A Biobehavioral Intervention for Young Men With Testicular Cancer

Testis Cancer Clinical Trial

Official title:

A Biobehavioral Intervention for Young Men With Testicular Cancer: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04150848
• Other study ID #: 2018-4676
• Status: Recruiting
• Phase: Phase 2
• Start date: November 1, 2018
• Est. completion date: December 2021

Study information

• Verified date: December 2020
• Source: University of California, Irvine
• Contact: Michael A Hoyt, PhD
• Phone: 949-824-9937
• Email: mahoyt[@]uci.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a randomized controlled biobehavioral pilot trial designed to investigate the feasibility and preliminary efficacy 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 Therapy (ISP) 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) and twelve weeks after intervention at T2. Additionally, identified biomarkers will be measured at baseline and at T2.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2021
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• between the ages of 18 and 39 years at the time of consent
• confirmed diagnosis of testis cancer (any stage)
• completed chemotherapy for testis cancer within 2 years prior to consent
• fluency in English (per self-report)
• sub-optimal self-regulation as evidenced by a score of 1.8 or below on the Goal Navigation Scale or a score of 4 or greater on the Distress Thermometer (DT)

Exclusion Criteria:

• lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder (per self-report)
• active suicide plan
• disorder that compromises comprehension of assessments or informed consent information
• self-reported medical condition or medication use known to confound measures of systemic inflammation
• daily smoking

Related Conditions & MeSH terms

• Testicular Neoplasms
• Testis Cancer

Intervention

Behavioral:
• Goal-Focused Emotion Regulation Therapy (GET)
Six sessions delivered individually over 8 weeks
• Individual Supportive Psychotherapy (ISP)
Six sessions delivered individually over 8 weeks

Locations

Country	Name	City	State
United States	University of California, Irvine	Irvine	California
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

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) at 12-weeks Post-Intervention (T2)
Primary	Change in Systemic Pro-inflammatory Cytokine Levels (IL-6, IL-1ra, CRP, sTNFaRII)	The investigators will focus on four biomarkers, IIL-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) at intrervention completion, an average of 8 weeks
Primary	Change in Salivary Diurnal Cortisol Slope and 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. 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.	Change from Baseline (T0) at intrervention completion, an average of 8 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) at 12-weeks Post-Intervention (T2)
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 testicular cancer survivors.	Change from Baseline (T0) at 12-weeks Post-Intervention (T2)
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) at 12-weeks Post-Intervention (T2)