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Trial registered on ANZCTR


Registration number
ACTRN12622000420741
Ethics application status
Approved
Date submitted
1/03/2022
Date registered
14/03/2022
Date last updated
26/08/2022
Date data sharing statement initially provided
14/03/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Feasibility of a Stepped-Care Cognitive Behaviour Therapy Program for Cancer Fatigue Management
Scientific title
Feasibility of a Stepped-Care Cognitive Behaviour Therapy Program for Cancer Fatigue Management
Secondary ID [1] 306565 0
None
Universal Trial Number (UTN)
Trial acronym
REFRESH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 325464 0
Cancer related fatigue 325535 0
Condition category
Condition code
Cancer 322844 322844 0 0
Any cancer
Other 322906 322906 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Stepped-care cognitive behaviour therapy (CBT) for cancer survivors with persistent fatigue.
STEP 1: Participants who are experiencing moderate to severe fatigue are provided with a self-management CBT booklet to assist them with managing symptoms of fatigue and increasing energy. The booklet was designed specifically for this study and includes 17 tasks e.g. activity diary, fatigue diary, relaxation practice, thinking traps. Participants work through the booklet independently for 5 weeks, for 15-20 minutes a day. Telephone support from a Psychologist for 10-15 mins at weeks 2 and 5 and email support (psychologist) at weeks 1, 3 and 4 will be provided to support and monitor adherence, and to address any concerns raised.
At the completion of 5 weeks, participants’ fatigue symptoms and adherence to the program will be reassessed. Those whose fatigue level does not improve significantly are referred to STEP 2.
STEP 2: 4 x 50 minute face-to-face/Telehealth individual or group CBT sessions with a Clinical Psychologist will be offered commencing within 4 weeks of completing STEP 1, depending on group and participant availability. Sessions will occur weekly with up to 4 participants. Topics covered in CBT sessions will align with booklet chapters: Fatigue and your feelings, Behaviours to help fatigue, Your thoughts about fatigue, Moving on. Activities include relaxation, group discussion and worksheets. Adherence will be monitored using attendance records.
Intervention code [1] 322997 0
Behaviour
Intervention code [2] 323057 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330627 0
Acceptability of Intervention Measure (AIM) will be used to measure acceptability of stepped-care CBT for fatigue
Timepoint [1] 330627 0
6 & 12 weeks post intervention commencement
Primary outcome [2] 330654 0
Appropriateness of stepped-care CBT for fatigue evaluated using Intervention Appropriateness Measure (IAM)
Timepoint [2] 330654 0
6 and 12 weeks post intervention commencement
Primary outcome [3] 330655 0
Feasibility - accrual, attrition and cost will be evaluated using Feasibility of Intervention Measure (FIM), time to administer program and recruitment records
Timepoint [3] 330655 0
Monthly, end of data collection
Secondary outcome [1] 407041 0
Functional Assessment of Chronic Illness Therapy fatigue module (FACIT-Fatigue)
Timepoint [1] 407041 0
6 weeks, 12 weeks post intervention commencement
Secondary outcome [2] 407042 0
Participant perception of ability to self-manage fatigue assessed using Perceived self-efficacy for fatigue self-management (PSEFSM)
Timepoint [2] 407042 0
6 weeks, 12 weeks post intervention commencement
Secondary outcome [3] 407043 0
Quality of Life - Euroquol 5D-5L
Timepoint [3] 407043 0
6 weeks, 12 weeks post intervention commencement

Eligibility
Key inclusion criteria
• Aged 18 years or older at the time of recruitment
• Reports moderate to severe fatigue based on a series of screening questions administered on the phone prior to recruitment
• Is English speaking and able to read English (the intervention is only available in English)
• Cancer criteria: EITHER
i. Completed primary treatment for any cancer at least 3 months prior (to allow natural recovery)
OR
ii. Diagnosed with stage III or stage IV melanoma AND
• is receiving maintenance treatment using a single-agent immune checkpoint inhibitor (immunotherapy) or targeted therapy AND
• has an objective partial or complete tumour response by computed-tomography based imaging, or partial or complete metabolic response by positron emission tomography for a duration greater than 3 months
OR
iii. Diagnosed with a haematological cancer AND
• a partial or complete response as demonstrated by routine response assessment (ie Imaging or pathology) after at least 3 months treatment with long term therapy OR
• have previously demonstrated partial or complete response by routine response assessment post intensive treatment and have completed at least 3 months of maintenance therapy or observation OR
• has not received treatment for a chronic blood cancer due to being below treatment threshold (e.g. indolent disease)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Insufficient English
• At clinical screening interview is identified as
o likely experiencing a significant sleep disorder and would better benefit from our usual care CBT sleep intervention (CAN-Sleep) and/or
o experiencing psychosis, significant psychological distress or risk of suicide or self-harm
o not been experiencing persistent fatigue (i.e., symptom duration too brief)

