NCT07636200
The EASE Study: Randomized Trial of a Novel Approach to Addressing Fear of Progression in Advanced Cancer
Recruiting
NAAges 18+InterventionalSupportive careUniversity of Colorado, BoulderInvestigator-initiated
~250 participants
Updated 2026-06-09 on ClinicalTrials.gov
What's tested:Written Exposure-Based Coping Intervention (EASE)Usual Care Control Condition
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Fear of Progression Questionnaire, Short Form (with cancer as the disease)
Measured over Assessed four times with parallel timing in the control group: prior to the intervention (Pre), following session 3 of the intervention (Mid), within one week after the end of the weekly intervention (Post), at 3-month follow-up (FU).
+1 more outcome measured
Conditions
Where it's being run
2 sites across 1 statesColorado2
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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.
What this trial measures
- Fear of Progression Questionnaire, Short Form (with cancer as the disease)Assessed four times with parallel timing in the control group: prior to the intervention (Pre), following session 3 of the intervention (Mid), within one week after the end of the weekly intervention (Post), at 3-month follow-up (FU).
Assesses fear of cancer progression. Higher scores = higher fear of progression.
- Impact of Events Scale-Revised (with cancer as the event)Assessed four times with parallel timing in the control group: prior to the intervention (Pre), following session 3 of the intervention (Mid), within one week after the end of the weekly intervention (Post), at 3-month follow-up (FU).
Cancer-related trauma symptoms. Higher scores = higher symptom levels.