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Trial registered on ANZCTR


Registration number
ACTRN12611000338965
Ethics application status
Approved
Date submitted
10/03/2011
Date registered
31/03/2011
Date last updated
31/03/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
TOPS trial: Treatment of Post-Cancer Fatigue Study
Scientific title
A controlled trial of an optimized multidisciplinary intervention for post-cancer fatigue.
Secondary ID [1] 259726 0
None
Universal Trial Number (UTN)
Trial acronym
TOPS Trial (Treatment of Post-Cancer Fatigue Study).
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post cancer fatigue in breast and colon cancer survivors 261306 0
Condition category
Condition code
Cancer 259504 259504 0 0
Breast
Cancer 259505 259505 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Physical Medicine / Rehabilitation 265613 265613 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This randomized control trial will assign patients to receive either:
Arm 1: a simple education intervention - consisting of patient information booklet outlining the principles of the management program implemented in the CBT intervention and will meet with the clinicians (both the exercise physiologist and clinical psychologist) once, for approximately 45 mins, to further discuss the principles of the intervention.

Arm 2: a 12-week supervised, graded exercise program (GET) and cognitive behavioral therapy (CBT) intervention aimed at managing the fatigue state and improving functional status. The program consists of exercise / activity and psychological interventions and is conducted by trained exercise physiologists and clinical psychologists, based on consultations of 45mins each. In week 1, before commencing any exercise program the participants’ current exercise / activity capacity will be assessed by interview and by completion of a diary. The planned exercise / activity program will be tailored to the subjects’ capacity. Progress will be reviewed at weeks 2, 3, 5 and 7, either in person or by telephone, each consultation taking approximately 45mins.

At the end of 12 weeks and again at 24 weeks, subjects in both arms of the study will be interviewed (for approximately one hour) and have their exercise capacity reassessed via a consultation of approximately one hour.
Intervention code [1] 264151 0
Rehabilitation
Intervention code [2] 264152 0
Behaviour
Intervention code [3] 264153 0
Lifestyle
Comparator / control treatment
Simple education intervention group
Control group
Active

Outcomes
Primary outcome [1] 262263 0
Improvement in the clinically-significant fatigue state identified by interviews conducted by a psychologist independent of the treating practitioners utilizing the SCIN (The Structured Clinical Interview for Neurasthenia [Bennett B et al, manuscript submitted]. A decrease of one standard deviation (SD) or greater from baseline to week 12 and week 24 on of the global score (previous studies by the investigators indicate one SD equates to 2.8 points on the scoring algorithm which has a possible range of 0-15).
Timepoint [1] 262263 0
Baseline (pre-intervention), 12 weeks (immediately post-intervention) and 24 weeks (in follow-up).
Secondary outcome [1] 273419 0
The secondary endpoints will include improvement of at least one standard deviation from baseline to week 12, or week 24 in scores on: i) the fatigue subscale of the SPHERE questionnaire.
Timepoint [1] 273419 0
Baseline (pre-intervention), 12 weeks (immediately post-intervention) and 24 weeks (in follow-up).
Secondary outcome [2] 273420 0
Improvement of at least one standard deviation from baseline to week 12, or week 24 in scores on:ii) physical functioning subscale on the SF-36 questionnaire.
Timepoint [2] 273420 0
Baseline (pre-intervention), 12 weeks (immediately post-intervention) and 24 weeks (in follow-up).
Secondary outcome [3] 273421 0
Improvement of at least one standard deviation from baseline to week 12, or week 24 in scores on ; iii) the global score on the IPAQ questionnaire.
Timepoint [3] 273421 0
Baseline (pre-intervention), 12 weeks (immediately post-intervention) and 24 weeks (in follow-up).
Secondary outcome [4] 273422 0
Improvement of at least one standard deviation from baseline to week 12, or week 24 in scores on ; iv) sleep disturbance scores on the PSQI.
Timepoint [4] 273422 0
Baseline (pre-intervention), 12 weeks (immediately post-intervention) and 24 weeks (in follow-up).
Secondary outcome [5] 273423 0
Improvement of at least one standard deviation from baseline to week 12, or week 24 in scores on v) the depression and anxiety subscales measuring mood disturbance on the POMS questionnaire.
Timepoint [5] 273423 0
Baseline (pre-intervention), 12 weeks (immediately post-intervention) and 24 weeks (in follow-up).

