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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
Scientific title
Fatigue management education compared to control for improving chemotherapy and radiotherapy patients’ performance of daily living activities: a Pilot study
Secondary ID [1] 282483 0
Nil
Universal Trial Number (UTN)
U1111-1142-9547
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cancer 289116 0
fatigue 289166 0
Condition category
Condition code
Cancer 289450 289450 0 0
Any cancer
Physical Medicine / Rehabilitation 289451 289451 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 287132 0
Lifestyle
Intervention code [2] 287163 0
Behaviour
Comparator / control treatment
Treatment as usual, which includes provision of a written pamphlet on energy conservation and relaxation
Control group
Active

Outcomes
Primary outcome [1] 289552 0
Competence self-rating on the Occupational Self Assessment (a measure of participation in everyday activities).
Timepoint [1] 289552 0
Post completion of all radiotherapy/chemotherapy treatment, and
6 weeks follow-up
Primary outcome [2] 289553 0
Health related quality of life (EQ-5D)
Timepoint [2] 289553 0
Post completion of all radiotherapy/chemotherapy treatment, and
6 weeks follow-up
Secondary outcome [1] 302719 0
Fatigue (using Multi-dimensional Fatigue Inventory )
Timepoint [1] 302719 0
Post completion of all radiotherapy/chemotherapy treatment, and
6 weeks follow-up
Secondary outcome [2] 302721 0
Distress (as measured using distress thermometer)
Timepoint [2] 302721 0
Post completion of all radiotherapy/chemotherapy treatment, and
6 weeks follow-up

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

Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
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.
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
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/10/2012
Actual
15/10/2012
Date of last participant enrolment
Anticipated
20/12/2012
Actual
20/12/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 981 0
The Alfred - Prahran
Recruitment postcode(s) [1] 6877 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 287260 0
Other Collaborative groups
Name [1] 287260 0
Southern Melbourne Integrated Cancer Service
Country [1] 287260 0
Australia
Primary sponsor type
Hospital
Name
The Alfred
Address
55 Commercial Rd
Melbourne 3004
Victoria
Country
Australia
Secondary sponsor category [1] 286014 0
University
Name [1] 286014 0
Monash University
Dept of Occupational Therapy
Address [1] 286014 0
McMahon's Rd
Frankston 3199
Victoria
Country [1] 286014 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289246 0
The Alfred HREC
Ethics committee address [1] 289246 0
Ethics committee country [1] 289246 0
Australia
Date submitted for ethics approval [1] 289246 0
Approval date [1] 289246 0
12/10/2011
Ethics approval number [1] 289246 0
408/10

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

Contacts
Principal investigator
Name 39938 0
Dr Lisa O'Brien
Address 39938 0
Occupational Therapy Department
The Alfred
55 Commercial Rd
Melbourne 3004
Victoria
Country 39938 0
Australia
Phone 39938 0
+61390763230
Fax 39938 0
+61390762920
Email 39938 0
l.obrien@alfred.org.au
Contact person for public queries
Name 39939 0
Anna Loughnan
Address 39939 0
Occupational Therapy Department
The Alfred
55 Commercial Rd
Melbourne 3004
Victoria
Country 39939 0
Australia
Phone 39939 0
+61390763230
Fax 39939 0
Email 39939 0
a.loughnan@alfred.org.au
Contact person for scientific queries
Name 39940 0
Lisa O'Brien
Address 39940 0
Occupational Therapy Department
The Alfred
55 Commercial Rd
Melbourne 3004
Victoria
Country 39940 0
Australia
Phone 39940 0
+61390763230
Fax 39940 0
Email 39940 0
l.obrien@alfred.org.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.