Virtual Testis Cancer Lay Support and Survivorship Aim 2
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-95
SponsorUNC Lineberger Comprehensive Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Woman gender
Non-English speaking
Unwilling or unable to complete informed consent.
On active treatment for another cancer.
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual support
BehavioralSubjects will use a virtual support platform that was built for their needs.
Patient educational material
BehavioralParticipants will have access to patient educational material.
Treatment groups
360 Participants
are divided into 2 treatment groupsGroup A: Virtual supportExperimental treatment 1 intervention
Group B: Patient educational materialOther 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
At baseline, 3-months, and 6-monthsSecondary outcomes
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.
Time frame
At baseline, 3-months, and 6-months2
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.
Time frame
At baseline, 3-months, and 6-months3
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.
Time frame
At baseline, 3-months, and 6-months4
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.
Time frame
At baseline, 3-months, and 6-monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
UNC Lineberger Comprehensive Cancer Center
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: