Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000349347
Ethics application status
Not yet submitted
Date submitted
25/06/2008
Date registered
23/07/2008
Date last updated
23/07/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Survivorship Clinic for Hodgkin's Lymphoma Survivors
Scientific title
Survivorship Clinic for Hodgkin's Lymphoma Survivors to monitor the 'late effects' of curative treatment.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
second maligancies 3308 0
cardiovascular problems 3309 0
hypothyroidism 3310 0
fertility issues 3311 0
pulmonary impairment 3312 0
psychological issues 3313 0
Condition category
Condition code
Cancer 3471 3471 0 0
Breast
Cancer 3472 3472 0 0
Lung - Non small cell
Cardiovascular 3473 3473 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants who are five years or more disease-free following curative treatment for Hodgkin's Lymphoma (also known as Hodgkin's Disease) will be invited to attend a specialized Survivor's Clinic. The Clinic will deliver a complete health review to monitor for complications resulting from the curative treatment. Second malignancies and cardiovascular complications are the two most serious resulting problems of the curative treatment; thyroid, pulmonary and fertility problems are also reported. Through lifestyle advice and checks appropriate to the particular treatment received early detection can prevent the development and/or the severity of such complications, known also as 'late effects'. This is the purpose of the Survivorship Clinic.
1.teaching breast self-examination techniques - the nurse will give a pamphlet describing the technique and will go through it with the survivor - 15 minutes required, one session.
2. Mammograms - yearly for life from the age of 40 or if family history of breast cancer or if received mantle field radiotherapy as part of curative treatment.
3. Smoking cessation nurse to advise particular problems with smoking and then to refer to GP if help required to quit. 15 minutes to ascertain smoking habit and appropriate course of action ie. referral to GP. Smoking habits to be addressed at every yearly review.
4. Computed tomography of chest yearly where indicated ie if mantle field radiotherapy given as curative treatment.
5 .Echocardiogram - an ultrasound scan of the heart to check its efficiency. To be carried out yearly if mantle field radiotherapy was given as curative treatment.
6. All of these interventions will be carried out at least yearly for the rest of these individuals lives.
Intervention code [1] 3083 0
Early detection / Screening
Comparator / control treatment
There is no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4375 0
to detect early signs of malignancies by physical examination and questioning individuals about their health and family history.
Timepoint [1] 4375 0
at first appointment in Survivorship Clinic and yearly following the clinic commencing - on-going for patients' life.
Secondary outcome [1] 7589 0
to detect early signs of cardiovascular problems. by performing an echocardiogram and questioning individuals about their health, lifestyle and family history
Timepoint [1] 7589 0
at first appointment in Survivorship Clinic and yearly following the clinic commencing - ongoing for life.
Secondary outcome [2] 7590 0
to detect early signs of thyroid function problems, by blood tests measuring thyroid function.
Timepoint [2] 7590 0
at first appointment in Survivorship Clinic and yearly following the clinic commencing - on-going for life

Eligibility
Key inclusion criteria
All 5-year survivors of Hodgkin's Lymphoma (HL) treated and The Queen Elizabeth Hospital, SA. Later to include all 5-year survivors of HL treated at The Royal Adelaide Hospital, SA.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
There are no exclusion criteria - ALL Hodgkin's Lymphoma survivors (5 years or more disease-free) will be eligible.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 919 0
5011

Funding & Sponsors
Funding source category [1] 3516 0
Other Collaborative groups
Name [1] 3516 0
Haem/Onc Department Private Doctor's Fund, The Queen Elizabeth Hospital
Country [1] 3516 0
Australia
Funding source category [2] 3542 0
Hospital
Name [2] 3542 0
The Queen Elizabeth Hospital
Country [2] 3542 0
Australia
Primary sponsor type
Individual
Name
Dr Uwe Hahn
Address
The Queen Elizabeth Hospital,
28 Woodville Road,
Woodville South
SA 5011
Country
Australia
Secondary sponsor category [1] 3156 0
Individual
Name [1] 3156 0
Alison Keenan RN
Address [1] 3156 0
28 Woodville Road
The Queen Elizabeth Hospital,
28 Woodville Road,
Woodville South
SA5011
Country [1] 3156 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 5553 0
Ethics committee address [1] 5553 0
Ethics committee country [1] 5553 0
Date submitted for ethics approval [1] 5553 0
25/06/2008
Approval date [1] 5553 0
Ethics approval number [1] 5553 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28699 0
Address 28699 0
Country 28699 0
Phone 28699 0
Fax 28699 0
Email 28699 0
Contact person for public queries
Name 11856 0
Alison Keenan
Address 11856 0
28 Woodville Road
Woodville South
SA 5011
Country 11856 0
Australia
Phone 11856 0
061 8 8222 6632
Fax 11856 0
Email 11856 0
[email protected]
Contact person for scientific queries
Name 2784 0
Dr Uwe Hahan
Address 2784 0
28 Woodville Road
Woodville South
SA 5011
Country 2784 0
Australia
Phone 2784 0
061 8 8222 6826
Fax 2784 0
061 8 8222 6046
Email 2784 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.