Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001645448
Ethics application status
Approved
Date submitted
28/11/2016
Date registered
29/11/2016
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 pilot trial of the iCanADAPT Advanced Program, an internet Cognitive Behaviour Therapy (iCBT) program for the treatment of depression and anxiety in ambulatory advanced-stage cancer patients.
Scientific title
A pilot trial of the iCanADAPT Advanced Program, an internet Cognitive Behaviour Therapy (iCBT) program for the treatment of depression and anxiety in ambulatory advanced-stage cancer patients.
Secondary ID [1] 290149 0
Nil known
Universal Trial Number (UTN)
Trial acronym
iCanADAPT Advanced
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 300252 0
Anxiety 300253 0
Cancer 300254 0
Condition category
Condition code
Mental Health 300117 300117 0 0
Depression
Mental Health 300118 300118 0 0
Anxiety
Cancer 300119 300119 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 advanced-stage cancer patients. It is called iCanADAPT Advanced. Aspects of existing online interventions for anxiety and depression were adapted to the cancer context in the development of the iCanADAPT Advanced program. iCanADAPT Advanced is a 12 week self-managed mixed anxiety and depression program that is tailored to unique aspects of the cancer context, such as adapting to illness, fear of cancer progression and end-of-life concerns.

PROPOSAL
The proposed study will explore the outcomes of the clinician-guided iCBT program for people experiencing anxiety and/or depression symptoms who have been diagnosed with advanced-stage cancer.

ALLOCATION
Participants with elevated anxiety and depression scores who have been diagnosed with advanced-stage cancer 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.

OVERVIEW OF PROGRAM
The iCanADAPT Advanced program consists of six 'Modules' based on cognitive behavioural therapy (CBT). They include all treatment components typically seen in face-to-face CBT (the first-line treatment for depression and anxiety in people diagnosed with advanced-stage cancer). Each of the six '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 Module (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:
Lesson 1: Learning about Depression and Anxiety
Lesson 2: Adjusting to change
Lesson 3: Identifying and Tackling Thoughts
Lesson 4: Tackling unhelpful Behaviours
Lesson 5: Facing your fears
Lesson 6: Maintaining your skills

EXAMPLE OF A MODULE
Hence, for ‘Module 4’ 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. Your Checklist
6. Summary

HOW TO WORK THROUGH THE PROGRAM
Participants will be 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 the 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). The participants 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, or 'Module'', similar 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 and Lesson Summary etc. The 5-day lock-out refers to specific time points for the release of the next lesson and it's associated Lesson Summary. For example, if a participant undertook Lesson 3 in one sitting and hence downloaded the Lesson 3 Summary on 01st of the month, we purposely do not allow them to start 'Module 4' i.e., Lesson 4, 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 3, Lesson 3 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 registrar/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] 295887 0
Treatment: Other
Intervention code [2] 295922 0
Behaviour
Comparator / control treatment
Non-randomised trial
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299600 0
Changes in combined mean anxiety and depression scores according to the Hospital Anxiety and Depression Scale Total Score (HADS-T)
Timepoint [1] 299600 0
Baseline (just prior to commencing the program i.e., prior to Lesson 1)
Midpoint of the program (before Lesson 4, approximately 6 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 program)
Secondary outcome [1] 327657 0
Changes in severity of psychological distress according to mean scores on the Kessler-10 (K10)
Timepoint [1] 327657 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)
Secondary outcome [2] 327658 0
Changes in physical, social, emotional and functional status as measured by the Functional Assessment of Cancer Therapy=General Version scale (FACT-G QOL).
Timepoint [2] 327658 0
Baseline (just prior to commencing the program i.e., prior to Lesson 1)
Midpoint of the program (before Lesson 4, approximately 6 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 program)
Secondary outcome [3] 327659 0
Changes in the Fear of Cancer Progression Questionnaire (FCPQ)
Timepoint [3] 327659 0
Baseline (just prior to commencing the program i.e., prior to Lesson 1)
Midpoint of the program (before Lesson 4, approximately 6 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 program)
Secondary outcome [4] 327660 0
The feasibility of the treatment in terms of acceptability to patients and practicality for clinicians (as measured by the Credibility/Expectancy Questionnaire; CEQ)
Timepoint [4] 327660 0
Baseline (just prior to commencing the program i.e., prior to Lesson 1)
One week post-treatment (1 week post end of the program)

