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Trial registered on ANZCTR


Registration number
ACTRN12615000570583
Ethics application status
Approved
Date submitted
24/03/2015
Date registered
2/06/2015
Date last updated
22/11/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised trial of Telehealth intervention for patient’s post-Hematopoietic Stem Cell Transplant (post-HSCT)
Scientific title
Effectiveness of a telehealth programme of combined physical and psychological training in patients following Hematopoietic Stem Cell Transplant (HSCT) on quality of life improvement: a randomised trial
Secondary ID [1] 286402 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blood Cancer
294558 0
Condition category
Condition code
Blood 294866 294866 0 0
Haematological diseases
Physical Medicine / Rehabilitation 294931 294931 0 0
Other physical medicine / rehabilitation
Mental Health 294932 294932 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will participate in a half-day (2.5-3 hours) face-to-face orientation session, including familiarisation with their program materials, procedures, and requirements. Intervention subjects will have the same half-day orientation with the addition of education into the training program and its associated materials. This session will also involve patients completing a number of written and physical assessments to obtain a baseline assessment. These include:
*Anthropometric measures (BMI & waist circumference), 6-Minute Walk test, 1km Walk Test, Grip Strength Measurement, Sit-to- stand Test (STS), International Physical Activity Questionnaire (IPAQ).
*HADS, DASS-21, Pittsburgh Sleep Quality Index, Godin-Shephard Leisure Time index, Functional Assessment of Cancer Therapy (FACT)-BMT, Functional Assessment of Cancer Therapy- Fatigue (FACT-F), Karnofsky Performance Scale, Health Resource Utilization form, EQ-5D-5L.



Intervention arm:
For patients randomised to the intervention group, they will be given an orientation session, internet-based training and have reinforcement sessions.
The orientation session will involve an introduction to mindfulness-based stress reduction (MBSR) and exercise techniques. Baseline physical and psychological measures will be conducted during this session. Trial materials including a CD or USB with voice-recordings of guided mindfulness tracks for MBSR skill practice, and resistance bands for exercise practice, will be provided. A training and information booklet that includes information on skills, exercises, assessments and goals, practice logs, and appointment schedules will be supplied.

Internet-based Training: Each patient will undergo 6 weekly one-to-one sessions with each of the exercise and stress management trainers via the internet (through Skype), for approximately 1hr. Training sessions will be conducted with appropriately trained staff members, such as a psychologist, and an exercise physiologist.
During the stress management sessions, common manifestations of anxiety and current cognitive and behavioural coping methods, and the use of stress management techniques to improve well-being will be discussed. Following MBSR methods, participants will be trained in grounding and mindfulness strategies, and a guided mindfulness practice may be included in each session. Training will be individualised to the patient, depending on their skill level and needs.
The exercise training will be comprised of moderate to high intensity aerobic and resistance exercises and stretching. The target during cardio-vascular exercise is to reach 50-75% of predicted heart rate reserve, and resistance/strength training with the target of 65–80% of one-repetition maximum (1-RM) as defined by the Rating of Perceived Exertion (RPE) scale (aiming to train at moderate-to-high intensities: between ratings of 11 and 15 on the RPE). Training will be adapted to the participant’s initial fitness level, and gradually increase in intensity and duration.
For both exercise and stress management skill practice, patients will complete training logs in order to keep track of their progress, and will be provided with recommendations for regular practice, during and at the end of the supervised training period.

Reinforcement Phase for Intervention arm: Commencing at 3 months post the internet based training period, patients will have a monthly Skype appointment with a trainer/s for three months. This aims to strengthen behavioural change in the long-term using methods found to facilitate long-term behavioural change by identifying values-based goals and attempting to resolve ambivalence and using motivational interviewing techniques. These techniques have been found to have sustained efficacy in promoting health behaviours in a cost effective manner. Patients will be reminded of their initial goals (GAS/ SMART goals), discussing adherence using a training diary, structured problem solving and value-based goal setting, to increase their abilities to meet their training goals. Setting SMART goals and a goal attainment scale (GAS) will also function as an objective end point measurement. Sustainability of outcomes will be assessed at 12 and 18 months after the supervised training period.
Intervention code [1] 291473 0
Rehabilitation
Intervention code [2] 291534 0
Treatment: Other
Intervention code [3] 291535 0
Behaviour
Comparator / control treatment
Standard Care arm:
Patients randomised into the standard care arm will continue to have their regular follow-ups with their treating specialist. If their specialists deem necessary, or if the assessments show a need, the patient will be referred to the appropriate allied health services. An information booklet will be provided with information on standard care and assessments, contacts and appointment schedules.
Control group
Active

Outcomes
Primary outcome [1] 294616 0
To determine if an Internet-based supervised physical and psychological exercise programme with post-training reinforcement will improve physical fitness at 3 months post-intervention compared to standard care post-HSCT.
This will be assessed through the 6minute walk test, Sit to stand test and grip strength test.
Timepoint [1] 294616 0
3months
Secondary outcome [1] 313722 0
To evaluate the composite effect of the programme on measures of quality of life (QOL), at 6 and 12 months post-intervention.
This will be assessed through the questionnaires HADS, DASS-21, Pittsburgh Sleep Quality Index, Godin-Shephard Leisure Time index, Functional Assessment of Cancer Therapy (FACT)-BMT, Functional Assessment of Cancer Therapy- Fatigue (FACT-F), Karnofsky Performance Scale

