Trial from ANZCTR


Trial ID ACTRN12610000805077
Trial Status: Registered
Date Submitted: 6/09/2010
Date Registered: 27/09/2010
Retrospectively registered

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Public title RESTORE: Recovery exercises and Stepping On after fracture.
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format Self-managed home exercise plus group-based discussion compared with usual care to improve physical functioning and prevent falls in older people who have completed rehabilitation for a lower limb or pelvic fracture: a randomised controlled trial
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Secondary ID [1] 252360 0
Northern Sydney Central Coast Health (NSCCH)
Local Reference: Protocol 0905-089M
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UTN
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Trial acronym RESTORE
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Health condition(s) or problem(s) studied:
Lower limb and pelvic fracture in older people 257873 0
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Condition category: Condition code:
Injuries and Accidents Fractures
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258033 258033 0 0
Physical Medicine / Rehabilitation Physiotherapy
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Descriptions of intervention(s) / exposure Participants randomised to the intervention group will receive home visits of 45-60 minutes duration from a physiotherapist. The physiotherapist will prescribe an individualised exercise program and use motivational interviewing and goal setting to encourage behaviour change with regard to exercise. The physiotherapists will conduct ten home visits throughout the 12-month study period and provide fortnightly phone calls. Participants will be encouraged to continue the exercises three times weekly at home. The program will involve the following features: exercise will be individually prescribed based on assessment of physical abilities; there will be an emphasis on functionally-relevant weight-bearing exercise designed primarily to reduce falls and disability by enhancing balance and functional abilities; and exercises will include repetitions of the sit-to-stand movement, semisquats from a standing position, reaching in standing, forward, backward and sideways walking and stepping up onto blocks. The exercise intervention is suitable for people after lower limb or pelvic fracture on the basis of previous work led by Investigators Sherrington, Moseley, Lord and Cameron. The physiotherapist will provide additional information about bone health and will arrange a referral to local geriatrician and/or falls clinic if indicated.
Intervention group participants will also be offered the Stepping On program developed by Chief Investigator Clemson as implemented by the NSW Department of Health: weekly 2-hour group discussion sessions for seven weeks plus an additional booster session at 3-months. The Stepping On content will be relevant to people with fall-related lower limb or pelvic fracture and will cover coping with visual loss and regular visual screening, medication management, environmental and behavioural home safety, and community safety. Group sessions will be held in rooms at local community centres or hospitals. Transport will be provided for those who would otherwise be unable to attend the sessions. Each program will be attended by up to 13 people. The group sessions will be facilitated by a occupational therapist or other health professional. The group sessions will be completed within the 12-month study period, with the timing depending on availability of a Stepping On program.
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Intervention Code:
Rehabilitation 256924 0
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Comparator / control treatment Usual care for the duration of one year. Usual care is a
combination of aged care and health services that are
routinely provided. They may include referral to a physiotherapist or falls clinic.
