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Trial registered on ANZCTR


Registration number
ACTRN12618001264279
Ethics application status
Approved
Date submitted
5/07/2018
Date registered
26/07/2018
Date last updated
26/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A telehealth model for education and monitoring for early lymphoedema detection and shoulder dysfunction in patients after breast cancer surgery: a pilot study
Scientific title
A telehealth model for education and monitoring for early lymphoedema detection and shoulder dysfunction in patients after breast cancer surgery: a pilot study
Secondary ID [1] 295433 0
Nil Known
Universal Trial Number (UTN)
U1111-1216-7288
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 308690 0
Lymphodema 308691 0
Condition category
Condition code
Cancer 307620 307620 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will consist of education and monitoring for early lymphoedema post breast surgery provided and conducted via by Telehealth. The group lymphoedema education session will include information regarding lymphoedema, risk minimisation practices, and progression of post-operative exercises to optimise recovery of shoulder ROM and strength. This session will be approximately one hour. Following the group education session, participants will undertake a 1:1 remote assessment with the physiotherapist, to be scheduled on the same day. This session allows the patient ask questions and raise concerns, includes measurement of shoulder range of motion and an examination of the scar via telemedicine. This section will take 30 minutes. the overall contact will be 1.5 hours. The patients will all be at a similar stage post surgery but the 30 minute session will be individualized as to surgery. Some patients may have had full mastectomies , others excision of lump only.

The session will be a once only session provided in the patient's home via a telehealth link.

It will be an individualized session and will last 1.5 hours.

The telehealth intervention will utilise eHAB® (eHAB), a clinically validated telerehabilitation system whose software platform allows multi-point groups and individual assessments. eHAB has been previously validated for lymphodema measurements and range of joint motion in musculoskeletal assessments.

The session will be provided by senior physiotherapists expert in the management of breast cancer and preventing, detecting and treating lymphodema post breast surgery. It will be scheduled between 4 to 6 weeks post breast surgery.
Intervention code [1] 301742 0
Early detection / Screening
Intervention code [2] 301743 0
Treatment: Other
Comparator / control treatment
Standard care will involve face to face attendance at a group lymphoedema education session (the same content as for the telehealth group) and same-day individual assessment by the senior Breast Clinic physiotherapist at the hospital. This will last for 1.5 hours and will be standardized with the opportunity for patients to ask questions.

The group lymphoedema education session will include information regarding lymphoedema, risk minimisation practices, and progression of post-operative exercises to optimise recovery of shoulder ROM and strength. Following the group education session, participants will undertake a 1:1 face to face assessment with the physiotherapist, to be scheduled on the same day.

The session will be provided by senior physiotherapists expert in the management of breast cancer and preventing, detecting and treating lymphedema post breast surgery. It will be scheduled between 4 to 6 weeks post breast surgery.

The control is considered standard care and they will receive similar information apart from the different method of delivery.
Control group
Active

Outcomes
Primary outcome [1] 306601 0
Attendance rates overall for both sessions
Timepoint [1] 306601 0
7 weeks post breast surgery
Primary outcome [2] 306602 0
Lymphoedema symptoms - Breast Cancer and Lymphedema Symptom Experience Index (BCLE-SEI), symptom occurrence section only
Timepoint [2] 306602 0
3, 5 and 8 months post breast surgery
Primary outcome [3] 306603 0
Shoulder function - quick DASH (disabilities of the arm, shoulder and hand) questionnaire
Timepoint [3] 306603 0
3, 5 and 8 months post breast surgery
Secondary outcome [1] 348978 0
Observation and rating of the scar – The Patient and Observer Scar Assessment Scale (POSAS) patient scale, observer scale
Timepoint [1] 348978 0
3, 5 and 8 months post breast surgery
Secondary outcome [2] 348981 0
Post Breast Cancer Morbidity Screening Tool (MST), lymphoedema short form only
Timepoint [2] 348981 0
3, 5 and 8 months post breast surgery
Secondary outcome [3] 348982 0
Cost analysis diary ie for travel, parking, child care,
Timepoint [3] 348982 0
7weeks post breast surgery
Secondary outcome [4] 348983 0
Technical issues associated with Telehealth (intervention group only)
The patient will be asked for issues associated with their computer or tablet. The possible replies will be coded into
- No technical issues
- Required refresh
- Required exit & recall
- Audio failure
- Visual failure
- Unable to establish viable connection

