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NCT Number: 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 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.

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Key information

Age range

18 year–95 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Virtual support

Behavioral

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

Patient educational material

Behavioral

Participants will have access to patient educational material.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Negative mental health comparison

    Time frame: At baseline, 3-months, and 6-months

    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.

  2. Social well-being, acceptance and inclusion comparison

    Time frame: At baseline, 3-months, and 6-months

    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.

  3. Financial Toxicity comparison

    Time frame: At baseline, 3-months, and 6-months

    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.

  4. Self-efficacy comparison

    Time frame: At baseline, 3-months, and 6-months

    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.

  5. Sexual Function and Satisfaction comparison

    Time frame: At baseline, 3-months, and 6-months

    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.

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

    Time frame: At baseline, 3-months, and 6-months

    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.

  7. General Quality of Life comparison

    Time frame: At baseline, 3-months, and 6-months

    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

  8. General Self-Efficacy comparison

    Time frame: At baseline, 3-months, and 6-months

    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.

  9. Virtual platform usage

    Time frame: At baseline, 3-months, and 6-months

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

  10. Healthcare and supportive care utilization

    Time frame: At baseline, 3-months, and 6-months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Deborah S Usinger

CONTACT

[email protected]

919-962-5431

Taylor J Greene

CONTACT

[email protected]

919-962-5506

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

Virtual Testicular Cancer Lay Support and Survivorship (VITALSS Study) Aim 2

Acronym: VITALSS

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Nov 25, 2024
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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