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Control group Active
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Primary Outcome: Mobility-related disability will be assessed with the Short Physical Performance Battery (SPPB) and the computerised version of the Boston University Activity Measure for Post Acute Care (AM-PAC) 258882 0
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Timepoint: Baseline and 12 months after randomisation The AM-PAC will also be administered by phone at 3, 6, 9 and 12 months after randomisation. 258882 0
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Primary Outcome: The life role participation aspect of functioning will be assessed using the Late Life Functioning and Disability Instrument, Disability Component. 258883 0
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Timepoint: Baseline and 12 months after randomisation 258883 0
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Primary Outcome: Falls will be assessed by comparing the rate of falls and the proportion of fallers in intervention and control groups 258885 0
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Timepoint: Assessed as the total number of falls occurring in the 12 months after randomisation as assessed by monthly calendars and phone calls. 258885 0
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Secondary Outcome: Hospital re-admission rates 265235 0
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Timepoint: Monthly via calendars for the first 12 months after randomisation. With data linkage at 2 and 4 years after randomisation 265235 0
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Secondary Outcome: Falls risk using physiological Profile Assessment 265300 0
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Timepoint: Baseline and 12 months after randomisation 265300 0
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Secondary Outcome: Frailty will be assessed using a continuous scale based on the Fried criteria. 265301 0
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Timepoint: Baseline and 12 months after randomisation 265301 0
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Secondary Outcome: Balance and mobility will be assessed with individual components of the Physiological Profile Assessment (PPA), Short Physical Performance Battery (SBBP) and the Step Test, maximal balance range, co-ordinated stability, choice stepping reaction time and ankle flexibility. 265302 0
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Timepoint: Baseline and 12 months after randomisation 265302 0
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Secondary Outcome: Nutritional status will be assessed indirectly using Body Mass Index 265303 0
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Timepoint: Baseline and 12 months after randomisation 265303 0
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Secondary Outcome: Physical activity will be assessed using the Incidental and Planned Exercise Questionnaire. 265304 0
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Timepoint: Baseline and 12 months after randomisation 265304 0
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Secondary Outcome: Pain will be assessed on a 7-point scale. 265305 0
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Timepoint: Baseline and 12 months after randomisation 265305 0
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Secondary Outcome: Falls efficacy will be assessed with the short version of the Falls Efficacy Scale-International. 265306 0
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Timepoint: Baseline and 12 months after randomisation 265306 0
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Secondary Outcome: Mood will be assessed using the Geriatric Depression Scale and the Positive and Negative Affect Scale 265307 0
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Timepoint: Baseline and 12 months after randomisation 265307 0
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Secondary Outcome: Quality of life will be assessed using the European Quality of Life-5 dimensions (EQ-5D) and the Short Form 12-item Survey(SF-12). 265308 0
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Timepoint: Baseline and 12 months after randomisation. The EQ-5D will also be administered by phone at 3, 6, and 9 months after randomisation 265308 0
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Secondary Outcome: Adverse effects of the intervention program will be monitored. A musculoskeletal adverse event will be defined as musculoskeletal soreness that interferes with Activities of Daily Living for more for 48 hours or requires medical attention. 265309 0
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Timepoint: Baseline and 12 months after randomisation 265309 0
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Key inclusion criteria People with a fall-related lower limb or pelvic fracture who have completed active physiotherapy and/or rehabilitation and who are living at home or in a hostel
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Minimum age 60 Years
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Maximum age No limit
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Gender Both males and females
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Healthy volunteers? No
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Key exclusion criteria Residing in nursing home, Mini Mental State Examination (MMSE) under 24, insufficient English language skills, inability to walk 10 metres despite assistance from another person or walking aid, a progressive neurological disease e.g. Parkinsons disease and a medical condition precluding exercise e.g. unstable cardiac disease, uncontrolled hypertension, uncontrolled metabolic diseases, large abdominal aneurysm
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Study type Interventional
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Purpose of the study Prevention
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) The research assistant screens for inclusion criteria. If the person satisfies criteria the research assistant completes baseline assessment then contacts the lead investigator who will determine group allocation. The lead investigator will not be directly involved in participant recruitment. Allocation therefore involves contacting the holder of the allocation schedule who is at central administration site.
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) The randomisation sequence will be determined using a computer generated random number schedule with randomly permuted block sizes. The schedule will be developed by the lead investigator who will not be directly involved in participant recruitment.
