Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000172202
Ethics application status
Approved
Date submitted
22/01/2018
Date registered
2/02/2018
Date last updated
28/01/2020
Date data sharing statement initially provided
28/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Haem-Fit: Exercise and Wellness Program for Haematology Cancer patients
Scientific title
Haem-Fit: A 3 month intervention trial to assess patient adherence and maintenance of muscle mass by implementing an exercise and wellness program for haematology cancer patients in hospital for 7 days or more
Secondary ID [1] 293817 0
none
Universal Trial Number (UTN)
U1111-1208-0385
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
haematological cancers 306232 0
physical deconditioning 306233 0
stress and anxiety 306235 0
physical inactivity 306236 0
loss of muscle mass 306237 0
Condition category
Condition code
Cancer 305335 305335 0 0
Leukaemia - Acute leukaemia
Cancer 305336 305336 0 0
Leukaemia - Chronic leukaemia
Cancer 305337 305337 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 305338 305338 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 305426 305426 0 0
Myeloma
Cancer 305427 305427 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participant will be assessed by a physiotherapist (face to face) and provided with an exercise program. This initial assessment will take approximately 30-60 minutes depending on patient needs, but it will not be time restricted. Each patient will be provided with an exercise routine of 10-15 minutes duration that combines simple exercises for maintaining strength and balance and is tailored to their personal fitness levels and health circumstances.. They will be expected to perform the routine at least once per day, plus additional time (at least 10 minutes) walking. The level of intensity should be about 3-4 (slight shortness of breath) on the 10 point modified Borg Scale. Tailored exercises will be necessary to account for patients with central or PICC lines, receiving chemotherapy, or suffering low blood counts. Five different alternating exercises will be prescribed to be preformed at least once daily while in hospital. Ward nurses will be trained to assist with monitoring correct performance of the exercises. Subsequent referral to a physiotherapist can be made at any time as per normal standard of care. Each participant will also be given written information on diet, nutrition, and exercise. These resources have been specifically designed for the study and will not be made available to non-study participants. Participants will be asked to keep a diary to assess adherence.
Intervention code [1] 300083 0
Prevention
Intervention code [2] 300084 0
Lifestyle
Intervention code [3] 300085 0
Behaviour
Comparator / control treatment
A survey of haematology in-patients was conducted at the Calvary Mater Newcastle in NSW over a 12 week period from Aug – Oct, 2017. All patients admitted with a haematological malignancy and an anticipated length of stay of at least 7 days were eligible. 19 participants were recruited and completed impedance measurements using InBody570, Hospital and Anxiety Depression Scale and a Quality of Life Questionnaire survey on admission and discharge. All participants received current standard of care without addition of a structured exercise program.
Control group
Historical

Outcomes
Primary outcome [1] 304498 0
Rate of patient adherence (patient diaries)
% of exercises attempted (out of 5 per day x days in hospital) and number of days exercised (out of total in hospital days)
Timepoint [1] 304498 0
at discharge
Primary outcome [2] 304499 0
change in muscle mass using impedance measurement (InBody570)
Timepoint [2] 304499 0
at discharge
Secondary outcome [1] 342157 0
patient satisfaction by phone interview. Participants will be asked a series of 12 yes/no questions and encouraged to give additional feedback on why/why not.
Timepoint [1] 342157 0
1 week post discharge
Secondary outcome [2] 342389 0
staff satisfaction by paper questionnaire which was designed specifically for this study. Staff will be given a set of 10 statements and asked to rate their agreement from 1-5 with 1 being 'strongly agree' and 5 being 'strongly disagree'.
Timepoint [2] 342389 0
end of accrual

Eligibility
Key inclusion criteria
all hematology cancer patient admissions with 7 or more days anticipated length of stay
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• People with artificial electrical implants such as a defibrillator or pacemaker will be excluded due to inability to undergo impedance bodycomposition testing
• Inability to communicate in English

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
Completed
Date of first participant enrolment
Anticipated
5/02/2018
Actual
27/02/2018
Date of last participant enrolment
Anticipated
Actual
22/05/2018
Date of last data collection
Anticipated
Actual
15/06/2018
Sample size
Target
20
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9835 0
Calvary Mater Newcastle - Waratah
Recruitment postcode(s) [1] 18613 0
2298 - Waratah

Funding & Sponsors
Funding source category [1] 298431 0
Other
Name [1] 298431 0
Hunter Cancer Research Alliance
Country [1] 298431 0
Australia
Primary sponsor type
Hospital
Name
Calvary MAter Newcastle Hunter Haematology Unit
Address
Calvary Mater Newcastle
Edith St
Waratah
NSW 2298
Country
Australia
Secondary sponsor category [1] 297573 0
Hospital
Name [1] 297573 0
Calvary Mater Newcastle Physiotherapy department
Address [1] 297573 0
Calvary Mater Newcastle
Edith St
Waratah
NSW 2298
Country [1] 297573 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299427 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 299427 0
Ethics committee country [1] 299427 0
Australia
Date submitted for ethics approval [1] 299427 0
30/11/2017
Approval date [1] 299427 0
01/02/2018
Ethics approval number [1] 299427 0
17/12/13/5.15

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2409 2409 0 0
/AnzctrAttachments/374327-1712135.15 Ongoing LNR Approval Single-Site Under 12mths.pdf (Ethics approval)
Attachments [2] 2410 2410 0 0
/AnzctrAttachments/374327-1712135.15 CMN Governance Authorisation Letter.pdf (Other)

Contacts
Principal investigator
Name 80366 0
Prof Philip Rowlings
Address 80366 0
Hunter Haematology Unit
Calvary Mater Newcastle
Edith St
Waratah
NSW 2298
Country 80366 0
Australia
Phone 80366 0
+61 2 40143027
Fax 80366 0
+61 2 49602136
Email 80366 0
[email protected]
Contact person for public queries
Name 80367 0
Casey Hutchinson
Address 80367 0
Hunter Haematology Unit
Calvary Mater Newcastle
Edith St
Waratah
NSW 2298
Country 80367 0
Australia
Phone 80367 0
+61 2 40143087
Fax 80367 0
+61 2 49602136
Email 80367 0
[email protected]
Contact person for scientific queries
Name 80368 0
Lisa Lincz
Address 80368 0
Hunter Haematology Research Group
Calvary Mater Newcastle
Edith St
Waratah
NSW 2298
Country 80368 0
Australia
Phone 80368 0
+61 2 40143049
Fax 80368 0
+61 2 49602136
Email 80368 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6625Informed consent form    374327-(Uploaded-17-01-2020-10-19-33)-Study-related document.doc
6626Ethical approval    374327-(Uploaded-17-01-2020-10-20-20)-Study-related document.pdf
6627Study protocol  [email protected]



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.