Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000527561
Ethics application status
Approved
Date submitted
6/05/2015
Date registered
26/05/2015
Date last updated
26/05/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot randomised controlled trial of a structured exercise intervention after the completion of cancer treatment in
adolescents and young adults
Scientific title
A pilot randomised controlled trial of a structured exercise intervention after the completion of cancer treatment in
adolescents and young adults
Secondary ID [1] 286647 0
Nil
Universal Trial Number (UTN)
U1111-1169-9181
Trial acronym
YCS ET1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 294977 0
Condition category
Condition code
Cancer 295242 295242 0 0
Any cancer
Physical Medicine / Rehabilitation 295243 295243 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects randomised to the intervention arm will receive a 10-week intensive exercise programme from an exercise physiologist. Specifically, they will be asked to attend two supervised gym or home-based exercise sessions per week for 10 weeks. An Exercise Physiologist will design an individual exercise prescription for each participant based on results from the baseline functional assessments. Exercise will be mixed mode and will incorporate a combination of aerobic and resistance exercises. Exercises to improve flexibility will be included at the end of each exercise session. Exercise sessions will last no longer than 60 minutes. Over time it is expected that each participant will engage in 30 minutes of aerobic exercise and 30 minutes of resistance training, plus flexibility exercises. Exercise intensity will be monitored using heart rate monitors and participants will be encouraged to exercise at a moderate to high intensity (60% to 85% heart rate max). The Exercise Physiologist will aim to progress exercise intensity as tolerated. Participants will also be encouraged to engage in aerobic exercise outside of supervised exercise sessions.
Participants will also be provided with informal education sessions on the importance of exercise post cancer therapy. Parents and/or partners of participants will also be invited and encouraged to attend education sessions regarding the importance of physical activity and exercise post treatment.
Intervention code [1] 291790 0
Rehabilitation
Comparator / control treatment
The control group will receive usual care (ie routine medical follow-up; no exercise physiology involvement) and will not be offered an exercise intervention during the study period. No restrictions will be imposed on their activities, but they will not receive the exercise intervention during the study period.

Once the 6 month follow-up evaluation is complete, control subjects will be offered the exercise intervention, but this will not be evaluated as part of the study.
Control group
Active

Outcomes
Primary outcome [1] 294991 0
Functional capacity (as measured by Cardiopulmonary exercise testing / VO2 max and other standardised measures of fitness)
Timepoint [1] 294991 0
10 weeks after commencement of the exercise intervention
Primary outcome [2] 294992 0
Quality of Life (as measured by AQoL-6D, EORTC-C30, FACT-G, Peds-QL (AYA modification)
Timepoint [2] 294992 0
10 weeks after commencement of the exercise intervention
Primary outcome [3] 294993 0
Fatigue score (as measured by FACIT fatigue scale)
Timepoint [3] 294993 0
10 weeks after commencement of the exercise intervention
Secondary outcome [1] 314519 0
Functional capacity (as measured by Cardiopulmonary exercise testing / VO2 max and other standardised measures of fitness)
Timepoint [1] 314519 0
6 months after commencement of the exercise intervention
Secondary outcome [2] 314520 0
Quality of Life (as measured by AQoL-6D, EORTC-C30, FACT-G, Peds-QL (AYA modification)
Timepoint [2] 314520 0
6 months after commencement of the exercise intervention
Secondary outcome [3] 314521 0
Fatigue Score (as measured by FACIT-fatigue scale)
Timepoint [3] 314521 0
6 months after commencement of the exercise intervention
Secondary outcome [4] 314522 0
Participation in physical fitness activities (as measured by Godin Leisure Time Exercise questionnaire)
Timepoint [4] 314522 0
6 months after commencement of the exercise intervention

Eligibility
Key inclusion criteria
- Participants must be aged between 15 and 25 years of age
- Diagnosed with a haematological malignancy or solid tumour
- Completed systemic cancer treatment e.g. chemotherapy, radiation therapy or a combination of both (participants who have undergone surgery will only be eligible for the trial if surgery is used in combination with chemotherapy or radiation).
- Cancer therapy completed within the previous two months (or have started maintenance therapy for acute lymphoblastic leukaemia (or lymphoblastic lymphoma) within the past two months)
- Medically stable (as determined by a medical practitioner) and written clearance from a doctor in their treating team to undertake a progressive exercise program.
Minimum age
15 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Cognitive impairment (determined by a medical practitioner)
- Patients who undergo surgery only
- <6 months life expectancy
- Absolute contraindications to exercise e.g. unstable angina, uncontrolled heart failure, acute systemic infection accompanied by fever.
- Insufficient English to participate in the exercise programme and exercise assessments, or to complete the questionnaires

