Virtual Testis Cancer Lay Support and Survivorship Aim 2 (VITALSS)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Testis Cancer; Testicular Cancer
• Intervention / Treatment: Behavioral: Virtual support; Behavioral: Patient educational material

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Deborah S Usinger; Phone Number: 919-962-5431; Email: dusinger@email.unc.edu
• Study Contact Backup: Name: Taylor J Greene; Phone Number: 919-962-5506; Email: taylor_greene@med.unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Lineberger Comprehensive Cancer Center
      • Principal Investigator: Hung-Jui Tan, MD, MSHPM
      • Contact: Deborah M Usinger; Phone Number: 919-962-0000; Email: dusinger@email.unc.edu
      • Contact: Taylor L Greene; Phone Number: (919) 962-0000; Email: taylor_greene@med.unc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual support; Participants will have access to the virtual support platform.	Behavioral: Virtual support; Subjects will use a virtual support platform that was built for their needs.
Other: Patient educational material; Participants will have access to patient educational material only.	Behavioral: Patient educational material; Participants will have access to patient educational material.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline, 3-months, and 6-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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	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.	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.	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.	At baseline, 3-months, and 6-months

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Hung-Jui Tan, MD, UNC Lineberger Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• Clinical trials at UNC Lineberger

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: November 20, 2024
• First Submitted That Met QC Criteria: November 20, 2024
• First Posted (Actual): November 25, 2024

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: quality of life; self-efficacy; financial toxicity; virtual support; emotional well-being
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Male Urogenital Diseases; Behavioral Symptoms; Endocrine Gland Neoplasms; Gonadal Disorders; Stress, Psychological; Testicular Diseases; Behavior; Financial Stress; Testicular Neoplasms
• Other Study ID Numbers: LCCC2418 AIM2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No