Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05836688
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2023-04-19
Brief Title:
A Biobehavioral Intervention to Reduce Adverse Outcomes in Young Adult Testicular Cancer Survivors
Sponsor:
University of California Irvine
Organization:
University of California Irvine
Study Overview
Official Title:
A Biobehavioral Intervention to Reduce Adverse Outcomes in Young Adult Testicular Cancer Survivors
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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 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 eg enhanced inflammation dysregulated stress hormones which influence morbidity and disease-related vulnerabilities However few targeted effective interventions exist to assist young 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 groups 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 the need for feasible effective and scalable interventions we will randomly allocate 250 young adult ages 18 -39 testicular cancer patients to 6 sessions of GET or ISL and evaluate primary and secondary outcomes at baseline post-treatment 3-month follow-up and 6-months follow-up We predict that GET will be associated with superior distress outcomes and comparatively greater reductions in adverse biobehavioral indicators dysregulated diurnal stress hormones elevated systemic inflammation and these advantages will be maintained at three- and six-months following intervention The intervention will be delivered via an interactive video platform to enhance access 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
This study capitalizes on the study teams unique expertise in biobehavioral oncology and salivary bioscience to test a novel behavioral intervention for young adult survivors It has potential to understand how to alter proximal behavioral biological and psychological factors that underscore long term adverse effects
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 groups 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 the need for feasible effective and scalable interventions we will randomly allocate 250 young adult ages 18 -39 testicular cancer patients to 6 sessions of GET or ISL and evaluate primary and secondary outcomes at baseline post-treatment 3-month follow-up and 6-months follow-up We predict that GET will be associated with superior distress outcomes and comparatively greater reductions in adverse biobehavioral indicators dysregulated diurnal stress hormones elevated systemic inflammation and these advantages will be maintained at three- and six-months following intervention The intervention will be delivered via an interactive video platform to enhance access 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
This study capitalizes on the study teams unique expertise in biobehavioral oncology and salivary bioscience to test a novel behavioral intervention for young adult survivors It has potential to understand how to alter proximal behavioral biological and psychological factors that underscore long term adverse effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01CA276143-01A1 | NIH | None | httpsreporternihgovquickSearch1R01CA276143-01A1 |