Testicular CancerNCT07615998
Young Adult Latino Testicular Cancer Survivors: a Pilot Study of Goal-Focused Emotion Regulation Therapy (GET)
A study testing Goal-focused Emotion-regulation Therapy in people with Testicular Cancer, run by University of California, Irvine at 1 site in United States.
Trial summary
Testicular cancer diagnosis and treatment, especially given its threat to sexuality and reproductive health, can be distressing in the formative period of young adulthood. Responsive to the need for feasible, effective, and scalable interventions that meet the needs of ethnic minority men, 35 Hispanic/Latino young… Read more about this study
- Who is it for?
- Ages 18 to 39 years, men only
- Conditions the study is for
- Testicular Cancer
- What is being tested?
- Goal-focused Emotion-regulation Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2020to 14 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 39 years at time of consent
- A confirmed diagnosis of testis cancer
- Completion of primary medical treatment for testicular cancer within 4 years at time of consent
- Hispanic/Latino identification (self or cancer registry confirmed)
- A score of < 1.8 on the goal navigation scale or < 0.6 on the goal facility scale of the CAYA or >4 on the Distress Thermometer
- English or Spanish fluency, as per medical record documenting preferred language or in the judgment of the investigator
- Able to perform informed consent
Who cannot join
- Lifetime history of psychiatric of cognitive disturbance as per self-report or medical record
- In the judgment of the consenting professional, is unable to provide informed consent and complete study sessions and assessment
- 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)
- Regular smoker (daily use)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine
Irvine, California, 92697
About this study
Testicular cancer diagnosis and treatment, especially given its threat to sexuality and reproductive health, can be distressing in the formative period of young adulthood. Responsive to the need for feasible, effective, and scalable interventions that meet the needs of ethnic minority men, 35 Hispanic/Latino young adults (ages 18-39) with testicular cancer will receive 6 sessions of GET. We will evaluate primary and secondary outcomes at baseline, post-treatment, and 3-month follow-up. In addition, identified biomarkers will be assessed at baseline and post-intervention.
Read the detailed description
Testicular cancer diagnosis and treatment, especially given its threat to sexuality and reproductive health, can be distressing in the formative period of young adulthood. Cohort studies reveal the prevalence of depressive symptoms in testicular cancer exceeds the general population, and young Hispanic/Latino men are at particular risk for adverse outcomes after treatment. In fact, the majority of young adult cancer survivors will experience impairing, distressing, and modifiable physical, behavioral, and psychosocial adverse outcomes that persist long after the completion of primary medical treatment. These include psychological distress, impairment in the navigation and pursuit of life goals, persistent side effects, elevated risk of secondary malignancies and chronic illness, and biobehavioral burden (e.g., enhanced inflammation, dysregulated stress hormones) which influence morbidity and disease-related vulnerabilities. However, few targeted, tailored, culturally-relevant interventions exist to assist young Hispanic/Latino survivors in re-negotiating life goals and regulating cancer-related emotions and none focus on reducing the burden of morbidity via biobehavioral mechanisms.
Young or "emerging" adulthood is a period marked by goal attainment. Chronic illness experienced as "off time" in the lifespan interrupts goal pursuits and threatens valued life directions. As young adults return to goal pursuits, re-entry to post-cancer life can be a critical point in the survivorship trajectory. Behavioral intervention at this time is well positioned to confer longer-term impact. Emergent from our group's preliminary research, we developed and pilot-tested Goal-focused Emotion-Regulation Therapy (GET) as 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. GET is a promising candidate intervention to address the mechanisms likely complicating the resolution of cancer-related burden.
Responsive to the need for feasible, effective, and scalable interventions that meet the needs of ethnic minority men, 35 Hispanic/Latino young adults (ages 18-39) with testicular cancer will receive 6 sessions of GET. We will evaluate primary and secondary outcomes at baseline, post-treatment, and 3-month follow-up. In addition, identified biomarkers will be assessed at baseline and post-intervention. We predict that GET will be associated with superior distress outcomes, and these advantages will be maintained at 3-months following intervention. We also expect to observe pre-post reductions in adverse biobehavioral indicators (dysregulated diurnal stress hormones, elevated systemic inflammation)
The intervention will be delivered via an interactive video platform to enhance access. However, we believe that GET could be optimized to meet the needs of this group. To this end, we will examine the influence of Latino cultural processes (Machismo, Simpatia, Acculturative Stress), and conduct in-depth qualitative interviews. Findings will be used to adapt the GET intervention for a future randomized efficacy trial. An additional exploratory aim focuses on potential epigenetic vulnerabilities, to understand how environmental influences (via DNA methylation) on genes implicated in stress reactivity and mood regulation are related to cancer adjustment and intervention response.
