Biobehavioral Intervention for Testicular Cancer
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, Irvine
Disqualifiers: Autoimmune disorder, Inflammatory disease, Type I diabetes, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Goal-Focused Emotion-Regulation Therapy (GET) for testicular cancer?
Research shows that GET can help young adult testicular cancer survivors by reducing stress-related markers in the body and improving emotional regulation and goal-setting skills, which are important for managing the psychological impact of cancer.
12345Is Goal-Focused Emotion-Regulation Therapy (GET) safe for humans?
GET has been studied in young adult testicular cancer survivors and showed potential to reduce stress-related processes and inflammation without significant adverse effects reported. More research is needed to confirm its safety and effectiveness.
12345How is the treatment Goal-Focused Emotion-Regulation Therapy (GET) unique for testicular cancer survivors?
Goal-Focused Emotion-Regulation Therapy (GET) is unique because it specifically targets the emotional and goal-related challenges faced by young adult testicular cancer survivors, aiming to improve distress symptoms and emotion regulation while also addressing stress-sensitive biomarkers, which is not commonly the focus of other treatments for this condition.
12346Eligibility Criteria
This trial is for young adults aged 18-39 who have had testicular cancer and finished chemotherapy within the last 4 years. They must be fluent in English or Spanish, feel distressed (scoring >4 on a Distress Thermometer), and be able to consent. It's not for regular smokers, those with immune-affecting conditions, recent heart attacks or strokes, Type I diabetes, acute hepatitis, recent vaccinations, or a history of psychiatric or cognitive disturbances.Inclusion Criteria
I am between 18 and 39 years old.
Able to perform informed consent
English fluency, as per medical record documenting preferred language or in the judgment of the investigator
+4 more
Exclusion Criteria
I am unable to understand or complete the study requirements.
You smoke cigarettes every day.
I do not have immune-related conditions that could affect the study.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive six sessions of Goal-focused Emotion-Regulation Therapy (GET) or Individual Supportive Listening (ISL) over eight weeks
8 weeks
6 sessions (virtual)
Follow-up
Participants are monitored for psychological and biobehavioral outcomes post-treatment
24 weeks
Assessments at 3-month and 6-month post-intervention
Participant Groups
The study tests Goal-focused Emotion-Regulation Therapy (GET) against Individual Supportive Listening (ISL) to see if GET can better improve emotional distress symptoms and skills like emotion regulation and goal setting in testicular cancer survivors. Participants will get six sessions over eight weeks with follow-up assessments up to six months after the therapy.
2Treatment groups
Experimental Treatment
Active Control
Group I: Goal-Focused Emotion-Regulation Therapy (GET)Experimental Treatment1 Intervention
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.
Group II: Individual Supportive ListeningActive Control1 Intervention
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California, IrvineIrvine, CA
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Who Is Running the Clinical Trial?
University of California, IrvineLead Sponsor
National Cancer Institute (NCI)Collaborator
Memorial Sloan Kettering Cancer CenterCollaborator
References
Goal-focused Emotion-Regulation Therapy for young adult survivors of testicular cancer: Feasibility of a behavioral intervention. [2021]Young adult cancer testicular survivors experience impairing, distressing, and modifiable physical, behavioral, and psychosocial adverse outcomes that persist long after the completion of primary medical treatment. These include psychological distress and poor psychosocial adjustment, impaired navigation of life goals, persistent treatment side effects, and fear associated with elevated risk of secondary malignancies and chronic illness. This paper describes the feasibility and acceptability of a novel intervention, Goal-focused Emotion-Regulation Therapy (GET) aimed at improving distress symptoms, emotion regulation, and goal navigation skills in young adult testicular cancer patients.
Goal-Focused Emotion-Regulation Therapy (GET) in Young Adult Testicular Cancer Survivors: A Randomized Pilot Study. [2023]Young adult testicular cancer survivors experience adverse impacts after treatment. We developed Goal-focused Emotion-regulation Therapy (GET) to improve distress symptoms, emotion regulation, and goal navigation skills.
Goal-Focused Emotion-Regulation Therapy (GET) for young adult survivors of testicular cancer: a pilot randomized controlled trial of a biobehavioral intervention protocol. [2021]Testicular cancer diagnosis and treatment, especially given its threat to sexuality and reproductive health, can be distressing in the formative period of young adulthood and the majority of young survivors experience impairing, distressing, and modifiable adverse outcomes that can persist long after medical treatment. These include psychological distress, impairment in pursuit of life goals, persistent physical side effects, elevated risk of secondary malignancies and chronic illness, and biobehavioral burden (e.g., enhanced inflammation, dysregulated diurnal stress hormones). However, few targeted interventions exist to assist young survivors in renegotiating life goals and regulating cancer-related emotions, and none focus on reducing the burden of morbidity via biobehavioral mechanisms. This paper describes the methodology of a randomized controlled biobehavioral trial designed to investigate the feasibility and preliminary impact 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.
A Randomized Controlled Trial of Goal-Focused Emotion-Regulation Therapy for Young Adult Survivors of Testicular Cancer: Effects on Salivary and Inflammatory Stress Markers. [2022]Despite the substantial adverse psychological impact of testicular cancer, few interventions have sought to improve psychosocial functioning and stress-related biomarkers in young adult survivors. Goal-focused Emotion-regulation Therapy (GET) is designed to improve distress symptoms, emotion regulation, and goal navigation skills, which would be expected to improve regulation of stress-sensitive biomarkers. The aim was to examine the effects of GET versus an active control intervention on salivary stress and circulating inflammatory markers in young adult survivors of testicular cancer. Young adult men with testicular cancer (N = 44) who had undergone chemotherapy within the last 2 years were randomized to GET or individual supportive therapy (ISP) delivered over 8 weeks. Saliva samples were collected for 2 consecutive days at baseline and post-intervention (awakening, 8 hr later, bedtime) to measure diurnal rhythm. Circulating plasma levels of CRP, IL-6, IL-1ra, TNFαRII, and VEGF were measured at baseline and post-intervention. Regression modeling demonstrated a significant group effect on daily output of salivary cortisol (area under the curve) (β = -57, p < .05), with cortisol output decreasing from baseline to post-intervention for those receiving GET (Cohen's d = 0.45). There were no significant intervention effects in salivary alpha-amylase. Plasma levels of IL-1ra were significantly lower post-intervention in GET compared to ISP; no other significant plasma effects were observed. GET, an intervention designed to promote goal-related and emotion-focused self-regulation, has potential to mitigate stress-related processes and inflammation in this young adult survivor group. More research is needed to determine efficacy.
The aim of psychotherapeutic intervention in cancer patients. [2019]Two main groups of goals in psychotherapeutic interventions in cancer patients are identified. First, process goals, which include the provision of information and instrumental support, assistance in expressing emotions, dealing with the the meaning of the disease, increasing patients' sense of coherence, enhancing personal resources, improving communication, gaining control and improving the ability to cope. Second, primary goals, which are aimed at decreasing somatic symptoms and psychosocial sequelae of cancer and its treatment, and enhancing adjustment, acceptance, and quality of life.
Goal Navigation, Approach-Oriented Coping, and Adjustment in Young Men with Testicular Cancer. [2018]Cancer can challenge important life goals for young adult survivors. Poor goal navigation skills might disrupt self-regulation and interfere with coping efforts, particularly approach-oriented attempts. Two studies are presented that investigated relationships among goal navigation processes, approach-oriented coping, and adjustment (i.e., social, emotional, and functional well-being) in separate samples of young adults with testicular cancer.