NCT06702592

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
25mo left

Started May 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
May 2026Jun 2028

First Submitted

Initial submission to the registry

November 20, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 25, 2024

Completed
1.4 years until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

2.1 years

First QC Date

November 20, 2024

Last Update Submit

April 24, 2026

Conditions

Testicular CancerTestis Cancer

Keywords

virtual supportemotional well-beingself-efficacyfinancial toxicityquality of life

Outcome Measures

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.

    At baseline, 3-months, and 6-months

Secondary Outcomes (10)

  • Negative mental health comparison

    At baseline, 3-months, and 6-months

  • Social well-being, acceptance and inclusion comparison

    At baseline, 3-months, and 6-months

  • Financial Toxicity comparison

    At baseline, 3-months, and 6-months

  • Self-efficacy comparison

    At baseline, 3-months, and 6-months

  • Sexual Function and Satisfaction comparison

    At baseline, 3-months, and 6-months

  • +5 more secondary outcomes

Study Arms (2)

Virtual support

EXPERIMENTAL

Participants will have access to the virtual support platform.

Behavioral: Virtual support

Patient educational material

OTHER

Participants will have access to patient educational material only.

Behavioral: Patient educational material

Interventions

Virtual supportBEHAVIORAL

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

Virtual support
Patient educational materialBEHAVIORAL

Participants will have access to patient educational material.

Patient educational material

Eligibility Criteria

Age18 Years - 95 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

MeSH Terms

Conditions

Testicular NeoplasmsFinancial Stress

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesEndocrine System DiseasesTesticular DiseasesGonadal DisordersStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Hung-Jui Tan, MD

    UNC Lineberger Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Deborah S Usinger

CONTACT

919-962-5431dusinger@email.unc.edu

Taylor J Greene

CONTACT

919-962-5506taylor_greene@med.unc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2024

First Posted

November 25, 2024

Study Start

May 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

April 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)