Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06338475
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-03-23
Brief Title:
A Biobehavioral Intervention for LatinoHispanic Young Adults With Cancer
Sponsor:
University of California Irvine
Organization:
University of California Irvine
Study Overview
Official Title:
A Biobehavioral Intervention for LatinoHispanic Young Adults With Cancer
Status:
RECRUITING
Status Verified Date:
2024-05
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:
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 LatinoHispanic 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
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
Detailed Description:
Cancer diagnosis and treatment can be distressing in the formative period of young adulthood Cohort studies reveal the prevalence of depressive symptoms in young cancer survivors exceeds the general population and young HispanicLatino 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 eg enhanced inflammation dysregulated stress hormones which influence morbidity and disease-related vulnerabilities However few targeted tailored culturally-relevant interventions exist to assist young HispanicLatino 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 the investigators 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 that meet the need of ethnic minority survivors 100 HispanicLatino young adults ages 18-39 with cancer will receive 6 sessions of GET or ISL Our team will evaluate primary and secondary outcomes at baseline post-treatment and 3-month follow-up The investigators 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 3-months following intervention The intervention will be delivered via an interactive video platform to enhance access However the investigators believe that GET could be optimized to meet the needs of this group To this end the investigators will examine the influence of Latino cultural processes Familism MachismoCaballarismo Simpatia Acculturative Stress
Findings will be used to adapt the GET intervention for a future randomized efficacy trial
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 the investigators 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 that meet the need of ethnic minority survivors 100 HispanicLatino young adults ages 18-39 with cancer will receive 6 sessions of GET or ISL Our team will evaluate primary and secondary outcomes at baseline post-treatment and 3-month follow-up The investigators 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 3-months following intervention The intervention will be delivered via an interactive video platform to enhance access However the investigators believe that GET could be optimized to meet the needs of this group To this end the investigators will examine the influence of Latino cultural processes Familism MachismoCaballarismo Simpatia Acculturative Stress
Findings will be used to adapt the GET intervention for a future randomized efficacy trial
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