Biobehavioral Intervention for Testicular Cancer

Overseen By Michael A Hoyt, PhD

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: University of California, Irvine

Disqualifiers: Autoimmune disorder, Inflammatory disease, Type I diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 8 weeks

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new therapy called Goal-focused Emotion-Regulation Therapy (GET) for young adults who have had testicular cancer. The aim is to determine if GET can reduce distress, improve emotional regulation, and enhance skills in setting and achieving personal goals. Participants will either try GET or engage in supportive listening sessions (Individual Supportive Listening Therapy) over eight weeks to compare effects. This trial suits those aged 18 to 39 who completed chemotherapy for testicular cancer in the last four years and frequently experience distress, as measured by a simple screening tool. As an unphased trial, it offers a unique opportunity to explore innovative therapy options that could enhance emotional well-being and goal achievement.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this biobehavioral intervention is safe for young adult testicular cancer patients?

A previous study found Goal-Focused Emotion-Regulation Therapy (GET) to be a practical and well-liked method for helping young adults with testicular cancer manage stress and enhance emotional skills. Participants appreciated the therapy, which caused no major problems or side effects.

Similarly, Individual Supportive Listening (ISL) emphasizes careful listening and encourages self-expression. It aims to help individuals manage stress and boost self-esteem. Reports indicate no negative effects from ISL, making it a safe choice.

Both treatments are non-invasive and aim to improve mental well-being, generally posing a low risk of harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for testicular cancer because they address emotional well-being in unique ways. Unlike traditional approaches that focus primarily on medical or physical symptoms, Goal-Focused Emotion-Regulation Therapy (GET) helps young adults improve their emotional resilience by enhancing goal-setting skills and emotional regulation. Individual Supportive Listening offers a non-directive space for patients to express their feelings, promoting self-esteem and stress management. Together, these interventions aim to provide a more holistic approach to patient care, potentially leading to improved quality of life for those undergoing treatment for testicular cancer.

What evidence suggests that this trial's treatments could be effective for testicular cancer patients?

Research shows that Goal-Focused Emotion-Regulation Therapy (GET), one of the treatments in this trial, helps young adults with testicular cancer by reducing distress and enhancing their ability to manage emotions and set goals. Studies have found that GET is practical and well-received by these patients, yielding promising results. In contrast, Individual Supportive Listening (ISL), another treatment option in this trial, is a common method in cancer care that aids patients in handling stress through attentive listening and support. While ISL is a well-known approach, GET may better improve emotion management and overall well-being. Both treatments in this trial aim to help patients navigate emotional challenges during and after cancer treatment. ^{1 2 3 5 6}

Who Is on the Research Team?

Michael A Hoyt, PhD

Principal Investigator

University of California, Irvine

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Able to perform informed consent

English fluency, as per medical record documenting preferred language or in the judgment of the investigator

Spanish fluency, as per medical record documenting preferred language or in the judgment of the investigator

Exclusion Criteria

You smoke cigarettes every day.

I am unable to understand or complete the study requirements.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive six sessions of Goal-focused Emotion-Regulation Therapy (GET) or Individual Supportive Listening (ISL) over eight weeks

8 weeks

6 sessions (virtual)

Follow-up

Participants are monitored for psychological and biobehavioral outcomes post-treatment

24 weeks

Assessments at 3-month and 6-month post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• Goal-Focused Emotion-Regulation Therapy (GET)
• Individual Supportive Listening

Trial Overview 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.

How Is the Trial Designed?

Group I: Goal-Focused Emotion-Regulation Therapy (GET) Experimental Treatment 1 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 Listening Active Control 1 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.

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Memorial Sloan Kettering Cancer Center

Collaborator

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

Goal-focused Emotion-regulation Therapy (GET) was found to be a feasible and acceptable intervention for young adult testicular cancer survivors, with 81.1% of participants completing all sessions, indicating high engagement.

Participants in the GET group experienced greater reductions in anxiety and depressive symptoms compared to those receiving Individual Supportive Listening (ISL), with medium effect sizes suggesting meaningful improvements in mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Goal-Focused Emotion-Regulation Therapy (GET) in Young Adult Testicular Cancer Survivors: A Randomized Pilot Study. Hoyt, MA., Wang, AW., Ceja, RC., et al.[2023]

A randomized controlled trial is being conducted to evaluate Goal-focused Emotion-Regulation Therapy (GET) for young adult testicular cancer survivors, aiming to improve psychological distress and emotional regulation over 8 weeks with six therapy sessions.

