Clinical trial · Interventional
A Biobehavioral Intervention for Latino/Hispanic Young Adults with Cancer
- 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)
Building upon the results of a single-arm trial designed to investigate the feasibility and acceptability of a novel intervention, Goal-focused Emotion-Regulation Therapy (GET), this trial is a randomized-controlled biobehavioral pilot trial of GET versus a time-and attention matched control (Instrumental Supportive Listening; ISL) in Latino/Hispanic young adult survivors of adolescent and young adult (AYA) cancer (age 15-39 years at diagnosis). Outcomes include improved distress symptoms, emotion regulation, goal navigation skills, and changes in stress-sensitive biomarkers. Participants will be randomized to receive six sessions of GET or ISL delivered over eight weeks. In addition to indicators of intervention feasibility, the investigators will measure primary and secondary psychological outcomes prior to (T0), immediately after (T1), and twelve weeks after intervention (T2). Additionally, identified biomarkers will be measured at baseline and at T1, and 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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Goal-Focused Emotion-Regulation Therapy (GET) | Behavioral | — | UNRESOLVED |
| Individual Supportive Listening (ISL) | 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 (ISL)
- 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 (ISL)
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 * Male gender; self-identified * A confirmed diagnosis of cancer (any stage) * Diagnosed with cancer between the ages of 15 and 39 * Hispanic/Latino identification * A score ≤ 1.8 on the Goal Navigation Scale or ≥ 4 on the Distress Thermometer * English or Spanish fluency Exclusion Criteria: * lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder (self-report) * compromised cognitive capacity * self-reported medical condition or medication use known to confound measures of systemic inflammation (e.g., autoimmune disorder, active infection)
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