Clinical trial · Interventional
A Biobehavioral Intervention for Young Men With Testicular Cancer
A Biobehavioral Intervention for Young Men With Testicular Cancer: A Pilot Study
- 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 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
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 |
|---|---|---|---|
| Testis Cancer | Testicular Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Goal-Focused Emotion Regulation Therapy (GET) | Behavioral | — | UNRESOLVED |
| Individual Supportive Psychotherapy (ISP) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Goal Focused Emotion-Regulation Therapy (GET)
- description
- 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).
- interventionNames
- Behavioral: Goal-Focused Emotion Regulation Therapy (GET)
- type
- ACTIVE_COMPARATOR
- label
- Individual Supportive Psychotherapy (ISP)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 39 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDHoyt 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
- DERIVEDHoyt 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