NCT01546233

Brief Summary

The purpose of this study is to compare the fatigue in lung cancer patients receiving chemotherapy treatment, between the education programme in self-care a multidisciplinary with the group who received standard care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2012

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

July 6, 2016

Status Verified

March 1, 2012

Enrollment Period

6 months

First QC Date

March 1, 2012

Last Update Submit

July 4, 2016

Conditions

Keywords

Lung cancerChemotherapyMultidisciplinary self care programmeFatigue

Outcome Measures

Primary Outcomes (1)

  • Measure fatigue by questionnaires

    August 2011 to august 2012 (up to 1 year)

Study Arms (2)

multidisiplinary self care program

Patient with Lung cancer will be participated in group education with multidisiplinary self care program

Behavioral: multidisciplinary education programme

Conventional education

Lung cancer patient will be received standard education

Behavioral: standard education

Interventions

Educate of self-care by Oncology nurses to relieve and prevent the fatigue of cancer chemotherapy, and provide the manual to read at home, take about 15 minutes. By using home exercise program, 30 minutes of physical education. Teaching and demonstration exercises of the muscles to breath and conservation of energy during exercise and record the exercise/walking diary, the nutritional education nutrition counseling, psychiatric assessment,self-care prevention of depression.

Also known as: multidisciplinary self care education programm
multidisiplinary self care program

standard education before and after chemotherapy

Also known as: standard education before and after chemotherapy
Conventional education

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Fatigue Lung Cancer Patients

You may qualify if:

  • Aged 45-65 years.
  • Has been diagnosed lung cancer stages 3-4 must be chemotherapy is platinum-based, and had received chemotherapy for at least one time, must be in the range of 2-4 cycles of chemotherapy.
  • Performance status: ECOG 0-1
  • No problem hearing it.
  • Read and write Thai.
  • Be willing to cooperate in research. And signed a joint research

You may not qualify if:

  • The complications include: high fever, severe nausea and vomiting.
  • Injection drug use in diabetes treatment.
  • Ischemic heart disease with heart arrhythmia and the drug continuously.
  • Is unable to daily living. Caused by defects in movement, and severe osteoarthritis, muscle atrophy, paralysis or walking flat less than 10 meters.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Chemotherapy Unit, Rajavithi Hospital

Bangkok, Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Lung NeoplasmsFatigue

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kotchukorn Wnagnum, Msc (nurse)

    Department of Medical Services Ministry of Public Health of Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2012

First Posted

March 7, 2012

Study Start

March 1, 2012

Primary Completion

September 1, 2012

Study Completion

December 1, 2012

Last Updated

July 6, 2016

Record last verified: 2012-03

Data Sharing

IPD Sharing
Will share

๋Journal of the medical association of Thailand

Locations