Timepoint [1] 313722 0
6 and 12 months
Secondary outcome [2] 313867 0
To evaluate the composite health outcomes of the program of allogeneic compared to autologous HSCT recipients, assessed through the questionnaires HADS, DASS-21, Pittsburgh Sleep Quality Index, Godin-Shephard Leisure Time index, Functional Assessment of Cancer Therapy (FACT)-BMT, Functional Assessment of Cancer Therapy- Fatigue (FACT-F), Karnofsky Performance Scale. Also through the physical measures of the 6minute walk test, Sit to stand test, grip strength test and anthropometric measures (BMI & waist circumference).
Timepoint [2] 313867 0
6 and 12 months post-intervention
Secondary outcome [3] 315054 0
To evaluate the composite effect of the program on functional and psychological wellbeing at 6 and 12 months post-intervention
This will be assessed through the questionnaires HADS, DASS-21, Pittsburgh Sleep Quality Index, Godin-Shephard Leisure Time index, Functional Assessment of Cancer Therapy (FACT)-BMT, Functional Assessment of Cancer Therapy- Fatigue (FACT-F), Karnofsky Performance Scale
Timepoint [3] 315054 0
6 and 12 months
Secondary outcome [4] 315055 0
To ascertain the impact of the training programme on the protein and gene expression levels of response biomarkers such as neuroendocrine hormones, inflammatory cytokines
Timepoint [4] 315055 0
3, 12 and 18 months

Eligibility
Key inclusion criteria
Had an Allogeneic or Autologous Haematological Stem Cell Transplant
- Male or Female
- Age range: 18 to 75
- Patient is at least 6 months post-transplant.
- Willingness to give written informed consent and willingness to participate in, and comply with the study.
- Possesses and is able to use a computer or a tablet with Internet connection
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient has severe Graft Versus Host Disease or other medical issues that require regular clinic visits
- Patient has physical or mental impediments which renders them unable to carry out the programs or assessment tasks,
- Patient has cardiac disease including arrhythmia
- Patient is deemed unfit for this study by the patient’s haematologist.
- Participants who fall in the severe or extremely severe range on psychological screening measures of anxiety and depression
- Participants with a history of a psychological illness or other condition which may interfere with their ability or limit their capacity to understand the requirements of the study.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be assessed for suitability, including consultation with the patient’s haematologist, and the completion of screening measures. Review of all the completed screening questionnaires will be done at the lead site. If deemed eligible, they will then be invited to participate. Once patients have been identified and the study has been discussed, they will sign a Participant Information Sheet and consent form.
Subjects will be randomized 1:1 to the intervention group and control group (standard care post-HSCT).
Allocation will be concealed by central randomisation through a computer program
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
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] 3601 0
St Vincent's Private Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [2] 3602 0
Westmead Hospital - Westmead
Recruitment hospital [3] 3603 0
Royal North Shore Hospital - St Leonards

Funding & Sponsors
Funding source category [1] 290971 0
Charities/Societies/Foundations
Name [1] 290971 0
Arrow Foundation
Address [1] 290971 0
16 Leichhardt Street, Darlinghurst NSW 2010
Country [1] 290971 0
Australia
Primary sponsor type
Hospital
Name
St Vincents
Address
370 Victoria St, Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 289699 0
Hospital
Name [1] 289699 0
Westmead Adult Hospital
Address [1] 289699 0
Crown Princess Mary Cancer Centre Westmead Hospital, level 1 Hawkesbury Rd, Westmead, NSW 2145
Country [1] 289699 0
Australia
Secondary sponsor category [2] 289700 0
Hospital
Name [2] 289700 0
Royal North Shore
Address [2] 289700 0
Reserve Road, St Leonards NSW 2065
Country [2] 289700 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292566 0
St Vincents
Ethics committee address [1] 292566 0
370 Victoria St
Darlinghurst NSW 2010
Ethics committee country [1] 292566 0
Australia
Date submitted for ethics approval [1] 292566 0
30/03/2015
Approval date [1] 292566 0
08/05/2015
Ethics approval number [1] 292566 0
HREC/15/SVH/104

Summary
Brief summary
There is a lack of expert health services for transplant survivors outside the capitals. Various approaches can be utilised to overcome some of these issues. The current solutions include regular dispatch of healthcare professionals to rural centres and ad hoc phone enquiries/consultations. There are a number of difficulties with this, so a pilot study was conducted to see the effectiveness of a health service delivered by qualified staff to improve the patient’s physical and mental wellbeing through web-based technology. The pilot study showed some positive results, and thus we are now proposing this randomised control trial, to be able to compare the difference between standard care and this intervention over time. The use of a standard care control group as a comparison is particularly important, as post-transplant patients will gradually improve over time.
The hypothesis is that delivery of home based health services i.e. supervised exercise and stress management with reinforcement strategy via multi-media technology will improve QOL and functional outcomes of patients following HSCT compared to standard care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55982 0
Prof David Ma
Address 55982 0
St Vincent's Hospital
370 Victoria St
Darlinghurst NSW
2010
Country 55982 0
Australia
Phone 55982 0
+61 2 9355 5656
Fax 55982 0
Email 55982 0
svhcancer_research@stvincents.com.au
Contact person for public queries
Name 55983 0
Ms Kimberley Au
Address 55983 0
The Kinghorn Cancer Centre
L6 370 Victoria St
Darlinghurst NSW 2010
Country 55983 0
Australia
Phone 55983 0
+61 2 93555703
Fax 55983 0
Email 55983 0
svhcancer_research@stvincents.com.au
Contact person for scientific queries
Name 55984 0
Prof David Ma
Address 55984 0
St Vincent's Hospital
370 Victoria St
Darlinghurst NSW
2010
Country 55984 0
Australia
Phone 55984 0
+61 2 9355 5656
Fax 55984 0
Email 55984 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