Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000085875
Ethics application status
Approved
Date submitted
16/01/2012
Date registered
17/01/2012
Date last updated
17/01/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Distance- Based Physical Activity Intervention for Rural Lung Cancer Survivors.
Scientific title
The Feasibility and Preliminary Efficacy of a Distance- Based Physical Activity Intervention for Rural Lung Cancer Survivors.
Secondary ID [1] 279729 0
Nil
Universal Trial Number (UTN)
U1111-1127-1666
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 285571 0
Condition category
Condition code
Cancer 285767 285767 0 0
Lung - Non small cell
Cancer 285777 285777 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomized to the intervention arm will receive print-based materials and telephone follow-up designed to increase physical activity participation for 12-weeks. Telephone follow-up and print materials mailout will occur weekly for one month, with fortnightly contact for the last two months. All physical activity will be home-based. Constructs from the Theory of Planned Behavior informed the intervention materials.
Intervention code [1] 284028 0
Lifestyle
Intervention code [2] 284038 0
Rehabilitation
Comparator / control treatment
The attention control group will receive phone calls during the intervention period to ask about their general health and well being over 12-weeks. At 6-months, following the final questionnaire assessment the control group will receive all print-based materials.
Control group
Active

Outcomes
Primary outcome [1] 286292 0
Feasibility of the intervention as measured by reach (participants enrolled/participants screened and eligible), retention (participants completing post intervention assessment/participants enrolled), adherence to telephone support (number of telephone sessions completed/total number possible), and adverse events (number of adverse events reported during telephone support, and/or in questionnaire).
Timepoint [1] 286292 0
Baseline, 3 months, and 6 months follow-up
Secondary outcome [1] 295541 0
Physical Activity assessed by the Godin Leisure-Time Questionnaire, and a domain specific sedentary behavior questionnaire, and triaxial accelerometry
Timepoint [1] 295541 0
Baseline, 3 months, and 6 months follow-up
Secondary outcome [2] 295542 0
Health-related quality of life, measured using: The Medical Outcomes Study Short-Form 36 and the Functional Assessment of Cancer Therapy - Lung Cancer
Timepoint [2] 295542 0
Baseline, 3 months, and 6 months follow-up
Secondary outcome [3] 295543 0
Fatigue using the FACIT-Fatigue scale
Timepoint [3] 295543 0
Baseline, 3 months, and 6 months follow-up
Secondary outcome [4] 295544 0
Anxiety and Depression: The Brief Symptom Inventory-18
Timepoint [4] 295544 0
Baseline, 3 months, and 6 months follow-up
Secondary outcome [5] 295545 0
Sleep quality, measured by the Pittsburgh Sleep Quality Index
Timepoint [5] 295545 0
Baseline, 3 months, and 6 months follow-up
Secondary outcome [6] 295546 0
Physical Activity Motivation: Theory of Planned Behaviour constructs (affective and instrumental attitude, injunctive and descriptive norm, self-efficacy, perceived behavioural control, intention, and planning) will be assessed using a standard TPB Questionnaire.
Timepoint [6] 295546 0
Baseline, 3 months, and 6 months follow-up
Secondary outcome [7] 295547 0
Shortness of breath measure by the cancer dyspnea scale and the MRC Dyspnea scale
Timepoint [7] 295547 0
Baseline, 3 months, and 6 months follow-up
Secondary outcome [8] 295548 0
Patient rated function: Late Life Function Index
Timepoint [8] 295548 0
Baseline, 3 months, and 6 months follow-up
Secondary outcome [9] 295549 0
Shortness of breath measure by the cancer dyspnea scale and the MRC Dyspnea scale
Timepoint [9] 295549 0
Baseline, 3 months, and 6 months follow-up
Secondary outcome [10] 295574 0
Ratings of burden and acceptability will be assessed by questionnaire specifically designed for this study.
Timepoint [10] 295574 0
Baseline, 3 months, and 6 months follow-up

Eligibility
Key inclusion criteria
Confirmed stage I-IIIB non-small cell lung cancer or
limited stage small cell lung cancer and not currently on treatment for cancer.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participating in regular exercise (performing 150 minutes of
aerobic exercise and resistance exercise 2 days/week) within the past 3 months.
Any musculoskeletal, neurological, or cardiovascular disorder that could inhibit exercise or put them at risk of injury or illness.
Metastatic disease or presence of bone metastases.

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)
Written informed consent will be required prior to any testing or randomisation. Assignments will be placed in sealed opaque envelopes and designated colours will be assigned for each group. The subject will open these envelopes after completion of all baseline testing. Subjects who dropout prior to completion of baseline testing will not be randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects are randomised after the baseline assessment has been completed to: 1. Physical activity interevntion or 2. attention control. Randomisation is at the level of the individual patient. Patients will be stratified on gender (male/female) and age (<65 / greater than or equal to 65) The list will be generated and maintained by a research assistant not otherwise involved in the study. The sequential treatment assignments are based on a computer-generated randomisation scheme (by using the Web site www.randomization.com set up by Dr Gerard E. Dallal).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 284516 0
University
Name [1] 284516 0
Edith Cowan University Early Career Researcher Grant Scheme
Country [1] 284516 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Drive
Joondalup, WA
6027
Country
Australia
Secondary sponsor category [1] 283445 0
Individual
Name [1] 283445 0
Dr. Carolyn McIntyre
Address [1] 283445 0
ECU Health and Wellness Institute
270 Joondalup Drive
Joondalup WA 6027
Country [1] 283445 0
Australia
Other collaborator category [1] 260447 0
Individual
Name [1] 260447 0
A/Prof Daniel Galvao
Address [1] 260447 0
ECU Health and Wellness Institute
270 Joondalup Drive
Joondalup WA 6027
Country [1] 260447 0
Australia
Other collaborator category [2] 260450 0
Individual
Name [2] 260450 0
Prof Robert Newton
Address [2] 260450 0
ECU Health and Wellness Institute
270 Joondalup Drive
Joondalup, WA
6027
Country [2] 260450 0
Australia
Other collaborator category [3] 260451 0
Individual
Name [3] 260451 0
Nigel Spry
Address [3] 260451 0
Clinical and Adjunct Staff (Medicine and Pharmacology, SCGH)
The University of Western Australia (M503)
35 Stirling Highway
CRAWLEY WA 6009
Country [3] 260451 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286501 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 286501 0
Ethics committee country [1] 286501 0
Australia
Date submitted for ethics approval [1] 286501 0
Approval date [1] 286501 0
30/11/2011
Ethics approval number [1] 286501 0
7421

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33632 0
Address 33632 0
Country 33632 0
Phone 33632 0
Fax 33632 0
Email 33632 0
Contact person for public queries
Name 16879 0
Dr. Carolyn McIntyre
Address 16879 0
270 Joondalup Drive
Joondalup, WA
6027
Country 16879 0
Australia
Phone 16879 0
+61 08 6304 3987
Fax 16879 0
+61 8 6304 2499
Email 16879 0
[email protected]
Contact person for scientific queries
Name 7807 0
Dr. Carolyn McIntyre
Address 7807 0
270 Joondalup Drive
Joondalup, WA
6027
Country 7807 0
Australia
Phone 7807 0
+61 8 6304 3987
Fax 7807 0
+61 8 6304 2499
Email 7807 0
[email protected]

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
No additional documents have been identified.