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Trial registered on ANZCTR
Registration number
ACTRN12623001168640
Ethics application status
Approved
Date submitted
19/10/2023
Date registered
10/11/2023
Date last updated
26/08/2024
Date data sharing statement initially provided
10/11/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
The effect of exercise intervention for adults undergoing treatment for breast cancer
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Scientific title
The effect of exercise intervention on quality of life for adults undergoing treatment for breast cancer using a Self-determined, Monitored and Adaptable Rehabilitation with Telehealth support (SMART) exercise intervention.
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Secondary ID [1]
310719
0
S01/2023
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Universal Trial Number (UTN)
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Trial acronym
SMART exercise intervention
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast cancer
331659
0
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Condition category
Condition code
Cancer
328380
328380
0
0
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The intervention will involve a state-of-the-art exercise program, with individual and periodized rehabilitation prescription, with adherence monitoring and regular one-on-one support to aid compliance. We refer to this as our “SMART” exercise intervention (Self-Determined, Monitored Adaptable Rehabilitation with Telehealth support). Individuals will be supported to build up or maintain a target exercise goal of 150 mins moderate intensity exercise per week (inclusive of 2 resistance sessions) as informed by guidelines from the American College of Sports Medicine for exercise and cancer. The intervention will run over a 16 week period.
The target behaviour of the SMART program is for participants to work towards or maintain 150 minutes per week of moderate intensity exercise (or 75 minutes per week of vigorous intensity exercise) including two resistance training sessions per week. Moderate intensity exercise will be defined as exercise performed at 60 to 75% of their age predicted maximum heart rate. Vigorous intensity exercise will be defined exercise performed at > 75% of their age predicted maximum heart rate. Resistance training session will encompass the major muscle groups and will be defined as completion of 3 sets of 8-12 repetitions of strength-based or functional tasks (for example, sit to stand, bicep curls, squats). The goal will be to report an intensity that is perceived a 15 (‘hard’) on the 6 to 20 Rating of Perceived Exertion. Intensity will be progressed by increasing the resistance and/or to a more challenging movement pattern. It has been mentioned that side effects relating to breast cancer (BC) treatments are expected to lead to deterioration in physical capacity, as well as associated side effects including but not limited to nausea, dizziness, arthralgia or bone pain. Resultantly, it is reasonable to expect that there will be some days/weeks where many participants will not be able to meet the above target guidelines. In addition to the target program, lower intensity options will also be prescribed to account for the expected fluctuation in treatment related side effects.
After initial recruitment, all study participants will complete an initial assessment to establish their baseline measures. The participants will be requested to complete the initial EORTC Quality of Life C30 questionnaire, as well as the breast cancer specific BR45 module. The trial physiotherapist will also assess participant muscle strength (grip strength, upper limb and lower limb muscle strength) and exercise tolerance (6-minute walking distance). Participant body composition will also be measured using the SOZO analyser. These outcomes are discussed in detail below.
After the randomisation, the SMART intervention group participants will attend an hour-long initial assessment session with a physiotherapist. During this appointment, the physiotherapist will provide education regarding the target exercise goal. Patients individual exercise preferences and existing exercise habits will be discussed and a treatment plan and goals will be made to work towards achieving or maintaining the target exercise dosage.
Online resources will be accessible by all participants in the SMART intervention group. These online resources will contain each individual with a personal login containing their target program, low intensity program, exercise logs, prompts to complete the program and to complete short questionnaires as required. The exercise programs will be available in written online form with short videos and/or photos specific to each individual. Flexibility in the program will be provided with exercises able to be completed either in participants own environment and/or during three weekly physiotherapy gym sessions at RPH.
The participants in the SMART intervention group will also be given weekly one-on-one telehealth calls (up to an hour duration) from a physiotherapist to supervise exercise sessions, provide behaviour change strategies to encourage regular exercise habits through their BC treatment and to problem solve during weeks of low adherence to help them get 'back on track'. During these weekly sessions, feedback from symptom monitoring questionnaires will be discussed and exercise programs will be progressed or tapered accordingly.
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Intervention code [1]
327118
0
Rehabilitation
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Comparator / control treatment
Usual care will involve education with a physiotherapist regarding the importance of exercise during cancer treatment according to the above-mentioned exercise target informed by the guidelines by the 2019 American College of Sports Medicine (ACSM) guidelines for exercise and cancer. This will be administered in a 30-minute, one-on-one session (face-to-face or telehealth delivery).
Participants will be provided with a pamphlet for appropriate off-site exercise groups such as Community Physiotherapy Services (CPS) exercise groups and/or Cancer Council Encore exercise groups.
