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Trial registered on ANZCTR
Registration number
ACTRN12609000312246
Ethics application status
Approved
Date submitted
16/01/2009
Date registered
15/05/2009
Date last updated
19/02/2016
Type of registration
Prospectively registered
Titles & IDs
Public title
A nurse led psychosocial intervention with peer support to reduce psychosocial needs in women with gynaecological cancer
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Scientific title
In patients with gynaegological cancer being treated curatively with radiotherapy, does a nurse led psychosocial intervention compared to usual care decrease psychosocial needs?
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Secondary ID [1]
288584
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
gynaecological cancer
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Condition category
Condition code
Cancer
4419
4419
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0
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Womb (Uterine or endometrial cancer)
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Cancer
4420
4420
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0
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Ovarian and primary peritoneal
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Cancer
4421
4421
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0
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Cervical (cervix)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This pilot / Phase I study aimed to develop a nurse-led psychosocial intervention with peer support to reduce anxiety, psychosocial and psychosexual needs and symptom distress of women receiving radiotherapy for gynaecological cancers. The intervention consists of 3 nurse consultations (pre-treatment, mid-treatment, end-of-treatment); 5 peer support consultations (phone) (pre-treatment, mid-treatment, end-of-treatment, 2 and 4 weeks post-treatment). The overall duration of the intervention is approximately 12 weeks. Consultations will take less than 1 hour. The intervention group will also receive usual care.
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Intervention code [1]
3921
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Treatment: Other
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Comparator / control treatment
usual care (weekly nursing consultations of approximately 20 minutes duration throughout treatment) over approximately 7 weeks.
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Control group
Active
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Outcomes
Primary outcome [1]
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Psychological distress (HADS - Hospital Anxiety & Depression Scale).
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Assessment method [1]
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Timepoint [1]
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Pre-treatment, first day of treatment, 4 wks post-treatment, 6 & 12 months post-treatment.
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Secondary outcome [1]
8924
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informational and psychological supportive care needs (Supportive Care Needs Survey (SCNS)).
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Assessment method [1]
8924
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Timepoint [1]
8924
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Pre-treatment, 4 wks post-treatment.
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Secondary outcome [2]
8925
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MSAS-SF (Memorial symptom Assessment scale - short form)
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Assessment method [2]
8925
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Timepoint [2]
8925
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Pre-treatment, 4 wks post-treatment.
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Secondary outcome [3]
8926
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SVQ - sexual function and vaginal changes questionnaire.
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Assessment method [3]
8926
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Timepoint [3]
8926
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Pre-treatment, 6 & 12 months post-treatment.
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Secondary outcome [4]
321001
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CaTS - Cancer Treatment Survey.
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Assessment method [4]
321001
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Timepoint [4]
321001
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Pre-treatment, first day of treatment, 4-wks post-treatment.
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Secondary outcome [5]
321002
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Adherence Questionnaire - Patient self-report adherence to recommendations for dilator use are assessed using this custom-made scale.
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Assessment method [5]
321002
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Timepoint [5]
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4-wks, 6 & 12 months post-treatment.
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Eligibility
Key inclusion criteria
a confirmed diagnosis of gynaecological cancer; scheduled to receive radiotherapy with curative intent to the pelvis; aged 18 years or older; able to read and write English; and give informed consent.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria are a severe psychiatric or cognitive disorder; treatment with palliative intent; or previous treatment with radiotherapy.
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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)
All participants will provide informed written consent, complete a baseline questionnaire, and then be randomly allocated to the intervention group or usual care group. The researcher will enter the participant into a randomisation database after consent and baseline data has been collected, therefore allocation concealment will be used.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
'Randomisation will be stratified by diagnosis and treatment type (External beam radiotherapy (EBR) alone; EBR plus brachytherapy; EBR plus chemotherapy). Randomised sequence will be generated by using a randomisation table created by computer software.
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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
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Phase
Not Applicable
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Type of endpoint/s
Safety
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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
1/01/2010
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Actual
21/01/2010
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Date of last participant enrolment
Anticipated
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Actual
20/04/2010
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
10
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Accrual to date
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Final
6
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Cancer Australia
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Address [1]
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PO Box 1201 Dickson Canberra ACT 2602
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Country [1]
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Australia
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Funding source category [2]
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Charities/Societies/Foundations
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Name [2]
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Beyond Blue
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Address [2]
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PO Box 6100 Hawthorn West
Victoria, Australia 3122
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Country [2]
292932
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Australia
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Primary sponsor type
Individual
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Name
Prof Penelope Schofield
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Address
Swinburne University - Department of Psychological Sciences
School of Health Sciences | Faculty of Health, Arts and Design
PO Box 218, HAWTHORN, VIC 3122 | Internal Mail H24
Department of Cancer Experiences Research
Peter MacCallum Cancer Centre
Locked Bag 1, A'Beckett Street
Victoria, 8006 Australia
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
4474
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Address [1]
4474
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Country [1]
4474
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
6436
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Peter MacCallum cancer centre HREC
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Ethics committee address [1]
6436
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10 St Andrews Pl
East Melbourne
Vic 3002
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Ethics committee country [1]
6436
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Australia
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Date submitted for ethics approval [1]
6436
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19/03/2009
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Approval date [1]
6436
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19/05/2009
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Ethics approval number [1]
6436
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09/07
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Summary
Brief summary
This study involved the development and pilot / phase I testing of a psychoeducational intervention involving tailored nursing consultations combined with peer telephone support to address the psychosocial needs of women with gynaecological cancer being treated with radiotherapy. The intervention was found to be feasible and acceptable to patients and clinicians. This intervention was then further modified and is being tested in a larger RCT to identify whether the support program reduces psychological distress, unmet supportive care needs, psychosexual difficulties, and improves quality of life and adherence to dilator use.
