Trial Title:
A Biobehavioral Intervention to Reduce Adverse Outcomes in Young Adult Testicular Cancer Survivors
NCT ID:
NCT05836688
Condition:
Testicular Cancer
Conditions: Official terms:
Testicular Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Participant)
Intervention:
Intervention type:
Behavioral
Intervention name:
Goal-Focused Emotion-Regulation Therapy (GET)
Description:
Patients will be asked to identify value-derived goals (i.e., goals for the most
important domains of one's life) and ones sufficiently important to sustain movement
toward them in the short-term future. Patients will discuss their goal possibilities,
providing a forum to ensure that goals are manageable and consistent with identified
values. Patients will learn strategies to refine their goals (e.g., approaching goals
rather than avoiding obstacles, defining markers of progress), generate pathways to
goals, and address potential obstacles and blockages. The overall goal is to enhance
self-regulation through improved goal navigation skills, improved sense of meaning and
purpose, and better ability to regulate specific emotional responses.
Arm group label:
Goal-Focused Emotion-Regulation Therapy (GET)
Intervention type:
Behavioral
Intervention name:
Individual Supportive Listening
Description:
ISL sessions will be matched in terms of time and attention. 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. This
will be delivered in the same manner as GET (individually) and is a common, non-directive
control method in intervention research.
Arm group label:
Individual Supportive Listening
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.
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 (e.g., 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 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 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 team's 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age 18 to 39 years at time of consent
- A confirmed diagnosis of testis cancer (any stage)
- Completion of chemotherapy for testis cancer within 4 years prior to consent
- A score of >4 on the Distress Thermometer
- English fluency, as per medical record documenting preferred language or in the
judgment of the investigator
- Spanish fluency, as per medical record documenting preferred language or in the
judgment of the investigator
- Able to perform informed consent
Exclusion Criteria:
- 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)
Gender:
Male
Minimum age:
18 Years
Maximum age:
39 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California, Irvine
Address:
City:
Irvine
Zip:
92697-3954
Country:
United States
Status:
Recruiting
Contact:
Last name:
Michael A Hoyt, PhD
Phone:
949-824-5281
Email:
mahoyt@uci.edu
Start date:
November 1, 2023
Completion date:
July 2028
Lead sponsor:
Agency:
University of California, Irvine
Agency class:
Other
Collaborator:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
University of California, Irvine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05836688
