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Trial registered on ANZCTR
Registration number
ACTRN12613000555752
Ethics application status
Approved
Date submitted
10/05/2013
Date registered
16/05/2013
Date last updated
23/05/2013
Type of registration
Retrospectively registered
Titles & IDs
Public title
Fatigue management education for improving chemotherapy and radiotherapy patients’ performance of daily living activities
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Scientific title
Fatigue management education compared to control for improving chemotherapy and radiotherapy patients’ performance of daily living activities: a Pilot study
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Secondary ID [1]
282483
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Nil
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Universal Trial Number (UTN)
U1111-1142-9547
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
cancer
289116
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fatigue
289166
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Condition category
Condition code
Cancer
289450
289450
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0
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Any cancer
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Physical Medicine / Rehabilitation
289451
289451
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0
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Occupational therapy
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
A one hour group education session on how to manage fatigue caused by cancer treatment. It is delivered using a PowerPoint presentation and participants will be given a handbook, a goal setting sheet and a progress diary.
The group session will be conducted before participants commence the course of treatment (chemotherapy and/or radiotherapy). 2 x 15 minute follow-up phone calls using a structured script will be provided 2 and 4 weeks after each session to reinforce information given in the group.
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Intervention code [1]
287132
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Lifestyle
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Intervention code [2]
287163
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Behaviour
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Comparator / control treatment
Treatment as usual, which includes provision of a written pamphlet on energy conservation and relaxation
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Control group
Active
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Outcomes
Primary outcome [1]
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Competence self-rating on the Occupational Self Assessment (a measure of participation in everyday activities).
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Assessment method [1]
289552
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Timepoint [1]
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Post completion of all radiotherapy/chemotherapy treatment, and
6 weeks follow-up
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Primary outcome [2]
289553
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Health related quality of life (EQ-5D)
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Assessment method [2]
289553
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Timepoint [2]
289553
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Post completion of all radiotherapy/chemotherapy treatment, and
6 weeks follow-up
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Secondary outcome [1]
302719
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Fatigue (using Multi-dimensional Fatigue Inventory )
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Assessment method [1]
302719
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Timepoint [1]
302719
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Post completion of all radiotherapy/chemotherapy treatment, and
6 weeks follow-up
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Secondary outcome [2]
302721
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Distress (as measured using distress thermometer)
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Assessment method [2]
302721
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Timepoint [2]
302721
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Post completion of all radiotherapy/chemotherapy treatment, and
6 weeks follow-up
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Eligibility
Key inclusion criteria
All patients undergoing outpatient chemotherapy and/or radiotherapy aged over 18 years and booked for 20 or more days of treatment
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1) low performance status (as determined by the ECOG Performance Status Scale, with those rated 3 [Capable of only limited self care, confined to bed or chair more than 50% of waking hours] or more excluded);
(2) undergoing treatment with palliative intent;
(3) involvement in other programmes or research specifically targeting fatigue;
(4) inability to complete questionnaires due to cognitive or literacy levels.
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will be identified from the Radiation, Medical Oncology and Haematology units at The Alfred. All patients undergoing outpatient chemotherapy and/or radiotherapy aged over 18 years and booked for 20 or more days of treatment will be flagged by the treating team, and provided with written and verbal information regarding the study by the principal investigator. If informed consent is provided, relevant demographic, condition and treatment information will be gathered from the participant’s medical record or obtained from participants at the initial interview.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised (using a computerised random number generator) to either control or treatment group. Allocation concealment will be ensured by having the supervising researcher place the sequence into opaque, sealed, sequentially numbered envelopes
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
As this is a Pilot study to see if the intervention is appropriate for people undergoing chemotherapy and/or radiotherapy, we calculated that 15 people per group would give us a reasonable estimate of its effect.
Participant outcome measures collected at baseline and at the two reviews will be compared between groups using t tests for normally distributed data and Wilcoxon rank-sum tests for skewed data. Where summary scores were utilised, recommended scoring methods for each measure were applied.
Linear mixed models (or generalised estimating equations) will be used by a blinded statistical analyst to compare follow-up scores for the primary and secondary outcomes between groups, (group treated as a fixed factor, participant and assessment as random factors, assessment nested within participant) while adjusting for the covariates of age, gender, baseline value of the dependent variable and whether participants were working or not at the baseline assessment.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
15/10/2012
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Actual
15/10/2012
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Date of last participant enrolment
Anticipated
20/12/2012
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Actual
20/12/2012
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
981
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The Alfred - Prahran
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Recruitment postcode(s) [1]
6877
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3004 - Melbourne
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Funding & Sponsors
Funding source category [1]
287260
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Other Collaborative groups
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Name [1]
287260
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Southern Melbourne Integrated Cancer Service
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Address [1]
287260
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Monash Medical Centre Moorabbin
823 - 865 Centre Road
East Bentleigh
Victoria
3165
Australia
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Country [1]
287260
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Australia
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Primary sponsor type
Hospital
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Name
The Alfred
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Address
55 Commercial Rd
Melbourne 3004
Victoria
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Country
Australia
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Secondary sponsor category [1]
286014
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University
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Name [1]
286014
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Monash University
Dept of Occupational Therapy
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Address [1]
286014
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McMahon's Rd
Frankston 3199
Victoria
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Country [1]
286014
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289246
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The Alfred HREC
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Ethics committee address [1]
289246
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55 Commercial Rd
Melbourne 3004
Victoria
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Ethics committee country [1]
289246
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Australia
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Date submitted for ethics approval [1]
289246
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Approval date [1]
289246
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12/10/2011
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Ethics approval number [1]
289246
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408/10
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Summary
Brief summary
This study is evaluating the effect of fatigue management education on chemotherapy and radiotherapy patients' performance of daily living. Who is it for? You may be eligible to join this study if you are aged over 18 years and are scheduled to undergo outpatient chemotherapy and/or radiotherapy treatment for 20 or more days. Trial details: Participants in this study will be randomly (by chance) divided into one of two groups. Participants in one group will attend a one hour group education session on how to manage fatigue caused by cancer treatment. It is delivered using a PowerPoint presentation and participants will be given a handbook, a goal setting sheet and a progress diary. The group session will be conducted before participants commence the course of treatment (chemotherapy and/or radiotherapy). Two follow-up phone calls using a structured script will be provided 2 and 4 weeks after each session to reinforce information given in the group. Participants in the second study group will continue to receive standard care. Participants will be required to complete some questionnaires at completion of treatment and 6 weeks later in order to evaluate their participation in everyday activities, health-related quality of life, fatigue and distress.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
39938
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Dr Lisa O'Brien
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Address
39938
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Occupational Therapy Department
The Alfred
55 Commercial Rd
Melbourne 3004
Victoria
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Country
39938
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Australia
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Phone
39938
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+61390763230
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Fax
39938
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+61390762920
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Email
39938
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[email protected]
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Contact person for public queries
Name
39939
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Ms Anna Loughnan
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Address
39939
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Occupational Therapy Department
The Alfred
55 Commercial Rd
Melbourne 3004
Victoria
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Country
39939
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Australia
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Phone
39939
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+61390763230
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Fax
39939
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Email
39939
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[email protected]
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Contact person for scientific queries
Name
39940
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Dr Lisa O'Brien
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Address
39940
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Occupational Therapy Department
The Alfred
55 Commercial Rd
Melbourne 3004
Victoria
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Country
39940
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Australia
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Phone
39940
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+61390763230
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Fax
39940
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Email
39940
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[email protected]
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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.
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