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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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
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.
- Conditions
- Testicular Cancer, Testis Cancer
- 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 group | Role | What they receive |
|---|---|---|
| Virtual support | Experimental | Participants will have access to the virtual support platform. Receives: Behavioral: Virtual support |
| Patient educational material | Other | Participants 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.
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)
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
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
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
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
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
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
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
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
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
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.
- First posted25 Nov 2024
- Study startSep 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testicular CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Hung-Jui Tan, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Testicular Cancer Lay Support and Survivorship (VITALSS Study) Aim 2
- ClinicalTrials.gov ID
- NCT06702592
- Acronym / sponsor ID
- VITALSS / LCCC2418 AIM2
- Conditions
- Testicular Cancer, Testis Cancer
- Keywords
- virtual support, emotional well-being, self-efficacy, financial toxicity, quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 25 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual support | Experimental | Behavioral: Virtual supportParticipants will have access to the virtual support platform. |
| Patient educational material | Other | Behavioral: Patient educational materialParticipants will have access to patient educational material only. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual supportSubjects will use a virtual support platform that was built for their needs. | Behavioural | Virtual support |
| Patient educational materialParticipants will have access to patient educational material. | Behavioural | Patient educational material |
Primary outcome
Emotional well-being scores comparison
Time frame: At baseline, 3-months, and 6-months
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.
10 secondary outcomes
Negative mental health comparison
Time frame: At baseline, 3-months, and 6-months
Social well-being, acceptance and inclusion comparison
Time frame: At baseline, 3-months, and 6-months
Financial Toxicity comparison
Time frame: At baseline, 3-months, and 6-months
Self-efficacy comparison
Time frame: At baseline, 3-months, and 6-months
Sexual Function and Satisfaction comparison
Time frame: At baseline, 3-months, and 6-months
Functional well-being comparison Functional well-being comparison
Time frame: At baseline, 3-months, and 6-months
General Quality of Life comparison
Time frame: At baseline, 3-months, and 6-months
General Self-Efficacy comparison
Time frame: At baseline, 3-months, and 6-months
Virtual platform usage
Time frame: At baseline, 3-months, and 6-months
Healthcare and supportive care utilization
Time frame: At baseline, 3-months, and 6-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Clinical trials at UNC LinebergerLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hung-Jui Tan, MD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
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.