Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000001796
Ethics application status
Approved
Date submitted
12/12/2012
Date registered
2/01/2013
Date last updated
11/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Finding My Way: A randomised controlled trial of an online self-help coping program for reducing cancer distress.
Scientific title
A randomised controlled trial comparing the efficacy of 'Finding My Way' with an information-control in reducing distress for patients with early stage cancer.
Secondary ID [1] 279847 0
Nil
Universal Trial Number (UTN)
Trial acronym
FMW
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 285735 0
Psychological distress 285736 0
Condition category
Condition code
Cancer 285916 285916 0 0
Any cancer
Mental Health 285917 285917 0 0
Depression
Mental Health 288331 288331 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
'Finding My Way' (FMW) is a 6-week multimedia internet application, where a new module is released to participants each week, with a reminder email to use the program. The frequency in which participants will access these modules will be at the participants' discretion. Modules cover a range of commonly experienced psychosocial issues. Each module of FMW is comprised of three main components: psycho-education, cognitive-behavioural worksheets / strategies, and survivor stories and quotes. An online journal-blog and a resource section is available throughout the duration of the program.
Intervention code [1] 284169 0
Behaviour
Intervention code [2] 286195 0
Treatment: Other
Comparator / control treatment
An online information-only version of Finding My Way will be simultaneously developed to provide an appropriate attention control for the study. The control condition covers the same 6 module topics, but has no interactive features(i.e., no worksheets, activities, relaxation exercises, or journal-blog).
Control group
Active

Outcomes
Primary outcome [1] 286411 0
Negative affect: the total scale score of the Depression, Anxiety, Stress Scale.
Timepoint [1] 286411 0
Pre-treatment, post-treatment, then 3 and 6 months after treatment-completion
Primary outcome [2] 286412 0
Traumatic stress: the total scale score of the Post-Traumatic Stress Scale - Self Report. This scale measures cancer-specific distress.
Timepoint [2] 286412 0
Pre-treatment, post-treatment, then 3 and 6 months after treatment-completion
Secondary outcome [1] 295804 0
Coping: Helplessness Hopelessness as measured by the mini-MAC
Timepoint [1] 295804 0
Pre-treatment, post-treatment, then 3 and 6 months after treatment-completion
Secondary outcome [2] 300219 0
Coping: Anxious Preoccupation as measured by the mini-MAC
Timepoint [2] 300219 0
Pre-treatment, post-treatment, then 3 and 6 months after treatment-completion
Secondary outcome [3] 300220 0
Coping: Cognitive Avoidance as measured by the mini-MAC
Timepoint [3] 300220 0
Pre-treatment, post-treatment, then 3 and 6 months after treatment-completion
Secondary outcome [4] 300221 0
Coping: Fatalism as measured by the mini-MAC
Timepoint [4] 300221 0
Pre-treatment, post-treatment, then 3 and 6 months after treatment-completion
Secondary outcome [5] 300222 0
Coping: Fighting Spirit as measured by the mini-MAC
Timepoint [5] 300222 0
Pre-treatment, post-treatment, then 3 and 6 months after treatment-completion
Secondary outcome [6] 300223 0
Health Related Quality of Life (QOL): Total QOL

as measured by the European Organisation for Research on the Treatment of Cancer (EORTC) Quality of Life Qustionaire Cancer-30 item scale (QLQ-C30).
Timepoint [6] 300223 0
Pre-treatment, post-treatment, then 3 and 6 months after treatment-completion
Secondary outcome [7] 300224 0
QOL: Role functioning, as measured by the EORTC QLQ-C30
Timepoint [7] 300224 0
Pre-treatment, post-treatment, then 3 and 6 months after treatment-completion
Secondary outcome [8] 300225 0
QOL: Physical functioning, as measured by the EORTC QLQ-C30
Timepoint [8] 300225 0
Pre-treatment, post-treatment, then 3 and 6 months after treatment-completion
Secondary outcome [9] 300226 0
QOL: Emotional functioning, as measured by the EORTC QLQ-C30
Timepoint [9] 300226 0
Pre-treatment, post-treatment, then 3 and 6 months after treatment-completion
Secondary outcome [10] 300227 0
QOL: Cognitive functioning, as measured by the EORTC QLQ-C30
Timepoint [10] 300227 0
Pre-treatment, post-treatment, then 3 and 6 months after treatment-completion
Secondary outcome [11] 300228 0
QOL: Social functioning, as measured by the EORTC QLQ-C30
Timepoint [11] 300228 0
Pre-treatment, post-treatment, then 3 and 6 months after treatment-completion

Eligibility
Key inclusion criteria
1. Cancer being treated with curative intent (e.g., breast, prostate, colorectal, testicular, lymphomas, haematologic or gynaecologic malignancies)
2. Currently receiving active cancer treatment (surgery, chemotherapy, radiotherapy)
3. Age 18 years or over
4. Sufficient English language literacy
5. Access to the internet (home or work)
6. Provide an active email address and phone number
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Diagnosis of advanced cancer
(While advanced cancer patients will not be targeted for recruitment, this is a population that asks for interventions and may self-refer to the program. Therefore individuals who specifically request to participate will be enrolled, but not included in primary analyses. If a large enough sub-sample self-refers to the program, a sub-analysis will be conducted.)

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)
The allocation is concealed until interventions are assigned: This process will be automated within the website, therefore it is central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation with stratification: A computer sequence generation algorithm in blocks to either ‘intervention’ or ‘attention control’, and each condition is assigned in random order within the block. The stratification variable is 'gender' - to ensure balance across conditions within gender.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2013
Actual
30/09/2013
Date of last participant enrolment
Anticipated
Actual
17/11/2015
Date of last data collection
Anticipated
Actual
26/06/2016
Sample size
Target
188
Accrual to date
Final
191
Recruitment in Australia
Recruitment state(s)
ACT,QLD,SA,WA,VIC
Recruitment postcode(s) [1] 6092 0
5042
Recruitment postcode(s) [2] 6093 0
3181
Recruitment postcode(s) [3] 6094 0
3002
Recruitment postcode(s) [4] 6095 0
3050
Recruitment postcode(s) [5] 6096 0
4001

Funding & Sponsors
Funding source category [1] 286434 0
Government body
Name [1] 286434 0
NHMRC
Country [1] 286434 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
School of Psychology
GPO Box 2100
Adelaide
SA, 5001
Country
Australia
Secondary sponsor category [1] 285219 0
None
Name [1] 285219 0
Address [1] 285219 0
Country [1] 285219 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288512 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 288512 0
Ethics committee country [1] 288512 0
Australia
Date submitted for ethics approval [1] 288512 0
Approval date [1] 288512 0
09/11/2012
Ethics approval number [1] 288512 0
1/10/0372

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

Contacts
Principal investigator
Name 33716 0
Dr Lisa Beatty
Address 33716 0
School of Psychology,
Flinders University
GPO Box 2100
Adelaide, SA, 5001
Country 33716 0
Australia
Phone 33716 0
+61882012506
Fax 33716 0
+61882013877
Email 33716 0
[email protected]
Contact person for public queries
Name 16963 0
Lisa Beatty
Address 16963 0
School of Psychology,
Flinders University
GPO Box 2100
Adelaide, SA, 5001
Country 16963 0
Australia
Phone 16963 0
+61882012506
Fax 16963 0
+61882013877
Email 16963 0
[email protected]
Contact person for scientific queries
Name 7891 0
Lisa Beatty
Address 7891 0
School of Psychology,
Flinders University
GPO Box 2100
Adelaide, SA, 5001
Country 7891 0
Australia
Phone 7891 0
+61882012506
Fax 7891 0
+61882013877
Email 7891 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

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFinding My Way: results of a multicentre RCT evaluating a web-based self-guided psychosocial intervention for newly diagnosed cancer survivors.2019https://dx.doi.org/10.1007/s00520-018-4526-1
EmbaseModerators of intervention efficacy for Finding My Way: A web-based psychosocial intervention for cancer-related distress.2021https://dx.doi.org/10.1007/s00520-021-06291-w
N.B. These documents automatically identified may not have been verified by the study sponsor.