In addition, a 30-minute follow-up by phone every 4 weeks will be provided by a physiotherapist to assess exercise using the International Physical Activity Questionnaire.
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Control group
Active
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Outcomes
Primary outcome [1]
336221
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EORTC C30 and BR45 quality of life questionnaires
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Assessment method [1]
336221
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EORTC Quality of Life C30 questionnaire with the breast cancer specific BR45 module and the EQ5D5L
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Timepoint [1]
336221
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The primary outcomes will be assessed at the following time points:
-Baseline
-Mid intervention (8 weeks following baseline)
-End of intervention (16 weeks following baseline)
-Long term assessment: (1 year following baseline)
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Primary outcome [2]
338451
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Quality of Life
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Assessment method [2]
338451
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EQ5D5L quality of life questionnaire
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Timepoint [2]
338451
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- Baseline
- Mid intervention (8 weeks following baseline)
- End of intervention (16 weeks following baseline)
- Long term assessment: (1 year following baseline)
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Secondary outcome [1]
427399
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Absenteeism from work
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Assessment method [1]
427399
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The IMTA Productivity Cost Questionnaire
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Timepoint [1]
427399
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-Baseline
-Mid intervention (8 weeks following baseline)
-End of intervention (16 weeks following baseline)
-Long term assessment: (1 year following baseline)
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Secondary outcome [2]
428016
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Chemotherapy completion rates
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Assessment method [2]
428016
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Chemotherapy completion (% of planned treatment) will be collected from individual patient medical records.
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Timepoint [2]
428016
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End of chemotherapy treatment date
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Secondary outcome [3]
435978
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Health care utilisation measure.
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Assessment method [3]
435978
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The iMTA Medical Consumption questionnaire
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Timepoint [3]
435978
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- Baseline
- Mid intervention (8 weeks following baseline)
-End of intervention (16 weeks following baseline)
-Long term assessment: (1 year following baseline)
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Secondary outcome [4]
439011
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Capability, opportunity, and motivation to exercise
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Assessment method [4]
439011
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COM Questionnaire
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Timepoint [4]
439011
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Secondary outcome [5]
439012
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Capability, opportunity, and motivation to exercise
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Assessment method [5]
439012
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COM Questionnaire
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Timepoint [5]
439012
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-Baseline
-Mid intervention (8 weeks following baseline)
-End of intervention (16 weeks following baseline)
-Long term assessment: (1 year following baseline)
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Secondary outcome [6]
439013
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Impairment in functioning
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Assessment method [6]
439013
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Work and Social Adjustment Scale
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Timepoint [6]
439013
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-Baseline
-Mid intervention (8 weeks following baseline)
-End of intervention (16 weeks following baseline)
-Long term assessment: (1 year following baseline)
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Secondary outcome [7]
439014
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Impairment in functioning
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Assessment method [7]
439014
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Work and Social Adjustment Scale
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Timepoint [7]
439014
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-Baseline
-Mid intervention (8 weeks following baseline)
-End of intervention (16 weeks following baseline)
-Long term assessment: (1 year following baseline)
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Secondary outcome [8]
439015
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General self-control
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Assessment method [8]
439015
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Brief Self-Control Scale
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Timepoint [8]
439015
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-Baseline
-Mid intervention (8 weeks following baseline)
-End of intervention (16 weeks following baseline)
-Long term assessment: (1 year following baseline)
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Secondary outcome [9]
439016
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General self-control
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Assessment method [9]
439016
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Brief Self-Control Scale
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Timepoint [9]
439016
0
-Baseline
-Mid intervention (8 weeks following baseline)
-End of intervention (16 weeks following baseline)
-Long term assessment: (1 year following baseline)
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Secondary outcome [10]
439017
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Physical exercise-related barrier self-efficacy
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Assessment method [10]
439017
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Barrier Self-Efficacy Scale
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Timepoint [10]
439017
0
-Baseline
-Mid intervention (8 weeks following baseline)
-End of intervention (16 weeks following baseline)
-Long term assessment: (1 year following baseline)
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Secondary outcome [11]
439018
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Physical exercise-related barrier self-efficacy
