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Trial registered on ANZCTR


Registration number
ACTRN12616000231448
Ethics application status
Approved
Date submitted
3/02/2016
Date registered
19/02/2016
Date last updated
18/01/2019
Date data sharing statement initially provided
18/01/2019
Date results provided
18/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised Controlled Trial (RCT) of iCanADAPT, an internet Cognitive Behavioural Therapy (iCBT) program for the treatment of depression and anxiety in early stage
cancer patients and cancer survivors.
Scientific title
A Randomised Controlled Trial (RCT) of iCanADAPT, an internet Cognitive Behavioural Therapy (iCBT) program for the treatment of depression and anxiety in early stage
cancer patients and cancer survivors.
Secondary ID [1] 288474 0
Nil known
Universal Trial Number (UTN)
U1111-1179-1481
Trial acronym
iCanADAPT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 297510 0
Anxiety 297511 0
Cancer 297512 0
Condition category
Condition code
Mental Health 297708 297708 0 0
Depression
Mental Health 297709 297709 0 0
Anxiety
Cancer 297710 297710 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
INTRODUCTION
The Clinical Research Unit for Anxiety and Depression (CRUfAD) have developed an online cognitive behavioural therapy (CBT) intervention for anxiety and depression in cancer patients and survivors. It is called iCanADAPT. Aspects of existing online interventions for anxiety and depression were adapted to the cancer context in the development of the iCanADAPT program. iCanADAPT is a 16week self-managed, mixed anxiety and depression program that is tailored to unique aspects of the cancer context, such as fear of cancer recurrence and adapting to illness, side-effects and survivorship.

PROPOSAL
The proposed study will evaluate the efficacy of the newly developed program as a cancer specific, online intervention for anxiety and depression and will aim to demonstrate that iCBT is an effective program for reducing anxiety and depressive symptoms in cancer patients and survivors.

ALLOCATION
Participants with elevated anxiety and depression scores and either a current early stage cancer or a prior cancer diagnosis will be recruited. They will complete online screening questionnaires on CRUfAD's clinical trials website (www.virtualclinic.org.au) to assess eligibility to participate, and provide informed consent, before being interviewed over the telephone to assess eligibility for inclusion into the study. If accepted into the study, the participant will be randomly allocated into one of two groups:
GROUP 1 receive access to the iCanADAPT program
GROUP 2 treatment as usual group (may access care at any point) and after a 16 week period, will then be offered access the iCanADAPT program.

OVERVIEW OF PROGRAM
The iCanADAPT program consists of eight ‘Modules’ based on cognitive behavioural therapy (CBT). It includes all treatment components typically seen in face-to-face CBT (the first-line treatment for depression and anxiety in early stage cancer patients and survivors). Each of the eight ‘Modules’ can be considered as a discrete package. Each of the ‘Modules’ contains:
- A Lesson (consists of a comic based, easy to read story, pertinent to all participants),
- An associated Lesson Summary (consists of more dense reading material, likely pertinent to all participants)
- Any additional resources for that part (which may not be needed by all participants)
- Any additional worksheets for that part (pertinent to all participants)

THEMES of THE MODULES
The overriding messages in each ‘Module’ i.e. the each ‘Lesson’ and it’s associated ‘Lesson Summary’, and any additional resources is arranged by themes. The main themes are:
Module/Lesson 1 Learning about Depression and Anxiety in the cancer context
Module /Lesson 2 Identifying and Tackling Thoughts
Module/Lesson 3 Tackling Unhelpful Behaviours
Module/Lesson 4 Helpful Coping
Module/Lesson 5 Adjusting to Change
Module/Lesson 6 Tackling Avoidance
Module/Lesson 7 Mastering Your Skills
Module/Lesson 8 Staying Well in the Long Term and Getting Even Better

EXAMPLE of a MODULE
Hence, for ‘Module 3’ the theme is “Tackling Unhelpful Behaviours”, hence the Lesson shows the characters addressing their unhelpful behaviours in a comic based, easy to follow story. Further specific, more detailed, writing is contained in the Lesson summary, in this case under the following headings:
1. Tackling Low Activity
2. Before starting activity scheduling and physical activity
3. Daily Activity Scheduling
4. Physical Activity
5. Structured Problem Solving
6. Assertive Communication Skills
7. Your Checklist
8. Summary
In this case, the Extra Resources in ‘Module 3’ are:
3.1 - 100 Things To Do (List of Pleasant Activities)
3.2 - Diet
3.3 - Smoking
3.4 - FAQs Module 3
Furthermore, worksheets relevant to the Lesson/ Lesson Summary are provided:
3.W1 - Activity planning and Monitoring worksheet
3.W2 Structured Problem Solving worksheet
3.W3 Pros and Cons Worksheet