Eligibility
Key inclusion criteria
report clinically significant fatigue (i.e. ‘SOMA positive’ status on the SPHERE questionnaire);
be at least 18 years of age;
have completed adjuvant therapy for cancer at least three months prior;
be free of co-morbid medical or psychiatric conditions which explain ongoing fatigue, or preclude participation in an exercise/activities program (e.g. organ dysfunction such as cardiac, renal or liver disease);
be free of clinical or laboratory evidence of cancer recurrence;
are within 12 months of finishing adjuvant therapy for either breast or colon cancer.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
they are unable to adequately speak or understand or read English;
they have significant co-morbid conditions precluding participation;
their primary physician declines their participation on clinical grounds;
are unable to attend the face-to-face sessions of the program.

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)
The method of allocation concealment is via sealed opaque envelopes conducted by an independent psychologist
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation by using a randomization table created by a computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 264605 0
Government body
Name [1] 264605 0
Cancer Australia
Country [1] 264605 0
Australia
Primary sponsor type
University
Name
University of NSW
Address
Faculty of Medicine
The University of New South Wales
Sydney NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 263785 0
None
Name [1] 263785 0
Address [1] 263785 0
Country [1] 263785 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260603 0
UNSW HREC
Ethics committee address [1] 260603 0
UNSW Research Services
Rupert Myers Building, Level 3
The University of New South Wales NSW 2052
Ethics committee country [1] 260603 0
Australia
Date submitted for ethics approval [1] 260603 0
01/11/2010
Approval date [1] 260603 0
19/11/2010
Ethics approval number [1] 260603 0
10381

Summary
Brief summary
Some people have problems with a profound lack of energy (fatigue) after finishing cancer treatment known as post cancer fatigue. They also commonly have difficulties in concentration, sleep disturbance and low mood. The experts in the Lifestyle Clinic have developed an exercise and support program for people with post cancer fatigue which will now be evaluated in a trial.
Who are the clinicians?
The exercise physiologist helps with:
- Activity pacing - helping to better manage day to day symptoms and activity levels;
- Graded exercise therapy - increasing capacity for activity to improve health.
The clinical psychologist helps with:
- Memory, concentration and attention problems;
- Sleep issues ;
- Anxiety, mood and coping.
What is involved?
Those eligible will be randomized into either a simple education group or an intervention group. Regardless of what group you are allocated to you will be interviewed and asked to complete a series of questionnaires about your health and lifestyle at the beginning, at 12weeks and then 3 months later.
Participation is free of charge.
The education group will receive a booklet describing the principles of the treatment program and will meet with the clinicians to ensure they understand the plan. They will provide clear advice on how to implement these principles yourself at home over the 12 weeks.
Those in the intervention group will receive this booklet but will also participate in regular sessions implementing the 12 week program.
What is the 12 week intervention?
The 12 week program is run by an exercise physiologist and clinical psychologist, designed to better manage your fatigue and related symptoms and to increase your day to day function.
The program includes:
- Assessment of symptoms and activity patterns with an exercise physiologist.
- Assessment of your well-being with a clinical psychologist
The treatment program is ‘home-based’ and is designed to suit your individual needs and current level of activity. This includes fortnightly consults either in the Clinic or by phone with your clinicians to review your progress.
What happens after the trial if I get randomized into the education group?
If the intervention proves to be effective and you were allocated to the education group you will be offered the intervention without cost to you.
Who can participate?
- People who have completed adjuvant treatment (chemotherapy, radiotherapy or hormonal treatment) for breast or bowel cancer, who have symptoms of unexplained fatigue reducing activity levels.
- People who have finished treatment at least 3 months ago but less than 12 months ago.
-Aged at least 18 years
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32307 0
Address 32307 0
Country 32307 0
Phone 32307 0
Fax 32307 0
Email 32307 0
Contact person for public queries
Name 15554 0
Carolina Sandler
Address 15554 0
38 Botany st
RANDWICK
NSW 2031
Country 15554 0
Australia
Phone 15554 0
+61 2 9385 3352
Fax 15554 0
+61 2 9385 3195
Email 15554 0
[email protected]
Contact person for scientific queries
Name 6482 0
Prof Andrew Lloyd
Address 6482 0
38 Botany st
RANDWICK
NSW 2031
Country 6482 0
Australia
Phone 6482 0
+61 2 9385 3352
Fax 6482 0
+61 2 9385 3195
Email 6482 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

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