Virtual Support for Testicular Cancer

(VITALSS Trial)

Overseen By Deborah S Usinger

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

Disqualifiers: Woman, Non-English, Other cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

360 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on virtual support rather than medication changes.

How is the virtual support treatment for testicular cancer different from other treatments?

Virtual support for testicular cancer is unique because it focuses on providing online resources and social media tools to address the supportive care needs of young adults, particularly in areas like sexual health and emotional support, which are often unmet by traditional treatments. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Virtual support for testicular cancer?

The e-TC study shows that online interventions can help reduce anxiety and depression in testicular cancer survivors, suggesting that virtual support can be a feasible and acceptable way to address emotional needs in these patients. ^{3 6 7 8 9}

Who Is on the Research Team?

Hung-Jui Tan, MD

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for men in North Carolina with testicular cancer. It's designed to see if virtual support can help improve their emotional and overall well-being after treatment.

Inclusion Criteria

The subject is willing and able to comply with study procedures based on the judgment of the investigator

Electronic informed consent was obtained to participate in the study

I was diagnosed with testicular cancer less than 5 years ago.

Exclusion Criteria

Unwilling or unable to complete informed consent

I am a woman.

Non-English speaking

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline assessments for emotional well-being, self-efficacy, financial toxicity, and quality of life

1 week

1 visit (virtual)

Intervention

Participants are randomized into two groups: one with access to a virtual support platform and the other with access to patient educational materials only

6 months

Ongoing virtual engagement

Follow-up

Participants are monitored for changes in emotional well-being, self-efficacy, financial toxicity, and quality of life at 3 months and 6 months

6 months

2 assessments (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Virtual support

Trial Overview The study compares two groups: one using a virtual support platform and the other given patient educational materials only. Their well-being will be assessed at 3 and 6 months.

How Is the Trial Designed?

Group I: Virtual support Experimental Treatment 1 Intervention

Participants will have access to the virtual support platform.

Group II: Patient educational material Experimental Treatment 1 Intervention

Participants will have access to patient educational material only.

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Citations

1. Germany pubmed.ncbi.nlm.nih.gov

[National second opinion network for testicular cancer patients - transferring guidelines into practice!]. [2017]

2. England pubmed.ncbi.nlm.nih.gov

Testicular cancer: improving outcomes with national quality performance indicators. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Identifying the unmet supportive care needs of individuals affected by testicular cancer: a systematic review. [2022]

4. Australia pubmed.ncbi.nlm.nih.gov

The management of testicular cancer in Victoria, 1988-1993. Urology Study Committee of the Victorian Co-operative Oncology Group. [2021]

5. England pubmed.ncbi.nlm.nih.gov

e-TC: Development and pilot testing of a web-based intervention to reduce anxiety and depression in survivors of testicular cancer. [2018]

6. Germany pubmed.ncbi.nlm.nih.gov

Testicular cancer survivors' supportive care needs and use of online support: a cross-sectional survey. [2021]

7. Ireland pubmed.ncbi.nlm.nih.gov

Male sexuality after cancer treatment--needs for information and support: testicular cancer compared to malignant lymphoma. [2019]

8. Netherlands pubmed.ncbi.nlm.nih.gov

[Issues around testicular carcinoma]. [2011]

9. Scotland pubmed.ncbi.nlm.nih.gov

Barriers and facilitators for oncology nurses discussing sexual issues with men diagnosed with testicular cancer. [2015]