Clinical trial · Interventional
A Biobehavioral Intervention to Reduce Adverse Outcomes in Young Adult Testicular Cancer Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Testicular Cancer | Malignant Testicular Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Goal-Focused Emotion-Regulation Therapy (GET) | Behavioral | — | UNRESOLVED |
| Individual Supportive Listening | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Goal-Focused Emotion-Regulation Therapy (GET)
- description
- 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.
- interventionNames
- Behavioral: Goal-Focused Emotion-Regulation Therapy (GET)
- type
- ACTIVE_COMPARATOR
- label
- Individual Supportive Listening
- description
- 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.
- interventionNames
- Behavioral: Individual Supportive Listening
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 39 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
References
Publications (3)
- BACKGROUNDHoyt 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
- BACKGROUNDHoyt 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
- BACKGROUNDHoyt 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