Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000504415
Ethics application status
Approved
Date submitted
25/09/2007
Date registered
4/10/2007
Date last updated
26/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Gynaecology services for women who have had a bone marrow transplant.
Scientific title
An observational study investigating the objective and subjective impact of a structured gynaecology service for women who have undergone allogeneic stem cell transplant.
Secondary ID [1] 253233 0
CEN/07/07/051
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fertility issues around transplantation. 2394 0
Sexuality issues around transplantation. 2395 0
Vaginal Graft versus Host Disease. 2396 0
Condition category
Condition code
Cancer 2497 2497 0 0
Leukaemia - Acute leukaemia
Reproductive Health and Childbirth 2498 2498 0 0
Other reproductive health and childbirth disorders
Cancer 2499 2499 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Nil interventions. It is a questionnaire based study only. The questionnaire asks questions about the information people received about fertility, sexuality and vaginal Graft versus Host Disease (GVHD). It also questions whether women had problems with these issues and whether these problems were effectively resolved. There is only one questionnaire for participants to complete. It will be posted out to eligible women (women who are at least 6 months post transplant). This will take participants 15 - 20 minutes to complete. If the questionnaire is not returned within 4 weeks a reminder post card will be sent out.
Intervention code [1] 2119 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3394 0
To investigate the impact that a transplant specific gynaecology service for women has for women undergoing allogeneic stem cell transplantation in the areas of fertility, sexuality and vaginal graft versus host disease.
Timepoint [1] 3394 0
Study to be completed by 2010.
The study consists of a single questionnaire. I am hoping that the required number of participants will have completed the questionnaire by then and I will be analysing the data and writing up the research.
Secondary outcome [1] 5629 0
Nil
Timepoint [1] 5629 0
Nil

Eligibility
Key inclusion criteria
Women over 16 years of age who have had an allogeneic stem cell transplant greater than six months ago and are able to give written informed consent.
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Male.
Under 16 years of age.
Not able to sign written informed consent.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2010
Actual
8/05/2009
Date of last participant enrolment
Anticipated
Actual
28/09/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
72
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 263 0
3050
Recruitment outside Australia
Country [1] 607 0
New Zealand
State/province [1] 607 0
Wellington

Funding & Sponsors
Funding source category [1] 2647 0
Charities/Societies/Foundations
Name [1] 2647 0
Wellington Division, Cancer Society of New Zealand
Country [1] 2647 0
New Zealand
Primary sponsor type
Individual
Name
Catherine Wood
Address
C/- Wellington Blood and Cancer Centre
Wellington Hospital
Private Bag 7902
Wellington 6242
Country
New Zealand
Secondary sponsor category [1] 2396 0
University
Name [1] 2396 0
University of Otago
Address [1] 2396 0
Division of Health Sciences
P O Box 9054
Dunedin
Country [1] 2396 0
New Zealand
Other collaborator category [1] 53 0
Hospital
Name [1] 53 0
Professor Jeff Szer
Address [1] 53 0
Royal Melbourne Hospital
Grattan Street
Parkville
Melbourne 3050
Country [1] 53 0
Australia
Other collaborator category [2] 54 0
Hospital
Name [2] 54 0
Associate Professor John Carter
Address [2] 54 0
Wellington Blood and Cancer Centre
Wellington Hospital
Private Bag 7902
Wellington 6242
Country [2] 54 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4566 0
Central Regional Ethics Committee
Ethics committee address [1] 4566 0
P O Box 5013
Wellington
Ethics committee country [1] 4566 0
New Zealand
Date submitted for ethics approval [1] 4566 0
09/07/2007
Approval date [1] 4566 0
16/08/2007
Ethics approval number [1] 4566 0
CEN/07/07/051

Summary
Brief summary
Sexuality and fertility concerns confront men and women post allogeneic haematolpoietic stem cell transplant (HSCT). Surviving a transplant is much more likely today due to better supportive care and better medications. Improving the lives of people who have had transplants is increasingly the main focus of ongoing care. Many of the problems that occur after a transplant are related to graft versus host disease (GVHD). GVHD can affect the vagina and is an important post transplant adverse event. This study uses a questionnaire to formally evaluate how a structured gynaecology service for women who have had a transplant assists in the prevention and early treatment of this complication. It will also assess the information needs of women in order that better resources might be made available to women in this area of currently unmet need.
Trial website
Trial related presentations / publications
Nil publications to date.
Public notes

Contacts
Principal investigator
Name 28069 0
Ms Catherine Wood
Address 28069 0
WBCC, Wellington Hospital, Private Bag 7902, Wellington 6242, New Zealand
Country 28069 0
New Zealand
Phone 28069 0
+6448062091
Fax 28069 0
Email 28069 0
[email protected]
Contact person for public queries
Name 11226 0
Ms Catherine Wood
Address 11226 0
Wellington Blood and Cancer Centre
Wellington Hospital
Private Bag 7902
Wellington 6242
Country 11226 0
New Zealand
Phone 11226 0
+ 64 4 806 2091
Fax 11226 0
+ 64 4 385 5843
Email 11226 0
[email protected]
Contact person for scientific queries
Name 2154 0
Ms Catherine Wood
Address 2154 0
Wellington Blood and Cancer Centre
Wellington Hospital
Private Bag 7902
Wellington 6242
Country 2154 0
New Zealand
Phone 2154 0
+ 64 4 806 2091
Fax 2154 0
+ 64 4 385 5843
Email 2154 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.