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

Trial Summary

What is the purpose of this trial?

This study is a randomized controlled biobehavioral efficacy trial designed to investigate the feasibility and acceptability of a novel intervention, Goal-focused Emotion-Regulation Therapy (GET) aimed at improving distress symptoms, emotion regulation, goal navigation skills, and stress-sensitive biomarkers in young adult testicular cancer patients. Participants will be randomized to receive six sessions of GET or Individual Supportive Listening (ISL) delivered over eight weeks. In addition to indicators of intervention feasibility, the investigators will measure primary (depressive and anxiety symptoms) and secondary (emotion regulation and goal navigation skills, career confusion) psychological outcomes prior to (T0), immediately after (T1), twelve weeks after intervention (T2) and 24 weeks after the intervention (T3). Additionally, identified biomarkers will be measured at baseline and at T1, T2, and T3.

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 data supports the effectiveness of the treatment Goal-Focused Emotion-Regulation Therapy (GET) for testicular cancer?

Research shows that GET can help young adult testicular cancer survivors by reducing stress-related markers in the body and improving emotional regulation and goal-setting skills, which are important for managing the psychological impact of cancer. ^{1 2 3 4 5}

Is Goal-Focused Emotion-Regulation Therapy (GET) safe for humans?

GET has been studied in young adult testicular cancer survivors and showed potential to reduce stress-related processes and inflammation without significant adverse effects reported. More research is needed to confirm its safety and effectiveness. ^{1 2 3 4 5}

How is the treatment Goal-Focused Emotion-Regulation Therapy (GET) unique for testicular cancer survivors?

Goal-Focused Emotion-Regulation Therapy (GET) is unique because it specifically targets the emotional and goal-related challenges faced by young adult testicular cancer survivors, aiming to improve distress symptoms and emotion regulation while also addressing stress-sensitive biomarkers, which is not commonly the focus of other treatments for this condition. ^{1 2 3 4 6}

Research Team

Michael A Hoyt, PhD

Principal Investigator

University of California, Irvine

Eligibility Criteria

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

I am unable to understand or complete the study requirements.

You smoke cigarettes every day.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

Goal-Focused Emotion-Regulation Therapy (GET) in Young Adult Testicular Cancer Survivors: A Randomized Pilot Study. [2023]

3. England 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. [2021]

4. United States 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. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

Goal Navigation, Approach-Oriented Coping, and Adjustment in Young Men with Testicular Cancer. [2018]