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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 information initially 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

Secondary ID [1]

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

Anxiety

Cancer

Condition category

Condition code

Mental Health

Depression

Mental Health

Anxiety

Cancer

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]

Treatment: Other

Intervention code [2]

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]

Changes in combined mean anxiety and depression scores according to the Hospital Anxiety and Depression Scale Total Score (HADS-T)

Timepoint [1]

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]

Changes in severity of psychological distress according to mean scores on the
Kessler-10 (K10)

Timepoint [1]

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]

Changes in fear of cancer recurrence (Fear of Cancer Recurrence Inventory, FCRI)

Timepoint [2]

Secondary outcome [3]

Changes in physical, social, emotional and functional status as measured by the Functional Assessment of Cancer Therapy-General Version (FACT-G QOL).

Timepoint [3]

Secondary outcome [4]

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]

Secondary outcome [5]

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]

Secondary outcome [6]

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]

Secondary outcome [7]

Changes in mean anxiety scores according to the Hospital Anxiety and Depression Scale - Anxiety sub scale score (HADS-A)

Timepoint [7]

Secondary outcome [8]

Changes in mean depression scores according to the Hospital Anxiety and Depression Scale - Depression sub scale score (HADS-D)

Timepoint [8]

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?

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]

St Vincent's Hospital (Darlinghurst) - Darlinghurst

Recruitment hospital [2]

Westmead Hospital - Westmead

Recruitment hospital [3]

Nepean Hospital - Kingswood

Recruitment postcode(s) [1]

2010 - Darlinghurst

Recruitment postcode(s) [2]

2145 - Wentworthville

Recruitment postcode(s) [3]

2747 - Kingswood

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Psycho-oncology Co-operative Research Group (PoCoG)

Address [1]

Psycho-oncology Co-operative Research Group (PoCoG)
Level 6, Chris O'Brien Lifehouse (C39Z)
The University of Sydney, NSW, 2006

Country [1]

Australia

Primary sponsor type

Hospital

Name

St. Vincent's Hospital

Address

390 Victoria Street
Darlinghurst
NSW 2010

Country

Australia

Secondary sponsor category [1]

Other Collaborative groups

Name [1]

Psycho-oncology Co-operative Research Group (PoCoG)

Address [1]

Psycho-oncology Co-operative Research Group (PoCoG)
Level 6, Chris O'Brien Lifehouse (C39Z)
The University of Sydney, NSW, 2006

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St Vincent's Hospital HREC (EC00140)

Ethics committee address [1]

St. Vincent's Hospital Research Office
Level 6, de Lacy Building
390 Victoria Street
Darlinghurst
NSW 2010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

23/11/2015

Approval date [1]

18/01/2016

Ethics approval number [1]

HREC/15/SVH/432

Summary

Brief summary

The primary purpose of this trial is to evaluate the efficacy of an internet program, iCanADAPT, for depression and anxiety in adults diagnosed with cancer.

Who is it for?
You may be eligible to participate in this study if you are aged 18 or over, suffer from anxiety or depression and have an early stage cancer, or have survived an early stage cancer in the past.

Study details
All participants enrolled in this study will be randomly allocated (by chance) to receive the iCanADAPT program soon after enrolment or 16 weeks later. The iCanADAPT program is a 16 week online program which involves learning about tackling depression with a form of therapy called Cognitive Behavioural Therapy (CBT). CBT looks at improving how we manage our thoughts, actions and feelings. There are 8 lessons, each one taking up to an hour to complete, with the recommendation to do a new lesson every 1 – 2 weeks. There will also then be additional activities to do for around 3 hours per week. The program is tailored to unique aspects of the cancer context, such as fear of cancer recurrence and adapting to illness, side effects, and survivorship.
Participants will complete a number of important questionnaires to assess their depression and anxiety levels among other psychological factors, at the beginning of the program, mid-way through, then again at the end of the program and the last time is 3 months after finishing the program. Participants will also be asked to complete a short questionnaire before every lesson.

It is hoped that the findings of this trial will provide information regarding the efficacy of the iCanADAPT program in reducing depression and anxiety in cancer patients and cancer survivors.

Trial website

www.virtualclinic.org.au

Trial related presentations / publications

Nil as yet

Public notes

Attachments [1]

/AnzctrAttachments/370059-Letter - HREC FINAL approval at HREC Exec meeting 12 01 2016 - 15 286.pdf

Contacts

Principal investigator

Name

Prof Gavin Andrews

Address

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

Australia

Phone

+61283821400

Fax

+61283821401

[email protected]

Contact person for public queries

Name

Dr Michael Murphy

Address

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

Australia

Phone

+61283821400

Fax

+61283821401

[email protected]

Contact person for scientific queries

Name

Dr Michael Murphy

Address

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

Australia

Phone

+61283821400

Fax

+61283821401

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Conference abstract	No		Murphy M;Newby J;Butow P;Kirsten L;Shepherd H;Shaw... [More Details]
Plain language summary	No		The internet CBT intervention was helpful. People ... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	iCanADAPT 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.	2017	https://dx.doi.org/10.1186/s12885-017-3182-z

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically