Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000278932
Ethics application status
Approved
Date submitted
17/02/2011
Date registered
16/03/2011
Date last updated
26/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
My Road Ahead: An Online Psychological Intervention for Men with Prostate Cancer
Scientific title
Assessing the efficacy of an online psychological intervention for men with prostate cancer: Impact on quality of life and mood state
Secondary ID [1] 259631 0
MHREC 2010.282
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 261195 0
Anxiety 261196 0
Depression 261197 0
Psychological distress 261198 0
Condition category
Condition code
Mental Health 259348 259348 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants who consent to take part in the study will be required to complete a series of questions online. This developed online assessment will include a measure of anxiety, depression and stress, quality of life, relationship satisfaction and sexual function. Participants will be randomly assigned to one of three groups; group 1 will receive access to the online intervention plus use of a moderated bulletin board. Group 2 will receive access to the online intervention only and group three will receive access to the moderated bulletin board only. Group 3 will be offered the option to complete the online intervention at the conclusion of the study if they would like to. The online intervention is a 6 module self-directed online internet based psychological intervention. Participants will explore emotional responses, thoughts and beliefs, masculinity, sexuality and intimacy, relationship factors and coping with uncertainty. The 6 modules are designed to be complted one module per week; a total of 6 weeks with an estimated time commitment of approximately 1 hour per week.
Intervention code [1] 258063 0
Lifestyle
Intervention code [2] 264220 0
Treatment: Other
Comparator / control treatment
Control participants in group 3 will receive no access to the developed online intervention but will receive access to the moderated bulletin board and will be used as the comparator group.
Control group
Active

Outcomes
Primary outcome [1] 262154 0
Quality of life:
The prostate cancer-related quality of life scales (PCa-QoL) (Clark et al., 2003)
The impact of erectile dysfunction on sexual and masculine identity will be measured using the Prostate cancer-related scales, which measure men's perceptions of early prostate cancer treatment outcomes, focussing on behavioural, interpersonal and emotional changes that patients attribute to prostate cancer (Clark et al., 2003). The prostate cancer-related quality of life questionnaire was developed from focus groups with 130 men (> 50 years old) who had been diagnosed with early stage prostate cancer (T1-T3, N0/X, M0/X) 12-24 months previously (39% treated with prostatectomy; 39% treated with radiotherapy; 8% treated with hormone therapy and 9% chose watchful waiting). The scales contains 84 Likert type items that fall into 11 scales including: 1. Urinary control (behavioural and interpersonal implications of impaired control of one's bladder); 2. Sexual ability - sexual intimacy (ability to perform sexually and feelings of frustration, embarrassment or failure); 3. Sexual confidence (confidence and anxiety about intimate activity and sexual thoughts); 4. Spouse affection (misgivings about demonstrations of affection with one's spouse), 5. Masculine self-esteem; 6. Health worry (uncertainty about one's health); 7. PSA concern; 8. Cancer control; 9. Informed decision; 10. Regret; and, 11. Positive outlook.
Timepoint [1] 262154 0
Baseline, 6 weeks, 12 weeks and 6 months
Primary outcome [2] 262155 0
Anxiety
Distress will be measured using the Depression Anxiety and Stress Scales (DASS-21) short version (Lovibond & Lovibond, 1995). The DASS is a set of three self-report scales designed to measure the negative emotional states of depression, anxiety and stress (Lovibond & Lovibond, 1995). Each of the three DASS scales contains 7 items. The depression scale measures dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest/involvement, anhedonia and inertia. The anxiety scale measures autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The stress scale assesses difficulty relaxing, nervous arousal, being irritable and impatient. Subjects are asked to rate the extent to which they have experienced each state over the past week, using a 4-point severity/frequency scale. The DASS scales have good concurrent validity with the Beck measures of depression and anxiety (BDI & BAI) and good internal consistency and reliability (Lovibond & Lovibond, 1995).
Timepoint [2] 262155 0
Baseline, 6 weeks, 12 weeks and 6 months
Primary outcome [3] 262156 0
Depression
Distress will be measured using the Depression Anxiety and Stress Scales (DASS-21) short version (Lovibond & Lovibond, 1995). The DASS is a set of three self-report scales designed to measure the negative emotional states of depression, anxiety and stress (Lovibond & Lovibond, 1995). Each of the three DASS scales contains 7 items. The depression scale measures dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest/involvement, anhedonia and inertia. The anxiety scale measures autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The stress scale assesses difficulty relaxing, nervous arousal, being irritable and impatient. Subjects are asked to rate the extent to which they have experienced each state over the past week, using a 4-point severity/frequency scale. The DASS scales have good concurrent validity with the Beck measures of depression and anxiety (BDI & BAI) and good internal consistency and reliability (Lovibond & Lovibond, 1995).
Timepoint [3] 262156 0
Baseline, 6 weeks, 12 weeks and 6 months
Secondary outcome [1] 273239 0
International Index of Erectile Function (IIEF)
The international index of erectile function (IIEF) is a 15-item self-report measure that was developed to assess sexual function among men with Erectile Dysfunction (ED) (Rosen et al., 1997). The IIEF instructs respondents to answer items according to functioning during the past 4 weeks. Responses to items are summed to determine the total IIEF score. Rosen et al. reported high internal consistency, for the total IIEF scale (a=0.91), as well as high test-retest reliability(r=0.82).
Timepoint [1] 273239 0
Baseline, 6 weeks, 12 weeks and 6 months
Secondary outcome [2] 273240 0
Kansas Marital Satisfaction Scale (KMSS). This is a three item questionnaire that measures overall marital satisfaction.
Timepoint [2] 273240 0
Baseline, 6 weeks, 12 weeks and 6 months
Secondary outcome [3] 279405 0
Communication Patterns Questionnaire Short Form (CPQ-SF). The CPQ-SF is an 11-item self report questionnaire that assess communication styles within a marital dyad. This scale yields three subscale scores including criticize/defend, discuss/avoid, and positive interaction patterns.
Timepoint [3] 279405 0
Baseline, 6 weeks, 12 weeks and 6 months

Eligibility
Key inclusion criteria
Men who have received treatment for localised prostate cancer at least 6 months ago.
Minimum age
18 Years
Maximum age
100 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Advanced prostate cancer including locally advanced disease and metastatic disease. Any uncontrolled mental health disorder or any signficant cognitive disorder or dementia.