HOW TO WORK THROUGH THE PROGRAM
Participants will asked to complete the Lesson (including the questionnaires beforehand for that lesson). Each lesson will take approximately 45 - 60 minutes to complete. They may go through all slides in a single sitting, or they may take multiple sittings to get to the end. Once they have completed the Lesson, the computer system automatically releases the associated Lesson Summary (i.e. it becomes available for download on completion of the lesson). They participant are asked to practice any associated skills/activities over the course of the following 14 days. Furthermore, upon completion of the Lesson, the extra resources for that part of the course, that ‘Module’, similarly become available. We ask participants to aim for an additional 3 hours per week to read these associated resources and to put into practice the CBT skills.

TIMING of EACH MODULE
There is a purposeful lock-out time of 5 days between release of the subsequent ‘Module’ i.e. next Lesson & Lesson Summary etc. The 5-day lock-out refers to specific time points for the release of the next lesson and its associated lesson summary. For example, if a participant undertook Lesson 4 in one sitting & hence downloaded the Lesson 4 Summary on 01st of the month, we purposely do not allow them to start ‘Module 5’, i.e. Lesson 5, until at least 5 days later, the 05th of the month. We will recommend instead that they spend up to two weeks (until the 14th of the month) reflecting and working through the prior Module i.e. Lesson 4, Lesson 4 Summary/ recommendations. However, as some patients prefer to progress at a quicker pace we do not necessitate the full 14 day period. Instead a five day minimum is set; to ensure that the patient does not get information overload and to encourage them to reflect and undertake activities for at least a short time period.

CONTACT
Routine email contact from the clinician (registered clinical psychologist or psychiatry trainee/ medical officer) after completion of the first two lessons will occur. Further email contact will occur then as required. The participant is also able to email or phone the clinician at any point during the trial as required. The participant completes a measure of psychological distress before each lesson and if their scores increase by one or more standard deviations the clinician is automatically alerted and initiates contact with the participant by phone or email.

ADHERENCE
Strategies used to improved adherence to intervention protocols and procedures for monitoring adherence include: automated email reminders, monitoring the downloading of homework, collection of data on how long participants spent reading lessons and practicing skills.
Intervention code [1] 293811 0
Treatment: Other
Intervention code [2] 293812 0
Behaviour
Comparator / control treatment
Control GROUP - treatment as usual group (may access care at any point) and after a 16 week period, will then be offered access the iCanADAPT program.

These participants will complete 3 sets of questionnaires during their waiting period. Once the immediate treatment group has completed the iCanADAPT online program and post-treatment questionnaires (at week 17), the control group will be offered the same program.

Should participants wish may access standard care for depression/anxiety through their usual healthcare pathway. In the case of these participants we foresee that they may attend local mental health practitioners/ GP, or psycho-social support staff at their local cancer centre during this time period. Should they choose to do so, we ask them to let us know. They are not excluded from the trial if they choose to access assistance.
Control group
Active

