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The EASE Study: Randomized Trial of a Novel Approach to Addressing Fear of Progression in Advanced Cancer

RecruitingNAAges 18 Years - anyAllUniversity of Colorado, Boulder
NCT07636200 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Precision oncology has led to a growing population of adults with advanced cancer living increasingly longer lives in the face of profound uncertainty about the future, with over half reporting moderate to high fear of cancer progression (FoP). These fears are associated with anxiety and depression, over-use of healthcare, physical symptom burden, higher treatment regret, fatigue, and, in many studies, poorer quality of life. Moreover, FoP is strongly correlated with cancer-related trauma symptoms-physical hyperarousal, intrusiveness of cancer thoughts/images, and avoidance of cancer-related thoughts and feelings, suggesting overlapping symptoms. While behavioral interventions exist to target fear of recurrence in early-stage cancer survivors, there is a dearth of behavioral interventions to address FoP or cancer-related trauma symptoms in adults with advanced cancer, and no known publis

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adults, age 18 or older * Have been diagnosed with either (a) Stage IV metastatic cancer of any solid tumor type, (b) Stage III ovarian cancer that has recurred, (c) 'extensive stage' small cell lung cancer, or (d) glioblastomas of any staging * Are capable at time of consent of understanding and voluntarily consenting themselves to the study, attending intervention sessions, and writing for 30 minutes, confirmed by an Eastern Cooperative Group Performance Status Scale of ≤2 * Report elevated FoP and cancer-related trauma symptoms on the screening measures: FoP-Q 12-item short version: mean score of 2.5 (or total score of 30), IES-R: mean of 1.5 (or total score of 33) * Are fluent in English or Spanish and can read English proficiently (for the surveys, which are in English) Exclusion Criteria: * Patients who have a history of chronic untreated trauma unrelated to their cancer, psychiatric hospitalization or suicide attempt(s) in the past 2 years, or current high suicide risk, as identified in the screening. * EMR-noted cognitive impairment (such as dementia) is an exclusion due to potential impairments in neural learning mechanisms that may affect the efficacy of exposure therapy.
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What it tests

  • Written Exposure-Based Coping Intervention (EASE)
  • Usual Care Control Condition
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Where

2 sites
University of Colorado Anschutz Medical Campus
Aurora, United States
University of Colorado Boulder
Boulder, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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