- Conditions
- Testicular Cancer
- Being tested
- Goal-focused Emotion-regulation Therapy
- Keywords
- Testicular Cancer, Young Adult, Depression, Anxiety, Stress
- Medical subject headings
- Testicular Neoplasms, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal-focused Emotion-regulation TherapyBehavioural
GET is a 6-session intervention delivered over 8 weeks to enhance self-regulation through improved goal navigation skills, improved sense of meaning and purpose, and better ability to regulate specific emotional responses. Session topics include a review of cancer-related experiences and influences on goal pursuits, psychoeducation regarding emotions, skills, and values (Session 1), values clarifications and emotional awareness (Session 2), achievability of goals, cognitive skills training (Sessions 3), goal pathway mapping, navigating blocked goals and re-directing energy (Sessions 4), goal motivation and agentic actions, self-care behavior (Session 5), and goal pursuits moving forward (session 6). The first session is 90 minutes and each subsequent session is 60 minutes. Participants are given structured at home exercises via an interactive digital workbook designed to facilitate skill acquisition.
| Study group | Role | What they receive |
|---|---|---|
| Goal-focused Emotion-regulation Therapy (GET) | Experimental | GET is a 6-session intervention delivered over 8 weeks to enhance self-regulation through improved goal navigation skills, improved sense of meaning and purpose, and better ability to regulate specific emotional responses. Session topics include a review of cancer-related experiences and influences on goal pursuits, psychoeducation regarding emotions, skills, and values (Session 1), values clarifications and emotional awareness (Session 2), achievability of goals, cognitive skills training (Sessions 3), goal pathway mapping, navigating blocked goals and re-directing energy (Sessions 4), goal motivation and agentic actions, self-care behavior (Session 5), and goal pursuits moving forward (session 6). The first session is 90 minutes and each subsequent session is 60 minutes. Participants are given structured at home exercises via an interactive digital workbook designed to facilitate skill acquisition. Receives: Behavioral: Goal-focused Emotion-regulation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Anxiety and Depression Scale (HADS)
The HADS was developed to assess anxiety and depression in medical patients. It purposefully excluded somatic symptoms (e.g., sleep disturbance) to reduce confounding psychological symptoms with disease or treatment. The HADS has become a "benchmark" measure of anxiety and depression among diverse clinical and nonclinical hospital populations, including individuals diagnosed with cancer. The HADS is a 14-item self-administered questionnaire, with 7 items assigned to each the HADS-Anxiety and HADS-Depression subscales. Each item is rated on a 4-point response scale (from 0 to 3). Subscale scores are typically categorized to indicate the level of anxiety or depression experienced where scores of less than 8 are categorized as normal, scores of 8-10 as borderline, and scores of 11-21 as clinical. A number of psychometric studies have established the scale's strengths, including its brevity, reliability, and validity and availability of comparison scores across different populations.
Measured: Baseline (T0), Within 2 weeks of completing last intervention session (T1), Within 2 weeks of 3-months of completing last intervention session (T2)
Secondary outcomes (2)
Cancer Assessment for Young Adults (CAYA-T)
Goal navigation capacity includes elements of goal setting, goal clarification, goal adjustment, and goal initiation. It will be measured by the Goal Navigation subscale of the Cancer Assessment for Young Adults -Testicular (CAYA-T) (Hoyt et al., 2013). The scale is composed of five items (e.g., "I am able to identify goals in my life", "I know what steps to take to make progress toward my goals", and "I am able to redirect my energy when I feel my life isn't going in the right direction"). Participants indicate how often each item is true of them over the past 7 days on a 3-point response scale ranging from 0 (None of the time) to 2 (Much or most of the time). Criterion, construct, and procedural validity have been established with young adult testicular cancer survivors.
Measured: Baseline (T0), Within 2 weeks of completing last intervention session (T1), Within 2 weeks of 3-months of completing last intervention session (T2)
Emotion Regulation Questionnaire (ERQ)
Emotion regulation skills will be measured by the Emotion Regulation Questionnaire (ERQ). The ERQ is a widely used 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree). The ERQ is widely used in the context of clinical treatment trials and has well established validity, reliability, and factor structure (Goldin, Manber-Ball, Werner, Heimberg, \& Gross, 2009; Gross \& John, 2003).
