360 Participants Needed

Virtual Support for Testicular Cancer

(VITALSS Trial)

TJ
DS
Overseen ByDeborah S Usinger
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: UNC Lineberger Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 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.12345

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.36789

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.

Research Team

HT

Hung-Jui Tan, MD

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria

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
See 2 more

Timeline

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)

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Virtual supportExperimental Treatment1 Intervention
Participants will have access to the virtual support platform.
Group II: Patient educational materialExperimental Treatment1 Intervention
Participants will have access to patient educational material only.

Find a Clinic Near You

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+

References

[National second opinion network for testicular cancer patients - transferring guidelines into practice!]. [2017]
Testicular cancer: improving outcomes with national quality performance indicators. [2020]
Identifying the unmet supportive care needs of individuals affected by testicular cancer: a systematic review. [2022]
The management of testicular cancer in Victoria, 1988-1993. Urology Study Committee of the Victorian Co-operative Oncology Group. [2021]
e-TC: Development and pilot testing of a web-based intervention to reduce anxiety and depression in survivors of testicular cancer. [2018]
Testicular cancer survivors' supportive care needs and use of online support: a cross-sectional survey. [2021]
Male sexuality after cancer treatment--needs for information and support: testicular cancer compared to malignant lymphoma. [2019]
[Issues around testicular carcinoma]. [2011]
Barriers and facilitators for oncology nurses discussing sexual issues with men diagnosed with testicular cancer. [2015]
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