Young Adult Latino Testicular Cancer Survivors: a Pilot Study of Goal-Focused Emotion Regulation Therapy (GET)
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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, and young Hispanic/Latino 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 (e.g., enhanced inflammation, dysregulated stress hormones) which influence morbidity and disease-related vulnerabilities. However, few targeted, tailored, culturally-relevant interventions exist to assist young Hispanic/Latino 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 to the need for feasible, effective, and scalable interventions that meet the needs of ethnic minority men, 35 Hispanic/Latino young adults (ages 18-39) with testicular cancer will receive 6 sessions of GET. We will evaluate primary and secondary outcomes at baseline, post-treatment, and 3-month follow-up. In addition, identified biomarkers will be assessed at baseline and post-intervention. We predict that GET will be associated with superior distress outcomes, and these advantages will be maintained at 3-months following intervention. We also expect to observe pre-post reductions in adverse biobehavioral indicators (dysregulated diurnal stress hormones, elevated systemic inflammation)
The intervention will be delivered via an interactive video platform to enhance access. However, we believe that GET could be optimized to meet the needs of this group. To this end, we will examine the influence of Latino cultural processes (Machismo, Simpatia, Acculturative Stress), and conduct in-depth qualitative interviews. Findings will be used to adapt the GET intervention for a future randomized efficacy trial. 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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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California
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Irvine, California, Spojené státy, 92697
- University of California, Irvine
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Age 18 to 39 years at time of consent
- A confirmed diagnosis of testis cancer
- Completion of primary medical treatment for testicular cancer within 4 years at time of consent
- Hispanic/Latino identification (self or cancer registry confirmed)
- A score of < 1.8 on the goal navigation scale or < 0.6 on the goal facility scale of the CAYA or >4 on the Distress Thermometer
- English or 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)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Goal-focused Emotion-regulation Therapy (GET)
GET is a 6-session intervention delivered over 8 weeks to enhance self-regulation through improved goal navigation skills, improved sense of meaning and purpose, and better ability to regulate specific emotional responses.
Session topics include a review of cancer-related experiences and influences on goal pursuits, psychoeducation regarding emotions, skills, and values (Session 1), values clarifications and emotional awareness (Session 2), achievability of goals, cognitive skills training (Sessions 3), goal pathway mapping, navigating blocked goals and re-directing energy (Sessions 4), goal motivation and agentic actions, self-care behavior (Session 5), and goal pursuits moving forward (session 6).
The first session is 90 minutes and each subsequent session is 60 minutes.
Participants are given structured at home exercises via an interactive digital workbook designed to facilitate skill acquisition.
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GET is a 6-session intervention delivered over 8 weeks to enhance self-regulation through improved goal navigation skills, improved sense of meaning and purpose, and better ability to regulate specific emotional responses.
Session topics include a review of cancer-related experiences and influences on goal pursuits, psychoeducation regarding emotions, skills, and values (Session 1), values clarifications and emotional awareness (Session 2), achievability of goals, cognitive skills training (Sessions 3), goal pathway mapping, navigating blocked goals and re-directing energy (Sessions 4), goal motivation and agentic actions, self-care behavior (Session 5), and goal pursuits moving forward (session 6).
The first session is 90 minutes and each subsequent session is 60 minutes.
Participants are given structured at home exercises via an interactive digital workbook designed to facilitate skill acquisition.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Hospital Anxiety and Depression Scale (HADS)
Časové okno: Baseline (T0), Within 2 weeks of completing last intervention session (T1), Within 2 weeks of 3-months of completing last intervention session (T2)
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The HADS was developed to assess anxiety and depression in medical patients.
It purposefully excluded somatic symptoms (e.g., sleep disturbance) to reduce confounding psychological symptoms with disease or treatment.
The HADS has become a "benchmark" measure of anxiety and depression among diverse clinical and nonclinical hospital populations, including individuals diagnosed with cancer.
The HADS is a 14-item self-administered questionnaire, with 7 items assigned to each the HADS-Anxiety and HADS-Depression subscales.
Each item is rated on a 4-point response scale (from 0 to 3).
Subscale scores are typically categorized to indicate the level of anxiety or depression experienced where scores of less than 8 are categorized as normal, scores of 8-10 as borderline, and scores of 11-21 as clinical.
A number of psychometric studies have established the scale's strengths, including its brevity, reliability, and validity and availability of comparison scores across different populations.
