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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)

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

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,926,191 Total Patients Enrolled

4 Trials studying Testicular Cancer

65,363 Patients Enrolled for Testicular Cancer

University of California, IrvineLead Sponsor

544 Previous Clinical Trials

1,922,793 Total Patients Enrolled

Memorial Sloan Kettering Cancer CenterOTHER

1,936 Previous Clinical Trials

588,648 Total Patients Enrolled

2 Trials studying Testicular Cancer

81 Patients Enrolled for Testicular Cancer

Media Library

Goal-Focused Emotion-Regulation Therapy (GET) Clinical Trial Eligibility Overview. Trial Name: NCT05836688 — N/A

Testicular Cancer Research Study Groups: Individual Supportive Listening, Goal-Focused Emotion-Regulation Therapy (GET)

Testicular Cancer Clinical Trial 2023: Goal-Focused Emotion-Regulation Therapy (GET) Highlights & Side Effects. Trial Name: NCT05836688 — N/A

Goal-Focused Emotion-Regulation Therapy (GET) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05836688 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must participants meet to be eligible for this clinical investigation?

"The parameters for eligibility include being aged between 18 and 39 years old, while also having been diagnosed with testicular cancer. To meet the recruitment goals of this investigation, 250 volunteers are sought out."

Answered by AI

Does this study include adults aged over fifty?

"According to the trial's parameters, eligible participants must be within 18 and 39 years old. Separately, 6 studies are designed for people below the age of majority and 16 research endeavours focus on seniors above 65."

Answered by AI

Are there any available slots for people to participate in this medical experiment?

"The research hosted on clinicaltrials.gov reveals that this trial, which commenced its recruitment process on July 1st 2023 and was last edited April 19th 2023, is not presently accepting participants. However, there are 22 other studies actively seeking enrolment at the moment."

Answered by AI

What is the primary purpose of this medical trial?

"The primary objective of this clinical trial is to evaluate the fluctuation in systemic pro-inflammatory cytokine levels (IL-6, IL-1ra, CRP and sTNFαRII) from baseline assessment (at T0), 8 weeks post intervention completion, 20 weeks after treatment conclusion and 32 weeks following therapy cessation. Secondary endpoints include monitoring changes in career thoughts inventory global score (CTI – a 48 item self administered survey with scores ranging between 0 - 3; measuring dissonant thinking during career decision making/problem solving), emotion regulation questionnaire scale scores (a 10 item Likert type survey assessing cognitive reappraisal"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Biobehavioral Intervention to Reduce Adverse Outcomes in Young Adult Testicular Cancer Survivors

Michael Hoyt 2023. "A Biobehavioral Intervention to Reduce Adverse Outcomes in Young Adult Testicular Cancer Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05836688.

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