Outcomes
Primary outcome [1] 297241 0
Changes in combined mean anxiety and depression scores according to the Hospital Anxiety and Depression Scale Total Score (HADS-T)
Timepoint [1] 297241 0
Baseline (just prior to commencing the program i.e. prior to Lesson 1).
Midpoint of the program (before Lesson 5, approximately 8 weeks after commencement of the program).
One week post-treatment (1 week post end of the program),
At 3-months post-treatment (3 months post end of the program, for treatment group only).
Secondary outcome [1] 320434 0
Changes in severity of psychological distress according to mean scores on the
Kessler-10 (K10)
Timepoint [1] 320434 0
Baseline (just prior to commencing the program i.e. prior to Lesson 1).
Prior to every subsequent lesson of the program.
One week post-treatment (1 week post end of the program),
At 3-months post-treatment (3 months post end of the program, for treatment group only).
Secondary outcome [2] 320435 0
Changes in fear of cancer recurrence (Fear of Cancer Recurrence Inventory, FCRI)
Timepoint [2] 320435 0
Baseline (just prior to commencing the program i.e. prior to Lesson 1).
Midpoint of the program (before Lesson 5, approximately 8 weeks after commencement of the program).
One week post-treatment (1 week post end of the program),
At 3-months post-treatment (3 months post end of the program, for treatment group only).
Secondary outcome [3] 320436 0
Changes in physical, social, emotional and functional status as measured by the Functional Assessment of Cancer Therapy-General Version (FACT-G QOL).
Timepoint [3] 320436 0
Baseline (just prior to commencing the program i.e. prior to Lesson 1).
Midpoint of the program (before Lesson 5, approximately 8 weeks after commencement of the program).
One week post-treatment (1 week post end of the program),
At 3-months post-treatment (3 months post end of the program, for treatment group only).
Secondary outcome [4] 320748 0
Changes in suicidal ideation and/or passive death wish (as measured by the The Patient Health Questionnaire, Question 9 (PHQ-9, Q9) and the Beck Depression Inventory-II, Item 9 (BDI-II, Item 9).
Timepoint [4] 320748 0
Baseline (just prior to commencing the program i.e. prior to Lesson 1).
Midpoint of the program (before Lesson 5, approximately 8 weeks after commencement of the program).
One week post-treatment (1 week post end of the program),
At 3-months post-treatment (3 months post end of the program, for treatment group only).
Secondary outcome [5] 320749 0
Proportion of participants with a change in the frequency of service use
and days out of role according to the Service Use and Days out of Role
Questionnaire (SUDOR)
Timepoint [5] 320749 0
Baseline (just prior to commencing the program i.e. prior to Lesson 1).
Midpoint of the program (before Lesson 5, approximately 8 weeks after commencement of the program).
One week post-treatment (1 week post end of the program),
At 3-months post-treatment (3 months post end of the program, for treatment group only).
Secondary outcome [6] 320750 0
The feasibility of the treatment in terms of acceptability to patients and practicality for clinicians (as measured by changes in the Credibility/Expectancy Questionnaire; CEQ) - composite measure
Timepoint [6] 320750 0
Baseline (just prior to commencing the program i.e. prior to Lesson 1).
Midpoint of the program (before Lesson 5, approximately 8 weeks after commencement of the program).
One week post-treatment (1 week post end of the program),
At 3-months post-treatment (3 months post end of the program, for treatment group only).
Secondary outcome [7] 320752 0
Changes in mean anxiety scores according to the Hospital Anxiety and Depression Scale - Anxiety sub scale score (HADS-A)
Timepoint [7] 320752 0
Baseline (just prior to commencing the program i.e. prior to Lesson 1).
Midpoint of the program (before Lesson 5, approximately 8 weeks after commencement of the program).
One week post-treatment (1 week post end of the program),
At 3-months post-treatment (3 months post end of the program, for treatment group only).
Secondary outcome [8] 320753 0
Changes in mean depression scores according to the Hospital Anxiety and Depression Scale - Depression sub scale score (HADS-D)
Timepoint [8] 320753 0
Baseline (just prior to commencing the program i.e. prior to Lesson 1).
Midpoint of the program (before Lesson 5, approximately 8 weeks after commencement of the program).
One week post-treatment (1 week post end of the program),
At 3-months post-treatment (3 months post end of the program, for treatment group only).

Eligibility
Key inclusion criteria
Adults, aged over 18 years old with no maximum age.
Self-identified as suffering from depression and/or anxiety and have online questionnaire scores indicating a clinical level of anxiety and/or depression on the Hospital Anxiety and Depression Scale (HADS).
Results of telephone diagnostic interview consistent with one, or more, diagnoses of Major Depressive Disorder (MDD), Generalised Anxiety Disorder (GAD), Panic Disorder or Agoraphobia, Illness Anxiety Disorder (IAD), or Adjustment disorder.
Presence of current early stage cancer, or early stage cancer survivorship, will be based on self-report.
Participants must be prepared to provide name/location of primary cancer care centre.
Prepared to provide own name, phone number and address.
Prepared to provide the name and address of a local general practitioner, and to provide written informed consent.
English language skills equivalent to a School Certificate level. Have access to a phone and a computer with internet and a printer.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Mental health exclusion criteria will include psychosis, bipolar disorder, substance abuse or dependence and current suicidality.

Cancer related exclusion criteria will include:
- Any metastases (cancer spread). The rationale being that the iCanADAPT program is specifically designed for early stage cancer i.e. cancer with curative intention to treat.
- Currently in-patient.
- Being within the first 6 weeks of cancer diagnosis.
- Brain cancer/ malignancy.

Physical health status exclusion will be an ECOG (Eastern Cooperative Oncology Group) performance status of greater than 1 (Oken et al., 1982).

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)
Random allocation to groups will be stratified according to cancer status (current cancer/cancer survivorship). Within those two groups patients who meet inclusion criteria for the study will be randomly allocated to one of the two groups (Group 1 iCBT; Group 2 deferred iCBT).

