A Biobehavioral Intervention for Young Men With Testicular Cancer
NCT ID: NCT04150848
Last Updated: 2020-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
2018-11-01
2021-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Goal Focused Emotion-Regulation Therapy (GET)
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).
Goal-Focused Emotion Regulation Therapy (GET)
Six sessions delivered individually over 8 weeks
Individual Supportive Psychotherapy (ISP)
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.
Individual Supportive Psychotherapy (ISP)
Six sessions delivered individually over 8 weeks
Interventions
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Goal-Focused Emotion Regulation Therapy (GET)
Six sessions delivered individually over 8 weeks
Individual Supportive Psychotherapy (ISP)
Six sessions delivered individually over 8 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
39 Years
MALE
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
University of California, Irvine
OTHER
Responsible Party
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Locations
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University of California, Irvine
Irvine, California, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Michael A Hoyt, PhD
Role: primary
Attending Psychologist
Role: primary
References
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Hoyt 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.
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.
Other Identifiers
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2018-4676
Identifier Type: -
Identifier Source: org_study_id