Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000204549
Ethics application status
Approved
Date submitted
15/05/2006
Date registered
29/05/2006
Date last updated
17/06/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
An expressive writing randomised controlled trial with colorectal cancer patients: A test of the underlying mechanism
Scientific title
A randomised controlled trial with curative colorectal cancer patients to test the effectiveness of an expressive writing intervention to improve psychological adjustment and lessen the physical symptoms resulting from cancer treatment
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer 1182 0
Condition category
Condition code
Cancer 1265 1265 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study tests an expressive writing intervention. Expressive writing is the writing of deep thoughts and feelings about a cancer diagnosis and treatment. Participants engage in 4 writing sessions of 30 minutes duration each, spaced one week apart. Participants are allocated to one of two groups: Intervention group or Waitlist control group. The Intervention group participates in the intervention up to 4 weeks post their final cancer treatment session. The intervention is carried out individually by participants in their own homes, with phone assistance from a research assistant.
Intervention code [1] 1039 0
Other interventions
Comparator / control treatment
The Waitlist control group particpates in the intervention 5 months after their last treatment session.
Control group
Active

Outcomes
Primary outcome [1] 1703 0
Improvement in physical symptoms and symptom distress (Symptom Experience Index)
Timepoint [1] 1703 0
Questionnaire is administered immediately prior to intervention, immediately after the intervention and at 4 months follow-up. The Waitlist control group fills out a questionnaire at timepoints identical to the Intervention group, plus an additional questionnaire immediately after their writing intervention.
Primary outcome [2] 1704 0
Reduction in psychological distress
Timepoint [2] 1704 0
Questionnaire is administered immediately prior to intervention, immediately after the intervention and at 4 months follow-up. The Waitlist control group fills out a questionnaire at timepoints identical to the Intervention group, plus an additional questionnaire immediately after their writing intervention.
Primary outcome [3] 1705 0
Anxiety and depression (Brief Symptom Inventory)
Timepoint [3] 1705 0
Questionnaire is administered immediately prior to intervention, immediately after the intervention and at 4 months follow-up. The Waitlist control group fills out a questionnaire at timepoints identical to the Intervention group, plus an additional questionnaire immediately after their writing intervention.
Primary outcome [4] 1706 0
Increase in post-traumatic growth (Post-traumatic Growth Inventory)
Timepoint [4] 1706 0
Questionnaire is administered immediately prior to intervention, immediately after the intervention and at 4 months follow-up. The Waitlist control group fills out a questionnaire at timepoints identical to the Intervention group, plus an additional questionnaire immediately after their writing intervention.
Secondary outcome [1] 3055 0
Illness appraisals (Illness Perception Questionnaire - Revised), global beliefs (World Assumption Scale), social constraint (Social Contraint Scale), avoidance and intrusive thoughts (Impact of Events Scale).
Timepoint [1] 3055 0
These outcomes are measured in the same questionnnaire and at the same measurement timepoints as for the primary outcomes (immediately prior to intervention, immediately after the intervention and at 4 months follow-up).

Eligibility
Key inclusion criteria
(a) colon or rectal cancer (Dukes stage A, B or C), (b) completed all cancer treatment within last 4 weeks, (c) can read/write English.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) has metastatic disease, (b) has recurrent colorectal cancer, (c) previous cancer diagnosis of any type, (d) psychiatric illness (not related to cancer diagnosis).

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)
Allocation is not concealed. Patients are aware that they will complete the writing intervention 1 month post treatment completion if allocated to intervention group, or do no writing if allocated to the control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified, biased coin randomisation. Stratification is across disease stage (ie, three groups of Dukes A, B, C or D).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
None.
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/06/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1385 0
University
Name [1] 1385 0
University of Melbourne
Country [1] 1385 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Peter MacCallum Cancer Centre
Address
Peter MacCallum Foundation, Peter MacCallum Cancer Centre Level 3 St Andrews Place Locked Bag 1 A'Beckett Street East Melbourne VIC 8006
Country
Australia
Secondary sponsor category [1] 1219 0
University
Name [1] 1219 0
The University of Melbourne
Address [1] 1219 0
Postgraduate Scholarships Office
The University of Melbourne
Grattan Street
Parkville, VIC, 3010
Country [1] 1219 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2735 0
Peter MacCallum Cancer Centre
Ethics committee address [1] 2735 0
Ethics committee country [1] 2735 0
Australia
Date submitted for ethics approval [1] 2735 0
Approval date [1] 2735 0
16/03/2006
Ethics approval number [1] 2735 0
05/70
Ethics committee name [2] 5522 0
St. Vincent's Health
Ethics committee address [2] 5522 0
Ethics committee country [2] 5522 0
Australia
Date submitted for ethics approval [2] 5522 0
Approval date [2] 5522 0
02/11/2006
Ethics approval number [2] 5522 0
107/06
Ethics committee name [3] 5523 0
Goulburn Valley Health
Ethics committee address [3] 5523 0
New ethics address. Please modify.
Ethics committee country [3] 5523 0
Australia
Date submitted for ethics approval [3] 5523 0
Approval date [3] 5523 0
01/03/2007
Ethics approval number [3] 5523 0
10/06
Ethics committee name [4] 5524 0
Epworth HealthCare
Ethics committee address [4] 5524 0
New ethics address. Please modify.
Ethics committee country [4] 5524 0
Australia
Date submitted for ethics approval [4] 5524 0
Approval date [4] 5524 0
28/03/2007
Ethics approval number [4] 5524 0
36506
Ethics committee name [5] 5525 0
Melbourne Health
Ethics committee address [5] 5525 0
New ethics address. Please modify.
Ethics committee country [5] 5525 0
Australia
Date submitted for ethics approval [5] 5525 0
Approval date [5] 5525 0
15/05/2007
Ethics approval number [5] 5525 0
2007.100

Summary
Brief summary
This study will test an expressive writing intervention with bowel cancer patients to determine whether participation in the intervention leads to improved physical functioning, lessened psychological distress and increased personal growth, compared to those who do not participate in the intervention. Expressive writing is the writing of deep thoughts and feelings connected to a person's cancer diagnosis and treatment experiences. Participants in the intervention group will write in a journal for 30 minutes, 4 times, over 3 weeks. Participants will fill out questionnaires before and after the intervention as well as 2 months later, to determine whether they experience positive change, and changes over time.
Trial website
Trial related presentations / publications
Poster presentation at Australian Psychological Society 40th Annual Conference, Melbourne, November 2005.
Poster presentation at COSA Conference, November 2006.
Poster presentation at IPOS Conference, Venice, October 2006.
Public notes

Contacts
Principal investigator
Name 36187 0
Address 36187 0
Country 36187 0
Phone 36187 0
Fax 36187 0
Email 36187 0
Contact person for public queries
Name 10228 0
Ms Jenny Anderson
Address 10228 0
Cancer Nursing Research & Education
Peter MacCallum Cancer Centre
Level 3
St Andrews Place
Locked Bag 1 A'Beckett Street
East Melbourne VIC 8006
Country 10228 0
Australia
Phone 10228 0
+61 3 96563783
Fax 10228 0
+61 3 96561337
Email 10228 0
[email protected]
Contact person for scientific queries
Name 1156 0
Ms Jenny Anderson
Address 1156 0
Cancer Nursing Research & Education
Peter MacCallum Cancer Centre
Level 3
St Andrews Place
Locked Bag 1 A'Beckett Street
East Melbourne VIC 8006
Country 1156 0
Australia
Phone 1156 0
+61 3 96563783
Fax 1156 0
+61 3 96561337
Email 1156 0
[email protected]

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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