A Biobehavioral Intervention for Young Men With Testicular Cancer

NCT04150848 | Unknown Phase 2

• 1 other identifier: 2018-4676
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Testis 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) at 12-weeks Post-Intervention (T2)

• Change in Systemic Pro-inflammatory Cytokine Levels (IL-6, IL-1ra, CRP, sTNFαRII)

  The investigators will focus on four biomarkers, IIL-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) at intrervention completion, an average of 8 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. 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 Outcomes (3)

• Change in Emotion Regulation Questionnaire (ERQ) Scale Scores

  Change from Baseline (T0) at 12-weeks Post-Intervention (T2)

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

  Change from Baseline (T0) at 12-weeks Post-Intervention (T2)

• Change in Career Thoughts Inventory (CTI) Global Score

  Change from Baseline (T0) at 12-weeks Post-Intervention (T2)

Study Arms (2)

Goal Focused Emotion-Regulation Therapy (GET)

EXPERIMENTAL

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. GET has an emphasis on goal navigation skill building. This includes work on goal setting with a focus on assessing progress toward achieving specific, realistic, and measurable goals. Emotion regulation components include basic cognitive restructuring skills, cognitive distancing, and coping efficacy skills (matching the correct coping skill to specific circumstances).

Behavioral: Goal-Focused Emotion Regulation Therapy (GET)

Individual Supportive Psychotherapy (ISP)

ACTIVE COMPARATOR

ISP includes 6-sessions of individual supportive psychotherapy and includes components of genuineness, unconditional positive regard, and empathic understanding through reassurance, explanation, guidance, suggestion, encouragement, affecting changes in patient's environment, and permission for catharsis. ISP emphasizes maintaining focus on the cancer experience, supporting participants in the "here and now," fostering expression of emotion and discussion of difficult topics, and creating a sense of being understood.

Behavioral: Individual Supportive Psychotherapy (ISP)

Interventions

Goal-Focused Emotion Regulation Therapy (GET) BEHAVIORAL

Six sessions delivered individually over 8 weeks

Goal Focused Emotion-Regulation Therapy (GET)

Individual Supportive Psychotherapy (ISP) BEHAVIORAL

Six sessions delivered individually over 8 weeks

Individual Supportive Psychotherapy (ISP)

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead
• Memorial Sloan Kettering Cancer Center: collaborator

Study Sites (2)

University of California, Irvine

Irvine, California, 92697-3957, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10017, United States

RECRUITING

Related Publications (2)

• Hoyt MA, Wang AW, Ceja RC, Cheavens JS, Daneshvar MA, Feldman DR, Funt SA, Nelson CJ. Goal-Focused Emotion-Regulation Therapy (GET) in Young Adult Testicular Cancer Survivors: A Randomized Pilot Study. Ann Behav Med. 2023 Aug 21;57(9):777-786. doi: 10.1093/abm/kaad010.

  PMID: 37078969 DERIVED

• 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 DERIVED

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

Central Study Contacts

Michael A Hoyt, PhD

CONTACT

949-824-9937; mahoyt@uci.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: November 5, 2019
• Study Start: November 1, 2018
• Primary Completion: November 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 19, 2020

Record last verified: 2020-12

Locations

US (2)