Virtual Testis Cancer Lay Support and Survivorship Aim 2

Not Applicable

Not yet recruiting

• Conditions: Testicular Cancer; Testis Cancer

• Registration Number: NCT06702592
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-20
• Study First Submitted QC: 2024-11-20
• Study First Posted: 2024-11-25
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-05
• Study Start: 2025-06
• Primary Completion: 2028-06
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 360

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Emotional well-being scores comparison	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 Outcome Measures

Name	Time	Method
Sexual Function and Satisfaction comparison	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.
Negative mental health comparison	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.
Social well-being, acceptance and inclusion comparison	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.
Financial Toxicity comparison	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.
Self-efficacy comparison	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.
Virtual platform usage	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.
Functional well-being comparison Functional well-being comparison	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.
General Quality of Life comparison	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
General Self-Efficacy comparison	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.
Healthcare and supportive care utilization	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.

Trial Locations

Locations (1)

UNC Lineberger Comprehensive Cancer Center; 🇺🇸 Chapel Hill, North Carolina, United States