A Biobehavioral Intervention for Young Men With Testicular Cancer

University of California Irvine (UCI)

Status and phase: Unknown; Phase 2

Conditions: Testis Cancer

Treatments: Behavioral: Goal-Focused Emotion Regulation Therapy (GET); Behavioral: Individual Supportive Psychotherapy (ISP)

Study type: Interventional

Funder types: Other

Identifiers

NCT04150848

2018-4676

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Goal Focused Emotion-Regulation Therapy (GET)

Experimental group

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).

Treatment:

Behavioral: Goal-Focused Emotion Regulation Therapy (GET)

Individual Supportive Psychotherapy (ISP)

Active Comparator group

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.

Treatment:

Behavioral: Individual Supportive Psychotherapy (ISP)