for symptom domains and single-items, lower scores represent less symptoms.
The primary time point is the change from baseline to 12 weeks. This outcome will also be measured at 6 months post-baseline.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Exercise Capacity
Time Frame: 1) baseline, 2) 12 week, and 3) 6 months post-baseline.
All participants will complete a Incremental Shuttle Walking Test following published guidelines.
1) baseline, 2) 12 week, and 3) 6 months post-baseline.
Seven-day Physical Activity
Time Frame: 1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.
Will be measured objectively using an pedometer at baseline, 12 weeks and 6 months post-baseline. It is worn for 7 consecutive days and a minimum of four full days (8 hours/day) is required for valid analyses.
1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.
Grip strength
Time Frame: 1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.
A hand held dynamometry manual muscle test is a common, simple measurement of strength and has been used in many patient populations including cancer and is reliable and sensitive to change. We will measure hand grip strength bilaterally
1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.
30-Second Chair Stand
Time Frame: 1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.
To test leg strength and endurance. A below average score indicates a risk for falls.
1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.
International physical activity questionnaire(IPAQ)
Time Frame: 1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.
The International Physical Activity Questionnaire (IPAQ) scores are categorised as high/moderate (meeting PA guidelines) or low (not meeting PA guidelines) and as a continuous energy expenditure score (metabolic equivalent of task (MET) minutes per week). Higher scores indicate increased PA.
1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.
Self-Rating Anxiety Scale(SAS)
Time Frame: 1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.
To test the anxiety level of the patients. It has 20 items and are four-point scale(rated 1-4), some of the items are reversely scored. Score ranges from 0~100, higher score means worse anxiety status.
1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.
Self-Rating Depression Scale(SDS)
Time Frame: 1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.
To test the depression level of the patients. It has 20 items and are four-point scale(rated 1-4), some of the items are reversely scored. Score ranges from 0~100, higher score means worse depression status.
1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.
Pittsburgh Sleep Quality Index(PSQI)
Time Frame: 1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.
Pittsburgh Sleep Quality Index(PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores. The sum of scores for these seven components yields one global score, and the higher score means the worse sleep quality. Score ranges from 0~21, higher score means worse sleep quality.
1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.
MD Anderson Symptom Inventory-lung cancer (MDASI-LC)
Time Frame: 1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.
To evaluate to the severity and interference of the symptom in participants.The MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) will be used to measure symptom severity and distress. The symptom severity component comprises 13 core and three lung cancer specific items, measured on a 0-10 numerical rating scale. The average score is reported, with higher scores indicating worse symptoms. The MCID in lung cancer has been reported as being between 0.98 to 1.21 points
1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.
Australia-modified Karnofsky Performance Status(AKPS)
Time Frame: 1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.
To evaluate the performance of the whole well-being of the participants. Score ranges from 0~100, higher score means better status.
1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.
European quality of life 5-dimension 5-level(EQ-5D-5L)
Time Frame: 1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.
European quality of life 5-dimension 5-level(EQ-5D-5L) is a family of instruments to describe and value health. It comprises a short descriptive system questionnaire and a visual analogue scale that are cognitively undemanding. A value set provides values(weights) for each health state description according to the preferences of the general population of a country/region.
1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to the program
Time Frame: 12 weeks post-program
Intervention group participants who complete either 17 out of 24 hospital-sessions or 12 out of 24 hospital sessions and at least 10 minutes walking at home twice a week will be considered to be adherent to the protocol.
12 weeks post-program
Program costs
Time Frame: Baseline, 12 weeks (post-program) and 6 months
We will consider the additional implementation costs of rehabilitation, including patient costs, compared with usual care in addition to the downstream cost differences associated with hospital usage (including hospital admissions and their length of stay, visits to accident and emergency and clinic appointments). Health from baseline to 6 months (with modelling to 12 months) will be measured using Quality Adjusted Life Years (QALYs) and then within trial follow-up cost per additional QALY will be estimated and compared with levels considered to provide good value for money. Probabilistic sensitivity analysis will be conducted to explore the robustness of the conclusions reached.
Baseline, 12 weeks (post-program) and 6 months
Survival
Time Frame: 12 months post baseline
We will follow up survival in all groups and censor at 1 year.
12 months post baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantong University

Collaborators

The First Affiliated Hospital with Nanjing Medical University
University of Melbourne

Investigators

  • Principal Investigator: Jun Ni, MD, Nantong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2019

Primary Completion (Anticipated)

February 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

November 23, 2019

First Submitted That Met QC Criteria

December 2, 2019

First Posted (Actual)

December 4, 2019

Study Record Updates

Last Update Posted (Actual)

April 3, 2020

Last Update Submitted That Met QC Criteria

April 1, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NantongU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available to other investigators for individual participant data meta-analysis.

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication.

IPD Sharing Access Criteria

Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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