Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000252213
Ethics application status
Approved
Date submitted
14/04/2009
Date registered
12/05/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
An excercise intervention for women undergoing primary treatment for ovarian cancer: feasibility and preliminary outcomes
Scientific title
An excercise intervention for women undergoing primary treatment for ovarian cancer: feasibility and preliminary outcomes (chemotherapy completions, fatigue, physical functioning and distress)
Secondary ID [1] 540 0
Queensland Insititute of Medical Research project number P1222
Secondary ID [2] 783 0
Royal Brisbane and Women's Hospital project number Human Research Ethics Committee/08/Queensland Royal Brisbane and Women's/19
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ovarian cancer 3903 0
Condition category
Condition code
Cancer 4103 4103 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
low risk excercise intervention including low to moderate intensity walking, accumulating approximately 30 minutes daily, during 18 weeks of chemotherapy. Patients in this intervention will be undergoing first-line chemotherapy. Most ovarian cancer patients in Australia receive 6, 3 weekly cycles of intravenous carboplatin and paclitaxel as first-line chemotherapy. The length of time in between cycles will be 3 weeks i.e. women receiving first-line chemotherapy are generally administered agents intravenously on day 1 of week 1, 4, 7, 10, 13 and 16.
Intervention code [1] 3629 0
Behaviour
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4995 0
Feasibility i.e. ability to recruit and retain participants, assessing achievable amount, intensity and pace of exercise prescription (via a log-book), measuring exercise adherence (via a log-book and accelerometer) and any adverse effects (via a log-book and medical records review). During the intervention women will be asked to complete a exercise log-book of their exercise duration and intensity each week of the intervention. "Assessing achievable amount" simply refers to the weekly medium minutes (and range) of exercise women with ovarian cancer achieve over the course of their treatment. Participants complete the exercise log-book. The exercise physiologist will visit each participant weekly and collect exercise adherence data and information on any adverse events.
Timepoint [1] 4995 0
at end of study ie end of primary treatment
Participants will be contacted by our exercise physiologist to organise a baseline assessment prior to chemotherapy commencement and a follow-up assessment, at the end of first-line chemotherapy. The timepoint above refers to the follow-up assessment. Both the baseline and follow-up assessments will include the six minute walk test and questionnaire about demographics (baseline only), distress, quality-of-life, symptoms, current physical activity and support services utilised. At the end of the study we will look at changes in outcomes from baseline to follow-up. Additionally the exercise physiologist will collect weekly data on exercise adherence and any adverse effects. A follow-up post-intervention review of medical records will also be conducted to obtain other outcome data e.g. chemotherapy completion information and adverse events recorded by clinicians. The exercise physiologist will collect data on exercise adherence and any adverse effects weekly for 18 weeks during the study duration.
Secondary outcome [1] 6886 0
Potential efficacy i.e. number of chemotherapy cycles completed and overall chemotherapy completion rates (assessed by medical records review) and change in fatigue, physical function and distress over the chemotherapy course (assessed via baseline and follow-up questionnaires). The questionnaire includes validated measures of current physical activity (Active Australia Survey), fatigue, pain, cognition, and insomnia (Memorial Symptom Assessment Scale), distress (Hospital Anxiety and Depression Scale), quality-of-life (Functional Assessment of Cancer Therapy-Ovarian) and standardised demographic questions.
Timepoint [1] 6886 0
Participants will be contacted by our exercise physiologist to organise a baseline assessment prior to chemotherapy commencement and a follow-up assessment, at the end of first-line chemotherapy. The timepoint above refers to the follow-up assessment. Both the baseline and follow-up assessments will include the six minute walk test and questionnaire about demographics (baseline only), distress, quality-of-life, symptoms, current physical activity and support services utilised. At the end of the study we will look at changes in outcomes from baseline to follow-up. Additionally the exercise physiologist will collect weekly data on exercise adherence and any adverse effects. A follow-up post-intervention review of medical records will also be conducted to obtain other outcome data e.g. chemotherapy completion information and adverse events recorded by clinicians. The exercise physiologist will collect weekly data on exercise adherence and any adverse effects weekly for 18 weeks during the study duration.

