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Testicular CancerVITALSSNCT06702592

Virtual Testis Cancer Lay Support and Survivorship Aim 2

A study testing Virtual support and Patient educational material in people with Testicular Cancer and Testis Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 95 years, men only
Conditions the study is for
Testicular Cancer, Testis Cancer
What is being tested?
Virtual support and Patient educational material
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
1 siteUnited States
Study dates
Sep 2026to Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 95 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Deborah S Usinger contact

919-962-5431

dusinger@email.unc.edu

United States1 site
  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

    Deborah M Usinger, 919-962-0000, dusinger@email.unc.edu

    Taylor L Greene, (919) 962-0000, taylor_greene@med.unc.edu

Other trials in United States

About this study

Official title: Virtual Testicular Cancer Lay Support and Survivorship (VITALSS Study) 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 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.

Being tested
Virtual support, Patient educational material
Keywords
virtual support, emotional well-being, self-efficacy, financial toxicity, quality of life
Medical subject headings
Testicular Neoplasms, Financial Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual supportBehavioural

    Subjects will use a virtual support platform that was built for their needs.

  • Patient educational materialBehavioural

    Participants will have access to patient educational material.

Study groups in NCT06702592
Study groupRoleWhat they receive
Virtual supportExperimentalParticipants will have access to the virtual support platform.
Receives: Behavioral: Virtual support
Patient educational materialOtherParticipants will have access to patient educational material only.
Receives: Behavioral: Patient educational material

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Emotional well-being scores comparison

    Emotional well-being will be assessed by patient-reported outcomes questionnaires using a 9-item Positive Affect and Well-Being assessment from the Neuro-QOL Item Bank v1. Emotional well-being scores in virtual support and enhanced usual care will be compared. It is a 5-point Likert scale, higher scores reflect better emotional well-being.

    Measured: At baseline, 3-months, and 6-months

Secondary outcomes (10)
  1. Negative mental health comparison

    Negative mental health will be assessed by patient-reported outcomes questionnaires using 17 PROMIS items for anxiety, depression, loneliness, and stress. Negative mental health scores in virtual support and enhanced usual care will be compared. Scoring: Each item is rated on a 5-point scale between never (1) to always (5). The responses for each item are summed to get a total raw score. T-Scores: The raw score is then converted to a T-score using a scoring table specific to the PROMIS Anxiety item bank. T-scores standardize the results, making them comparable across different populations and studies. A T-score has a mean of 50 and a standard deviation of 10 in the general population.

    Measured: At baseline, 3-months, and 6-months

  2. Social well-being, acceptance and inclusion comparison

    Social well-being will be assessed by patient-reported outcomes questionnaires using the 6-item Acceptance/Inclusion subscale of the General Belongingness Scale (GBS). GBS measures an individual's sense of belonging and social connectedness. It consists of 12 items that assess feelings of acceptance and inclusion. Each item is rated on a 7-point Likert scale (1 = Strongly Disagree and 7 = Strongly Agree). Higher scores reflect better inclusion. Scores in virtual support and enhanced usual care will be compared.

    Measured: At baseline, 3-months, and 6-months

  3. Financial Toxicity comparison

    Financial Toxicity will be assessed by patient-reported outcomes questionnaires using a 12-item Comprehensive Score for Financial Toxicity (COST) instrument. Each item is rated on a 5-point Likert scale 0= = Not at all to 4= Very much. Higher scores indicate higher financial difficulties. Scores in virtual support and enhanced usual care will be compared.

    Measured: At baseline, 3-months, and 6-months

  4. Self-efficacy comparison

    Self-efficacy will be assessed by patient-reported outcomes questionnaires using 20 PROMIS items for self-efficacy for managing daily activities, emotions, social interactions, and symptoms. Self-efficacy scores in virtual support and enhanced usual care will be compared. Each item is rated on a 5-point scale ( 1 = Never, 5 = Always). Responses are summed to get a total raw score for each domain. Raw scores are converted to T-scores using a scoring table. T-scores standardize results, with a mean of 50 and a standard deviation of 10 in the general population.

    Measured: At baseline, 3-months, and 6-months

  5. Sexual Function and Satisfaction comparison

    Sexual Function and Satisfaction will be assessed by patient-reported outcomes questionnaires using a 20-item PROMIS SexFS instrument with domains for interest in sexual activity, global satisfaction with sex life, orgasm, and erectile function. Scores in virtual support and enhanced usual care will be compared. Each item is rated on a 5-point Likert scale: 1 = Not at all to 5= Very much. Raw scores are converted to T-scores using a scoring table specific to the PROMIS Sexual Function and Satisfaction profile. T-scores standardize the results, with a mean of 50 and a standard deviation of 10 in the general population.Higher T-scores indicate better sexual function and satisfaction.

    Measured: At baseline, 3-months, and 6-months

  6. Functional well-being comparison Functional well-being comparison

    Functional well-being will be assessed by patient-reported outcomes questionnaires using a 7-item subscale of the Functional Assessment of Cancer Therapy (FACT-G) instrument. Each item is rated on a 5-point Likert scale, 0= = Not at all to 4= Very much. Higher scores indicate better well-being. Scores in virtual support and enhanced usual care will be compared.

    Measured: At baseline, 3-months, and 6-months

  7. General Quality of Life comparison

    General Quality of Life will be assessed by patient-reported outcomes questionnaires using the PROMIS Global Health scale is an 8-item, validated survey that represents five core domains (physical function, pain, fatigue, emotional distress, social health). Two items each for physical and mental health as well as a question on quality of life will be administered. Scores in virtual support and enhanced usual care will be compared.

    Each item is rated on a 5-point Likert scale:1 = Poor to 5 = Excellent. Responses are summed to get a total raw score. The raw score is converted to a T-score using a scoring table. T-scores standardize the results, with a mean of 50 and a standard deviation of 10 in the general population. Higher T-scores indicate better overall health

    Measured: At baseline, 3-months, and 6-months

  8. General Self-Efficacy comparison

    General Self-Efficacy will be assessed by patient-reported outcomes questionnaires using the 4-item PROMIS instrument that measures the respondent's belief in managing specific problems or issues. Each item is scored on a 5-point Likert scale, 1 = Never to 5 = Always. The raw score is then converted to a T-score using a scoring table specific to the PROMIS domain being measured. T-scores standardize the results, with a mean of 50 and a standard deviation of 10 in the general population. Higher T-scores indicate more of the concept being measured Scores in virtual support and enhanced usual care will be compared.

    Measured: At baseline, 3-months, and 6-months

  9. Virtual platform usage

    Virtual platform usage will be assessed by time, visits, scrolling, posts, and messages spent on the virtual platform.

    Measured: At baseline, 3-months, and 6-months

  10. Healthcare and supportive care utilization

    Self-reported use of healthcare and supportive care services will be assessed by a survey. Participants will be asked to quantify healthcare or other supportive care visits over the intervention period.

    Measured: At baseline, 3-months, and 6-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2024
  2. Study startSep 2026 (estimated)
  3. Primary completionJun 2028 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06702592
Sponsor's protocol ID
LCCC2418 AIM2
Acronym
VITALSS
Status last verified
Aug 2026
First submitted
20 Nov 2024
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Virtual support and Patient educational material in people with Testicular Cancer and Testis Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Deborah S Usinger (919-962-5431, dusinger@email.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Emotional well-being scores comparison (time frame: At baseline, 3-months, and 6-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.

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