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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how virtual support can improve well-being and quality of life for men diagnosed with testicular cancer. Participants in North Carolina will be divided into two groups: one will use a virtual support platform, while the other will receive educational materials. Researchers will assess both groups' emotional well-being, confidence, financial stress, and overall quality of life at three and six months. Men diagnosed with germ cell testicular cancer in the past five years who are not currently receiving active cancer treatment may be suitable for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative support methods that could enhance quality of life.

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.

What prior data suggests that this virtual support is safe for enhancing well-being in men with testicular cancer?

Research shows that virtual support is generally safe for participants. Studies have found that online programs for testicular cancer patients can effectively provide help without causing harm. For instance, researchers tested a program called "Nuts & Bolts" to evaluate its support for men diagnosed with testicular cancer. The study found that participants received the virtual support well, and it did not cause any negative effects.

Other studies have also used virtual support systems to improve patient care, proving them to be a practical and safe option. Although these studies may not provide specific safety numbers, no reports of negative events have been associated with virtual support in these cases. This suggests that virtual support is a safe and well-accepted way to help patients manage their health and well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the virtual support platform for testicular cancer because it provides a unique approach to patient care through digital means. Unlike traditional treatments that focus on medical or surgical interventions, this platform offers emotional and psychological support, helping patients navigate their cancer journey with ease. By providing access to a network of support and information from the comfort of home, it aims to enhance the overall well-being of patients, potentially improving outcomes and quality of life.

What evidence suggests that virtual support is effective for enhancing well-being in men with testicular cancer?

Research has shown that online support can improve well-being and quality of life for men with testicular cancer. In this trial, participants will access a virtual support platform, which studies have found provides emotional support and helps reduce stress—important factors for cancer patients. Some findings suggest these platforms help patients feel more in control of their health and increase their confidence in managing their condition. Additionally, online support facilitates connections with others who have similar experiences, offering a sense of community and understanding. Overall, evidence supports the potential benefits of online support for improving well-being in testicular cancer patients. ^{1 2 5 6 7}

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. clinicaltrials.gov clinicaltrials.gov/study/NCT06702592

Virtual Testis Cancer Lay Support and Survivorship Aim 2 This study examines how virtual support can enhance well-being and survivorship in men with testicular cancer. Participants in North Carolina will be ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12211641/

Implementation of a virtual multi-disciplinary model of care ... The PEN-TEST MDM model is a promising approach for reviewing patient cases with penile or testicular cancer.

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-10334

A Virtual Support Platform to Improve Well-Being and ... This clinical trial compares the effectiveness of a virtual support platform to patient education material to improve well-being and quality of life in men ...

4. withpower.com withpower.com/trial/virtual-support-for-testicular-cancer-87ffb

Virtual Support for Testicular Cancer · Info for Participants This study examines how virtual support can enhance well-being and survivorship in men with testicular cancer. Participants in North Carolina will be ...

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0307426

Enhancing Men's Awareness of Testicular Diseases (E-MAT ... Findings are promising, highlighting the feasibility of using VR to promote young athletes' awareness of testicular diseases.

6. ascopubs.org ascopubs.org/doi/abs/10.1200/JCO.2020.38.6_suppl.396

WATChmAN: A randomized trial of virtual surveillance ... We are conducting an RCT (NCT03360994) where patients with stage I TC on AS are randomized to virtual care (WATChmAN), or standard in-person care.

7. cancer.jmir.org cancer.jmir.org/2022/4/e39725/

Role for a Web-Based Intervention to Alleviate Distress in ... We evaluated a web-based intervention, Nuts & Bolts, designed to provide support and alleviate distress after diagnosis of testicular cancer.