The clinician conducting the telehealth session will record this information at the end of the session.
Timepoint [4] 348983 0
7 weeks post intervention
Secondary outcome [5] 348984 0
Patient satisfaction questionnaire

This questionaire was designed especially for Telehealth studies we are undertaking in various health conditions. It has not been validated.
Timepoint [5] 348984 0
Post education session - 7 weeks post breast surgery

Eligibility
Key inclusion criteria
Patients included will be male or female, over 18 years, having undergone breast wide local excision or mastectomy and axillary lymph node dissection for breast cancer at Royal Brisbane and Women’s Hospital.

To be eligible to receive the telehealth service, patients must be able to access an Internet-enabled computer device within their own home.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those patients that require an accredited interpreter or have significant visual, hearing or cognitive deficits will be excluded.

Breast cancer surgery patients who have not undergone axillary lymph node dissection will be excluded, as these patients have a low risk for lymphoedema and having not had a drain in situ postoperatively, recover their shoulder movement more easily.

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)
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
Efficacy
Statistical methods / analysis
At present, completion rates for usual care (face-to-face) are 50%. Based on a comparison of completion rates for telehealth and usual care with power of 80% and Type I error rate of 5% and estimating that 80% of patients will compete telehealth, this requires a total of 36 subjects. Based on usual figures during recruitment 9/2018-3/2019, 40 patients will be eligible for the study.

The percentage of patients selecting and completing (attending the education session and completing all assessment items, with the clinician able to adequately assess the patient) the telehealth method will be compared to usual care using a chi-square cross tabs analysis.

Patient demographics, satisfaction and associated costs, along with session length and technical issues will be compared between groups.

BCLE-SEI, MST, POSAS and quickDASH scores and joint ROM will be linear measurements. They will be tested for normality and if appropriate, unpaired t-tests (or equivalent non-parametric statistical methods) will be utilised to compare outcomes between the two patient cohorts.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/09/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 11317 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 23215 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 300020 0
Government body
Name [1] 300020 0
Health Practitioner Research Scheme, Queensland Government
Country [1] 300020 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane & Womens' Hospital
Address
Bowen Bridge Road & Butterfield St,
Herston QLD 4029 QLD
Country
Australia
Secondary sponsor category [1] 299408 0
None
Name [1] 299408 0
Address [1] 299408 0
Country [1] 299408 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300872 0
Human Research Ethics Committee, Royal Brisbane & Womens' Hospital
Ethics committee address [1] 300872 0
Ethics committee country [1] 300872 0
Australia
Date submitted for ethics approval [1] 300872 0
30/04/2018
Approval date [1] 300872 0
04/07/2018
Ethics approval number [1] 300872 0
HREC/18/QRBW/249

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

Contacts
Principal investigator
Name 85110 0
Ms Leonie Naumann
Address 85110 0
Physiotherapy Department
Level 2, Ned Hanlon Building
Royal Brisbane and Women's Hospital
Butterfield Street, Herston, QLD, 4029
Country 85110 0
Australia
Phone 85110 0
61 7 3646 4472
Fax 85110 0
61 7 36461665
Email 85110 0
Leonie.Naumann@health.qld.gov.au
Contact person for public queries
Name 85111 0
Leonie Naumann
Address 85111 0
Physiotherapy Department
Level 2, Ned Hanlon Building
Royal Brisbane and Women's Hospital
Butterfield Street, Herston, QLD, 4029
Country 85111 0
Australia
Phone 85111 0
61 7 3646 4472
Fax 85111 0
61 7 36461665
Email 85111 0
Leonie.Naumann@health.qld.gov.au
Contact person for scientific queries
Name 85112 0
Leonie Naumann
Address 85112 0
Physiotherapy Department
Level 2, Ned Hanlon Building
Royal Brisbane and Women's Hospital
Butterfield Street, Herston, QLD, 4029
Country 85112 0
Australia
Phone 85112 0
61 7 3646 4472
Fax 85112 0
61 7 35461665
Email 85112 0
Leonie.Naumann@health.qld.gov.au

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
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