Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000934246
Ethics application status
Approved
Date submitted
30/10/2009
Date registered
2/11/2009
Date last updated
2/11/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Psychological Adjustment to Breast Cancer Diagnosis and Treatment: Evaluating an Interactive Self-Help Workbook.
Scientific title
A randomised controlled trial comparing a self-help workbook with an information-control in improving coping, distress and quality of life in women recently diagnosed with breast cancer.
Universal Trial Number (UTN)
Trial acronym
FYW
Linked study record

Health condition
Health condition(s) or problem(s) studied:
breast cancer 252083 0
distress 252084 0
Condition category
Condition code
Cancer 252288 252288 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The self-help workbook was entitled "Finding Your Way". This intervention consisted of several components, including: education about common psychosocial issues, relaxation and meditation (relaxation/meditation CD included), suggestions, cognitive behaviour therapy worksheets, survivor quotes and stories, and therapeutic writing. The level of utilisation was up to participants, but was monitred via structured feedback phone calls at 1 and 2 months, and via self-report at follow-up assessments. The total duration of the study was 6 months.
Intervention code [1] 241475 0
Behaviour
Intervention code [2] 241479 0
Treatment: Other
Intervention code [3] 241480 0
Other interventions
Comparator / control treatment
Information-control: this was also entitled "Finding Your Way" and contained identical information to the workbook, but provided no suggestions, worksheets or relaxation/meditation CD. Usage of the control condition was monitored via self-report at the 3 and 6-month follow-up assessments. The overall duration of the study was 6 months.
Control group
Active

Outcomes
Primary outcome [1] 253158 0
Distress: Depression scores as measured by Depression Anxiety stress Scale
Timepoint [1] 253158 0
baseline, then 3-month and 6-months after intervention received
Primary outcome [2] 253159 0
Distress: Anxiety scores as measured by Depression Anxiety Stress Scale
Timepoint [2] 253159 0
baseline, then 3-month and 6-months after intervention received
Primary outcome [3] 253160 0
Distress: Truamatic stress as measured by the total scale score of the Posttraumatic Stress Scale-Self Report
Timepoint [3] 253160 0
baseline, then 3-month and 6-months after intervention received
Secondary outcome [1] 262057 0
Quality of life (QOL): Global QOL, measured by EORTC QLQ-C30
Timepoint [1] 262057 0
baseline, then 3-month and 6-months after intervention received
Secondary outcome [2] 262058 0
Quality of life: Body Image, measured by EORTC BR-23.
Timepoint [2] 262058 0
baseline, then 3-month and 6-months after intervention received
Secondary outcome [3] 262059 0
Maladaptive coping: helplessness/hopelessness - measured by the mini-Mental Adjustment to Cancer Scale
Timepoint [3] 262059 0
baseline, then 3-month and 6-months after intervention received
Secondary outcome [4] 262060 0
Maladaptive coping: anxious preoccupation - measured by the mini-Mental Adjustment to Cancer Scale
Timepoint [4] 262060 0
baseline, then 3-month and 6-months after intervention received
Secondary outcome [5] 262061 0
Maladaptive coping: cognitive avoidance - measured by the mini-Mental Adjustment to Cancer Scale
Timepoint [5] 262061 0
baseline, then 3-month and 6-months after intervention received

Eligibility
Key inclusion criteria
Stage 0 to II breast cancer, diagnosed in the previous month, English speaking, aged 18 years or over
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
pre-existing neurological condition (e.g., dementia)
Insufficient english to complete questionnaires/read workbook

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Women were informed of the study by a breast care nurse, and those interested were subsequently contacted by the researcher. Allocation was implemented through the use of numbered containers and the sequence was concealed until interventions were assigned.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation was employed, and the sequence was generated via computer.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 243942 0
University
Name [1] 243942 0
Flinders University
Country [1] 243942 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
GPO Box 2100,
Adelaide, SA 5001
Country
Australia
Secondary sponsor category [1] 251299 0
Charities/Societies/Foundations
Name [1] 251299 0
Flinders Medical Centre Foundation Lyn Wrigley Award
Address [1] 251299 0
Flinders Drive, Bedford Park, SA 5042
Country [1] 251299 0
Australia
Other collaborator category [1] 916 0
Hospital
Name [1] 916 0
Flinders Medical Centre
Address [1] 916 0
Flinders Drive
Bedford Park, SA, 5042
Country [1] 916 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244058 0
Flinders Clinical Research Ethics Committee
Ethics committee address [1] 244058 0
Flinders University,
GPO Box 2100 Adelaide SA 5001
Ethics committee country [1] 244058 0
Australia
Date submitted for ethics approval [1] 244058 0
Approval date [1] 244058 0
24/11/2006
Ethics approval number [1] 244058 0
62/067
Ethics committee name [2] 244059 0
Ethics of Human Research Committee (The Queen Elizabeth Hospital & Lyell McEwin Hospital)
Ethics committee address [2] 244059 0
Ethics committee country [2] 244059 0
Australia
Date submitted for ethics approval [2] 244059 0
Approval date [2] 244059 0
04/10/2007
Ethics approval number [2] 244059 0
2007134

Summary
Brief summary
Despite the impact of breast cancer on distress and quality of life (QOL), most Australian women refuse to participate in group psychological treatments. Therefore innovative interventions are required. The current study aimed to evaluate whether an interactive self-help workbook (WB) has greater improvements than an information booklet in depression, anxiety, traumatic stress, QOL and coping for women recently diagnosed with breast cancer.
Trial website
Trial related presentations / publications
1. The International Psycho-Oncology Society 10th World Congress of Psycho-Oncology, Madrid, Spain, 9-13 June 2008
2. The 31st Australian Association for Cognitive Behaviour Therapy National Conference, Adelaide, Australia, September 17-21 2008
Public notes

Contacts
Principal investigator
Name 30437 0
Address 30437 0
Country 30437 0
Phone 30437 0
Fax 30437 0
Email 30437 0
Contact person for public queries
Name 13684 0
Dr Lisa Beatty
Address 13684 0
Flinders University
School of Psychology
GPO Box 2100
Adelaide, SA, 5001
Country 13684 0
Australia
Phone 13684 0
+61882012506
Fax 13684 0
Email 13684 0
lisa.beatty@flinders.edu.au
Contact person for scientific queries
Name 4612 0
Dr Lisa Beatty
Address 4612 0
Flinders University
School of Psychology
GPO Box 2100
Adelaide, SA, 5001
Country 4612 0
Australia
Phone 4612 0
+61882012506
Fax 4612 0
Email 4612 0
lisa.beatty@flinders.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

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