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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613001054707
Ethics application status
Approved
Date submitted
25/02/2013
Date registered
23/09/2013
Date last updated
8/12/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
An innovative home-based internet health service project to improve outcomes for Haematopoietic Stem Cell Transplant survivors
Scientific title
An innovative home-based exercise and stress management program to improve outcomes for Haematopoietic Stem Cell Transplant survivors using the internet
Secondary ID [1] 282003 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allogeneic Haematopoietic Stem Cell Transplant patients 288439 0
Condition category
Condition code
Blood 288787 288787 0 0
Haematological diseases
Inflammatory and Immune System 288788 288788 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Supervised home based training sessions on exercise and stress management techniques will be conducted over 4-6 weeks by a trained physiotherapist and psychologist using the internet. The exact number of sessions will be determined by ongoing individual needs.
The Proposed exercise intervention will be supervised home based training for aerobic and resistance exercises with stretching and resistance/strength training. The programme includes a goal attainment scale (GAS) to aid adherence and as an objective end point measurement.
Patients will be given recommendations for daily practice. The initial consultation includes 6 minute walk test. Following the initial consultation, 3-4 reinforcement sessions will be conducted over 4-6 weeks, duration of each session maybe between 15 -30 mins. This will be followed by assessment at end of the training period and then at 3, 6, and 12 months after the training sessions.
All participants will undergo an initial 1 hour face-to-face assessment session conducted by a Clinical Psychologist to screen for psychosocial risk factors and levels of anxiety and depression. All patients will complete a 1.5 hour psycho-education session with a psychologist that will include a discussion and training in general stress management techniques as well as provision of written materials on stress management strategies and audio recordings of the relaxation technique . All sessions will be one on one, and face to face using the internet.
Participants will undergo live training over the internet using Skype with the physiotherapist and psychologist.
The recommended Australian immunisation guidelines following HSCT will be used to check participants' medical records for evidence of post-transplant vaccination. Vaccination status will also be assessed using serology (on blood tests) to specified pathogens at baseline. Any deficiencies in vaccination will be addressed with re-immunisation.
Intervention code [1] 286574 0
Rehabilitation
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288928 0
Examine the feasibility of delivering exercise, psychological and re-vaccination programmes to patients at home utilising telecommunication technology, assessed clinically and by ongoing reviews of programme. Assessment is done by both patient and staff on how compliant the patient is during the study- How many continue the programme, drop out of the programme.
Timepoint [1] 288928 0
Assessment at end of the training period and then at 3, 6, and 12 months
Primary outcome [2] 288929 0
Examine the feasibility of web-based and self-assessment tools and supervision of these programmes using telecommunication technology, assessed clinically and on an individual patient basis. After the initial training period, the participant will provide information on whether the programs were useful to them, changed their habits, and wether the methods of program delivery were appropriate using 5-point Likert Scales and open responses.
Timepoint [2] 288929 0
assessment at end of the training period only
Secondary outcome [1] 301376 0
Evaluate the outcome of these programmes in regards to their acceptability, utility and benefits. This will be assessed using standardised assessment tool, 6-minute walk test.
Timepoint [1] 301376 0
Assessment at end of the training period and then at 3, 6, and 12 months
Secondary outcome [2] 301926 0
Evaluate the outcome of these programmes in regards to their acceptability, utility and benefits. This will be assessed using standardised assessment tool - Goal Attainment Scale,
Timepoint [2] 301926 0
Assessment at end of the training period and then at 3, 6, and 12 months
Secondary outcome [3] 301927 0
Evaluate the outcome of these programmes in regards to their acceptability, utility and benefits. This will be assessed using standardised assessment tools including: Hospital Anxiety and Depression Scale (HADS)
Timepoint [3] 301927 0
Assessment at end of the training period and then at 3, 6, and 12 months
Secondary outcome [4] 301928 0
Evaluate the outcome of these programmes in regards to their acceptability, utility and benefits. This will be assessed using standardised assessment tool, Rating of Perceived Exertion. The patient rates their perceived rate of exertion at each timepoint, basic assessment ratingsuch as easy or hard the level of activity was, this is giving a rating and monitored/compared to the previuos / baseline level.
Timepoint [4] 301928 0
Assessment at end of the training period and then at 3, 6, and 12 months
Secondary outcome [5] 301929 0
Evaluate the outcome of these programmes in regards to their acceptability, utility and benefits. This will be assessed using standardised assessment tool, Karnofsky Scale
Timepoint [5] 301929 0
Assessment at end of the training period and then at 3, 6, and 12 months

Eligibility
Key inclusion criteria
Allogeneic HSCT patients, > 6 months post-transplant with no severe GVHD or other medical issues that requires regular clinic visits, no physical or mental impediments to carry out the programmes or assessment tasks,
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
has cardiac disease including arrhythmia,living alone and not approved by the patient’s haematologist.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
open label
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)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 640 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 6373 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 286781 0
Charities/Societies/Foundations
Name [1] 286781 0
ARROW Foundation
Address [1] 286781 0
16 Leichhardt St, Darlinghurst, NSW 2010
Country [1] 286781 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital, Sydney
Address
390 Victoria St
Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 285564 0
None
Name [1] 285564 0
Address [1] 285564 0
Country [1] 285564 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288846 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 288846 0
St Vincent'sHospital, Sydney
390 Victoria St
Darlinghurst NSW 2010
Ethics committee country [1] 288846 0
Australia
Date submitted for ethics approval [1] 288846 0
30/08/2012
Approval date [1] 288846 0
05/10/2012
Ethics approval number [1] 288846 0
LNR/12/SVH/240

Summary
Brief summary
Patients will be assessed for suitability for this study and then invited to participate. All participants will then undergo an initial face-to-face session by the investigators on matters related to methodology and technical requirements on conducting home-based internet programmes on exercise and stress management techniques. Following this initial session, supervised home based training sessions will be conducted over 4-6 weeks. This will be followed by assessment at end of the training period and then at 3, 6, and 12 months after the training sessions. .
Trial website
Trial related presentations / publications
No publications were done, A funding report was provided to Arrow Foundation
Public notes

Contacts
Principal investigator
Name 38046 0
Prof David Ma
Address 38046 0
Kinghorn Cancer Centre
St Vincent'sHospital, Sydney
370 Victoria St
Darlinghurst NSW 2010
Country 38046 0
Australia
Phone 38046 0
6 12 9355 5656
Fax 38046 0
61 2 9355 5735
Email 38046 0
svhcancer_research@stvincents.com.au
Contact person for public queries
Name 38047 0
Ms Patricia Plenge
Address 38047 0
Kinghorn Cancer Centre
St Vincent'sHospital, Sydney
370 Victoria St
Darlinghurst NSW 2010
Country 38047 0
Australia
Phone 38047 0
6 12 9355 5656
Fax 38047 0
61 2 9355 5735
Email 38047 0
svhcancer_research@stvincents.com.au
Contact person for scientific queries
Name 38048 0
Prof David Ma
Address 38048 0
Kinghorn Cancer Centre
St Vincent'sHospital, Sydney
370 Victoria St
Darlinghurst NSW 2010
Country 38048 0
Australia
Phone 38048 0
6 12 9355 5656
Fax 38048 0
61 2 9355 5735
Email 38048 0
svhcancer_research@stvincents.com.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary