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

Trial Summary

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 data supports the effectiveness of the treatment Goal-Focused Emotion-Regulation Therapy (GET) for young adults with 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. This suggests that GET may help manage stress and improve overall well-being in young adults with cancer. ^{1 2 3 4 5}

Is Goal-Focused Emotion-Regulation Therapy (GET) safe for young adults with cancer?

GET has been studied in young adult testicular cancer survivors and has shown potential to reduce stress-related processes and inflammation, with no significant adverse effects reported in the studies. More research is needed to fully determine its safety and efficacy. ^{1 2 3 4 5}

How is Goal-Focused Emotion-Regulation Therapy (GET) different from other treatments for young adults with cancer?

GET is unique because it specifically targets the emotional and goal-setting challenges faced by young adult cancer survivors, using a biobehavioral approach that combines psychological and biological strategies to reduce stress and improve life goal navigation, which is not commonly addressed by other treatments. ^{1 2 3 6 7}

What is the purpose of this trial?

Building upon the results of a single-arm trial designed to investigate the feasibility and acceptability of a novel intervention, Goal-focused Emotion-Regulation Therapy (GET), this trial is a randomized-controlled biobehavioral pilot trial of GET versus a time-and attention matched control (Instrumental Supportive Listening; ISL) in Latino/Hispanic young adult survivors of adolescent and young adult (AYA) cancer (age 15-39 years at diagnosis). Outcomes include improved distress symptoms, emotion regulation, goal navigation skills, and changes in stress-sensitive biomarkers. Participants will be randomized to receive six sessions of GET or ISL delivered over eight weeks. In addition to indicators of intervention feasibility, the investigators will measure primary and secondary psychological outcomes prior to (T0), immediately after (T1), and twelve weeks after intervention (T2). Additionally, identified biomarkers will be measured at baseline and at T1, and T2.

Research Team

Michael A Hoyt, PhD

Principal Investigator

University of California, Irvine

Eligibility Criteria

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 male.

I have been diagnosed with cancer.

I identify as Hispanic or Latino.

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

Follow-up

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

12 weeks

Treatment Details

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.

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 (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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. 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]

2. Netherlands pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

How do cancer patients manage unattainable personal goals and regulate their emotions? [2015]

5. 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]

6. United States pubmed.ncbi.nlm.nih.gov

Advancing biobehavioral research in childhood cancer. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

The biology of stress in cancer: Applying the biobehavioral framework to adolescent and young adult oncology research. [2021]