Biobehavioral Intervention for Young Adults With Cancer

Overseen By Michael A Hoyt, PhD

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: University of California, Irvine

Disqualifiers: Bipolar, Schizophrenia, Autoimmune, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of support for young adult Latino/Hispanic cancer survivors. One group receives Goal-focused Emotion-Regulation Therapy (GET) to help manage emotions and set goals, while the other group receives Individual Supportive Listening (ISL), which focuses on listening and emotional support. The researchers aim to determine which method better reduces distress and improves mental well-being. Suitable participants include male, Hispanic/Latino young adults diagnosed with cancer between the ages of 15 and 39 who struggle with stress or goal-setting. As an unphased trial, this study offers a unique opportunity to explore personalized support methods that could enhance emotional well-being.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have a medical condition or are taking medication that affects inflammation, you may not be eligible to participate.

What prior data suggests that this biobehavioral intervention is safe for young adults with cancer?

Research has shown that Goal-Focused Emotion-Regulation Therapy (GET) is safe and well-received by young adults. Studies have found that GET is practical and helpful for reducing negative effects in young adults who have had testicular cancer. No major reports of harmful side effects from GET have emerged, making it a promising option for improving emotional health and coping skills. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Goal-Focused Emotion-Regulation Therapy (GET) because it offers a novel approach to managing emotional stress in young adults with testicular cancer. Unlike standard treatments that primarily focus on physical symptoms, GET enhances self-regulation by improving goal navigation skills and fostering a stronger sense of purpose. This unique method aims to help patients better manage their emotional responses, potentially leading to improved mental well-being and quality of life during cancer treatment.

What evidence suggests that this trial's treatments could be effective for young adults with cancer?

Research shows that Goal-Focused Emotion-Regulation Therapy (GET), one of the treatments in this trial, can reduce distress in young adults with cancer. In previous studies, participants experienced noticeable improvements in symptoms of depression and anxiety. Specifically, those who participated in GET showed a medium improvement in depression and a smaller improvement in anxiety compared to those who did not. GET helps individuals manage emotions better and set personal goals, aiming to enhance overall emotional well-being, which is crucial for young adults facing cancer. Another treatment arm in this trial involves Individual Supportive Listening (ISL), which reinforces a patient's ability to manage stressors through attentive listening and encourages the expression of thoughts and feelings. ^{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 Latino/Hispanic young adults aged 18-39 who have been diagnosed with cancer, can communicate in English or Spanish, and are experiencing distress or challenges managing goals. Men are specifically invited to participate.

Inclusion Criteria

I identify as Hispanic or Latino.

I identify as male.

I have been diagnosed with cancer.

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

Follow-up

Participants are monitored for psychological outcomes and biomarkers at 3-months post-intervention

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Goal-Focused Emotion-Regulation Therapy (GET)

Trial Overview The study compares Goal-Focused Emotion-Regulation Therapy (GET) with Individual Supportive Listening (ISL). Participants will be randomly assigned to one of these two approaches and receive six sessions over eight weeks.

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 (ISL) 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+

Published Research Related to This Trial

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]

In a study of 108 cancer patients, those who successfully disengaged from unattainable goals and reengaged in meaningful goals reported higher levels of positive affect and lower levels of negative affect.

Cognitive emotion-regulation strategies, such as positive refocusing, were linked to better psychological well-being, while rumination and catastrophizing were associated with increased negative emotions, suggesting that mindfulness techniques could help patients manage their emotional responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How do cancer patients manage unattainable personal goals and regulate their emotions? Schroevers, M., Kraaij, V., Garnefski, N.[2015]

Research on childhood cancer has primarily focused on behavioral and psychosocial aspects, but incorporating a biobehavioral perspective that includes psychological, sociocultural, and biological factors could enhance understanding of how families respond to a child's cancer diagnosis.

The article emphasizes the need for studies that link biological measures with psychosocial functioning and treatment outcomes, suggesting that this approach could lead to better strategies for supporting children and families during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancing biobehavioral research in childhood cancer. Moore, IM.[2017]

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]

The stress response plays a significant role in cancer development and progression, suggesting that understanding neuroimmune mechanisms can lead to better patient care and treatment strategies.

Adolescent and young adult (AYA) cancer patients, who often face worse mental health and cancer outcomes, could greatly benefit from biobehavioral approaches that combine psychosocial support with biomedical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The biology of stress in cancer: Applying the biobehavioral framework to adolescent and young adult oncology research. Taylor, MR., Knight, JM., Rosenberg, AR.[2021]

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]

Citations

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

Goal-Focused Emotion-Regulation Therapy (GET) in Young ... Participants exhibited a medium group-by-time effect size with greater reductions in depressive (d = 0.45) and anxiety (d = 0.29) symptoms for ...

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

Goal-Focused Emotion-Regulation Therapy (GET) in ... Among the 38 men randomized to GET, 81.1% completed all study sessions compared with 82.4% of the 37 men assigned to ISL. Fidelity to the ...

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 ... Participants exhibited a medium group-by-time effect size with greater reductions in depressive (d = 0.45) and anxiety (d = 0.29) symptoms for ...

4. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-04242-0

Goal-Focused Emotion-Regulation Therapy (GET) for young ... This paper describes the methodology of a randomized controlled biobehavioral trial designed to investigate the feasibility and preliminary ...

5. 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.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32290859/

Goal-Focused Emotion-Regulation Therapy (GET) for young ... Discussion: GET may have the potential to improve self-regulation across biobehavioral domains, improve overall cancer adjustment, and address ...