None listed
Conditions
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.
Interventions
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 w
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.
Sponsors
Royal Melbourne Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
Male
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
Men who have received treatment for localised prostate cancer at least 6 months ago.
Exclusion criteria
Advanced prostate cancer including locally advanced disease and metastatic disease. Any uncontrolled mental health disorder or any signficant cognitive disorder or dementia.
Outcome results
None listed