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Trial registered on ANZCTR


Registration number
ACTRN12609000450213
Ethics application status
Yes
Date submitted
22/05/2009
Date registered
12/06/2009
Date last updated

Titles & IDs
Public title
A randomised controlled trial assessing the efficacy of exercise versus a complementary therapy on physical and psychosocial outcomes in lymphoma and myeloma patients post chemotherapy
Scientific title
A randomised controlled trial assessing the efficacy of exercise versus a complementary therapy on physical and psychosocial outcomes in lymphoma and myeloma patients post chemotherapy
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
12 weeks aerobic exericse (supervised outdoor or treadmil walking, 3 x week, 20-45 min per session), 12 weeks progressive resistance training (supervised, 3 x week, program should take 20-45min to complete), 12 weeks Bowen therapy (1 x week, 30-60mins). 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 Usual Care - ‘Usual care’ in a Non-Hodgkins lymphoma or myeloma population typically includes receiving information and advice regarding life after treatment, literature detailing nutritional and healthy lifestyle recommendations, follow ups with health professionals and access to complementary services i.e. Solaris Care, Cancer Council WA etc.
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 Non-Hodgkins Lymphoma (NHL); doctors approval; pass a pre-exercise screening; able to provide 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
Not yet 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 outside Australia
Country [1] 237867 0
State/province [1] 237867 0

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
Yes
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 looks the efficacy of exercise versus a complementary therapy on the physical and psychosocial wellbeing of people who have undergone chemotherapy for lymphoma or myeloma. Who is it for? You can join this study if you are undergoing or due to c
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
Contact person for public queries
Contact person for scientific queries

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.