Virtual Testis Cancer Lay Support and Survivorship Aim 2
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Virtual support, Patient educational material.
- Who it may be relevant to
- Registry conditions: Testicular Cancer, Testis Cancer. Basic parameters: 18 years — 95 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Virtual Testicular Cancer Lay Support and Survivorship (VITALSS Study) Aim 2
Overview
This study examines how virtual support can enhance well-being and survivorship in men with testicular cancer. Participants in North Carolina will be randomized into two groups: one with access to a virtual support platform and the other with access to patient educational materials only. After six months, the emotional well-being, self-efficacy, financial toxicity, and quality of life of both groups will be compared at 3 months and 6 months after baseline assessments.
Interventions
- Behavioral Virtual support
Subjects will use a virtual support platform that was built for their needs. - Behavioral Patient educational material
Participants will have access to patient educational material.
Primary outcome measures
- Emotional well-being scores comparison [Time frame: At baseline, 3-months, and 6-months]
Secondary outcome measures (10)
- Negative mental health comparison [Time frame: At baseline, 3-months, and 6-months]
- Social well-being, acceptance and inclusion comparison [Time frame: At baseline, 3-months, and 6-months]
- Financial Toxicity comparison [Time frame: At baseline, 3-months, and 6-months]
- Self-efficacy comparison [Time frame: At baseline, 3-months, and 6-months]
- Sexual Function and Satisfaction comparison [Time frame: At baseline, 3-months, and 6-months]
- Functional well-being comparison Functional well-being comparison [Time frame: At baseline, 3-months, and 6-months]
- General Quality of Life comparison [Time frame: At baseline, 3-months, and 6-months]
- General Self-Efficacy comparison [Time frame: At baseline, 3-months, and 6-months]
- Virtual platform usage [Time frame: At baseline, 3-months, and 6-months]
- Healthcare and supportive care utilization [Time frame: At baseline, 3-months, and 6-months]
Eligibility criteria
Inclusion criteria
- Men within 5 years of their initial diagnosis of germ cell testicular cancer.
- The subject is willing and able to comply with study procedures based on the judgment of the investigator.
- Adults aged 18-95 years old.
- Electronic informed consent was obtained to participate in the study.
Exclusion criteria
- Woman gender
- Non-English speaking
- Unwilling or unable to complete informed consent.
- On active treatment for another cancer.
- Actively receiving chemotherapy, radiation, or surgery for testicular cancer.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- UNC Lineberger Comprehensive Cancer Center — Chapel Hill
Identifiers
NCT: NCT06702592 · LCCC2418 AIM2