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Trial registered on ANZCTR
Registration number
ACTRN12609000971235
Ethics application status
Approved
Date submitted
2/11/2009
Date registered
10/11/2009
Date last updated
11/10/2018
Type of registration
Retrospectively registered
Titles & IDs
Public title
The impact of physical activity on fatigue and quality of life in lung cancer patients.
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Scientific title
The impact of physical activty on fatigue and quality of life in non-resectable thoracic lung cancer patients.
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Secondary ID [1]
259751
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Phyiscal Activity in Lung Cancer Patients
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Universal Trial Number (UTN)
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Trial acronym
PAL (Physical Activity in Lung cancer patients)
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lung cancer-related fatigue.
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Quality of life.
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Condition category
Condition code
Cancer
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252300
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0
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Lung - Non small cell
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Cancer
252330
252330
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0
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants randomised to the intervention group will take part in an 8-week personalised physical activity program. The type (e.g. aerobic, resistance or flexibility), and intensity of the sessions will be tailored to the fitness level and preferences of the individual participant.
The physical activity sessions are for 1 hour / week for 8 weeks and also include a behavioural support session.
The behavioural support sessions include topics such as goal setting, plainng, motivation and time management.
The physical activity sessions are conducted face-to-face with an exercise physiologist or physiotherapist. They can be one-on-one or in a small group, depending on the preference of the participant.
The behavioural sessions can be either face-to-face or over the phone with a member of the research team.
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Intervention code [1]
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Lifestyle
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Comparator / control treatment
Participants randomised to the control group will receive standard of care treatment for their condition. They will be assessed at the same time points as the intervention group (i.e Baseline, 2, 4 and 6 months).
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Control group
Active
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Outcomes
Primary outcome [1]
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Self-reported fatigue (at 2 months)
Instrument: Functional Assessment of Cancer Therapy - Fatigue (FACT-F) subscale
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Assessment method [1]
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Timepoint [1]
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At baseline and 2 months from baseline.
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Secondary outcome [1]
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Self-reported fatigue (at 4 and 6 months).
Instrument: FACT-F subscale
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Assessment method [1]
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Timepoint [1]
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At baseline and 4 and 6 months from baseline.
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Secondary outcome [2]
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Health-related Quality of Life
Instrument: European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC-QLQ) -C30 and LC13-lung subscale.
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Assessment method [2]
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Timepoint [2]
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At baseline and 2, 4, and 6 months from baseline.
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Secondary outcome [3]
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Anxiety and Depression.
Instrument: General Health Questionnaire-12
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Assessment method [3]
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Timepoint [3]
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At baseline and 2, 4, and 6 months from baseline.
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Secondary outcome [4]
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Distress.
Instrument: Distress Thermometer
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Assessment method [4]
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Timepoint [4]
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At baseline and 2, 4, and 6 months from baseline.
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Secondary outcome [5]
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Sleep.
Instrument: Pittsburgh Sleep Quality Index
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Assessment method [5]
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Timepoint [5]
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At baseline and 2, 4, and 6 months from baseline.
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Secondary outcome [6]
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Sedentary Time.
Instrument: Sitting Questionnaire
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Assessment method [6]
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Timepoint [6]
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At baseline and 2, 4, and 6 months from baseline.
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Secondary outcome [7]
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Physical activity attitudes.
Instrument: Social Cognitive Determinants of Exercise Questionnaire
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Assessment method [7]
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Timepoint [7]
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At baseline and 2, 4, and 6 months from baseline.
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Secondary outcome [8]
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Perceived Cognitive Function.
Instrument: Functional Assessment of Cancer Therapy - Cognitive (FACT-Cog), v3
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Assessment method [8]
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Timepoint [8]
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At baseline and 2, 4, and 6 months from baseline.
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Secondary outcome [9]
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Breathing Difficulties.
Instrument: Shortness of Breath Questionnaire
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Assessment method [9]
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Timepoint [9]
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At baseline and 2, 4, and 6 months from baseline.
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Secondary outcome [10]
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Body Composition.
Instrument: Anthropometrics
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Assessment method [10]
262086
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Timepoint [10]
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At baseline and 2, 4, and 6 months from baseline.
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Secondary outcome [11]
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Physical activity behaviour.
Instrument: Active Australia Questionnaire
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Assessment method [11]
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Timepoint [11]
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At baseline and 2, 4, and 6 months from baseline.
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Secondary outcome [12]
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Physical Fitness.
Instruments: Senior's Fitness Test, dynamometer
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Assessment method [12]
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Timepoint [12]
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At baseline and 2, 4, and 6 months from baseline.
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Secondary outcome [13]
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Ability to perform everyday activities.
