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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
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?
Secondary ID [1] 288584 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gynaecological cancer 4208 0
Condition category
Condition code
Cancer 4419 4419 0 0
Womb (Uterine or endometrial cancer)
Cancer 4420 4420 0 0
Ovarian and primary peritoneal
Cancer 4421 4421 0 0
Cervical (cervix)

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 3921 0
Treatment: Other
Comparator / control treatment
usual care (weekly nursing consultations of approximately 20 minutes duration throughout treatment) over approximately 7 weeks.
Control group
Active

Outcomes
Primary outcome [1] 5304 0
Psychological distress (HADS - Hospital Anxiety & Depression Scale).
Timepoint [1] 5304 0
Pre-treatment, first day of treatment, 4 wks post-treatment, 6 & 12 months post-treatment.
Secondary outcome [1] 8924 0
informational and psychological supportive care needs (Supportive Care Needs Survey (SCNS)).
Timepoint [1] 8924 0
Pre-treatment, 4 wks post-treatment.
Secondary outcome [2] 8925 0
MSAS-SF (Memorial symptom Assessment scale - short form)
Timepoint [2] 8925 0
Pre-treatment, 4 wks post-treatment.
Secondary outcome [3] 8926 0
SVQ - sexual function and vaginal changes questionnaire.
Timepoint [3] 8926 0
Pre-treatment, 6 & 12 months post-treatment.
Secondary outcome [4] 321001 0
CaTS - Cancer Treatment Survey.
Timepoint [4] 321001 0
Pre-treatment, first day of treatment, 4-wks post-treatment.
Secondary outcome [5] 321002 0
Adherence Questionnaire - Patient self-report adherence to recommendations for dilator use are assessed using this custom-made scale.
Timepoint [5] 321002 0
4-wks, 6 & 12 months post-treatment.

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are a severe psychiatric or cognitive disorder; treatment with palliative intent; or previous treatment with radiotherapy.

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)
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.
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.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2010
Actual
21/01/2010
Date of last participant enrolment
Anticipated
Actual
20/04/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 4388 0
Government body
Name [1] 4388 0
Cancer Australia
Country [1] 4388 0
Australia
Funding source category [2] 292932 0
Charities/Societies/Foundations
Name [2] 292932 0
Beyond Blue
Country [2] 292932 0
Australia
Primary sponsor type
Individual
Name
Prof Penelope Schofield
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
Country
Australia
Secondary sponsor category [1] 4474 0
None
Name [1] 4474 0
Address [1] 4474 0
Country [1] 4474 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6436 0
Peter MacCallum cancer centre HREC
Ethics committee address [1] 6436 0
10 St Andrews Pl
East Melbourne
Vic 3002
Ethics committee country [1] 6436 0
Australia
Date submitted for ethics approval [1] 6436 0
19/03/2009
Approval date [1] 6436 0
19/05/2009
Ethics approval number [1] 6436 0
09/07

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.
Trial website
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.
Public notes

Contacts
Principal investigator
Name 35096 0
Prof Penelope Schofield
Address 35096 0
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
Country 35096 0
Australia
Phone 35096 0
+61 3 9214 4886
Fax 35096 0
Email 35096 0
[email protected]
Contact person for public queries
Name 12443 0
Penelope Schofield
Address 12443 0
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
Country 12443 0
Australia
Phone 12443 0
Ph: +61 3 9214 4886
Fax 12443 0
+61 3 9656 3502
Email 12443 0
[email protected]
Contact person for scientific queries
Name 3371 0
Penelope Schofield
Address 3371 0
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
Country 3371 0
Australia
Phone 3371 0
+61 3 9214 4886
Fax 3371 0
+61 3 9656 3502
Email 3371 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

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