The study will assess the feasibility of GET and its impact on depressive and anxiety symptoms, as well as stress-sensitive biomarkers, highlighting the need for targeted interventions to support young cancer survivors in managing their emotional and life goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Goal-Focused Emotion-Regulation Therapy (GET) for young adult survivors of testicular cancer: a pilot randomized controlled trial of a biobehavioral intervention protocol. Hoyt, MA., Wang, AW., Ryan, SJ., et al.[2021]

Goal-focused Emotion-regulation Therapy (GET) significantly reduced daily salivary cortisol levels in young adult survivors of testicular cancer, indicating a potential to lower stress-related biomarkers after an 8-week intervention with 44 participants.

GET also led to lower plasma levels of IL-1ra compared to the active control intervention, suggesting it may help reduce inflammation, although further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of Goal-Focused Emotion-Regulation Therapy for Young Adult Survivors of Testicular Cancer: Effects on Salivary and Inflammatory Stress Markers. Hoyt, MA., Wang, AW., Breen, EC., et al.[2022]

Young adult survivors of testicular cancer benefit from strong goal navigation skills, which are linked to better emotional, social, and functional well-being, as shown in a study of 171 men.

Approach-oriented coping strategies also contribute positively to well-being, and together with goal navigation skills, they can help mitigate the negative effects of cancer on life adjustment, suggesting they are important areas for therapeutic focus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Goal Navigation, Approach-Oriented Coping, and Adjustment in Young Men with Testicular Cancer. Hoyt, MA., Gamarel, KE., Saigal, CS., et al.[2018]

A novel intervention called Goal-focused Emotion-Regulation Therapy (GET) was found to be feasible and acceptable for young adult testicular cancer survivors, with positive feedback on its helpfulness and satisfaction from participants.

The intervention led to clinically meaningful improvements in symptoms of depression and anxiety, suggesting it could effectively support emotional well-being and goal navigation in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Goal-focused Emotion-Regulation Therapy for young adult survivors of testicular cancer: Feasibility of a behavioral intervention. Hoyt, MA., Nelson, CJ.[2021]

Psychotherapeutic interventions for cancer patients focus on two main types of goals: process goals, which help patients manage emotions and improve coping skills, and primary goals, which aim to reduce physical symptoms and enhance quality of life.

These interventions are designed to provide both emotional support and practical assistance, ultimately helping patients adjust better to their diagnosis and treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The aim of psychotherapeutic intervention in cancer patients. Cassileth, BR.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37078969/

Goal-Focused Emotion-Regulation Therapy (GET) in Young ... GET is a feasible and acceptable intervention for reducing adverse outcomes after testicular cancer for young adults. © Society of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10441857/

Goal-Focused Emotion-Regulation Therapy (GET) in ... GET is a feasible and acceptable intervention for reducing adverse outcomes after testicular cancer for young adults.

3. academic.oup.com academic.oup.com/abm/advance-article-abstract/doi/10.1093/abm/kaad010/7133535

Goal-Focused Emotion-Regulation Therapy (GET) in Young ... GET is a feasible and acceptable intervention for reducing adverse outcomes after testicular cancer for young adults. Observed effect sizes ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05836688?term=AREA%5BConditionSearch%5D(Testicular%20Diseases)%20AND%20AREA%5BOverallStatus%5D(RECRUITING)&rank=5

A Biobehavioral Intervention to Reduce Adverse Outcomes ... Goal-Focused Emotion-Regulation Therapy (GET). A novel behavioral intervention to enhance self-regulation through improved goal navigation skills, improved ...

5. link.springer.com link.springer.com/article/10.1007/s00520-024-08960-y

Young adult Latino testicular cancer survivors: a pilot study ... We developed Goal-focused Emotion regulation Therapy (GET) to improve distress symptoms, goal navigation skills, and emotion regulation.

6. urotoday.com urotoday.com/recent-abstracts/urologic-oncology/testicular-cancer/155955-young-adult-latino-testicular-cancer-survivors-a-pilot-study-of-goal-focused-emotion-regulation-therapy-get.html

Young adult Latino testicular cancer survivors: a pilot study ... We developed Goal-focused Emotion regulation Therapy (GET) to improve distress symptoms, goal navigation skills, and emotion regulation.