The ACTRN is the initial development & pilot testing phase is: ACTRN12609000312246.
A second ACTRN is for the phase III trial for which this study was the initial development & pilot testing phase has also been submitted: ACTRN12611000744954.
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Trial website
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Trial related presentations / publications
Rebecca J. Bergin; Suzi M. Grogan; David Bernshaw; Ilona Juraskova; Sylvia O Penberthy; Linda R. Mileshkin; Meinir Krishnasamy; Alison C. Hocking; Sanchia K. Aranda; Penelope E. Schofield. Developing an evidence-based, nurse-led psycho-educational intervention with peer support in gynaecological oncology. Cancer Nursing: An International Journal for Cancer Care, 2015 (e-publication April 15, 2015)
Bergin R, Grogan S, Sharkey K, Juraskova I, Mileshkin L, Krishnasamy M, Hocking A, Bernshaw B, Aranda S, Schofield P (Oral presentation): ‘The development of a nurse-led psychosocial intervention with peer support for women being treated with radiotherapy for gynaecological cancer (GC)’, 2010 OZPOS/PoCoG Psycho-oncology Professional Day, Clinical Oncological Society of Australia (COSA) - Melbourne AUSTRALIA.
Bergin R, Grogan S, Sharkey K, Juraskova I, Mileshkin L, Krishnasamy M, Hocking A, Bernshaw B, Aranda S, Schofield P (Poster presentation): ‘The development of a nurse-led psychosocial intervention with peer support for women being treated with radiotherapy for gynaecological cancer (GC)’, 2010 Clinical Oncological Society of Australia (COSA) - Melbourne AUSTRALIA.
Juraskova I, Bergin R, Grogan S, Sharkey K, Mileshkin L, Krishnasamy M, Hocking A, Bernshaw D, Aranda S and Schofield P (Poster Presentation): ‘The development of a nurse-led psychosocial intervention with peer support for women being treated with radiotherapy for gynaecological cancer (GC)’, 2010 13th Biennial Meeting of the International Gynecological Cancer Society (IGCS) - Prague CZECH REPUBLIC.
A, Bernshaw D and Aranda S (Poster Presentation): ‘The development of a nurse-led psychosocial intervention with peer support for women being treated with radiotherapy for gynaecological cancer’, 2010 European Association Communication in Healthcare conference - Verona, ITALY.
Schofield P Bergin R, Grogan S, Sharkey K, Juraskova I, Mileshkin L, Krishnasamy M, Hocking A, Bernshaw D and Aranda S (Poster Presentation): ‘The development of a nurse-led psychosocial intervention with peer support for women undergoing radiotherapy for gynaecological cancer (GC)’, 2010 Beyond Blue Research Forum – Melbourne AUSTRALIA.
Schofield P, Bergin R, Grogan S, Sharkey K, Juraskova I, Mileshkin L, Krishnasamy M, Hocking A, Bernshaw D and Aranda S (Poster Presentation): ‘The development of a nurse-led psychosocial intervention with peer support for women being treated with radiotherapy for gynaecological cancer (GC)’, 2010 Australian New Zealand Gynaecological Oncology Group (ANZGOG) annual scientific meeting – Noosa AUSTRALIA.
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Public notes
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Contacts
Principal investigator
Name
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Prof Penelope Schofield
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Address
35096
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Swinburne University - Department of Psychological Sciences
School of Health Sciences | Faculty of Health, Arts and Design
PO Box 218, HAWTHORN, VIC 3122 | Internal Mail H24
Department of Cancer Experiences Research
Peter MacCallum Cancer Centre
Locked Bag 1, A'Beckett Street
Victoria, 8006 Australia
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Country
35096
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Australia
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Phone
35096
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+61 3 9214 4886
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Fax
35096
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Email
35096
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[email protected]
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Contact person for public queries
Name
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Prof Penelope Schofield
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Address
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Swinburne University - Department of Psychological Sciences
School of Health Sciences | Faculty of Health, Arts and Design
PO Box 218, HAWTHORN, VIC 3122 | Internal Mail H24
Department of Cancer Experiences Research
Peter MacCallum Cancer Centre
Locked Bag 1, A'Beckett Street
Victoria, 8006 Australia
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Country
12443
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Australia
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Phone
12443
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Ph: +61 3 9214 4886
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Fax
12443
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+61 3 9656 3502
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Email
12443
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[email protected]
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Contact person for scientific queries
Name
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Prof Penelope Schofield
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Address
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Swinburne University - Department of Psychological Sciences
School of Health Sciences | Faculty of Health, Arts and Design
PO Box 218, HAWTHORN, VIC 3122 | Internal Mail H24
Department of Cancer Experiences Research
Peter MacCallum Cancer Centre
Locked Bag 1, A'Beckett Street
Victoria, 8006 Australia
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Country
3371
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Australia
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Phone
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+61 3 9214 4886
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Fax
3371
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+61 3 9656 3502
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Email
3371
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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
No additional documents have been identified.
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