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Assessment method [11]
439018
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Barrier Self-Efficacy Scale
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Timepoint [11]
439018
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-Baseline
-Mid intervention (8 weeks following baseline)
-End of intervention (16 weeks following baseline)
-Long term assessment: (1 year following baseline)
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Secondary outcome [12]
439019
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Habitual tendencies
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Assessment method [12]
439019
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Habitual Tendencies Questionnaire
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Timepoint [12]
439019
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-Baseline
-Mid intervention (8 weeks following baseline)
-End of intervention (16 weeks following baseline)
-Long term assessment: (1 year following baseline)
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Secondary outcome [13]
439020
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Habitual tendencies
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Assessment method [13]
439020
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Habitual Tendencies Questionnaire
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Timepoint [13]
439020
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-Baseline
-Mid intervention (8 weeks following baseline)
-End of intervention (16 weeks following baseline)
-Long term assessment: (1 year following baseline)
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Secondary outcome [14]
439021
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Physical exercise-related habit
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Assessment method [14]
439021
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Self-Report Behaviour Automaticity Index
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Timepoint [14]
439021
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-Baseline
-Mid intervention (8 weeks following baseline)
-End of intervention (16 weeks following baseline)
-Long term assessment: (1 year following baseline)
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Secondary outcome [15]
439022
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Physical exercise-related habit
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Assessment method [15]
439022
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Self-Report Behaviour Automaticity Index
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Timepoint [15]
439022
0
-Baseline
-Mid intervention (8 weeks following baseline)
-End of intervention (16 weeks following baseline)
-Long term assessment: (1 year following baseline)
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Secondary outcome [16]
439023
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Mood
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Assessment method [16]
439023
0
Positive and Negative Affect Scale
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Timepoint [16]
439023
0
-Baseline
-Mid intervention (8 weeks following baseline)
-End of intervention (16 weeks following baseline)
-Long term assessment: (1 year following baseline)
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Secondary outcome [17]
439024
0
Mood
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Assessment method [17]
439024
0
Positive and Negative Affect Scale
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Timepoint [17]
439024
0
-Baseline
-Mid intervention (8 weeks following baseline)
-End of intervention (16 weeks following baseline)
-Long term assessment: (1 year following baseline)
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Secondary outcome [18]
439025
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Intention to exercise
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Assessment method [18]
439025
0
Two items based on the theory of planned behaviour (Ajzen, 1991)
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Timepoint [18]
439025
0
-Baseline
-Mid intervention (8 weeks following baseline)
-End of intervention (16 weeks following baseline)
-Long term assessment: (1 year following baseline)
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Secondary outcome [19]
439026
0
Intention to exercise
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Assessment method [19]
439026
0
Two items based on the theory of planned behaviour (Ajzen, 1991)
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Timepoint [19]
439026
0
-Baseline
-Mid intervention (8 weeks following baseline)
-End of intervention (16 weeks following baseline)
-Long term assessment: (1 year following baseline)
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Secondary outcome [20]
439027
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Physical exercise-related task self-efficacy
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Assessment method [20]
439027
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Task Self-Efficacy Scale
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Timepoint [20]
439027
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-Baseline
-Mid intervention (8 weeks following baseline)
-End of intervention (16 weeks following baseline)
-Long term assessment: (1 year following baseline)
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Secondary outcome [21]
439028
0
Physical exercise-related task self-efficacy
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Assessment method [21]
439028
0
Task Self-Efficacy Scale
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Timepoint [21]
439028
0
-Baseline
-Mid intervention (8 weeks following baseline)
-End of intervention (16 weeks following baseline)
-Long term assessment: (1 year following baseline)
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Secondary outcome [22]
439029
0
Muscle strength
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Assessment method [22]
439029
0
Grip strength dynamometry using a Jamar hand-held dynamometer (Surgical Synergies, SI Instruments, SA, Australia). Starting position will be shoulder in adduction, elbow flexion to 90 degrees, forearm and wrist in neutral position. The participant will be encouraged to perform a maximal squeeze of the dynamometer for 3 seconds. The test will be repeated 5 times (on each hand) and the measure that is the highest, but within 10% of one other will be recorded as the test result in kilograms of force.
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Timepoint [22]
439029
0
-Baseline
-Mid intervention (8 weeks following baseline)
-End of intervention (16 weeks following baseline)
-Long term assessment: (1 year following baseline)
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Secondary outcome [23]
439030
0
Muscle strength
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Assessment method [23]
439030
0
Grip strength dynamometry using a Jamar hand-held dynamometer (Surgical Synergies, SI Instruments, SA, Australia). Starting position will be shoulder in adduction, elbow flexion to 90 degrees, forearm and wrist in neutral position. The participant will be encouraged to perform a maximal squeeze of the dynamometer for 3 seconds. The test will be repeated 5 times (on each hand) and the measure that is the highest, but within 10% of one other will be recorded as the test result in kilograms of force.