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)
Sealed Opaque Envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted Block Randomisation. Stratified according to treatment intensity (ie high intensity treatment (eg chemotherapy used in protocols to treat ALL, AML, Burkitt's, sarcoma, etc) vs less intense treatment (eg protocols for Hodgkin's, germ cell tumours, etc))
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power calculations have been determined, but as this is a pilot study with a limited funding period, a target sample of 20 subjects in each arm (ie total of 40 subjects) was chosen.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/04/2015
Actual
13/04/2015
Date of last participant enrolment
Anticipated
30/12/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 3752 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [2] 3753 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 3754 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment postcode(s) [1] 9631 0
5006 - North Adelaide
Recruitment postcode(s) [2] 9632 0
5000 - Adelaide
Recruitment postcode(s) [3] 9633 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 291224 0
Other Collaborative groups
Name [1] 291224 0
Australian and New Zealand Children's Haematology and Oncology Group (ANZCHOG)
Country [1] 291224 0
Australia
Funding source category [2] 291225 0
Charities/Societies/Foundations
Name [2] 291225 0
CanTeen Australia
Country [2] 291225 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australian and New Zealand Children's Haematology and Oncology Group
Address
27-31 Wright St
Clayton
VIC 3168
Country
Australia
Secondary sponsor category [1] 289901 0
None
Name [1] 289901 0
Address [1] 289901 0
Country [1] 289901 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292784 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 292784 0
72 King William Road
North Adelaide
South Australia
5006
Ethics committee country [1] 292784 0
Australia
Date submitted for ethics approval [1] 292784 0
Approval date [1] 292784 0
10/02/2015
Ethics approval number [1] 292784 0
HREC/14/WCHN/171

Summary
Brief summary
This pilot trial aims to evaluate if a structured exercise intervention improves fitness, lowers fatigue and improves quality of life in adolescents and young adults after the completion of cancer treatment.

Who is it for?
You may be eligible to join this study if you are aged between 15 and 25 years of age, are diagnosed with a haematological malignancy or solid tumour and have completed a systemic cancer treatment (ie chemotherapy and/or radiotherapy).

Study details:
Participants in this study will be assigned to either an intervention group or the control group by chance. Participants in the intervention group will receive 10 weeks of structured, individually tailored exercise intervention performed twice a week for 60 min per session. The control group will not receive exercise physiology input and will not be offered an exercise intervention during the study period; however no restrictions will be imposed on their activities. (Once the study is over, control patients will be offered participation in an exercise intervention if they want, but this will not be part of the study). Participants in both groups will have a blinded assessment of physical fitness, fatigue, and quality of life at baseline, 10 weeks, and 6 months. These measures will be compared between the group undertaking the programme and the control arm to determine whether the programme is associated with initial improvements, and whether these improvements are sustained at 6 months.

It is hoped that this study will help determine whether a structured exercise programme speeds up recovery of physical fitness, reduces fatigue, and improves quality of life in adolescent and young adult patients who have been treated for cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57014 0
Mr Morgan Atkinson
Address 57014 0
Youth Cancer Service
Royal Adelaide Hospital
MDP11, Level 4 East Wing, Royal Adelaide Hospital
North Terrace
Adelaide, SA 5000
Country 57014 0
Australia
Phone 57014 0
+61 8 82222804
Fax 57014 0
+61 8 82220740
Email 57014 0
[email protected]
Contact person for public queries
Name 57015 0
Mr Morgan Atkinson
Address 57015 0
Youth Cancer Service
Royal Adelaide Hospital
MDP11, Level 4 East Wing, Royal Adelaide Hospital
North Terrace
Adelaide, SA 5000
Country 57015 0
Australia
Phone 57015 0
+61 8 82222804
Fax 57015 0
+61 8 82220740
Email 57015 0
[email protected]
Contact person for scientific queries
Name 57016 0
Mr Morgan Atkinson
Address 57016 0
Youth Cancer Service
Royal Adelaide Hospital
MDP11, Level 4 East Wing, Royal Adelaide Hospital
North Terrace
Adelaide, SA 5000
Country 57016 0
Australia
Phone 57016 0
+61 8 82222804
Fax 57016 0
+61 8 82220740
Email 57016 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
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4538Study results articleYes Atkinson M, Murnane A, Goddard T, Pendergrast C, R... [More Details] 368489-(Uploaded-18-08-2023-23-02-27)-Journal results publication.pdf

Documents added automatically
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