Clinical trial NCT04150848: A Biobehavioral Intervention for Young Men With Testicular Cancer
Official title: A Biobehavioral Intervention for Young Men With Testicular Cancer: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Testis Cancer
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Memorial Sloan Kettering Cancer Center
First posted: 2019-11-05
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Hospital Anxiety and Depression Scale (HADS)
timeFrame: Change from Baseline (T0) at 12-weeks Post-Intervention (T2)
measure: Change in Systemic Pro-inflammatory Cytokine Levels (IL-6, IL-1ra, CRP, sTNFαRII)
timeFrame: Change from Baseline (T0) at intrervention completion, an average of 8 weeks
measure: Change in Salivary Diurnal Cortisol Slope and Daily Output
timeFrame: Change from Baseline (T0) at intrervention completion, an average of 8 weeks
Secondary outcomes:
measure: Change in Emotion Regulation Questionnaire (ERQ) Scale Scores
timeFrame: Change from Baseline (T0) at 12-weeks Post-Intervention (T2)
measure: Change in Cancer Assessment for Young Adults (CAYA-T) - Goal Navigation Score
timeFrame: Change from Baseline (T0) at 12-weeks Post-Intervention (T2)
measure: Change in Career Thoughts Inventory (CTI) Global Score
timeFrame: Change from Baseline (T0) at 12-weeks Post-Intervention (T2)
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
References:
citation: 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.