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)
Not applicable
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
Other
Other design features
Participants may receive Step 1 OR Step 1 followed by Step 2
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Fifty adults who have received cancer treatment will be recruited to the study. This number is in line with our previous studies and is assessed as feasible within the timelines of the study and sufficient for a feasibility study.
Analyses will include all available data and will be performed in R (reference index version 3.6.1 or higher). Responses to PROMs will be scored according to author guidelines. Values for missing forms (i.e. PROMs) will not be imputed.
Descriptive statistics will be used to summarise patient demographic and clinical characteristics of all patients enrolled on the study.
The main feasibility outcomes are acceptability, fidelity and practicability of the stepped-care CBT intervention, including recruitment, retention, adherence and costs. Recruitment data will be summarised using a rate and 95% CI using the Poisson distribution. Adherence and retention data will be summarised using a proportion and 95% CI; this will be estimated using the Wilson method. Descriptive statistics will also be used to summarise acceptability and feasibility.
Changes from baseline at follow-up assessments for fatigue (FACIT-F), self-efficacy (PSEFSM) and Quality of Life (Ed-5D-5L) will be analysed descriptively (means and standard deviations). This will be done separately for patients who participate in Step 1 only and for those who participate in Steps 1 and 2. Effect size estimates as described by Kazis, Anderson, & Meenen (1989), will be used to characterise the size of observed differences.
Free text items from participant questionnaires will be summarised using content analysis, whereby the content of free responses will be coded and grouped, where applicable.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
19/11/2021
Date of last participant enrolment
Anticipated
22/04/2022
Actual
6/05/2022
Date of last data collection
Anticipated
1/07/2022
Actual
19/08/2022
Sample size
Target
50
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 21863 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 36926 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 310898 0
Charities/Societies/Foundations
Name [1] 310898 0
Perpetual Impact
Country [1] 310898 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
305 Grattan ST
Melbourne Vic 3000
Australia
Country
Australia
Secondary sponsor category [1] 312252 0
None
Name [1] 312252 0
None
Address [1] 312252 0
None
Country [1] 312252 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310461 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [1] 310461 0
Ethics committee country [1] 310461 0
Australia
Date submitted for ethics approval [1] 310461 0
10/09/2021
Approval date [1] 310461 0
16/09/2021
Ethics approval number [1] 310461 0
HREC/78080/PMCC

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

Contacts
Principal investigator
Name 117742 0
Dr Elizabeth Pearson
Address 117742 0
Peter MacCallum Cancer Centre
Health Services Research
Level 4, 535 Elizabeth St
Melbourne Victoria 3000
Country 117742 0
Australia
Phone 117742 0
+613 85595915
Fax 117742 0
Email 117742 0
Elizabeth.Pearson@petermac.org
Contact person for public queries
Name 117743 0
Elizabeth Pearson
Address 117743 0
Peter MacCallum Cancer Centre
Health Services Research
Level 4, 535 Elizabeth St
Melbourne Victoria 3000
Country 117743 0
Australia
Phone 117743 0
+613 85595915
Fax 117743 0
Email 117743 0
Elizabeth.Pearson@petermac.org
Contact person for scientific queries
Name 117744 0
Lauren Williams
Address 117744 0
Peter MacCallum Cancer Centre
Health Services Research
Level 4, 535 Elizabeth St
Melbourne Victoria 3000
Country 117744 0
Australia
Phone 117744 0
+613 85599054
Fax 117744 0
Email 117744 0
Lauren.Williams@petermac.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethical approval for data sharing was not sought.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15260Study protocol  Elizabeth.Pearson@petermac.org 383671-(Uploaded-01-03-2022-20-48-44)-Study-related document.pdf
15262Ethical approval  Elizabeth.Pearson@petermac.org 383671-(Uploaded-01-03-2022-20-49-24)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseStepped-care cognitive behaviour therapy program for treating cancer-related fatigue: protocol for a feasibility study.2022https://dx.doi.org/10.1186/s40814-022-01062-8
EmbaseVirtual Delivery of Stepped-Care Cognitive Behaviour Therapy for Cancer Related Fatigue: A Feasibility Study.2023https://dx.doi.org/10.1177/15347354231191701
N.B. These documents automatically identified may not have been verified by the study sponsor.