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Masking / blinding Blinded (masking used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Not Applicable
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Anticipated date of first participant enrolment 1/04/2010
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 350
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Recruitment status Recruiting
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Recruitment in Australia

Recruitment state(s)
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Postcode: 2067 3115 0
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Postcode: 2095 3116 0
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Postcode: 2217 3117 0
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Postcode: 2250 3118 0
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Recruitment outside Australia

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Funding Source: Government body 257376 0
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Name: National Health and Medical Research Council 257376 0
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Address: GPO Box 1421
Canberra
ACT 2601
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Country: Australia 257376 0
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Primary Sponsor Individual
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Name: Dr Cathie Sherrington
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Address: The George Institute for Global Health,
PO Box M201, Missenden Road, NSW 2050
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Country: Australia
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Secondary Sponsor: None 256706 0
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Name: 256706 0
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Address: 256706 0
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Country: 256706 0
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Other Collaborator: Individual 251410 0
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Name: Associate Professor Lindy Clemson 251410 0
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Address: University of Sydney, Corner City Road and Butlin Avenue, Camperdown, NSW, 2050 251410 0
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Country: Australia 251410 0
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Other Collaborator: Individual 251411 0
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Name: Prof Stephen Lord 251411 0
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Address: Neuroscience Research Australia (NeuRA) - Formerly known as the Prince of Wales Medical Research Institute. Barker Street, Randwick, NSW, 2031 251411 0
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Country: Australia 251411 0
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Other Collaborator: Individual 251412 0
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Name: Dr Kirsten Howard 251412 0
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Address: University of Sydney, Corner City Road and Butlin Avenue, Camperdown, NSW, 2050. 251412 0
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Country: Australia 251412 0
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Other Collaborator: Individual 251413 0
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Name: Dr Anne Moseley 251413 0
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Address: The George Institute for Global Health,
PO Box M201,
Missenden Road, NSW 2050
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Country: Australia 251413 0
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Other Collaborator: Individual 251414 0
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Name: Dr Constance Vogler 251414 0
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Address: Geriatrician,
Royal North Shore Hospital, Reserve Road, St Leonards, NSW 2065
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Country: Australia 251414 0
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Other Collaborator: Individual 251415 0
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Name: Prof Ian Cameron 251415 0
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Address: Royal Rehabilitation Centre Sydney, Rehabilitation Studies
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PO Box 6 Ryde NSW 1680
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Country: Australia 251415 0
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Other Collaborator: Individual 251416 0
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Name: Assoc. Prof Jacqueline Close, 251416 0
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Address: Geriatrician
Prince of Wales Hospital, Barker Street, Randwick, NSW 2031
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Country: Australia 251416 0
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Other Collaborator: Individual 251417 0
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Name: Prof David Sonnabend 251417 0
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Address: Orthopaedic Unit
Royal North Shore Hospital, Reserve Road, St Leonards, NSW 2065
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Country: Australia 251417 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: HARBOUR Human Research Ethics Committee (HREC) of Northern Sydney Central Coast Health (NSCCH) 259394 0
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Address: The Reserach Office, Level 4, Vindin House, Royal North
Shore Hospital, St Leonards NSW 2065
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Country: Australia 259394 0
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Approval Date: 27/05/2009 259394 0
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Submitted Date: 09/04/2009 259394 0
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HREC: HREC/09/HARBR/57 259394 0
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Brief summary This National Health and Medical Research Council (NHMRC)funded clinical trial will assess the effect of an exercise-based self-management program for older people who have suffered a lower limb or pelvic fracture in the last two years. The intervention involves a combination of physiotherapy home-visits to establish a home-exercise program and the group-based the Stepping On program. Motivational interviewing and goal setting will be used to encourage behaviour change with regard to exercise and safe community mobility. Three hundred and fifty participants will be recruited from hospitals, health professional practices and general advertising. Primary outcomes are mobility-related disability, community participation and falls. Cost-effectiveness analysis will be undertaken for the primary outcomes.
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Trial website
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Dr Cathie Sherrington
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Address: The George Institute for Global Health, PO Box M201, Missenden Road, NSW 2050
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Country: Australia
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Tel: +61 2 9657 0300
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Fax: +61 2 9657 0301
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Email: csherrington@georgeinstitute.org.au
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Contact person for scientific queries
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Name: Dr Cathie Sherrington
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Address: The George Institute for Global Health, PO Box M201, Missenden Road, NSW 2050
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Country: Australia
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Contact person responsible for updating information
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Name: Dr Cathie Sherrington
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Address: The George Institute for Global Health, PO Box M201, Missenden Road, NSW 2050
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Addition Cancer fields
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