A Biobehavioral Intervention to Reduce Adverse Outcomes in Young Adult Testicular Cancer Survivors

NCT05836688 | Recruiting DMC

• 2 other identifiers: 202058121R01CA276143-01A1
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Testicular Cancer

Outcome Measures

Primary Outcomes (3)

• 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), and to 6-month post-intervention (~32 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.

  Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks), and to 6-month post-intervention (~32 weeks)

• 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. Salivary cortisol will be analyzed with a time-resolved fluorescence immunoassay. 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) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks), and to 6-month post-intervention (~32 weeks)

Secondary Outcomes (5)

• Change in Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp) Subscale Score

  Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks), and to 6-month post-intervention (~32 weeks)

• Change in Career Thoughts Inventory (CTI) Global Score

  Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks), and to 6-month post-intervention (~32 weeks)

• Change in Emotion Regulation Questionnaire (ERQ) Scale Scores

  Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks), and to 6-month post-intervention (~32 weeks)

• Change in Cancer Assessment for Young Adults (CAYA-T) - Goal Navigation Score

  Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks), and to 6-month post-intervention (~32 weeks)

• Change in Emotional Approach Coping Questionnaire (EAC) Scale Scores

  Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks), and to 6-month post-intervention (~32 weeks)

Study Arms (2)

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.

Behavioral: Goal-Focused Emotion-Regulation Therapy (GET)

Individual Supportive Listening

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.

Behavioral: Individual Supportive Listening

Interventions

Goal-Focused Emotion-Regulation Therapy (GET) BEHAVIORAL

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.

Goal-Focused Emotion-Regulation Therapy (GET)

Individual Supportive Listening BEHAVIORAL

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.

Individual Supportive Listening

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, Irvine: lead
• Memorial Sloan Kettering Cancer Center: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California, Irvine

Irvine, California, 92697-3954, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 32290859 BACKGROUND

• 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.

  PMID: 32913918 BACKGROUND

• 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.

  PMID: 34514890 BACKGROUND

MeSH Terms

Conditions

Testicular Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders

Study Officials

• Michael A Hoyt, PhD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael A Hoyt, PhD

CONTACT

949-824-5281; mahoyt@uci.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: May 1, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

US (1)