Measured: Baseline (T0), Within 2 weeks of completing last intervention session (T1), Within 2 weeks of 3-months of completing last intervention session (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start5 Aug 2020
- Primary completion4 Apr 2023
- Study completion14 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Testicular CancerStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Hoyt, University of California, Irvine
- Investigators
- Michael A Hoyt, PhD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615998
- Sponsor's protocol ID
- 20205703
- Status last verified
- Mar 2025
- First submitted
- 30 Mar 2025
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoyt MA, Campos B, Lechuga JG, Fortier MA, Llave K, Haydon M, Daneshvar M, Nelson CJ, Wu B. Young adult Latino testicular cancer survivors: a pilot study of Goal-focused Emotion regulation Therapy (GET). Support Care Cancer. 2024 Oct 30;32(11):758. doi: 10.1007/s00520-024-08960-y.
PubMed 39477849
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Young Adult Latino Testicular Cancer Survivors: a Pilot Study of Goal-Focused Emotion Regulation Therapy (GET)
- ClinicalTrials.gov ID
- NCT07615998
- Acronym / sponsor ID
- 20205703
- Conditions
- Testicular Cancer
- Keywords
- Testicular Cancer, Young Adult, Depression, Anxiety, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- 4 Apr 2023 (actual)
- Study completion
- 14 Aug 2023 (actual)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Testicular cancer diagnosis and treatment, especially given its threat to sexuality and reproductive health, can be distressing in the formative period of young adulthood. Responsive to the need for feasible, effective, and scalable interventions that meet the needs of ethnic minority men, 35 Hispanic/Latino young adults (ages 18-39) with testicular cancer will receive 6 sessions of GET. We will evaluate primary and secondary outcomes at baseline, post-treatment, and 3-month follow-up. In addition, identified biomarkers will be assessed at baseline and post-intervention.
Detailed description
Testicular cancer diagnosis and treatment, especially given its threat to sexuality and reproductive health, can be distressing in the formative period of young adulthood. Cohort studies reveal the prevalence of depressive symptoms in testicular cancer exceeds the general population, and young Hispanic/Latino men are at particular risk for adverse outcomes after treatment. In fact, the majority of young adult cancer survivors will experience impairing, distressing, and modifiable physical, behavioral, and psychosocial adverse outcomes that persist long after the completion of primary medical treatment. These include psychological distress, impairment in the navigation and pursuit of life goals, persistent side effects, elevated risk of secondary malignancies and chronic illness, and biobehavioral burden (e.g., enhanced inflammation, dysregulated stress hormones) which influence morbidity and disease-related vulnerabilities. However, few targeted, tailored, culturally-relevant interventions exist to assist young Hispanic/Latino survivors in re-negotiating life goals and regulating cancer-related emotions and none focus on reducing the burden of morbidity via biobehavioral mechanisms.
Young or "emerging" adulthood is a period marked by goal attainment. Chronic illness experienced as "off time" in the lifespan interrupts goal pursuits and threatens valued life directions. As young adults return to goal pursuits, re-entry to post-cancer life can be a critical point in the survivorship trajectory. Behavioral intervention at this time is well positioned to confer longer-term impact. Emergent from our group's preliminary research, we developed and pilot-tested Goal-focused Emotion-Regulation Therapy (GET) as 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. GET is a promising candidate intervention to address the mechanisms likely complicating the resolution of cancer-related burden.
