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Trial registered on ANZCTR


Registration number
ACTRN12614001311640
Ethics application status
Approved
Date submitted
27/10/2014
Date registered
16/12/2014
Date last updated
1/03/2023
Date data sharing statement initially provided
4/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase III randomised, controlled trial of exercise during chemotherapy for patients commencing first line treatment for ovarian cancer
Scientific title
A Phase III randomised, controlled trial to evaluate the effect of exercise during chemotherapy on progression-free survival and physical well-being in patients commencing first line treatment for ovarian cancer
Secondary ID [1] 285371 0
ANZGOG-1304
Secondary ID [2] 303585 0
CTC121
Universal Trial Number (UTN)
Trial acronym
ECHO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer 293102 0
Condition category
Condition code
Cancer 293376 293376 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will involve the individual prescription of aerobic and resistance exercise at moderate-intensity, accumulating at least 150 minutes per week (dose). Women will likely walk and undertake resistance exercises using free-weights or therabands, under mostly unsupervised conditions. A study-trained Exercise Professional (ExP) will prescribe and monitor exercise type, duration and frequency on a weekly basis and modify prescription according to presentation of symptoms and by adhering to the exercise principle of gradual progression. The exercise program will continue for the duration of chemotherapy or for a maximum of 18 weeks for participants who discontinue chemotherapy early.
Intervention code [1] 290285 0
Lifestyle
Comparator / control treatment
Usual care will include provision of the resilience pack from Ovarian Cancer Australia. It provides information about dealing with a diagnosis, treatment options and expectations, advice about living well with ovarian cancer and information about available support options.
Control group
Active

Outcomes
Primary outcome [1] 293204 0
Physical well-being
Physical wellbeing will be measured using a validated 7 item (score 0-28) subscale of the FACT-O (Functional Assessment of Cancer Therapy-Ovarian) QoL questionnaire
Timepoint [1] 293204 0
Baseline (pre-intervention) and at 6- and 12-months post-randomisation.
Primary outcome [2] 331923 0
Progression Free Survival (PFS).
Information relating to PFS will be extracted from medical records at pre-determined timepoints (3-6 weeks post-chemotherapy, 6- and 12-months post-randomisation, and in the final years of the study).
Timepoint [2] 331923 0
3-6 weeks post-chemotherapy, 6- and 12-months post-randomisation, and in the final years of the study.
Secondary outcome [1] 310579 0
Physical function
Fitness: Objectively measured using the Six-Minute Walk Test
Strength: Objectively measured using upper- and lower-body 10 repetition maximum test
Balance: Objectively measured single leg stance
Endurance: Objectively measured 30 second sit to stand
Physical function: Self-reported assessment using the Short Form (36) Health Survey (SF36
Timepoint [1] 310579 0
Baseline (pre-intervention) and at 6- and 12-months post-randomisation
Secondary outcome [2] 310580 0
Body composition
Fat mass and fat free mass will be objectively measured by bioimpedance spectroscopy
Timepoint [2] 310580 0
Baseline (pre-intervention) and at 6- and 12-months post-randomisation
Secondary outcome [3] 310581 0
Quality of life
Self-reported assessment using:
* Functional Assessment of Cancer Therapy-Ovarian
* MOST Measure of Ovarian Symptoms and Treatment Concerns
* PROMIS – Global Health
* Euro-Qol-5 - a standardised instrument for use as a measure of health utility
Timepoint [3] 310581 0
Baseline (pre-intervention) and at 6- and 12-months post-randomisation
Secondary outcome [4] 310582 0
fatigue
Self-reported assessment using FACIT Fatigue scale
Timepoint [4] 310582 0
Baseline (pre-intervention) and at 6- and 12-months post-randomisation
Secondary outcome [5] 310583 0
Sleep
Self-reported assessment using Insomnia Severity Index and Pittsburgh Sleep Quality Index
Timepoint [5] 310583 0
Baseline (pre-intervention) and at 6- and 12-months post-randomisation
Secondary outcome [6] 310584 0
Anxiety and depression
Self-reported assessment using the Hospital and Anxiety Depression Scale
Timepoint [6] 310584 0
Baseline (pre-intervention) and at 6- and 12-months post-randomisation
Secondary outcome [7] 310585 0
Adverse events
Adverse events (proportion of women reporting grade 3/4 adverse events related to treatment of ovarian cancer as measured by the standard CTC-AE version 4).
Timepoint [7] 310585 0
Baseline (pre-intervention) and at 6- and 12-months post-randomisation
Secondary outcome [8] 310586 0
Chemotherapy completion
The relative dose intensity (RDI) of each chemotherapy agent will be calculated as the delivered dose intensity (total dose delivered divided by total time of treatment) divided by the standard dose intensity calculated for each regimen.
Timepoint [8] 310586 0
Post-intervention
Secondary outcome [9] 310588 0
Overall survival
Timepoint [9] 310588 0
3-6 weeks post-chemotherapy, 6- and 12-months post-randomisation, and in the final years of the study.
Secondary outcome [10] 310589 0
Cost effectiveness
Australian unit costs will be applied to the resource usage data (e.g. Australian Refined Diagnostic Related Groups (AR-DRGs) costs for hospitalisations, and scheduled costs for Medical Benefits Schedule (MBS) and Pharmaceutical Benefits Schedule (PBS) items). The EQ-5D scores will be used to estimate QALYs. Both costs and QALYs will be combined into an incremental cost per QALY ratio of the exercise intervention compared with usual care.
Timepoint [10] 310589 0
Data (that covers 12m post-randomisation per participant) will be extracted on a yearly basis.
Secondary outcome [11] 411595 0
Physical activity levels
Self-reported assessment using the Active Australia questionnaire
Timepoint [11] 411595 0
Baseline (pre-intervention) and at 6- and 12-months post-randomisation
Secondary outcome [12] 411596 0
Lymphoedema status will be assessed objectively by bioimpedance spectroscopy
Timepoint [12] 411596 0
Baseline (pre-intervention) and at 6- and 12-months post-randomisation