Eligibility
Key inclusion criteria
1 aged 18 years or more;
2 living in commuting distance from Brisbane hospitals;
3 with histologically or cytologically verified ovarian cancer;
4 about to start first or second cycle of adjuvant or neoadjuvant chemotherapy
5 able to read and complete the questionnaires and give informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1 Women with borderline ovarian tumours or who have had a prior malignancy within the last 5 years (excluding carcinoma in-situ of the cervix or basal cell carcinoma of the skin).
2 If it is considered unsafe for the patient to undertake a graded exercise programme.

Study design
Purpose of the study
Treatment
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
None
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/04/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 1270 0
4029
Recruitment postcode(s) [2] 1271 0
4101
Recruitment postcode(s) [3] 1272 0
4066
Recruitment postcode(s) [4] 1273 0
4120
Recruitment postcode(s) [5] 1382 0
4000

Funding & Sponsors
Funding source category [1] 4103 0
Charities/Societies/Foundations
Name [1] 4103 0
Gynaecological Cancer Society
Country [1] 4103 0
Australia
Primary sponsor type
Government body
Name
Queensland Institute of Medical Research
Address
300 Herston Rd, Herston, Queensland 4006
Country
Australia
Secondary sponsor category [1] 3694 0
None
Name [1] 3694 0
Address [1] 3694 0
Country [1] 3694 0
Other collaborator category [1] 263 0
Hospital
Name [1] 263 0
The Wesley Hospital
Address [1] 263 0
Coronation Drive (corner Chasely Street), Auchenflower, Queensland 4066
Country [1] 263 0
Australia
Other collaborator category [2] 264 0
Hospital
Name [2] 264 0
Mater Misericordiae Adult Hospital
Address [2] 264 0
Raymond Terrace, South Brisbane, Queensland 4101
Country [2] 264 0
Australia
Other collaborator category [3] 461 0
Hospital
Name [3] 461 0
Royal Brisbane and Women's Hospital
Address [3] 461 0
Butterfield Street, Herston, Queensland 4029
Country [3] 461 0
Australia
Other collaborator category [4] 462 0
Hospital
Name [4] 462 0
Greenslopes Private Hosptial
Address [4] 462 0
Newdgate Street, Greenslopes, Queensland 4120
Country [4] 462 0
Australia
Other collaborator category [5] 527 0
Hospital
Name [5] 527 0
Brisbane Private Hospital
Address [5] 527 0
259 Wickham Terrace, Brisbane, Queensland 4000
Country [5] 527 0
Australia
Other collaborator category [6] 528 0
University
Name [6] 528 0
Queensland University of Technology
Address [6] 528 0
Victoria Park Road, Kelvin Grove, Brisbane, Queensland 4059
Country [6] 528 0
Australia
Other collaborator category [7] 529 0
University
Name [7] 529 0
University of Queensland
Address [7] 529 0
Herston Road, Hersotn, Brisbane, Queensland 4006
Country [7] 529 0
Australia
Other collaborator category [8] 530 0
Hospital
Name [8] 530 0
Mater Private Hospital
Address [8] 530 0
301 Vulture Street, South Brisbane, Queensland 4101
Country [8] 530 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5286 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 5286 0
Royal Brisbane and Women's Hospital, Herston Queensland 4029
Ethics committee country [1] 5286 0
Australia
Date submitted for ethics approval [1] 5286 0
12/11/2008
Approval date [1] 5286 0
Ethics approval number [1] 5286 0
EC00172
Ethics committee name [2] 5288 0
Mater Health Services Human Research Ethics Committee
Ethics committee address [2] 5288 0
Level 2 Aubigny Place, Raymond Rce, South Brisbane, Queensland 4101
Ethics committee country [2] 5288 0
Australia
Date submitted for ethics approval [2] 5288 0
Approval date [2] 5288 0
Ethics approval number [2] 5288 0
EC00332
Ethics committee name [3] 5294 0
United Healthcare Human Research Ethics Committee
Ethics committee address [3] 5294 0
The Wesley Hospital, Auchenflower, Queensland 4066
Ethics committee country [3] 5294 0
Australia
Date submitted for ethics approval [3] 5294 0
Approval date [3] 5294 0
Ethics approval number [3] 5294 0
EC00374
Ethics committee name [4] 6177 0
Greenslopes Private Hospital Human Research Ethics Committee
Ethics committee address [4] 6177 0
Greenslopes Private Hospital, Newdegate St, Greenslopes, Queensland 4120
Ethics committee country [4] 6177 0
Australia
Date submitted for ethics approval [4] 6177 0
Approval date [4] 6177 0
Ethics approval number [4] 6177 0
EC00161
Ethics committee name [5] 6319 0
Queensland Institute of Medical Research Human Research Ethics Committee
Ethics committee address [5] 6319 0
300 Herston Rd, Herston, Queensland 4006
Ethics committee country [5] 6319 0
Australia
Date submitted for ethics approval [5] 6319 0
Approval date [5] 6319 0
17/11/2008
Ethics approval number [5] 6319 0
EC00278
Ethics committee name [6] 6425 0
Queensland University of Technology Unniversity Human Research Ethics Committee
Ethics committee address [6] 6425 0
Office of Research, GPO Box 2434, Brisbane, Queensland 4101
Ethics committee country [6] 6425 0
Australia
Date submitted for ethics approval [6] 6425 0
Approval date [6] 6425 0
Ethics approval number [6] 6425 0
EC00171
Ethics committee name [7] 6426 0
Human Experimentation Ethical Review Committee
Ethics committee address [7] 6426 0
Research and Research Training Division, Cumbrae Stuart Building, University of Queensland, St Lucia, Brisbane, Queensland 4072
Ethics committee country [7] 6426 0
Australia
Date submitted for ethics approval [7] 6426 0
Approval date [7] 6426 0
Ethics approval number [7] 6426 0
EC00178

