None listed
Conditions
Brief summary
Assessing the Impact of an Online Intervention (TrueNTH Testicular Cancer) on Men with Newly Diagnosed Testicular Cancer. Who is it for? If you are an adult male who has been diagnosed with testicular cancer in the last 4 weeks, and you have regular access to the internet on your home computer or smartphone you may eligible to participate in this study. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will have immediate access to TrueNTH TC, an online intervention with testicular cancer-related information and peer support, and will have access for 4 weeks after initial login. Participants in the other group will have 'delayed' access to the intervention one week after study enrolment and will have access for 4 weeks after initial login. Throughout the four week study period, participants will be asked to complete the stress questionnaires at set timepoints, either online through the TrueNTH TC website or during a telephone interview. It is hoped that access to the TrueNTH TC website will reduce the stress and anxiety levels of newly diagnosed testicular cancer patients.
Interventions
TrueNTH TC, an online intervention designed to provide testicular cancer (TC) related information and peer support. The information and resources provided on the intervention website have been designed specifically for this study. Participants will have access to TrueNTH TC content for 4 weeks after initial login. Their tc-trial.org login will cease to function 4 weeks after initial login.
Patients will be randomised using an electronic randomisation tool at the coordinating site into the follo
TrueNTH TC, an online intervention designed to provide testicular cancer (TC) related information and peer support. The information and resources provided on the intervention website have been designed specifically for this study. Participants will have access to TrueNTH TC content for 4 weeks after initial login. Their tc-trial.org login will cease to function 4 weeks after initial login. Patients will be randomised using an electronic randomisation tool at the coordinating site into the following arms in a 1:1 ratio: 1) Arm 1: Early Intervention Arm Following consent to the study, - The participant will undergo baseline assessment of distress using distress thermometer (DT) and Hospital Anxiety and Depression Scale (HADS) with the Study Coordinator via a telephone interview. The study coordinator will also conduct a baseline demographic questionnaire over the phone at this time. - Participants will be provided with a unique URL to the study website immediately. The website can be accessed anywhere, on their mobile phone or at home on their PC or laptop.The website contains 3 main elements: (1) Information and resources about TC, (2) A peer support platform that allows men who are currently experiencing a diagnosis or treatment for TC to be offered advice by a long term TC survivor and (3) Frequently asked questions regarding TC (responses are from both clinicians and men who have lived the experience). Participants can choose whether or not they use the peer support platform to communicate with another man who is a long term TC survivor. If the participant does choose to use the peer support platform the study does not set the length of time or numbers of occasions that contact is made, this is up to the participant. A pool of unique URLs will be provided to the Study Coordinator prior to the commencement of the trial. This allows for coded data to be collected during the study with re-identification only possible by backward decoding of the unique URL at the study site. Each URL will contain an ID used to track the interactions of each participant throughout their on-line sessions. The ID contains no personal or patient specific data. -Participants will undergo the following assessments via the study website: 1. Modified DT via the TrueNTH TC website at time of initial login 2. Modified DT at time of leaving the website when total cumulative use of the website has reached 10 minutes. These will be completed by the participant through the provision of a unique link. - The participant will undergo assessment of distress using distress thermometer (DT) and Hospital Anxiety and Depression Scale (HADS) with the Study Coordinator via a telephone interview at the specified time points (2 times within a month of initial use of TrueNTH TC). 2) Arm 2: Delayed intervention arm - Participants will undergo baseline assessments of distress using DT and HADS twice, at study enrolment and one week later through a telephone interview with the study coordinator. The study coordinator will also conduct a baseline demographic questionnaire over the phone at the time of enrolment. - 1 week post enrolment, the participant will be provided with a unique URL to the study website. The website can be accessed anywhere, on their mobile phone or at home on their PC or laptop.The website contains 3 main elements: (1) Information and resources about TC, (2) A peer support platform that allows men who are currently experiencing a diagnosis or treatment for TC to be offered advice by a long term TC survivor and (3) Frequently asked questions regarding TC (responses are from both clinicians and men who have lived the experience). Participants can choose whether or not they use the peer support platform to communicate with another man who is a long term TC survivor. If participants do choose to use the peer support platform the study does not set the length of time or numbers of occasions that contact is made, this is up to the participant. A pool of unique URLs will be provided to the Study Coordinator prior to the commencement of the trial. This allows for coded data to be collected during the study with re-identification only possible by backward decoding of the unique URL at the study site. Each URL will contain an ID used to track the interactions of each participant throughout their on-line sessions. The ID contains no personal or patient specific data. -Participants will undergo the following assessments via the study website: 1. Modified DT via the TrueNTH TC website at time of initial login 2. Modified DT at time of leaving the website when total cumulative use of the website has reached 10 minutes. These will be completed by the participant through the provision of a unique link. - The Study Coordinator conducts DT and HADS assessment at the specified time points (2 more times within 1.5 months).
Sponsors
The Walter and Eliza Hall Institute of Medical Research (WEHI)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Men with newly diagnosed TC (within 4 weeks of patient becoming aware of TC diagnosis) • Consistent access to a computer/smart phone and internet
Exclusion criteria
• Men who are not proficient in reading and writing English are excluded from participating. Proficiency in English is defined as at least year 7 level of English education. • Age < 18 years old. It has been found that children and adolescents under the age of 18 affected by testicular cancer face different issues (e.g. disruption to school) to affected adults. • Significant cognitive impairment.
Outcome results
None listed