Instrument: Activities of Daily Living Questionnaire
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Assessment method [13]
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Timepoint [13]
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At baseline and 2, 4, and 6 months from baseline.
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Secondary outcome [14]
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Pulmonary function.
Instrument: Spirometer
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Assessment method [14]
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Timepoint [14]
262090
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At baseline and 2, 4, and 6 months from baseline.
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Secondary outcome [15]
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Glasgow Prognostic Score.
Instrument: Full blood count and C-Reactive Protein analysis
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Assessment method [15]
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Timepoint [15]
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At baseline and 2, 4, and 6 months from baseline.
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Secondary outcome [16]
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Patient hospitalisations.
Instrument: Medical Records
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Assessment method [16]
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Timepoint [16]
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At 2, 4, and 6 months from baseline.
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Secondary outcome [17]
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Eastern Co-operative Oncology Group (ECOG) Performance Status.
Instrument: Clinician, assessor and patient-rated
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Assessment method [17]
262093
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Timepoint [17]
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At baseline and 2, 4, and 6 months from baseline.
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Eligibility
Key inclusion criteria
1. Diagnosis of non-resectable invasive lung cancer, eg non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC).
2. Completion of treatment at least 4 weeks prior to study involvement for patients with Stage III NSCLC or Limited SCLC.
3. Age of a least 18 years.
4. Medically fit to participate on a physical activity programme.
5. Ability to complete study questionnaires in English.
6. Give written informed consent.
7. Completion of screening questionnaires within 14 days of registration.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Eastern Cooperative Oncology Group (ECOG) Performance Status of 3 or more. 2. Pre-existing significant comorbidities that preclude participation in a physical activity programme. 3. Life expectancy of less than 6 months. 4. Insufficient English fluency to complete questionnaires. 5. Inability to complete baseline exercise test done prior to randomisation
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients are randomly assigned to the intervention or control group using the National Health and Medical Research Coucnil (NHMRC) Clinical Trial Centre’s Randomisation Interactive Voice Response System.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The study will be stratified for disease stage (limited vs. advanced), performance status (ECOG PS 0 -1 vs. 2), and centre.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
N/A
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
24/06/2009
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Actual
3/08/2009
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Date of last participant enrolment
Anticipated
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Actual
3/10/2014
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Date of last data collection
Anticipated
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Actual
30/04/2015
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Sample size
Target
140
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Accrual to date
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Final
111
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment postcode(s) [1]
2173
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2139
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Recruitment postcode(s) [2]
2174
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2050
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Recruitment postcode(s) [3]
3857
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2145
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Lance Armstrong Foundation
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Address [1]
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1221 S. MoPac Expressway, Suite 350
Austin, Texas
78746
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Country [1]
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United States of America
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Primary sponsor type
Individual
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Name
Janette Vardy
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Address
Sydney Cancer Centre
Concord Repatriation and General Hospital
Hospital Rd.
Concord, NSW
2139
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Country
Australia
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Secondary sponsor category [1]
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University
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Name [1]
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The University of Sydney
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Address [1]
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Camperdown, NSW
2006
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Country [1]
251308
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Human Research Ethics Committe - Concord Zone
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Ethics committee address [1]
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Concord Repatriation and General Hospital Level 1, Building 75 Hospital Rd. Concord NSW 2139
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
244065
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Approval date [1]
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23/01/2009
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Ethics approval number [1]
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CH62/6/2008-185-J Vardy
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Summary
Brief summary
This study looks at the impact of physical activity on fatigue and quality of life in people with thoracic lung cancer. Who is it for? You may be eligible to join this study if you have invasive thoracic cancer which is not suitable for surgical removal. Trial details: Participants will be divided into two groups. One group (the control group) will receive standard care for 6 months. The other group will take part in a physical activity program, with behavioural support for 8 weeks in addition to standard care. Study aims: To compare self-reported fatigue levels and quality of life in the two groups to determine the effects of exercise.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Haryana Dhillon
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Address
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Centre for Medical Psychology and Evidence-based Decision-making (CeMPED)
The University of Sydney,
NSW 2006
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Country
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Australia
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Phone
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+61 2 9036 5392
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Fax
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+61 2 9036 5420
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Email
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[email protected]
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Contact person for scientific queries
Name
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Janette Vardy
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Address
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Sydney Cancer Centre
Concord Repatriation and General Hospital
Hospital Rd.
Concord, NSW 2139
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Country
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Australia
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Phone
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+61 2 9767 5000
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Fax
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Impact of physical activity on fatigue and quality of life in people with advanced lung cancer: A randomized controlled trial.
2017
https://dx.doi.org/10.1093/annonc/mdx205
N.B. These documents automatically identified may not have been verified by the study sponsor.
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