EASE: A new approach to help adults with advanced cancer cope with fear of progression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial uses a written exposure-based coping intervention (EASE) compared with usual care for adults with stage IV solid tumors, stage III recurrent ovarian cancer, extensive-stage small cell lung cancer, or glioblastoma. Participants complete screening for fear of progression and cancer-related trauma symptoms and are eligible if they meet performance status and language requirements. The study aims to determine whether the intervention can lessen FoP and trauma-related symptoms in this population. Outcomes include patient-reported measures and feasibility of delivering the intervention in multiple sites. The trial is sponsored by the University of Colorado Boulder with collaboration from NCI and CU Denver, conducted at Colorado sites.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Colorado Anschutz Medical Campus
  Aurora, Colorado, United States Recruiting
• University of Colorado Boulder
  Boulder, Colorado, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.