NCT03918538

Brief Summary

Aim: To develop and testing a home exercise program for lung cancer survivors to improve their exercise tolerance and quality of life during the rehabilitation phase. Design: An experimental design will be used in the study. The 90 lung cancer survivors, who were diagnosed with lung cancer within one year and have completed their initial cancer treatment, will be recruited and randomized to the control or intervention group. After pre-test, the intervention participants will receive a 60 minutes of teaching regarding the home rehabilitation exercise program, with a printed exercise manual. The intervention participant will also receive a weekly phone call from the interventionist to enhance their exercise adherence and helping to overcome exercise barriers. The similar outcome measures as study one will be assessed on the baseline, 1th month, 3th month, and 6th month. Measurements: The study outcomes will be evaluated by three physical measures, six-minute walk test, Modified Borg Scale, 30-second Chair Sit-to-Stand Test, and 30-second Chair Sit-to-Stand Test, as well as a study questionnaire including Functional Assessment of Cancer Therapy-Lung (FACT-L) and FACIT-Fatigue. For study one the following data will be collected from the patient'schart: post-operative pulmonary complications, days of chest tube insertion, and days of hospitalization. Data analysis: Descriptive analysis will be used to describe patients'demongraphics, disease variables, and outcome variables. The Chi-square, T-test, and General Linear Mix-effect Model will be used to test the efficacy of the study interventions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable lung-cancer

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 9, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2017

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 17, 2019

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

1.5 years

First QC Date

April 16, 2019

Last Update Submit

April 16, 2019

Conditions

Lung Cancer

Keywords

lung cancerearly physical rehabilitationmuscle enduranceaerobic capacityquality of life

Outcome Measures

Primary Outcomes (1)

  • six-minute walk test

    The six-minute walk test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.

    Change from Baseline to 6 months

Secondary Outcomes (4)

  • 30-second arm curl test

    Change from Baseline to 6 months

  • 30-second chair sit-to-stand test

    Change from Baseline to 6 months

  • Functional Assessment of Cancer Therapy-Lung (FACT-L)

    Change from Baseline to 6 months

  • The Functional Assessment of Chronic Illness Therapy-Fatigue

    Change from Baseline to 6 months

Study Arms (2)

The intervention group

EXPERIMENTAL

After pre-test, the intervention participants received a 60 minutes of teaching regarding the home rehabilitation exercise program, with a printed exercise manual. The intervention participants also received a weekly phone call from the interventionist to enhance their exercise adherence and helping to overcome exercise barriers.

Behavioral: Home rehabilitation exercise program

The control group

NO INTERVENTION

Participants in the control group received regular medication education.

Interventions

Home rehabilitation exercise programBEHAVIORAL

After pre-test, the intervention participants received a 60 minutes of teaching regarding the home rehabilitation exercise program, with a printed exercise manual. The intervention participants also received a weekly phone call from the interventionist to enhance their exercise adherence and helping to overcome exercise barriers.

The intervention group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 20 and older,
  • diagnosed with stage I-IIIB non-small cell lung cancer
  • completed initial cancer treatments and no planned cancer treatment in three months
  • Karnofsdy Performance Status equal or greater then 50
  • estimated survival time greater than six months
  • with the permission of the patient's physician

You may not qualify if:

  • having a medical condition precluding exercise (i.e. uncontrolled arrhythmias, uncontrolled hypertension, third-degree heart block, myocardial infarction within six months, unstable angina, acute congestive heart failure and taking anticoagulation for valve diseases).
  • poor controlled diabetics (HbA1C\>9%)
  • regularly exercising in moderate or higher intensity three time a week within three month
  • unable to walk independently
  • unable to communicate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (3)

  • Benzo R, Wigle D, Novotny P, Wetzstein M, Nichols F, Shen RK, Cassivi S, Deschamps C. Preoperative pulmonary rehabilitation before lung cancer resection: results from two randomized studies. Lung Cancer. 2011 Dec;74(3):441-5. doi: 10.1016/j.lungcan.2011.05.011. Epub 2011 Jun 12.

    PMID: 21663994BACKGROUND

  • Jones LW, Peddle CJ, Eves ND, Haykowsky MJ, Courneya KS, Mackey JR, Joy AA, Kumar V, Winton TW, Reiman T. Effects of presurgical exercise training on cardiorespiratory fitness among patients undergoing thoracic surgery for malignant lung lesions. Cancer. 2007 Aug 1;110(3):590-8. doi: 10.1002/cncr.22830.

    PMID: 17582629BACKGROUND

  • Peddle CJ, Jones LW, Eves ND, Reiman T, Sellar CM, Winton T, Courneya KS. Effects of presurgical exercise training on quality of life in patients undergoing lung resection for suspected malignancy: a pilot study. Cancer Nurs. 2009 Mar-Apr;32(2):158-65. doi: 10.1097/NCC.0b013e3181982ca1.

    PMID: 19258829BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Tsae Jyy Wang, PhD

    National Taipei University of Nursing and Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN PhD Professor

Study Record Dates

First Submitted

April 16, 2019

First Posted

April 17, 2019

Study Start

September 9, 2015

Primary Completion

March 17, 2017

Study Completion

March 17, 2017

Last Updated

April 17, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)