Lung Cancer Rehabilitation After Medical Treatment

NCT04185467 | Suspended DMC

• 1 other identifier: NantongU
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Lung Neoplasms

Keywords

lung cancer; exercise; rehabilitation; Tai Chi; health-related quality of life

Outcome Measures

Primary Outcomes (1)

• European Organization for the Research and Treatment of Cancer questionnaire (EORTC QLQ-C30-LC13)

  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 Outcomes (11)

• Functional Exercise Capacity

  1) baseline, 2) 12 week, and 3) 6 months post-baseline.

• Seven-day Physical Activity

  1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.

• Grip strength

  1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.

• 30-Second Chair Stand

  1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.

• International physical activity questionnaire(IPAQ)

  1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.

Other Outcomes (3)

• Adherence to the program

  12 weeks post-program

• Program costs

  Baseline, 12 weeks (post-program) and 6 months

• Survival

  12 months post baseline

Study Arms (2)

Usual care(both arms)

NO INTERVENTION

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.

Intervention (exercise rehabilitation)

EXPERIMENTAL

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)

Interventions

Intervention (rehabilitation exercise) OTHER

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.

Intervention (exercise rehabilitation)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nantong University: lead
• University of Melbourne: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator

Study Sites (2)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210000, China

Location

the Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226000, China

Location

Related Publications (13)

• Hung R, Krebs P, Coups EJ, Feinstein MB, Park BJ, Burkhalter J, Ostroff JS. Fatigue and functional impairment in early-stage non-small cell lung cancer survivors. J Pain Symptom Manage. 2011 Feb;41(2):426-35. doi: 10.1016/j.jpainsymman.2010.05.017. Epub 2011 Jan 8.

  PMID: 21216563 BACKGROUND

• Hong QY, Wu GM, Qian GS, Hu CP, Zhou JY, Chen LA, Li WM, Li SY, Wang K, Wang Q, Zhang XJ, Li J, Gong X, Bai CX; Lung Cancer Group of Chinese Thoracic Society; Chinese Alliance Against Lung Cancer. Prevention and management of lung cancer in China. Cancer. 2015 Sep 1;121 Suppl 17:3080-8. doi: 10.1002/cncr.29584.

  PMID: 26331814 BACKGROUND

• Polanski J, Jankowska-Polanska B, Rosinczuk J, Chabowski M, Szymanska-Chabowska A. Quality of life of patients with lung cancer. Onco Targets Ther. 2016 Feb 29;9:1023-8. doi: 10.2147/OTT.S100685. eCollection 2016.

  PMID: 27013895 BACKGROUND

• Zhang LL, Wang SZ, Chen HL, Yuan AZ. Tai Chi Exercise for Cancer-Related Fatigue in Patients With Lung Cancer Undergoing Chemotherapy: A Randomized Controlled Trial. J Pain Symptom Manage. 2016 Mar;51(3):504-11. doi: 10.1016/j.jpainsymman.2015.11.020. Epub 2015 Dec 22.

  PMID: 26721747 BACKGROUND

• John LD. Self-care strategies used by patients with lung cancer to promote quality of life. Oncol Nurs Forum. 2010 May;37(3):339-47. doi: 10.1188/10.ONF.339-347.

  PMID: 20439218 BACKGROUND

• Schmitz KH, Holtzman J, Courneya KS, Masse LC, Duval S, Kane R. Controlled physical activity trials in cancer survivors: a systematic review and meta-analysis. Cancer Epidemiol Biomarkers Prev. 2005 Jul;14(7):1588-95. doi: 10.1158/1055-9965.EPI-04-0703.

  PMID: 16030088 BACKGROUND

• Lin YY, Rau KM, Lin CC. Longitudinal study on the impact of physical activity on the symptoms of lung cancer survivors. Support Care Cancer. 2015 Dec;23(12):3545-53. doi: 10.1007/s00520-015-2724-7. Epub 2015 Apr 9.

  PMID: 25855040 BACKGROUND

• Wang JW, Gong XH, Ding N, Chen XF, Sun L, Tang Z, Yu DH, Yuan ZP, Wang XD, Yu JM. The influence of comorbid chronic diseases and physical activity on quality of life in lung cancer survivors. Support Care Cancer. 2015 May;23(5):1383-9. doi: 10.1007/s00520-014-2494-7. Epub 2014 Oct 31.

  PMID: 25358644 BACKGROUND

• Jones LW, Watson D, Herndon JE 2nd, Eves ND, Haithcock BE, Loewen G, Kohman L. Peak oxygen consumption and long-term all-cause mortality in nonsmall cell lung cancer. Cancer. 2010 Oct 15;116(20):4825-32. doi: 10.1002/cncr.25396.

  PMID: 20597134 BACKGROUND

• Brown JC, Schmitz KH. The prescription or proscription of exercise in colorectal cancer care. Med Sci Sports Exerc. 2014 Dec;46(12):2202-9. doi: 10.1249/MSS.0000000000000355.

  PMID: 24781887 BACKGROUND

• Gopalakrishnan V, Helmink BA, Spencer CN, Reuben A, Wargo JA. The Influence of the Gut Microbiome on Cancer, Immunity, and Cancer Immunotherapy. Cancer Cell. 2018 Apr 9;33(4):570-580. doi: 10.1016/j.ccell.2018.03.015.

  PMID: 29634945 BACKGROUND

• Keohane DM, Woods T, O'Connor P, Underwood S, Cronin O, Whiston R, O'Sullivan O, Cotter P, Shanahan F, Molloy MGM. Four men in a boat: Ultra-endurance exercise alters the gut microbiome. J Sci Med Sport. 2019 Sep;22(9):1059-1064. doi: 10.1016/j.jsams.2019.04.004. Epub 2019 Apr 18.

  PMID: 31053425 BACKGROUND

• Hamasaki H. Exercise and gut microbiota: clinical implications for the feasibility of Tai Chi. J Integr Med. 2017 Jul;15(4):270-281. doi: 10.1016/S2095-4964(17)60342-X.

  PMID: 28659231 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms; Motor Activity

Interventions

Methods; Exercise Therapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Jun Ni, MD

  Nantong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessor blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Rehabilitation Treatment Center

Model Details: Design: Two-site, assessor blinded, two-arm superiority randomised controlled trial. Setting: Participant recruitment from the affiliated hospital of Nantong University and the first affiliated hospital of Nanjing Medical University Procedure: Randomisation: Randomisation list devised by independent statistician; carried out using the REDCap randomisation function to ensure allocation concealment. Following consent and assessment, participants are randomised 1:1. Lung cancer with stage I-IIIA and treatment type is surgery +/- adjuvant treatment.

Study Record Dates

• First Submitted: November 23, 2019
• First Posted: December 4, 2019
• Study Start: December 5, 2019
• Primary Completion: February 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 3, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

Locations

CN (2)