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Timepoint [23]
439030
0
-Baseline
-End of intervention (16 weeks following baseline)
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Secondary outcome [24]
439031
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Muscle strength
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Assessment method [24]
439031
0
Hand held dynamometry (Lafayette Muscle Metre) to measure isometric peripheral muscle force generating capacity of the biceps, deltoid and quadriceps, recorded as peak kilograms of force for the left and right sides.
For the biceps and middle deltoid tests, the participant will perform the test in sitting. Starting position will be shoulder in adduction and neutral external rotation, elbow flexion to 90 degrees, forearm and wrist in neutral position. The participant will be encouraged to abduct their shoulder (for middle deltoids) or flex their elbow (for biceps brachii) with as much force as possible against the dynamometer for 3 seconds. The muscle meter will be stabilised with by the assessing therapist with the use of a nylon belt secured to the arm rest of the chair, in order to maximise reliability The test will be repeated 5 times (on each arm) and the measure that is the highest, but within 10% of one other will be recorded as the test result
For the quadriceps testing the participant will perform the test in sitting. Starting position will be hip and knee flexion to 90 degrees. The participant will be encouraged to extend their knee with as much force as possible against the dynamometer for 3 seconds. The muscle meter will be stabilised with by the assessing therapist with the use of a nylon belt secured to the back leg of the chair, in order to maximise reliability. The test will be repeated 5 times (on each leg) and the measure that is the highest, but within 10% of one other will be recorded as the test result.
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Timepoint [24]
439031
0
-Baseline
-End of intervention (16 weeks following baseline)
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Secondary outcome [25]
439032
0
Muscle strength
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Assessment method [25]
439032
0
Hand held dynamometry (Lafayette Muscle Metre) to measure isometric peripheral muscle force generating capacity of the biceps, deltoid and quadriceps, recorded as peak kilograms of force for the left and right sides.
For the biceps and middle deltoid tests, the participant will perform the test in sitting. Starting position will be shoulder in adduction and neutral external rotation, elbow flexion to 90 degrees, forearm and wrist in neutral position. The participant will be encouraged to abduct their shoulder (for middle deltoids) or flex their elbow (for biceps brachii) with as much force as possible against the dynamometer for 3 seconds. The muscle meter will be stabilised with by the assessing therapist with the use of a nylon belt secured to the arm rest of the chair, in order to maximise reliability The test will be repeated 5 times (on each arm) and the measure that is the highest, but within 10% of one other will be recorded as the test result
For the quadriceps testing the participant will perform the test in sitting. Starting position will be hip and knee flexion to 90 degrees. The participant will be encouraged to extend their knee with as much force as possible against the dynamometer for 3 seconds. The muscle meter will be stabilised with by the assessing therapist with the use of a nylon belt secured to the back leg of the chair, in order to maximise reliability. The test will be repeated 5 times (on each leg) and the measure that is the highest, but within 10% of one other will be recorded as the test result.
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Timepoint [25]
439032
0
-Baseline
-End of intervention (16 weeks following baseline)
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Secondary outcome [26]
439033
0
Walking tolerance
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Assessment method [26]
439033
0
6 minute walk test (6MWT): This test will be performed according to standard guidelines. The outcome measured is the distance walked in 6 minutes, in metres (6MWD). Each participant will perform the test twice and the longest 6MWD will be recorded as the test result.
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Timepoint [26]
439033
0
-Baseline
-End of intervention (16 weeks following baseline)
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Secondary outcome [27]
439034
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Walking tolerance
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Assessment method [27]
439034
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6 minute walk test (6MWT): This test will be performed according to standard guidelines. The outcome measured is the distance walked in 6 minutes, in metres (6MWD). Each participant will perform the test twice and the longest 6MWD will be recorded as the test result.
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Timepoint [27]
439034
0
-Baseline
-End of intervention (16 weeks following baseline)
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Secondary outcome [28]
439035
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Body composition
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Assessment method [28]
439035
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Body composition will be measured via bioimpedance spectroscopy.
This is a non-invasive measure of body composition performed using the SOZO analyser (Impedimed, Brisbane, Queensland). The test takes under a minute, with the participant clothed and standing on the testing platform and provides estimates of tissue composition including skeletal muscle mass, fat mass, fat free mass; recorded in kg and percent of body mass.
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Timepoint [28]
439035
0
-Baseline
-End of intervention (16 weeks following baseline)
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Secondary outcome [29]
439036
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Body composition
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Assessment method [29]
439036
0
Body composition will be measured via bioimpedance spectroscopy.
This is a non-invasive measure of body composition performed using the SOZO analyser (Impedimed, Brisbane, Queensland). The test takes under a minute, with the participant clothed and standing on the testing platform and provides estimates of tissue composition including skeletal muscle mass, fat mass, fat free mass; recorded in kg and percent of body mass.
