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NCT07636200 · ClinicalTrials.gov registry record · NA
The EASE Study: Randomized Trial of a Novel Approach to Addressing Fear of Progression in Advanced Cancer
A NA study, sponsored by University of Colorado, Boulder.
- Recruiting
- Registry status
- NA
- Development phase
- 250
- Enrollment target
NCT07636200 is a NA study that is actively recruiting participants, run by University of Colorado, Boulder. The registered enrollment target is 250 participants.
The verdict
NCT07636200, a NA study, is actively recruiting participants, sponsored by University of Colorado, Boulder.
- RECRUITING
- Registry status
- NA
- Development phase
- 250 participants
- Enrollment target
Study Summary
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 published randomized trials of such interventions in the United States. In addition, cutting-edge developments for the treatment of trauma in general populations have not been adapted to cancer populations. To address these critical gaps, we adapted a cutting-edge behavioral treatment for trauma to reduce FoP and cancer-related trauma symptoms among adults with advanced cancer. The intervention, titled EASE, is based on written exposure therapy, an efficacious approach for reducing trauma symptoms in general populations that is better accepted and far briefer than other gold-standard approaches. EASE adapts this approach to help advanced cancer patients with elevated FoP and cancer-related trauma symptoms reduce their fear of the future by using written exposure focused on their future worst-case scenario with cancer. Informed by the NIH stage model, we evaluated EASE delivered by telehealth in an open pilot trial for 29 adults with late-stage cancer and elevated FoP and cancer-related trauma symptoms. Pilot findings show strong acceptability, feasibility, and efficacy potential. We now pr
Interventions
- BEHAVIORAL Usual Care Control Condition
- BEHAVIORAL Written Exposure-Based Coping Intervention (EASE)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2026-05-04 |
| Est. Completion | 2030-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07636200
The ClinicalTrials.gov registry entry for NCT07636200 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Boulder, which has 69 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Usual Care Control Condition is the first listed.
NCT07636200 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07636200 about?
NCT07636200 is a clinical study titled "The EASE Study: Randomized Trial of a Novel Approach to Addressing Fear of Progression in Advanced Cancer". 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,...
What is the current status of trial NCT07636200?
This trial is currently recruiting. It is a NA study. The enrollment target is 250 participants. The study started on 2026-05-04. Estimated completion is 2030-05.
What interventions are being tested in trial NCT07636200?
The interventions under investigation include: Usual Care Control Condition (BEHAVIORAL), Written Exposure-Based Coping Intervention (EASE) (BEHAVIORAL).
Who is sponsoring clinical trial NCT07636200?
This trial is sponsored by University of Colorado, Boulder, which has 69 total clinical trials registered on ClinicalTrials.gov.
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