Trial Review

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
ACTRN12617000705381p
Ethics application status
Submitted, not yet approved
Date submitted
4/05/2017
Date registered
17/05/2017
Date last updated
17/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing physical and/or psychological changes and personal satisfaction in cancer patient’s who attend hydrotherapy as part of their rehabilitation.
Scientific title
Assessing physical and/or psychological changes and personal satisfaction in cancer patient’s who attend hydrotherapy as part of their rehabilitation.
Secondary ID [1] 291857 0
none
Universal Trial Number (UTN)
U1111-1196-2990
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cancer related fatigue 303128 0
Condition category
Condition code
Cancer 302578 302578 0 0
Any cancer
Physical Medicine / Rehabilitation 302617 302617 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
6 week rehabilitation program where patients attend twice a week and have land based exercises of 1 hour, water based exercises of 1 hour and information sessions of 1 hour.
Patients will complete the Depression, Anxiety and Stress Scale, the FACIT Fatigue Scale on admission to the program and on completion, as well as a personal satisfaction survey developed by the researcher.
The researcher has 18 years experience as a registered nurse and 10 years experience working in oncology rehabilitation.
The Exercise Physiologist has 6 years experience.
All exercise sessions are supervised and structured. Patients are assessed by an exercise physiologist prior to commencing to assess the ability of the patient and the exercise program is then prescribed.
The information sessions are face-to-face and are presented by our in house allied health team. Sessions use a variety of mediums, but most are powerpoint presentations or group discussions. The topics covered are the importance of exercise, stress management, pacing yourself, living with a chronic illness, and healthy diet options.
If a patient misses 50% or greater of the hydrotherapy sessions, their outcomes won't be included in this study.
All sessions are group based.
Patients attend twice a week for 2 hours each day, and all sessions are located onsite at St John of God Health Care Frankston Rehabilitation Hospital.
Intervention code [1] 297971 0
Rehabilitation
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301989 0
The FACIT Fatigue Scale will be used to assess change in cancer related fatigue
Timepoint [1] 301989 0
On admission and on discharge, 6 weeks between time points
Secondary outcome [1] 334459 0
Depression, Anxiety and Stress will be assessed at admission (baseline) and compared at discharge 6 weeks later using the Depression, Anxiety and Stress Scale.
This is a composite outcome,
Timepoint [1] 334459 0
on admission and on discharge, 6 weeks between time points
Secondary outcome [2] 334553 0
Changes in fitness using the 6 minute walk test and sit to stand test.
Timepoint [2] 334553 0
on admission and on discharge, 6 weeks between time points
Secondary outcome [3] 334671 0
Assess the enjoyment level of hydrotherapy sessions using the researcher designed hydrotherapy satisfaction survey.
Timepoint [3] 334671 0
This is assessed at discharge only, at the completion of the 6 week program.

Eligibility
Key inclusion criteria
cancer diagnosis
referred for rehabilitation open to either inpatients or outpatients
continent
18 years or older
cognitively intact
a good understanding of english
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
incontinent
younger than 18
unable to understand English
chemotherapy within the last 7 days

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)
allocation not concealed
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
Comparison of pre and post treatment outcomes

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/07/2017
Actual
Date of last participant enrolment
Anticipated
29/06/2018
Actual
Date of last data collection
Anticipated
10/08/2018
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7932 0
St John of God Nepean Rehabilitation Hospital - Frankston
Recruitment postcode(s) [1] 15894 0
3199 - Frankston

Funding & Sponsors
Funding source category [1] 296356 0
Hospital
Name [1] 296356 0
St John of God Health Care - Frankston Rehabilitation Hospital
Country [1] 296356 0
Australia
Funding source category [2] 296422 0
Other Collaborative groups
Name [2] 296422 0
Palliative Care Research Network
Country [2] 296422 0
Australia
Primary sponsor type
Hospital
Name
St John of God Health Care - Frankston Rehabilitation Hospital
Address
255 - 265 Cranbourne Road
Frankston, VIC, 3199
Country
Australia
Secondary sponsor category [1] 295372 0
None
Name [1] 295372 0
Address [1] 295372 0
Country [1] 295372 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 297586 0
St John of God Health Care HREC
Ethics committee address [1] 297586 0
Level 3, St John of God House,
177-179 Cambridge St,
WEMBLEY WA 6014
Ethics committee country [1] 297586 0
Australia
Date submitted for ethics approval [1] 297586 0
08/05/2017
Approval date [1] 297586 0
Ethics approval number [1] 297586 0

Summary
Brief summary
The primary purpose of this trial is to determine cancer patient’s physical and/or psychological changes and personal satisfaction following hydrotherapy rehabilitation.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above, have a cancer diagnosis and have been referred for rehabilitation.

Study details
All study participants will undergo a 6 week rehabilitation program where patients attend twice a week and have land based exercises, water based exercise and information sessions.

Each exercise session is supervised and structured and tailored to suit the ability of the patient. The information sessions are face to face with the opportunity to engage with other patients and the presenter.

It is hoped that this study shows that hydrotherapy is an effective and enjoyable form of rehabilitation for patients who have cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74526 0
Ms Rebecca Nolan
Address 74526 0
St John of God Frankston Rehabilitation Hospital,
255-265 Cranbourne Road,
Frankston, VIC, 3199
Country 74526 0
Australia
Phone 74526 0
+61 3 9788 3275
Fax 74526 0
Email 74526 0
[email protected]
Contact person for public queries
Name 74527 0
Ms Rebecca Nolan
Address 74527 0
St John of God Frankston Rehabilitation Hospital,
255-265 Cranbourne Road,
Frankston, VIC, 3199
Country 74527 0
Australia
Phone 74527 0
+61 3 9788 3275
Fax 74527 0
Email 74527 0
[email protected]
Contact person for scientific queries
Name 74528 0
Ms Rebecca Nolan
Address 74528 0
St John of God Frankston Rehabilitation Hospital,
255-265 Cranbourne Road,
Frankston, VIC, 3199
Country 74528 0
Australia
Phone 74528 0
+61 3 9788 3275
Fax 74528 0
Email 74528 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.