Responsive to the need for feasible, effective, and scalable interventions that meet the needs of ethnic minority men, 35 Hispanic/Latino young adults (ages 18-39) with testicular cancer will receive 6 sessions of GET. We will evaluate primary and secondary outcomes at baseline, post-treatment, and 3-month follow-up. In addition, identified biomarkers will be assessed at baseline and post-intervention. We predict that GET will be associated with superior distress outcomes, and these advantages will be maintained at 3-months following intervention. We also expect to observe pre-post reductions in adverse biobehavioral indicators (dysregulated diurnal stress hormones, elevated systemic inflammation)
The intervention will be delivered via an interactive video platform to enhance access. However, we believe that GET could be optimized to meet the needs of this group. To this end, we will examine the influence of Latino cultural processes (Machismo, Simpatia, Acculturative Stress), and conduct in-depth qualitative interviews. Findings will be used to adapt the GET intervention for a future randomized efficacy trial. An additional exploratory aim focuses on potential epigenetic vulnerabilities, to understand how environmental influences (via DNA methylation) on genes implicated in stress reactivity and mood regulation are related to cancer adjustment and intervention response.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Goal-focused Emotion-regulation Therapy (GET) | Experimental | Behavioral: Goal-focused Emotion-regulation TherapyGET is a 6-session intervention delivered over 8 weeks to enhance self-regulation through improved goal navigation skills, improved sense of meaning and purpose, and better ability to regulate specific emotional responses. Session topics include a review of cancer-related experiences and influences on goal pursuits, psychoeducation regarding emotions, skills, and values (Session 1), values clarifications and emotional awareness (Session 2), achievability of goals, cognitive skills training (Sessions 3), goal pathway mapping, navigating blocked goals and re-directing energy (Sessions 4), goal motivation and agentic actions, self-care behavior (Session 5), and goal pursuits moving forward (session 6). The first session is 90 minutes and each subsequent session is 60 minutes. Participants are given structured at home exercises via an interactive digital workbook designed to facilitate skill acquisition. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18 to 39 years at time of consent
- A confirmed diagnosis of testis cancer
- Completion of primary medical treatment for testicular cancer within 4 years at time of consent
- Hispanic/Latino identification (self or cancer registry confirmed)
- A score of < 1.8 on the goal navigation scale or < 0.6 on the goal facility scale of the CAYA or >4 on the Distress Thermometer
Key exclusion criteria (4 listed)
- Lifetime history of psychiatric of cognitive disturbance as per self-report or medical record
- In the judgment of the consenting professional, is unable to provide informed consent and complete study sessions and assessment
- 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)
- Regular smoker (daily use)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goal-focused Emotion-regulation TherapyGET is a 6-session intervention delivered over 8 weeks to enhance self-regulation through improved goal navigation skills, improved sense of meaning and purpose, and better ability to regulate specific emotional responses. Session topics include a review of cancer-related experiences and influences on goal pursuits, psychoeducation regarding emotions, skills, and values (Session 1), values clarifications and emotional awareness (Session 2), achievability of goals, cognitive skills training (Sessions 3), goal pathway mapping, navigating blocked goals and re-directing energy (Sessions 4), goal motivation and agentic actions, self-care behavior (Session 5), and goal pursuits moving forward (session 6). The first session is 90 minutes and each subsequent session is 60 minutes. Participants are given structured at home exercises via an interactive digital workbook designed to facilitate skill acquisition. | Behavioural | Goal-focused Emotion-regulation Therapy (GET) |
Primary outcome
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline (T0), Within 2 weeks of completing last intervention session (T1), Within 2 weeks of 3-months of completing last intervention session (T2)
The HADS was developed to assess anxiety and depression in medical patients. It purposefully excluded somatic symptoms (e.g., sleep disturbance) to reduce confounding psychological symptoms with disease or treatment. The HADS has become a "benchmark" measure of anxiety and depression among diverse clinical and nonclinical hospital populations, including individuals diagnosed with cancer. The HADS is a 14-item self-administered questionnaire, with 7 items assigned to each the HADS-Anxiety and HADS-Depression subscales. Each item is rated on a 4-point response scale (from 0 to 3). Subscale scores are typically categorized to indicate the level of anxiety or depression experienced where scores of less than 8 are categorized as normal, scores of 8-10 as borderline, and scores of 11-21 as clinical. A number of psychometric studies have established the scale's strengths, including its brevity, reliability, and validity and availability of comparison scores across different populations.
2 secondary outcomes
Cancer Assessment for Young Adults (CAYA-T)
Time frame: Baseline (T0), Within 2 weeks of completing last intervention session (T1), Within 2 weeks of 3-months of completing last intervention session (T2)
Emotion Regulation Questionnaire (ERQ)
Time frame: Baseline (T0), Within 2 weeks of completing last intervention session (T1), Within 2 weeks of 3-months of completing last intervention session (T2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Results publication: PubMed 39477849Hoyt MA, Campos B, Lechuga JG, Fortier MA, Llave K, Haydon M, Daneshvar M, Nelson CJ, Wu B. Young adult Latino testicular cancer survivors: a pilot study of Goal-focused Emotion regulation Therapy (GET). Support Care Cancer. 2024 Oct 30;32(11):758. doi: 10.1007/s00520-024-08960-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael A Hoyt, PhD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal-focused Emotion-regulation Therapy in people with Testicular Cancer, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety and Depression Scale (HADS) (time frame: Baseline (T0), Within 2 weeks of completing last intervention session (T1), Within 2 weeks of 3-months of completing last intervention session (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07615998, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.