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Biobehavioral Intervention for Testicular Cancer

N/A

Recruiting

Led By Michael A Hoyt, PhD

Research Sponsored by University of California, Irvine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 to 39 years at time of consent

A confirmed diagnosis of testis cancer (any stage)

Must not have

As per self-report, has medical conditions that affect the immune system and would confound immune evaluation (e.g., autoimmune disorder, inflammatory disease; uncontrolled thyroid disease; active infection; myocardial infarction or stroke in the last 6 months; Type I diabetes; acute hepatitis; recent vaccination for viral disease)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline (t0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks), and to 6-month post-intervention (~32 weeks)

Awards & highlights

No Placebo-Only Group

Summary

This trial will study a new therapy to help young adult testicular cancer patients reduce distress, regulate emotions, and reach goals.

Who is the study for?

This trial is for young adults aged 18-39 who have had testicular cancer and finished chemotherapy within the last 4 years. They must be fluent in English or Spanish, feel distressed (scoring >4 on a Distress Thermometer), and be able to consent. It's not for regular smokers, those with immune-affecting conditions, recent heart attacks or strokes, Type I diabetes, acute hepatitis, recent vaccinations, or a history of psychiatric or cognitive disturbances.

What is being tested?

The study tests Goal-focused Emotion-Regulation Therapy (GET) against Individual Supportive Listening (ISL) to see if GET can better improve emotional distress symptoms and skills like emotion regulation and goal setting in testicular cancer survivors. Participants will get six sessions over eight weeks with follow-up assessments up to six months after the therapy.

What are the potential side effects?

Since this trial involves psychological therapies rather than drugs, side effects are minimal but may include temporary increases in emotional distress due to discussing personal issues during therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 39 years old.

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I have been diagnosed with testicular cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have immune-related conditions that could affect the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline (t0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks), and to 6-month post-intervention (~32 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline (t0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks), and to 6-month post-intervention (~32 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline (t0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks), and to 6-month post-intervention (~32 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Hospital Anxiety and Depression Scale (HADS)

Change in Salivary Diurnal Cortisol Slope and Daily Output

Change in Systemic Pro-inflammatory Cytokine Levels (IL-6, IL-1ra, C-reactive Protein [CRP], sTNFαRII)

Secondary study objectives

Change in Cancer Assessment for Young Adults (CAYA-T) - Goal Navigation Score

Change in Career Thoughts Inventory (CTI) Global Score

Change in Emotion Regulation Questionnaire (ERQ) Scale Scores

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Goal-Focused Emotion-Regulation Therapy (GET)Experimental Treatment1 Intervention

A novel behavioral intervention to enhance self-regulation through improved goal navigation skills, improved sense of purpose, and better ability to regulate emotional responses in young adults with testicular cancer.

Group II: Individual Supportive ListeningActive Control1 Intervention

Supportive therapy will be non-directive and will primarily reinforce a patient's ability to manage stressors through attentively listening and encouraging expression of thoughts and feelings, assisting the individual to gain a greater understanding of their situation and alternatives, and helping to buttress the individual's self-esteem and resilience.

0 / 3Eligibility criteria met