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Timepoint [29]
439036
0
-Baseline
-End of intervention (16 weeks following baseline)
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Secondary outcome [30]
439037
0
Physical activity
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Assessment method [30]
439037
0
International Physical Activity Questionnaire (IPAQ)
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Timepoint [30]
439037
0
-Baseline
-End of intervention (16 weeks following baseline)
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Secondary outcome [31]
439038
0
Physical activity
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Assessment method [31]
439038
0
International Physical Activity Questionnaire (IPAQ)
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Timepoint [31]
439038
0
-Baseline
-1st quarter (4 weeks following baseline)
-Mid intervention (8 weeks following baseline)
-3rd quarter (12 weeks following baseline)
-End of intervention (16 weeks following baseline)
-Long term follow-up (1 year following baseline)
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Eligibility
Key inclusion criteria
Adults will be eligible to participate if they meet the following criteria:
1. Adult with newly diagnosed breast cancer
2. Planned treatment includes neo-adjuvant or adjuvant chemotherapy AND/OR endocrine therapy
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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
Adults will be not eligible to participate if they meet any of the following criteria:
1. Cognitive impairment or are unable to speak or read written English
2. Unable to access internet/phone app
3. Living in supported residential care
4. Any other co-morbidities where exercise is contra-indicated, at the discretion of the treating specialist
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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)
Computer based randomisation using REDCap software.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified based on treatment type and exercise history
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
17/06/2024
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Actual
17/06/2024
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Date of last participant enrolment
Anticipated
31/12/2025
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Actual
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Date of last data collection
Anticipated
30/06/2026
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Actual
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Sample size
Target
260
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Accrual to date
4
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
26646
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Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
42686
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6000 - Perth
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Funding & Sponsors
Funding source category [1]
314935
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Charities/Societies/Foundations
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Name [1]
314935
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Royal Perth Hospital Research Foundation
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Address [1]
314935
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50 Murray Street, Perth, WA, 6000.
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Country [1]
314935
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Australia
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Primary sponsor type
Hospital
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Name
Royal Perth Hospital Physiotherapy Department
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Address
Royal Perth Hospital, Wellington Street Campus, Perth, WA, 6000.
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Country
Australia
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Secondary sponsor category [1]
316942
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University
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Name [1]
316942
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Curtin University
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Address [1]
316942
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208 Kent St, Bentley, WA 6102
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Country [1]
316942
0
Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
313926
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Royal Perth Hospital Human Research Ethics Committee
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Ethics committee address [1]
313926
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East Metropolitan Health Service (EMHS) Research Ethics and Governance Ground Floor, Kirkman House, Royal Perth Hospital Wellington Street, PERTH WA 6000
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Ethics committee country [1]
313926
0
Australia
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Date submitted for ethics approval [1]
313926
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15/11/2023
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Approval date [1]
313926
0
22/02/2024
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Ethics approval number [1]
313926
0
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Summary
Brief summary
This study is investigating a state-of-the-art exercise intervention for those undergoing chemotherapy for breast cancer in comparison to usual care. Who is it for? You may be eligible for this study if you are an adult with newly diagnosed, non-metastatic breast cancer, with planned treatment including neo-adjuvant or adjuvant chemotherapy and/or endocrine therapy. Study details Participants will be randomly allocated to receive either a tailored exercise program, or usual care pathways without individualized exercise prescription. The tailored program will involve supervision of exercise sessions and ongoing personal support. Participants will be asked to fill in questionnaires about their quality of life and absenteeism from work, and other health data including chemotherapy completion rates will also be collected. It is hoped that findings from this study will help evaluate the utility of a personalised exercise intervention during breast cancer treatment.
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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
129814
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Mrs Kylie Hill
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Address
129814
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Curtin University, Faculty of Health Sciences, 208 Kent St, Bentley, WA 6102
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Country
129814
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Australia
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Phone
129814
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+61 8 9266 1717
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Fax
129814
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Email
129814
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[email protected]
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Contact person for public queries
Name
129815
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Kylie Hill
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Address
129815
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Curtin University, Faculty of Health Sciences, 208 Kent St, Bentley, WA 6102
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Country
129815
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Australia
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Phone
129815
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+61 8 9266 1717
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Fax
129815
0
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Email
129815
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[email protected]
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Contact person for scientific queries
Name
129816
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Kylie Hill
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Address
129816
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Curtin University, Faculty of Health Sciences, 208 Kent St, Bentley, WA 6102
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Country
129816
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Australia
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Phone
129816
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+61 8 9266 1717
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Fax
129816
0
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Email
129816
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Undecided
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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.
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