Summary
Brief summary
This study looks at the feasibility and potential benefits of exercise for women undergoing primary treatment for ovarian cancer.

Who is it for?
You can join this study if you have ovarian cancer and you are about to start your first or second cycle of adjuvant or neoadjuvant chemotherapy (a treatment given in addition to surgery to try to prevent a cancer from coming back) and if you live within approximately 30kms of Brisbane CBD.

Trial details
Participants will take part in a specially-designed exercise program, which includes low to moderate intensity walking, for around 30 minutes daily, over 18 weeks of chemotherapy. It will measure chemotherapy completion rates, fatigue, physical function and distress. Participants will be required to complete two questionnaires to measure these.

Approximately 36% of women do not complete adjuvant chemotherapy for ovarian cancer due to treatment side-effects, in particular fatigue. Incomplete chemotherapy may result in poorer survival. In other cancer groups, exercise programs are effective for increasing functional capacity, relieving fatigue, distress and extending survival.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28528 0
Address 28528 0
Country 28528 0
Phone 28528 0
Fax 28528 0
Email 28528 0
Contact person for public queries
Name 11685 0
Susan Brown
Address 11685 0
Queensland Institute of Medical Research, 300 Herston Rd, Herston Queensland 4029
Country 11685 0
Australia
Phone 11685 0
+61 7 3845 3549
Fax 11685 0
+61 7 3845 3502
Email 11685 0
Susan.Brown@qimr.edu.au
Contact person for scientific queries
Name 2613 0
Dr Vanessa Beesley
Address 2613 0
Queensland Institute of Medical Research, 300 Herston Rd, Herston Queensland 4029
Country 2613 0
Australia
Phone 2613 0
+61 7 3362 0270
Fax 2613 0
+61 7 3845 3502
Email 2613 0
Vanessa.Beesley@qimr.edu.au

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.