Recruiting
Phase 2

Biobehavioral Intervention

Sponsor:

UCLA

Code:

NCT04150848

Conditions

Testis Cancer

Eligibility Criteria

Sex: Male

Age: 18 - 39

Healthy Volunteers: Not accepted

Interventions

Goal-Focused Emotion Regulation Therapy (GET)

Individual Supportive Psychotherapy (ISP)

Study Details

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

Study ID

NCT04150848

Start date

Nov 1, 2018

Status verified date

Dec, 2020

Completion date

Dec, 2021

Anticipated

Primary completion date

Nov, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 39

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Goal Focused Emotion-Regulation Therapy (GET)

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).

active comparator: Individual Supportive Psychotherapy (ISP)

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.

Interventions

Goal-Focused Emotion Regulation Therapy (GET)

Six sessions delivered individually over 8 weeks

Individual Supportive Psychotherapy (ISP)

Six sessions delivered individually over 8 weeks

Primary outcome measure

  • Change in Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Change from Baseline (T0) at 12-weeks Post-Intervention (T2) ]
  • Change in Systemic Pro-inflammatory Cytokine Levels (IL-6, IL-1ra, CRP, sTNFαRII) [ Time Frame: Change from Baseline (T0) at intrervention completion, an average of 8 weeks ]
  • Change in Salivary Diurnal Cortisol Slope and Daily Output [ Time Frame: Change from Baseline (T0) at intrervention completion, an average of 8 weeks ]

Central Contacts and Locations

Central contacts

Michael A Hoyt, PhD

949-824-9937mahoyt@uci.edu

Locations

University of California, Irvine

Recruiting

Irvine, California, United States, 92697-3957

Contacts

Michael A Hoyt, PhD

949-824-9937mahoyt@uci.edu

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10017

Contacts

Attending Psychologist

nelsonc@mskcc.org

More Information

Sponsor

University of California, Irvine

Last update posted

Dec 19, 2020

Last verified

Dec, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2020-12-19.