A Biobehavioral Intervention for Latino/Hispanic Young Adults With Cancer

Cancer Clinical Trial

Official title:

A Biobehavioral Intervention for Latino/Hispanic Young Adults With Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06338475
• Other study ID #: 20205703
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: June 2026

Study information

• Verified date: May 2024
• Source: University of California, Irvine
• Contact: Michael A Hoyt, PhD
• Phone: 949-824-5281
• Email: mahoyt[@]uci.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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 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, 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 Hispanic/Latino 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, Machismo/Caballarismo, Simpatia, Acculturative Stress).

Findings will be used to adapt the GET intervention for a future randomized efficacy trial.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• Age 18 to 39 years at time of consent

• Male gender; self-identified

• A confirmed diagnosis of cancer (any stage)

• Diagnosed with cancer between the ages of 15 and 39

• Hispanic/Latino identification

• A score = 1.8 on the Goal Navigation Scale or = 4 on the Distress Thermometer

• English or Spanish fluency

Exclusion Criteria:

• lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder (self-report)

• compromised cognitive capacity

• self-reported medical condition or medication use known to confound measures of systemic inflammation (e.g., autoimmune disorder, active infection)

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Goal-Focused Emotion-Regulation Therapy (GET)
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.
• Individual Supportive Listening (ISL)
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

References & Publications (3)

Hoyt MA, Nelson CJ. Goal-focused Emotion-Regulation Therapy for young adult survivors of testicular cancer: Feasibility of a behavioral intervention. Contemp Clin Trials Commun. 2020 Aug 21;19:100648. doi: 10.1016/j.conctc.2020.100648. eCollection 2020 Sep. — View Citation

Hoyt MA, Wang AW, Breen EC, Nelson CJ. A Randomized Controlled Trial of Goal-Focused Emotion-Regulation Therapy for Young Adult Survivors of Testicular Cancer: Effects on Salivary and Inflammatory Stress Markers. Am J Mens Health. 2021 Sep-Oct;15(5):15579883211044557. doi: 10.1177/15579883211044557. — View Citation

Hoyt MA, Wang AW, Ryan SJ, Breen EC, Cheavens JS, Nelson CJ. Goal-Focused Emotion-Regulation Therapy (GET) for young adult survivors of testicular cancer: a pilot randomized controlled trial of a biobehavioral intervention protocol. Trials. 2020 Apr 14;21(1):325. doi: 10.1186/s13063-020-04242-0. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hospital Anxiety and Depression Scale (HADS)	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.	Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
Primary	Change in Systemic Pro-inflammatory Cytokine Levels (IL-6, IL-1ra, C-reactive Protein (CRP), sTNFaRII)	The investigators will focus on four biomarkers, IL-6, IL-1ra, CRP, sTNFaRII, that indicate systemic inflammation and are associated with distress symptoms and emotion regulation. Levels will be assessed from plasma. 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.	Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
Primary	Change in Salivary Diurnal Cortisol Daily Output	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. Salivary cortisol will be analyzed with a time-resolved fluorescence immunoassay. Cortisol output will be measured by area under the daily curve and total daily cortisol output.	Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
Secondary	Change in Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp) Subscale Score	A 12-item questionnaire that measures spiritual well-being in people with cancer and other chronic illnesses. The FACIT-Sp-12 is part of the larger Functional Assessment of Chronic Illness Therapy (FACIT) measurement system that assesses multidimensional HRQOL. It asks patients to describe aspects of spirituality and/or religious faith that contribute to HRQOL over the past 7 days. The measure was originally developed with 2 components or factors of a total (overall) score: a 4-item Faith component (e.g. I find comfort in my faith or spiritual beliefs), and an 8-item Meaning/Peace component (e.g. I feel a sense of purpose in my life, I feel peaceful).	Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
Secondary	Change in Career Thoughts Inventory (CTI) Global Score	The CTI (Sampson et al., 1996) is a 48-item self-administered instrument that measures an individual's level of dysfunctional thinking in career decision-making and career problem-solving. The CTI is normed on adults and broadly used in the context of I/O Psychology. Items are rated on a 4-point Likert scale ranging from 0 (strongly disagree) to 3 (strongly agree). CTI total score provides information about an individual's overall level of dysfunctional career thoughts, However, the CTI has three subscales: Decision-Making Confusion (difficulties with initiating or sustaining a career choice), Commitment Anxiety (difficulties with making a commitment to a career choice), and External Conflict (difficulties with balancing one's ideas with the ideas from others). The CTI has sound evidence for its content, construct, and criterion-related validity (Peila-Shuster & Feller, 2013; Sampson et al., 1996).	Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
Secondary	Change in Emotion Regulation Questionnaire (ERQ) Scale Scores	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).	Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
Secondary	Change in Cancer Assessment for Young Adults (CAYA-T) - Goal Navigation Score	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 cancer survivors.	Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
Secondary	Change in Emotional Approach Coping Questionnaire (EAC) Scale Scores	The EAC Scale is an 8-question, patient-rated, self-report scale designed to measure emotional coping. Participants are asked to rate their usual response to stress by rating each item on a 4-point Likert scale (1 = "I usually don't do this at all" to 4 = "I usually do this a lot"). The scores for the EAC range from 0 to 32, with lower scores representing poorer emotional coping.	Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
Secondary	Change in Salivary Diurnal Cortisol Slope	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. Salivary cortisol will be analyzed with a time-resolved fluorescence immunoassay. Diurnal slope will be calculated.	Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
Secondary	Change in Salivary Diurnal Cortisol Awakening Response	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. Salivary cortisol will be analyzed with a time-resolved fluorescence immunoassay. Cortisol awakening response will be calculated using the first two collection points across the 3 days of collection.	Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)