Allocation concealment will occur in the following way: A staff member not involved in the clinical trial will generate the sequence using computer software (www.random.org) and place each choice in a sequentially numbered, opaque sealed and stapled envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be done via www.random.org
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Deferred treatment.
All participants will be given access to the treatment program.
Group one will receive prompt access (for a 16 week period).
Group two will wait until the first group have completed the program, and at the 16 week point will be given access to the program.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
SAMPLE SIZE CALCULATION
We would expect pre-post improvement of Effect Size (ES) 1.0 for the iCBT group on the primary outcome measures. We also expect the iCBT group to improve more than the waitlist group by an ES of 0.6. Sample size is powered to have an 80% chance of detecting differences at p<.05.

ANALYSIS PLAN
All analyses will be undertaken using liner mixed models. Relationships between observations at different occasions will be modelled with an unstructured covariance matrix. For each experimental group, planned contrasts will be used to compare changes between pre- treatment and post-treatment, and at 3-month follow-up for the iCBT group only. Planned pairwise comparisons will be used to compare between-groups at post-treatment, and effect sizes will be calculated (Cohen’s d) to measure the size of the between-groups difference on primary and secondary outcome measures.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/02/2016
Actual
1/03/2016
Date of last participant enrolment
Anticipated
1/11/2016
Actual
22/11/2016
Date of last data collection
Anticipated
29/05/2017
Actual
10/08/2017
Sample size
Target
100
Accrual to date
Final
113
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 5224 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [2] 5225 0
Westmead Hospital - Westmead
Recruitment hospital [3] 5226 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 12696 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 12697 0
2145 - Wentworthville
Recruitment postcode(s) [3] 12698 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 292817 0
Other Collaborative groups
Name [1] 292817 0
Psycho-oncology Co-operative Research Group (PoCoG)
Country [1] 292817 0
Australia
Primary sponsor type
Hospital
Name
St. Vincent's Hospital
Address
390 Victoria Street
Darlinghurst
NSW 2010
Country
Australia
Secondary sponsor category [1] 291558 0
Other Collaborative groups
Name [1] 291558 0
Psycho-oncology Co-operative Research Group (PoCoG)
Address [1] 291558 0
Psycho-oncology Co-operative Research Group (PoCoG)
Level 6, Chris O'Brien Lifehouse (C39Z)
The University of Sydney, NSW, 2006
Country [1] 291558 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294323 0
St Vincent's Hospital HREC (EC00140)
Ethics committee address [1] 294323 0
Ethics committee country [1] 294323 0
Australia
Date submitted for ethics approval [1] 294323 0
23/11/2015
Approval date [1] 294323 0
18/01/2016
Ethics approval number [1] 294323 0
HREC/15/SVH/432

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 744 744 0 0
/AnzctrAttachments/370059-Letter - HREC FINAL approval at HREC Exec meeting 12 01 2016 - 15 286.pdf

Contacts
Principal investigator
Name 63294 0
Prof Gavin Andrews
Address 63294 0
Clinical Research Unit for Anxiety and Depression (CRUfAD)
4, The O'Brien Centre, St Vincent's Hospital, 394-404 Victoria St, Darlinghurst NSW 2010
Country 63294 0
Australia
Phone 63294 0
+61283821400
Fax 63294 0
+61283821401
Email 63294 0
[email protected]
Contact person for public queries
Name 63295 0
Michael Murphy
Address 63295 0
Clinical Research Unit for Anxiety and Depression (CRUfAD)
4, The O'Brien Centre, St Vincent's Hospital, 394-404 Victoria St, Darlinghurst NSW 2010
Country 63295 0
Australia
Phone 63295 0
+61283821400
Fax 63295 0
+61283821401
Email 63295 0
[email protected]
Contact person for scientific queries
Name 63296 0
Michael Murphy
Address 63296 0
Clinical Research Unit for Anxiety and Depression (CRUfAD)
4, The O'Brien Centre, St Vincent's Hospital, 394-404 Victoria St, Darlinghurst NSW 2010
Country 63296 0
Australia
Phone 63296 0
+61283821400
Fax 63296 0
+61283821401
Email 63296 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We have not sought ethics approval to provide IPD.


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
SourceTitleYear of PublicationDOI
EmbaseiCanADAPT Early protocol: Randomised controlled trial (RCT) of clinician supervised transdiagnostic internet-delivered cognitive behaviour therapy (iCBT) for depression and/or anxiety in early stage cancer survivors -vs- treatment as usual.2017https://dx.doi.org/10.1186/s12885-017-3182-z
N.B. These documents automatically identified may not have been verified by the study sponsor.