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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.
Scientific title
The impact of physical activty on fatigue and quality of life in non-resectable thoracic lung cancer patients.
Secondary ID [1] 259751 0
Phyiscal Activity in Lung Cancer Patients
Universal Trial Number (UTN)
Trial acronym
PAL (Physical Activity in Lung cancer patients)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung cancer-related fatigue. 252093 0
Quality of life. 252136 0
Condition category
Condition code
Cancer 252300 252300 0 0
Lung - Non small cell
Cancer 252330 252330 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 241486 0
Lifestyle
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).
Control group
Active

Outcomes
Primary outcome [1] 253173 0
Self-reported fatigue (at 2 months)
Instrument: Functional Assessment of Cancer Therapy - Fatigue (FACT-F) subscale
Timepoint [1] 253173 0
At baseline and 2 months from baseline.
Secondary outcome [1] 262077 0
Self-reported fatigue (at 4 and 6 months).
Instrument: FACT-F subscale
Timepoint [1] 262077 0
At baseline and 4 and 6 months from baseline.
Secondary outcome [2] 262078 0
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.
Timepoint [2] 262078 0
At baseline and 2, 4, and 6 months from baseline.
Secondary outcome [3] 262079 0
Anxiety and Depression.
Instrument: General Health Questionnaire-12
Timepoint [3] 262079 0
At baseline and 2, 4, and 6 months from baseline.
Secondary outcome [4] 262080 0
Distress.
Instrument: Distress Thermometer
Timepoint [4] 262080 0
At baseline and 2, 4, and 6 months from baseline.
Secondary outcome [5] 262081 0
Sleep.
Instrument: Pittsburgh Sleep Quality Index
Timepoint [5] 262081 0
At baseline and 2, 4, and 6 months from baseline.
Secondary outcome [6] 262082 0
Sedentary Time.
Instrument: Sitting Questionnaire
Timepoint [6] 262082 0
At baseline and 2, 4, and 6 months from baseline.
Secondary outcome [7] 262083 0
Physical activity attitudes.
Instrument: Social Cognitive Determinants of Exercise Questionnaire
Timepoint [7] 262083 0
At baseline and 2, 4, and 6 months from baseline.
Secondary outcome [8] 262084 0
Perceived Cognitive Function.
Instrument: Functional Assessment of Cancer Therapy - Cognitive (FACT-Cog), v3
Timepoint [8] 262084 0
At baseline and 2, 4, and 6 months from baseline.
Secondary outcome [9] 262085 0
Breathing Difficulties.
Instrument: Shortness of Breath Questionnaire
Timepoint [9] 262085 0
At baseline and 2, 4, and 6 months from baseline.
Secondary outcome [10] 262086 0
Body Composition.
Instrument: Anthropometrics
Timepoint [10] 262086 0
At baseline and 2, 4, and 6 months from baseline.
Secondary outcome [11] 262087 0
Physical activity behaviour.
Instrument: Active Australia Questionnaire
Timepoint [11] 262087 0
At baseline and 2, 4, and 6 months from baseline.
Secondary outcome [12] 262088 0
Physical Fitness.
Instruments: Senior's Fitness Test, dynamometer
Timepoint [12] 262088 0
At baseline and 2, 4, and 6 months from baseline.
Secondary outcome [13] 262089 0
Ability to perform everyday activities.
Instrument: Activities of Daily Living Questionnaire
Timepoint [13] 262089 0
At baseline and 2, 4, and 6 months from baseline.
Secondary outcome [14] 262090 0
Pulmonary function.
Instrument: Spirometer
Timepoint [14] 262090 0
At baseline and 2, 4, and 6 months from baseline.
Secondary outcome [15] 262091 0
Glasgow Prognostic Score.
Instrument: Full blood count and C-Reactive Protein analysis
Timepoint [15] 262091 0
At baseline and 2, 4, and 6 months from baseline.
Secondary outcome [16] 262092 0
Patient hospitalisations.
Instrument: Medical Records
Timepoint [16] 262092 0
At 2, 4, and 6 months from baseline.
Secondary outcome [17] 262093 0
Eastern Co-operative Oncology Group (ECOG) Performance Status.
Instrument: Clinician, assessor and patient-rated
Timepoint [17] 262093 0
At baseline and 2, 4, and 6 months from baseline.

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
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.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment postcode(s) [1] 2174 0
2050
Recruitment postcode(s) [2] 2173 0
2139
Recruitment postcode(s) [3] 3857 0
2145

Funding & Sponsors
Funding source category [1] 243952 0
Charities/Societies/Foundations
Name [1] 243952 0
Lance Armstrong Foundation
Address [1] 243952 0
1221 S. MoPac Expressway, Suite 350
Austin, Texas
78746
Country [1] 243952 0
United States of America
Primary sponsor type
Individual
Name
Janette Vardy
Address
Sydney Cancer Centre
Concord Repatriation and General Hospital
Hospital Rd.
Concord, NSW
2139
Country
Australia
Secondary sponsor category [1] 251308 0
University
Name [1] 251308 0
The University of Sydney
Address [1] 251308 0
Camperdown, NSW
2006
Country [1] 251308 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244065 0
Human Research Ethics Committe - Concord Zone
Ethics committee address [1] 244065 0
Concord Repatriation and General Hospital
Level 1, Building 75
Hospital Rd.
Concord NSW
2139
Ethics committee country [1] 244065 0
Australia
Date submitted for ethics approval [1] 244065 0
Approval date [1] 244065 0
23/01/2009
Ethics approval number [1] 244065 0
CH62/6/2008-185-J Vardy

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30445 0
Address 30445 0
Country 30445 0
Phone 30445 0
Fax 30445 0
Email 30445 0
Contact person for public queries
Name 13692 0
Haryana Dhillon
Address 13692 0
Centre for Medical Psychology and Evidence-based Decision-making (CeMPED)
The University of Sydney,
NSW 2006
Country 13692 0
Australia
Phone 13692 0
+61 2 9036 5392
Fax 13692 0
+61 2 9036 5420
Email 13692 0
haryana@psych.usyd.edu.au
Contact person for scientific queries
Name 4620 0
Janette Vardy
Address 4620 0
Sydney Cancer Centre
Concord Repatriation and General Hospital
Hospital Rd.
Concord, NSW 2139
Country 4620 0
Australia
Phone 4620 0
+61 2 9767 5000
Fax 4620 0
Email 4620 0
jvardy@med.usyd.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary