Clinical trial NCT06702592: Virtual Testis Cancer Lay Support and Survivorship Aim 2
Official title: Virtual Testicular Cancer Lay Support and Survivorship (VITALSS Study) Aim 2
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Testicular Cancer
Testis Cancer
Keywords: virtual support
emotional well-being
self-efficacy
financial toxicity
quality of life
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2024-11-25
Enrollment: 360
Sex: MALE
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


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.

Primary outcomes:
measure: Emotional well-being scores comparison
timeFrame: At baseline, 3-months, and 6-months
Secondary outcomes:
measure: Negative mental health comparison
timeFrame: At baseline, 3-months, and 6-months
measure: Social well-being, acceptance and inclusion comparison
timeFrame: At baseline, 3-months, and 6-months
measure: Financial Toxicity comparison
timeFrame: At baseline, 3-months, and 6-months
measure: Self-efficacy comparison
timeFrame: At baseline, 3-months, and 6-months
measure: Sexual Function and Satisfaction comparison
timeFrame: At baseline, 3-months, and 6-months
measure: Functional well-being comparison Functional well-being comparison
timeFrame: At baseline, 3-months, and 6-months
measure: General Quality of Life comparison
timeFrame: At baseline, 3-months, and 6-months
measure: General Self-Efficacy comparison
timeFrame: At baseline, 3-months, and 6-months
measure: Virtual platform usage
timeFrame: At baseline, 3-months, and 6-months
measure: Healthcare and supportive care utilization
timeFrame: At baseline, 3-months, and 6-months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Lineberger Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Hung-Jui Tan, MD
role: PRINCIPAL_INVESTIGATOR
References: