This trial studies how well a biobehavioral intervention (goal-focused emotion-regulation therapy) works in assisting young men with testicular cancer. Getting back to everyday life can be difficult for some cancer survivors, and goal navigation and adjustment may be critical to health and well-being. Participating in the goal-focused emotion-regulation therapy counselling sessions may help reduce the emotional distress experienced by patients with testicular cancer. This study may also help researchers better understand young men’s quality of life needs and further develop a program to provide services to survivors.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04150848.
PRIMARY OBJECTIVES:
I. Determine the feasibility, tolerability, and acceptability of a goal-focused emotion-regulation therapy (GET) for young adult men with testicular cancer.
II. Determine preliminary efficacy of a goal-focused emotion-regulation therapy (GET) for young adult men with testicular cancer on depression/anxiety, sense of meaning/purpose (including career confusion), and emotion regulation skill.
EXPLORATORY OBJECTIVES:
I. Determine the preliminary efficacy of a goal-focused emotion-regulation therapy (GET) for young adult men with testicular cancer on biological dysregulation.
II. If GET is found to impact study outcomes, then potential mediators and moderators will be explored.
OUTLINE: Patients are randomized in 1 of 2 groups.
GROUP I: Patients participate in 6 in-person GET counseling sessions over 60 minutes each weekly or every 2 weeks within a period of 14 weeks. Patients may also participate in an interview providing feedback about their experience.
GROUP II: Patients participate in 6 in-person supportive therapy counseling sessions over 60 minutes each weekly or every 2 weeks within a period of 14 weeks.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUC Irvine Health/Chao Family Comprehensive Cancer Center
Principal InvestigatorMichael Hoyt