Eligibility
Key inclusion criteria
1. Women with newly diagnosed epithelial ovarian, primary peritoneal or fallopian tube cancer of any histological type, suitable for first-line chemotherapy
2. Age > or = 18 years
3. ECOG status 0-2
4. Willing and able to comply with all study requirements, including the exercise intervention, timing and/or nature of required assessments
5. Sufficiently fluent in English to fully participate in data collection requirements and comprehend intervention requirements
6. Scheduled for chemotherapy or has commenced chemotherapy. Participants must be enrolled prior to commencement of the 2nd cycle of chemotherapy
7. Signed written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Women with diagnosis of recurrent ovarian cancer
2. History of another malignancy within 3 years prior to registration. Patients with a past history of adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, Stage I melanoma in situ or superficial transitional cell carcinoma of the bladder are eligible. Patients with a history of other malignancies are eligible if they have been continuously disease-free for at least 3 years after definitive primary treatment.
3. Concurrent illness, including severe infection or unstable angina that may jeopardise the ability of the patient to undergo the exercise intervention outlined in this protocol with reasonable safety.
4. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.

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)
Patients will be randomised centrally
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation with stratification
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Assessments will be blinded as far as possible, depending on the staff available at site
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Intention-to-treat
A total accrual of approximately 500 participants recruited over 6 years with an additional follow-up of 2 years provides 80% power to detect a true difference of 6.7 months in median PFS assuming a median PFS in the control group of 20 months (HR: 0.749, 400 observed PFS events), with a 2-sided type 1 error rate of 0.045. This includes over accrual of approximately 26 participants to account for ineligibility and missing data. Approximately 210 participants per group provides 80% power to detect an absolute minimum clinically important difference of 2 points between the mean physical wellbeing scores of the two groups at 6- and 12-months post-randomisation, assuming a standard deviation of 5.6, and a 2-sided Type 1 error rate of 0.005, with an allowance of approximately 15% for missing HRQL data.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
5/01/2015
Actual
30/06/2015
Date of last participant enrolment
Anticipated
31/12/2022
Actual
30/01/2023
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
500
Accrual to date
Final
524
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
Recruitment hospital [1] 3205 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 5801 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [3] 9552 0
The Canberra Hospital - Garran
Recruitment hospital [4] 9554 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [5] 9555 0
Westmead Hospital - Westmead
Recruitment hospital [6] 9556 0
Greenslopes Private Hospital - Greenslopes
Recruitment hospital [7] 9557 0
Mater Private Hospital - South Brisbane
Recruitment hospital [8] 18837 0
The Wesley Hospital - Auchenflower
Recruitment hospital [9] 18838 0
The Royal Women's Hospital - Parkville
Recruitment hospital [10] 20120 0
Gold Coast University Hospital - Southport
Recruitment hospital [11] 22758 0
Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [12] 22759 0
Griffith University – Nathan Campus - Nathan
Recruitment postcode(s) [1] 8845 0
4006 - Herston
Recruitment postcode(s) [2] 13242 0
4101 - South Brisbane
Recruitment postcode(s) [3] 18305 0
2605 - Garran
Recruitment postcode(s) [4] 18306 0
2050 - Camperdown
Recruitment postcode(s) [5] 18307 0
2560 - Campbelltown
Recruitment postcode(s) [6] 18308 0
2145 - Westmead
Recruitment postcode(s) [7] 18309 0
4120 - Greenslopes
Recruitment postcode(s) [8] 18310 0
4101 - South Brisbane
Recruitment postcode(s) [9] 33337 0
4066 - Auchenflower
Recruitment postcode(s) [10] 33338 0
3052 - Parkville
Recruitment postcode(s) [11] 34830 0
4215 - Southport
Recruitment postcode(s) [12] 38036 0
4111 - Nathan

Funding & Sponsors
Funding source category [1] 289983 0
Government body
Name [1] 289983 0
Cancer Australia
Country [1] 289983 0
Australia
Funding source category [2] 311783 0
Government body
Name [2] 311783 0
Cancer Council Queensland
Country [2] 311783 0
Australia
Funding source category [3] 311784 0
Charities/Societies/Foundations
Name [3] 311784 0
World Cancer Research Fund
Country [3] 311784 0
United Kingdom
Primary sponsor type
University
Name
University of Sydney
Address
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country
Australia
Secondary sponsor category [1] 288668 0
None
Name [1] 288668 0
Address [1] 288668 0
Country [1] 288668 0
Other collaborator category [1] 278158 0
Other Collaborative groups
Name [1] 278158 0
Australia New Zealand Gynaecological Oncology Group
Address [1] 278158 0
Locked Bag 77
Camperdown NSW 1450
Country [1] 278158 0
Australia
Other collaborator category [2] 281676 0
University
Name [2] 281676 0
Griffith University
Address [2] 281676 0
Griffith University
170 Kessels Road, Nathan, QLD 4111
Australia
Country [2] 281676 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291692 0
SLHD Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 291692 0
Ethics committee country [1] 291692 0
Australia
Date submitted for ethics approval [1] 291692 0
24/09/2014
Approval date [1] 291692 0
21/11/2014
Ethics approval number [1] 291692 0
HREC/14/RPAH/419
Ethics committee name [2] 311226 0
SLHD Ethics Review Committee (RPAH Zone)
Ethics committee address [2] 311226 0
Ethics committee country [2] 311226 0
Australia
Date submitted for ethics approval [2] 311226 0
16/11/2018
Approval date [2] 311226 0
20/02/2019
Ethics approval number [2] 311226 0
2019/ETH08923

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51550 0
Prof Sandra Hayes
Address 51550 0
Griffith University
170 Kessels Roads, Nathan, QLD 4111
Australia
Country 51550 0
Australia
Phone 51550 0
+61 7 3735 5194
Fax 51550 0
Email 51550 0
[email protected]
Contact person for public queries
Name 51551 0
Sandra Hayes
Address 51551 0
Griffith University
170 Kessels Roads, Nathan, QLD 4111
Australia
Country 51551 0
Australia
Phone 51551 0
+61 7 3735 5194
Fax 51551 0
Email 51551 0
[email protected]
Contact person for scientific queries
Name 51552 0
Sandra Hayes
Address 51552 0
Griffith University
170 Kessels Roads, Nathan, QLD 4111
Australia
Country 51552 0
Australia
Phone 51552 0
+61 7 3735 5194
Fax 51552 0
Email 51552 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
Please contact CTC for data sharing SOP


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.