Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000450213
Ethics application status
Approved
Date submitted
22/05/2009
Date registered
12/06/2009
Date last updated
6/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
THRIVING: A randomised controlled trial assessing the efficacy of exercise versus a complementary therapy on the physical and psychosocial outcomes in haematological cancers post treatment
Scientific title
THRIVING: A randomised controlled trial assessing the efficacy of exercise versus a complementary therapy on physical and psychosocial outcomes in haematological cancers post treatment
Universal Trial Number (UTN)
Trial acronym
THRIVING
Linked study record

Health condition
Health condition(s) or problem(s) studied:
non hodgkins lymphoma 4838 0
myeloma 4839 0
Hodgkins lymphoma 257167 0
Condition category
Condition code
Cancer 237180 237180 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 237181 237181 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 237182 237182 0 0
Myeloma
Cancer 257316 257316 0 0
Hodgkin's

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: 12 weeks best practice exercise (inc aerobic & resistance training, 3 x week, approximately 45min session including weight machines, walking, stationary cycling and rowing ergometry, self-directed sessions fully supervised by an exercise physiologist).
Arm 2 - 12 weeks Bowen Therapy (1 x week approximately 30-45mins: Bowen therapy is a dynamic system of muscle and connective tissue therapy that utilises subtle inputs to the body to stimulate the body to heal itself).
Intervention code [1] 4617 0
Lifestyle
Intervention code [2] 236713 0
Rehabilitation
Comparator / control treatment
12 weeks 'wait-list' Supportive Care - Wait listed for exercise or Bowen intervention whilst being provided with information and advice regarding life after treatment, literature detailing nutritional and healthy lifestyle recommendations, and given the option of participating in supportive care initiatives offered to all patients. All the above is included as part of standard care and will be delivered via seminars, information booklets provided by researchers, email and phone contact.
Control group
Active

Outcomes
Primary outcome [1] 237998 0
Schwartz cancer fatigue scale
Timepoint [1] 237998 0
0 weeks (pre-), 12 weeks (post-), 24 weeks (follow-up)
Primary outcome [2] 237999 0
Aerobic power index (Tri-level fitness test)
Timepoint [2] 237999 0
0 weeks (pre-), 12 weeks (post-), 24 weeks (follow-up)
Primary outcome [3] 238000 0
Quality of life (Functional Assessment of Cancer Therapy-General (FACT-G) and the Medical Outcome Study - 36 item short form (SF-36)
Timepoint [3] 238000 0
0 weeks (pre-), 12 weeks (post-), 24 weeks (follow-up)
Secondary outcome [1] 242132 0
Anxiety and depression (Hospital Anixety and Depression Scale (HADS))
Timepoint [1] 242132 0
0 weeks (pre-), 12 weeks (post-), 24 weeks (follow-up)
Secondary outcome [2] 242133 0
Muscle and Functional strength (5 repetition max (RM) tests, 3m timed up and go)
Timepoint [2] 242133 0
0 weeks (pre-), 12 weeks (post-), 24 weeks (follow-up)
Secondary outcome [3] 242134 0
Body composition (Dual energy x-ray absorptiometry scan (DEXA) - lean mass, fat mass, bone mineral density)
Timepoint [3] 242134 0
0 weeks (pre-), 12 weeks (post-), 24 weeks (follow-up)

Eligibility
Key inclusion criteria
Undergoing or due to complete chemotherapy treatment for a Haematological cancer (Non-Hodgkin's Lymphoma (NHL), Hodgkin's Lymphoma (HL) or myeloma); doctors approval; pass a pre-exercise screening; written consent
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
have pre-existing cardiac disease or uncontrolled hypertension; unable to participate in a 12 week structured program; unable to understand the implications of their participation; currently engaged in a structed exercise or complementary therapy program; have undergone recent surgery which limits their ability to participate in exercise

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Information regarding the study will be distributed throughout hospital wards, cancer care centres, media and the researchers website. Potential participants will be given an information booklet, and invited to a recuitment seminar where all protocols are explained. Once participants give written consent and obtain consent from their doctor they will be scheduled for baseline assessment and then randomly allocated by a computer randomisation program to one of the 4 groups.
The intervention will use a single blind protocol as participants can not be blinded to their treatment allocation. Research assistants will be blinded to the study group, and results until completion of the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A simple randomisation using a computer generated block randomisation, accounting for baseline assessments and gender.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 4997 0
Charities/Societies/Foundations
Name [1] 4997 0
SolarisCare Foundation
Country [1] 4997 0
Australia
Primary sponsor type
University
Name
University of Western Australia (UWA)
Address
School of Sport Science, Exercise & Health
M408, 35 Stirling Hwy
Crawley, WA 6009
Country
Australia
Secondary sponsor category [1] 4518 0
None
Name [1] 4518 0
Address [1] 4518 0
Country [1] 4518 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7099 0
Univesrity of Western Austraila Human research ethics commitee
Ethics committee address [1] 7099 0
M459 35 Stirling Hwy
Crawley, WA 6009
Ethics committee country [1] 7099 0
Australia
Date submitted for ethics approval [1] 7099 0
Approval date [1] 7099 0
26/09/2008
Ethics approval number [1] 7099 0
RA/4/1/2113

Summary
Brief summary
This study assesses the efficacy of exercise versus a complementary therapy on the physical and psychosocial well-being of people who have undergone treatment for haematological malignancies.

Who is it for?
You can join this study if you are undergoing or due to complete treatment for non Hodgkin's lymphoma (NHL), Hodgkin's Lymphoma (HL) or Myeloma.

Participants will be randomly divided into 3 groups. The groups will undertake 12 weeks of either exercise, Bowen therapy (a hands-on technique to enhance healing and relieve pain), or 'Wait-listed' supportive care. Participants will be assessed at 0 weeks (pre-), 12 weeks (mid), 24 weeks (post), and there will be the option of a 12 month follow-up. The study aims to measure key physiological and psychosocial outcomes following treatment including quality of life (QoL), anxiety, depression, fatigue, body composition, aerobic fitness and strength.
Trial website
www.solariscare.com.au - follow links to research 'Thriving' study
www.sseh.uwa.edu.au - follow links to research/thriving study
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29634 0
Address 29634 0
Country 29634 0
Phone 29634 0
Fax 29634 0
Email 29634 0
Contact person for public queries
Name 12881 0
Bonnie Furzer
Address 12881 0
School of Sport Science, Exercise & Health
M408, 35 Stirling Hwy
Crawley, WA 6009
Country 12881 0
Australia
Phone 12881 0
+61 8 6488 1383
Fax 12881 0
Email 12881 0
[email protected]
Contact person for scientific queries
Name 3809 0
Bonnie Furzer
Address 3809 0
School of Sport Science, Exercise & Health
M408, 35 Stirling Hwy
Crawley, WA 6009
Country 3809 0
Australia
Phone 3809 0
+61 8 6488 1383
Fax 3809 0
Email 3809 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
SourceTitleYear of PublicationDOI
EmbaseA randomised controlled trial comparing the effects of a 12-week supervised exercise versus usual care on outcomes in haematological cancer patients.2016https://dx.doi.org/10.1007/s00520-015-2955-7
EmbaseExercise and cancer survivorship.2015
N.B. These documents automatically identified may not have been verified by the study sponsor.