Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000629437
Ethics application status
Approved
Date submitted
10/12/2007
Date registered
12/12/2007
Date last updated
12/12/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
A workbook-journal for women with breast cancer: promoting psychological adjustment after treatment completion.
Scientific title
A randomised controlled trial comparing a self-help workbook-journal with treatment as usual in improving coping, quality of life, and psychological distress in breast cancer survivors.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 2621 0
Condition category
Condition code
Cancer 2737 2737 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One intervention was developed for the purpose of the study. This comprised a self-help workbook entitled “Women Moving On: A workbook~journal for women moving forward after treatment for breast cancer”. Self-management interventions have recently become a research focus, as they offer the benefits of being used in patients' own time, they overcome geographical barriers to attending psychological therapy, and are cost effective.

The interactive workbook developed for this study provides information, suggestions and worksheets, a relaxation/meditation tape, survivors’ stories, and opportunities for journal writing. The resource was based on themes derived from a series of focus-groups with breast cancer survivors (Oxlad et al., in press). The workbook was based on cognitive-behavioural strategies and emotional-expression, and encouraged women to actively process and engage in issues of relevance to them. It contained sections on (i) maintaining the medical partnership, (ii) physical well-being, (iii) feeling alone, (iv) family and friends, (v) emotional recovery, (vi) spirituality, (vii) seeking closure, (viii) moving forward, (ix) living the life you want, and (x) local and national resources. Some of the themes for the workbook were suggested by a previously evaluated American workbook (Angell et al., 2003).

Participants were encouraged to read sections of the workbook over the course of 3 months. Participants in the treatment condition were contacted after 4- and 8-weeks in order to receive qualitative feedback about the workbook.
Intervention code [1] 2356 0
Behaviour
Intervention code [2] 2357 0
Rehabilitation
Intervention code [3] 2358 0
Lifestyle
Comparator / control treatment
The control group received treatment as usual (TAU). At the end of the 6-month study period, participants in the control group received a copy of the workbook.
Control group
Active

Outcomes
Primary outcome [1] 3626 0
Examining if a significant change occurred in the following coping measures relative to the control group: Planning, Restraint, Seeking Social Support (Instrumental, Emotional), Turning to Religion, Venting Emotions, & Denial.
Timepoint [1] 3626 0
Baseline, 3 months and 6 months after receiving the workbook
Secondary outcome [1] 6077 0
Examining if a significant change occurred in the following distress and quality of life domains relative to the control group: Centre for Epidemiological Studies (CESD)Depression scale, Depression Anxiety Stress Scales (DASS) Anxiety subscale, Posttraumatic Stress Scale-Self Report (PSS-SR) Traumatic Stress Scale, European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Cancer 30 items (QLQ-C30) Global quality of life (QOL) scale and 5 functional subscales (physical, role, cognitive, social, emotional), and Breast-23 item Specific Module (BR-23) Body Image Scale.
Timepoint [1] 6077 0
Baseline, 3 months and 6 months.

Eligibility
Key inclusion criteria
Diagnosis of Primary Breast Cancer (Stages I-II), completed active treatment (surgery, radiotherapy, chemotherapy), aged 18 years or over, able to read sufficient English to be able to use the workbook.
Minimum age
18 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Recurrent Cancer

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)
All patients treated sequentially at one medical institution were offered the intervention by a clinical trials nurse after their active treatment was completed. Those who consented to participate were randomly allocated via a randomisation computer program to either the intervention, or to treatment as usual (TAU) by the clinical trials nurse. The randomisation schedule involved contacting the holder of the allocation schedule who was at the central administration (hospital) site. Therefore allocation was concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a computerised sequence generation.
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
4/03/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2874 0
University
Name [1] 2874 0
Flinders University
Country [1] 2874 0
Australia
Funding source category [2] 2875 0
Charities/Societies/Foundations
Name [2] 2875 0
Flinders Medical Centre Foundation
Country [2] 2875 0
Australia
Primary sponsor type
University
Name
Lisa Hallsworth
Address
School of Psychology, Flinders University
GPO Box 2100
Adelaide, SA, 5001
Country
Australia
Secondary sponsor category [1] 2591 0
University
Name [1] 2591 0
Tracey Wade
Address [1] 2591 0
School of Psychochology, Flinders University
GPO Box 2100
Adelaide, SA, 5001
Country [1] 2591 0
Australia
Other collaborator category [1] 107 0
Hospital
Name [1] 107 0
Bogda Koczwara
Address [1] 107 0
Department of Medical Oncology,
Flinders Medical Centre
Flinders Drive, Bedford Park, 5042
Country [1] 107 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4814 0
Flinders Clinical Research Ethics Committee
Ethics committee address [1] 4814 0
Ethics committee country [1] 4814 0
Australia
Date submitted for ethics approval [1] 4814 0
Approval date [1] 4814 0
02/11/2005
Ethics approval number [1] 4814 0
54/056

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

Contacts
Principal investigator
Name 28238 0
Address 28238 0
Country 28238 0
Phone 28238 0
Fax 28238 0
Email 28238 0
Contact person for public queries
Name 11395 0
Lisa Hallsworth
Address 11395 0
School of Psychology
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 11395 0
Australia
Phone 11395 0
+61 8 8201 2565
Fax 11395 0
Email 11395 0
lisa.hallsworth@flinders.edu.au
Contact person for scientific queries
Name 2323 0
Lisa Hallsworth
Address 2323 0
School of Psychology
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 2323 0
Australia
Phone 2323 0
+61882012565
Fax 2323 0
Email 2323 0
lisa.hallsworth@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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.