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)
The proposed study aims assess the efficacy of the online intervention utilising a randomised controlled trial and CONSORT requirements for randomised controlled trials will be adhered to throughout the study. This phase will assess the efficacy of the online intervention by comparing the outcome measures of participants in the online intervention group with either a group undertaking the online intervention plus access to the moderated bulletin board or a group that only has access to the moderated bulletin board.

All participants will be required to complete the online assessment developed in phase 1. Participants will then be randomly assigned to one of three (3) groups. Randomisation will be concealed and conducted via central randomisation through computer generated allocations. The randomisation process will be fully automated and researchers will be blind to the participant's group allocation.

Group 1 is the online intervention group whereby participants will be enrolled into the 6 module online program.

Group 2 is the online intervention plus access to the moderated bulletin board group.

Group 3 is the moderated bulletin board only group where participants allocated to this group will only receive access to the bulletin board across the duration of the study. Participants in this group will act as a wait-list control group and will be offered access to the online program following their completion of the week 18 assessment.

Participants in all groups will undertake the online assessment at three times; baseline, post-intervention (week 6 for group 3) and 12 weeks post intervention (week 18 for group 3).

Participants will also be asked to record the number of contacts they have with additional support services including psychiatrists, psychologists and social workers as well as attending a support group or accessing support from the cancer council or other online resources. These factors will be statistically controlled for when analysing the data.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated random grouping
Masking / blinding
Blinded (masking 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
Recruiting
Date of first participant enrolment
Anticipated
23/08/2011
Actual
30/04/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3624 0
3050

Funding & Sponsors
Funding source category [1] 258527 0
Charities/Societies/Foundations
Name [1] 258527 0
beyondblue
Country [1] 258527 0
Australia
Funding source category [2] 258528 0
Charities/Societies/Foundations
Name [2] 258528 0
Prostate Cancer Foundation of Australia
Country [2] 258528 0
Australia
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital
Address
Grattan St
Parkville, VIC 3050
Country
Australia
Secondary sponsor category [1] 257664 0
None
Name [1] 257664 0
Address [1] 257664 0
Country [1] 257664 0
Other collaborator category [1] 251820 0
University
Name [1] 251820 0
Swinburne University
Address [1] 251820 0
National eTherapy Centre
PO BOX 218
Hawthorn VIC, 3122
Country [1] 251820 0
Australia
Other collaborator category [2] 251821 0
University
Name [2] 251821 0
Deakin University
Address [2] 251821 0
School of Psychology
221 Burwood Highway
Burwood VIC 3125
Country [2] 251821 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260498 0
Melbourne Health Human ethics committee
Ethics committee address [1] 260498 0
Royal Melbourne Hospital
Grattan St
Parkville, VIC 3050
Ethics committee country [1] 260498 0
Australia
Date submitted for ethics approval [1] 260498 0
18/11/2010
Approval date [1] 260498 0
29/07/2011
Ethics approval number [1] 260498 0
MHREC: 2008.282

Summary
Brief summary
Objectives: The overarching objective of this proposal is to develop and assess the efficacy of a unique online psychological intervention that is accessible, user friendly and engaging to men with CaP and that reduces the stigma of psychological distress in the context of prostate cancer. Aims: This project will be conducted over three phases. Phase 1: Development of resources - Develop an online assessment template to assess the psychological status of men with prostate cancer and to highlight specific areas of distress to the patient and the researchers. - Develop a 6 module self-directed online CBT-based psychological intervention for men with CaP. Phase 2: Consumer evaluation of developed resources - Assess the usability and acceptability of the online program with a consumer population Phase 3: Randomised controlled trial examining the efficacy of the online intervention - Assess the efficacy of the online intervention as compared to a usual care group across a number of domains including: Mental Health -Anxiety, Depression, Stress (DASS); Marital Satisfaction; Prostate-Specific Quality of Life (QoL) 1. Urinary control; 2. Sexual intimacy; 3. Sexual confidence; 4. Spouse affection 5. Masculine self-esteem; 6. Health worry; 7. PSA concern; 8. Cancer control; 9. Informed decision; 10. Regret; and, 11. Positive outlook.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32235 0
Dr Addie Wootten
Address 32235 0
Department of Urology
Level 3 Centre, Royal Melbourne Hospital
Grattan St
Parkville, VIC 3050
Country 32235 0
Australia
Phone 32235 0
+61 3 93427458
Fax 32235 0
Email 32235 0
addie.wootten@mh.org.au
Contact person for public queries
Name 15482 0
Dr Dr Addie Wootten
Address 15482 0
Department of Urology
Royal Melbourne Hospital
Grattan St
Parkville VIC 3050
Country 15482 0
Australia
Phone 15482 0
+61 3 93427458
Fax 15482 0
Email 15482 0
addie.wootten@mh.org.au
Contact person for scientific queries
Name 6410 0
Dr Dr Addie Wootten
Address 6410 0
Department of Urology
Royal Melbourne Hospital
Grattan St
Parkville VIC 3050
Country 6410 0
Australia
Phone 6410 0
+61 3 9342 7458
Fax 6410 0
Email 6410 0
addie.wootten@mh.org.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.