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Baseline (T0), Within 2 weeks of completing last intervention session (T1), Within 2 weeks of 3-months of completing last intervention session (T2)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Cancer Assessment for Young Adults (CAYA-T)
Časové okno: Baseline (T0), Within 2 weeks of completing last intervention session (T1), Within 2 weeks of 3-months of completing last intervention session (T2)
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Goal navigation capacity includes elements of goal setting, goal clarification, goal adjustment, and goal initiation.
It will be measured by the Goal Navigation subscale of the Cancer Assessment for Young Adults -Testicular (CAYA-T) (Hoyt et al., 2013).
The scale is composed of five items (e.g., "I am able to identify goals in my life", "I know what steps to take to make progress toward my goals", and "I am able to redirect my energy when I feel my life isn't going in the right direction").
Participants indicate how often each item is true of them over the past 7 days on a 3-point response scale ranging from 0 (None of the time) to 2 (Much or most of the time).
Criterion, construct, and procedural validity have been established with young adult testicular cancer survivors.
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Baseline (T0), Within 2 weeks of completing last intervention session (T1), Within 2 weeks of 3-months of completing last intervention session (T2)
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Emotion Regulation Questionnaire (ERQ)
Časové okno: Baseline (T0), Within 2 weeks of completing last intervention session (T1), Within 2 weeks of 3-months of completing last intervention session (T2)
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Emotion regulation skills will be measured by the Emotion Regulation Questionnaire (ERQ).
The ERQ is a widely used 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression.
Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).
The ERQ is widely used in the context of clinical treatment trials and has well established validity, reliability, and factor structure (Goldin, Manber-Ball, Werner, Heimberg, & Gross, 2009; Gross & John, 2003).
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Baseline (T0), Within 2 weeks of completing last intervention session (T1), Within 2 weeks of 3-months of completing last intervention session (T2)
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Salivary Diurnal Cortisol
Časové okno: Baseline (T0), Within 2 weeks of completing last intervention session (T1)
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Diurnal rhythm in salivary cortisol will be measured over three days at each assessment.
Participants will collect saliva samples in their natural environment upon awakening, 30 minutes later, 8 hours later, and at bedtime.
Participants will complete a diary to assess relevant health behaviors (e.g., caffeine, tobacco, alcohol consumption; physical activity, sleep) as well as daily stress.
They will be instructed to avoid brushing their teeth, eating, or drinking within 20 minutes before sampling.
Participants will keep samples refrigerated prior to returning them to the research laboratory and returned salivettes will be stored in a -20-degree Celsius freezer until analyzed.
After data collection is complete, salivary cortisol will be analyzed with a time-resolved fluorescence immunoassay at the IISBR laboratory at UC Irvine.
Several indices will be computed including diurnal slope, area under the daily curve, cortisol awakening response, and total daily cortisol output.
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Baseline (T0), Within 2 weeks of completing last intervention session (T1)
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Pro-inflammatory Markers (IL-6, IL-1ra, CRP, PD1, TNFaRII, VEGF)
Časové okno: Baseline (T0), Within 2 weeks of completing last intervention session (T1)
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We will focus on a set of inflammatory biomarkers that indicate systemic inflammation and are associated with distress symptoms and emotion regulation.
Levels will be assessed via oral mucosal transudate (OMT).
OMT is an ultrafiltrate of blood and is a reflection of serum, rather than saliva.
Participants will be instructed to swab for 2 minutes with the OraSure collection device.
The pad is removed from the mouth and placed in the vial containing an aqueous antimicrobial preservative solution.
Samples are shipped by secured mail and are stable at standard temperatures for up to 21 days from the time of collection.
Upon return, the eluate will be transferred into a 4 ml cryovial and frozen at -80°C until assay.
Cytokine levels will be determined by immunosorbent assay (ELISA) according to assay manufacturer's protocols.
All samples will be run in duplicate, and assays will be repeated on two separate days; intra-assay and interassay mean levels will be used in all analyses.
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Baseline (T0), Within 2 weeks of completing last intervention session (T1)
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Michael A Hoyt, PhD, University of California, Irvine
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Urogenitální onemocnění
- Onemocnění genitálií
- Onemocnění endokrinního systému
- Duševní poruchy
- Genitální novotvary, muži
- Urogenitální novotvary
- Novotvary podle místa
- Novotvary
- Onemocnění pohlavních orgánů, muž
- Mužská urogenitální onemocnění
- Symptomy chování
- Novotvary endokrinních žláz
- Gonadální poruchy
- Testikulární nemoci
- Chování
- Úzkostné poruchy
- Deprese
- Testikulární novotvary
Další identifikační čísla studie
- 20205703
Plán pro data jednotlivých účastníků (IPD)
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Studuje lékový produkt regulovaný americkým FDA
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