CancerNCT06338475
A Biobehavioral Intervention for Latino/Hispanic Young Adults with Cancer
A study testing Goal-Focused Emotion-Regulation Therapy (GET) and Individual Supportive Listening (ISL) in people with Cancer, run by University of California, Irvine at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 39 years, men only
- Conditions the study is for
- Cancer
- What is being tested?
- Goal-Focused Emotion-Regulation Therapy (GET) and Individual Supportive Listening (ISL)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2024to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, Irvine
Irvine, California, 92617
Michael Hoyt, PhD, (949) 824-5281, mahoyt@uci.edu
About this study
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.
Read the 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 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.
- Conditions
- Cancer
- Being tested
- Goal-Focused Emotion-Regulation Therapy (GET), Individual Supportive Listening (ISL)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal-Focused Emotion-Regulation Therapy (GET)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Goal-Focused Emotion-Regulation Therapy (GET) | Experimental | 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. Receives: Behavioral: Goal-Focused Emotion-Regulation Therapy (GET) |
| Individual Supportive Listening (ISL) | Active comparator | 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. Receives: Behavioral: Individual Supportive Listening (ISL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
Change in Systemic Pro-inflammatory Cytokine Levels (IL-6, IL-1ra, C-reactive Protein (CRP), sTNFαRII)
The investigators will focus on four biomarkers, IL-6, IL-1ra, CRP, sTNFαRII, 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.
Measured: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
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.
Measured: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
Secondary outcomes (7)
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).
Measured: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
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).
Measured: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
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).
Measured: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
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.
Measured: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
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.
Measured: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
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.
Measured: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
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.
Measured: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start1 Jun 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Hoyt, University of California, Irvine
- Investigators
- Michael A Hoyt, PhD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338475
- Sponsor's protocol ID
- 5510
- Status last verified
- Mar 2025
- First submitted
- 23 Mar 2024
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32290859Hoyt 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.
PubMed 32913918Hoyt 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.
PubMed 34514890
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Biobehavioral Intervention for Latino/Hispanic Young Adults with Cancer
- ClinicalTrials.gov ID
- NCT06338475
- Acronym / sponsor ID
- 5510
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Goal-Focused Emotion-Regulation Therapy (GET) | Experimental | Behavioral: Goal-Focused Emotion-Regulation Therapy (GET)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. |
| Individual Supportive Listening (ISL) | Active comparator | Behavioral: Individual Supportive Listening (ISL)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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Goal-Focused Emotion-Regulation Therapy (GET) |
| 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. | Behavioural | Individual Supportive Listening (ISL) |
Primary outcome
Change in Hospital Anxiety and Depression Scale (HADS)
Time frame: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
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 in Systemic Pro-inflammatory Cytokine Levels (IL-6, IL-1ra, C-reactive Protein (CRP), sTNFαRII)
Time frame: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
The investigators will focus on four biomarkers, IL-6, IL-1ra, CRP, sTNFαRII, 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 in Salivary Diurnal Cortisol Daily Output
Time frame: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
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.
7 secondary outcomes
Change in Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp) Subscale Score
Time frame: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
Change in Career Thoughts Inventory (CTI) Global Score
Time frame: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
Change in Emotion Regulation Questionnaire (ERQ) Scale Scores
Time frame: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
Change in Cancer Assessment for Young Adults (CAYA-T) - Goal Navigation Score
Time frame: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
Change in Emotional Approach Coping Questionnaire (EAC) Scale Scores
Time frame: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
Change in Salivary Diurnal Cortisol Slope
Time frame: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
Change in Salivary Diurnal Cortisol Awakening Response
Time frame: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Background: PubMed 32290859Hoyt 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.
- Background: PubMed 32913918Hoyt 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.
- Background: PubMed 34514890Hoyt 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.
- Individual participant dataSharing planned: Undecided
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Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael A Hoyt, PhD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal-Focused Emotion-Regulation Therapy (GET) and Individual Supportive Listening (ISL) in people with Cancer, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael A Hoyt, PhD (949-824-5281, mahoyt@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hospital Anxiety and Depression Scale (HADS) (time frame: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06338475, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.