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 (PD) or Agoraphobia (Ag), Illness Anxiety Disorder (IAD), or Adjustment disorder (adj).
Presence of current advanced-stage cancer 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.
Prepared 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:
- Early-stage cancer patients or cancer survivors (i.e., localised cancer, no current cancer). The rational being that the iCanADAPT Advanced Program is specifically designed for advanced-stage cancer i.e., cancer with no curative intention to treat.
- Being within the first 6 weeks of de novo metastatic cancer diagnosis or initial diagnosis of recurrence of cancer. The rationale being that the program is not designed to address the immediate shock/distress of a cancer diagnosis; instead it is aimed to address clinical depression and clinical anxiety states
- Brain cancer/malignancy. The rationale being that intracranial neoplasm and their associated treatments regularly cause cognitive impairment and burdening a patient with an online modality of CBT would be a poor choice.
- Current hospitalisation.
- 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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
SAMPLE SIZE CALCULATION
In order to detect a difference on the primary outcome measure (HADS score) between baseline and post-treatment, recruitment of 30 participants will enable us to detect a minimum of 3.5 points difference (assuming standard deviation of 6.5 points on HADS total scores), at 80% power, and alpha set at 0.05.

ANALYSIS PLAN
All analyses will be undertaken using linear mixed and marginal models, with times as a fixed factor in the model, and subject as random intercept. Planned contrasts will be used to compare changes between pre- and post-treatment. Within-group effect sizes will be calculated (Hedges g) to measure the size of the within-group difference on primary and secondary outcome measures between pre- and post-treatment.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/03/2017
Actual
6/03/2017
Date of last participant enrolment
Anticipated
16/05/2017
Actual
9/02/2018
Date of last data collection
Anticipated
10/09/2018
Actual
11/09/2018
Sample size
Target
30
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 6656 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [2] 6657 0
Nepean Hospital - Kingswood
Recruitment hospital [3] 6658 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 14281 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 14282 0
2747 - Kingswood
Recruitment postcode(s) [3] 14283 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 294512 0
Other Collaborative groups
Name [1] 294512 0
Psycho-oncology Co-operative Research Group (PoCoG)
Country [1] 294512 0
Australia
Primary sponsor type
Hospital
Name
St. Vincent's Hospital, Sydney
Address
390 Victoria Street
Darlinghurst, NSW
2010
Country
Australia
Secondary sponsor category [1] 293376 0
Other Collaborative groups
Name [1] 293376 0
Psycho-oncology Co-operative Research Group (PoCoG)
Address [1] 293376 0
Psycho-oncology Co-operative Research Group (PoCoG)
Level 6, Chris O'Brien Lifehouse (C39Z)
The University of Sydney, NSW, 2006
Country [1] 293376 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295970 0
St Vincent's Hospital HREC
Ethics committee address [1] 295970 0
Ethics committee country [1] 295970 0
Australia
Date submitted for ethics approval [1] 295970 0
26/05/2016
Approval date [1] 295970 0
16/08/2016
Ethics approval number [1] 295970 0
HREC/16/SVH/147

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1273 1273 0 0
/AnzctrAttachments/371482-Letter - HREC FINAL approval at HREC Exec meeting 16 08 2016 - 16 096.pdf (Ethics approval)
Attachments [2] 1274 1274 0 0
/AnzctrAttachments/371482-Letter - SSA Authorisation - 16 096.pdf (Ethics approval)

Contacts
Principal investigator
Name 68986 0
Prof Gavin Andrews
Address 68986 0
Clinical Research Unit for Anxiety and Depression (CRUfAD)
Level 4, The O'Brien Centre, St Vincent's Hospital, Sydney
394-404 Victoria St.
Darlinghurst, NSW
2010
Country 68986 0
Australia
Phone 68986 0
+61283821400
Fax 68986 0
+61283821401
Email 68986 0
[email protected]
Contact person for public queries
Name 68987 0
Michael Murphy
Address 68987 0
Clinical Research Unit for Anxiety and Depression (CRUfAD)
Level 4, The O'Brien Centre, St Vincent's Hospital, Sydney
394-404 Victoria St.
Darlinghurst, NSW
2010
Country 68987 0
Australia
Phone 68987 0
+61283821400
Fax 68987 0
+61283821401
Email 68987 0
[email protected]
Contact person for scientific queries
Name 68988 0
Michael Murphy
Address 68988 0
Clinical Research Unit for Anxiety and Depression (CRUfAD)
Level 4, The O'Brien Centre, St Vincent's Hospital, Sydney
394-404 Victoria St.
Darlinghurst, NSW
2010
Country 68988 0
Australia
Phone 68988 0
+61283821400
Fax 68988 0
+61283821401
Email 68988 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
Ethics was not sought for this trial to make IPD available.


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.