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Trial registered on ANZCTR


Registration number
ACTRN12607000219482
Ethics application status
Approved
Date submitted
17/04/2007
Date registered
23/04/2007
Date last updated
13/04/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Treatment of Anxiety and Depression in Head and Neck Cancer Patients
Scientific title
Treatment of Anxiety and Depression in Head and Neck Cancer Patients: An Evaluation of Cognitive Behaviour Therapy and Supportive Counselling
Secondary ID [1] 288990 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety (including Acute Stress Disorder and Posttraumatic Stress Disorder) in Head and Neck Cancer. 1747 0
Depression in Head and Neck Cancer. 1748 0
Condition category
Condition code
Cancer 1838 1838 0 0
Head and neck
Mental Health 1839 1839 0 0
Depression
Mental Health 1840 1840 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants who are recently diagnosed with a first onset head and neck cancer (HNC) and who report experiencing acute stress symptoms and/or depressive symptoms within the initial 4-6 weeks post-cancer diagnosis and prior to commencing their radiotherapy (primary or adjuvant) will be randomly allocated to receive Cognitive Behaviour Therapy (CBT). The CBT intervention is a directive therapy that comprises relaxation, stress management and coping skills training. Therapy will be conducted on an individual face-to-face basis and will consist of 6 consecutive weekly meetings, 1.5 hours each, commencing on the same week as participants' scheduled radiotherapy program. Participants will also receive a booster (7th) session of CBT at 1-month following the completion of their radiotherapy.
Intervention code [1] 1505 0
Treatment: Other
Comparator / control treatment
Participants who are recently diagnosed with a first onset head and neck cancer (HNC) and who report experiencing acute stress symptoms and/or depressive symptoms within the initial 4-6 weeks post-cancer diagnosis and prior to commencing their radiotherapy (primary or adjuvant) will be randomly allocated to receive Supportive Counselling (SC). The SC intervention is a non-directive approach in which client-participants are encouraged to express their concerns in an unconditionally supportive therapeutic environment. Therapy will be conducted on an individual face-to-face basis and will consist of 6 consecutive weekly meetings, 1.5 hours each, commencing on the same week as participants' scheduled radiotherapy program. Participants will also receive a booster (7th) session of SC at 1-month following the completion of their radiotherapy.
Control group
Active

Outcomes
Primary outcome [1] 2577 0
1. Clinician Administered PTSD Scale (CAPS) to assess cancer-related Posttraumatic Stress Disorder (PTSD)
Timepoint [1] 2577 0
Pre-treatment; Post-Treatment; 1-month, 6-month and 12-month follow-up.
Primary outcome [2] 2578 0
2. Beck Depression Inventory - second edition (BDI-II) to assess depressive symptoms
Timepoint [2] 2578 0
Pre-treatment; Post-Treatment; 1-month, 6-month and 12-month follow-up.
Primary outcome [3] 2579 0
3. State Trait Anxiety Inventory (STAI-Y) to assess trait and situational anxiety levels.
Timepoint [3] 2579 0
Pre-treatment; Post-Treatment; 1-month, 6-month and 12-month follow-up.
Secondary outcome [1] 4436 0
1. Functional Assessment of Cancer Therapy (FACIT) to assess multiple dimensions of quality of life including head and neck cancer symptoms
Timepoint [1] 4436 0
Pre-treatment; Post-Treatment; 1-month, 6-month and 12-month follow-up.
Secondary outcome [2] 4437 0
2. Brief COPE (actual full name) to assess cognitive and behavioural coping strategies
Timepoint [2] 4437 0
Pre-treatment; Post-Treatment; 1-month, 6-month and 12-month follow-up.
Secondary outcome [3] 4438 0
3. Treatment Credibility Scale to assess individuals' beliefs about treatment efficacy contingent on the intervention they have been randomized to receive (i.e., CBT or SC).
Timepoint [3] 4438 0
Pre-treatment; Post-Treatment; 1-month, 6-month and 12-month follow-up.

Eligibility
Key inclusion criteria
(1) First onset Stage I, II, or III HNC with minimum 12-month prognosis; (2) scheduled to receive primary or adjuvant radiotherapy; (3) meeting criteria for cancer-related PTSD or other anxiety disorders according to DSM-IV AND/OR meeting criteria for Major Depressive Disorder (MDD) within 6-weeks post-cancer diagnosis; (4) able to speak, read and write basic English; (5) medically fit to respond to the assessment and intervention procedure.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Prior history of cancer; (2) brain metastasis at diagnosis; (3) prior history of significant brain impairment; (4) current diagnosis of psychotic, organic mental or substance use disorders; (5) current severe suicidal ideation; (6) undergoing psychiatric treatment for mental illness; and (7) significant concurrent medical problems (e.g., recent heart bypass surgery).

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 number table
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using randomisation table and stratified by age and gender
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Assessors will be blind
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/05/2007
Actual
5/09/2007
Date of last participant enrolment
Anticipated
Actual
28/06/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5604 0
Royal Prince Alfred Hospital - Camperdown

Funding & Sponsors
Funding source category [1] 1988 0
Charities/Societies/Foundations
Name [1] 1988 0
The Cancer Council New South Wales
Country [1] 1988 0
Australia
Primary sponsor type
Individual
Name
Dr Maria Kangas, Macquarie University Sydney Australia
Address
Macquarie University
Ryde NSW 2109
Country
Australia
Secondary sponsor category [1] 1800 0
None
Name [1] 1800 0
NA
Address [1] 1800 0
Country [1] 1800 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3693 0
Macquarie University
Ethics committee address [1] 3693 0
Ethics committee country [1] 3693 0
Australia
Date submitted for ethics approval [1] 3693 0
Approval date [1] 3693 0
05/04/2007
Ethics approval number [1] 3693 0
HE24NOV2006-R04953
Ethics committee name [2] 3694 0
Sydney South West Area Health Service (RPAH Zone)
Ethics committee address [2] 3694 0
Ethics committee country [2] 3694 0
Australia
Date submitted for ethics approval [2] 3694 0
Approval date [2] 3694 0
16/03/2007
Ethics approval number [2] 3694 0
X07-0019]

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

Contacts
Principal investigator
Name 27439 0
A/Prof Maria Kangas
Address 27439 0
Centre for Emotional Health,
Department of Psychology
C3A, 717
Macquarie University
Sydney NSW 2109
Australia
Country 27439 0
Australia
Phone 27439 0
+612 98508599
Fax 27439 0
Email 27439 0
maria.kangas@mq.edu.au
Contact person for public queries
Name 10694 0
Dr. Maria Kangas
Address 10694 0
Department of Psychology/Centre for Emotional Health
Macquarie University
Sydney NSW 2109
Country 10694 0
Australia
Phone 10694 0
+61 2 98508599
Fax 10694 0
+61 2 98508062
Email 10694 0
maria.kangas@mq.edu.au
Contact person for scientific queries
Name 1622 0
Dr. Maria Kangas
Address 1622 0
Department of Psychology/Centre for Emotional Health
Macquarie University
Sydney NSW 2109
Country 1622 0
Australia
Phone 1622 0
+61 2 98508599
Fax 1622 0
+61 2 98508062
Email 1622 0
maria.kangas@mq.edu.au

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
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Documents added automatically
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