Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001004358
Ethics application status
Approved
Date submitted
10/07/2017
Date registered
12/07/2017
Date last updated
18/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
ReCHARGE - Online self-management of cancer-related fatigue: a multimodal approach
Scientific title
ReCHARGE - an online multimodal self-management program evaluating the impact of 12 weeks participation on cancer-related fatigue as measured by change in fatigue score from baseline to 12 weeks
Secondary ID [1] 292398 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer-related fatigue 303965 0
Leukemia 303985 0
Lymphoma 303986 0
Myeloma 303987 0
Condition category
Condition code
Cancer 303318 303318 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 303326 303326 0 0
Leukaemia - Acute leukaemia
Cancer 303327 303327 0 0
Myeloma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 12-week web-based program was developed based on best evidence reflecting the recommendations of the recent American Society of Clinical Oncology guidelines for the non-pharmacological management of cancer-related fatigue. The intervention is delivered as an online program via the internet for individual participation. It is intended for use in the participants’ home, however can be accessed from any computer with internet capabilities.
The program consists of three components.
1.Education about cancer-related fatigue
2.Toolkit Modules covering: sleep therapy, energy management, physical activity and mind-body interventions (cognitive-behavioural therapy and mindfulness-based interventions)
3.Online self-assessments, tracking and progress monitoring
Materials and procedures: Each module includes educational content, interactive exercises, self-assessment and tracking. Educational content is provided by material written specifically for the program by recognised experts in the field. It includes a combination of text, images, audio and videos. The education sections will also be portals to existing curated high quality information. Interactive exercises check the participants’ understanding of information that is provided and ensures their ability to apply the information to their individual situation. Self-assessment and tracking capabilities of the program allow participants to monitor and track their individual progress over time in relation to level of cancer-related fatigue. Motivation and reinforcement is facilitated by these functions with direct visualisation of improvements using individualised tables and graphs for easy interpretation of progress.
The online program is self-paced with unlimited access during the intervention period of 12 weeks. Weekly motivational emails are sent to participants with a progress summary and a reminder to complete modules and activities that are still incomplete.
Participants will initially be directed to general information about cancer-related fatigue. They subsequently can choose the modules that they further participate in to allow for an individually tailored approach. They are provided with a suggested weekly schedule. Prompts and encouragement to ongoing participation are forwarded via email and the program is able to place reminders in an electronic calendar.
The program includes an administrator interface for access to usage analytics by authorised members of the research team. Adherence to intervention will be assessed using:
Number of website visits
Number of log-ins
Number of modules completed
Length of time logged in
Total length of intervention exposure
Intervention code [1] 298568 0
Other interventions
Comparator / control treatment
Wait-list control group will receive usual care i.e. routine care with no access to the intervention
After a period of 12 weeks, the wait-list control group will be given access to the intervention.
Control group
Active

Outcomes
Primary outcome [1] 302701 0
The impact of participating in the web-based program for 12 weeks on cancer-related fatigue as measured by change in fatigue score from baseline to 12 weeks on the Functional Assessment of Chronic Illness Therapy– Fatigue (FACIT-F) Scale.
Timepoint [1] 302701 0
12 weeks post-intervention commencement
Secondary outcome [1] 336775 0
Health-related quality of life and its individual domains as measured by the Funcitonal Assessment of cancer Therapy (FACT)-general questionnaire.
Timepoint [1] 336775 0
12 weeks post-intervention commencement
Secondary outcome [2] 336821 0
Physical activity levels as measured by the Godin Leisure-time activity score
Timepoint [2] 336821 0
12 weeks post-intervention commencement
Secondary outcome [3] 336822 0
General distress as measured by the DASS-21 questionnaire
Timepoint [3] 336822 0
12 weeks post-intervention commencement

Eligibility
Key inclusion criteria
Age greater than or equal to 18 years
Fatigue score greater than or equal to 4 on a 0-10 numeric rating scale
Diagnosis of haematological malignancy including acute leukaemia, lymphoma and
multiple myeloma
Completed cancer treatment delivered with intent to cure or induce long-term remission within 3 to 24 months
Comprehensive, focused clinical and laboratory assessment by medical team has failed to identify a medically reversible cause for fatigue
Life expectancy >6 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-English speaking or reading
Planned radiotherapy or chemotherapy
Physical activity contraindicated
Physiological reason for fatigue
Severe psychiatric disorder e.g. severe depression
Do not use or have access to the internet

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
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
Power calculations show that 99 patients are needed in each study arm assuming a significance of 5% (two tailed), with power of 80% to detect a clinically relevant change of 4 points on the primary outcome variable (FACIT-Fatigue).
Primary analysis will be based on intention to treat using Linear Mixed Effect Modelling to assess for between group differences at the various time points for the primary and secondary outcome measures.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/02/2018
Actual
Date of last participant enrolment
Anticipated
1/04/2019
Actual
Date of last data collection
Anticipated
1/07/2019
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 8508 0
The Alfred - Prahran
Recruitment hospital [2] 8509 0
Latrobe Regional Hospital - Traralgon
Recruitment hospital [3] 8510 0
Peninsula Oncology Centre - Frankston
Recruitment postcode(s) [1] 16601 0
3004 - Prahran
Recruitment postcode(s) [2] 16602 0
3844 - Traralgon
Recruitment postcode(s) [3] 16603 0
3199 - Frankston

Funding & Sponsors
Funding source category [1] 296950 0
Government body
Name [1] 296950 0
Victoria Department of Health and Human Services
Country [1] 296950 0
Australia
Primary sponsor type
Individual
Name
Sharon Avery
Address
Alfred Hospital
Commercial Road
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 295955 0
None
Name [1] 295955 0
Address [1] 295955 0
Country [1] 295955 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298155 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 298155 0
Ethics committee country [1] 298155 0
Australia
Date submitted for ethics approval [1] 298155 0
21/08/2017
Approval date [1] 298155 0
22/09/2017
Ethics approval number [1] 298155 0

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

Contacts
Principal investigator
Name 76166 0
Dr Sharon Avery
Address 76166 0
Alfred Hospital
Commercial Road
Melbourne VIC 3004
Country 76166 0
Australia
Phone 76166 0
+61 (0)3 9076 2000
Fax 76166 0
+61 (0)3 9076 2298
Email 76166 0
[email protected]
Contact person for public queries
Name 76167 0
Stella Neale
Address 76167 0
Alfred Hospital
Commercial Road
Melbourne VIC 3004
Country 76167 0
Australia
Phone 76167 0
+61 0407 589 284
Fax 76167 0
+61 (0)3 9076 2298
Email 76167 0
[email protected]
Contact person for scientific queries
Name 76168 0
Sharon Avery
Address 76168 0
Alfred Hospital
Commercial Road
Melbourne VIC 3004
Country 76168 0
Australia
Phone 76168 0
+61 (0)3 9076 2000
Fax 76168 0
+61 (0)3 9076 2298
Email 76168 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.