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

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 propose to conduct the first randomized trial of EASE, and, thus, first known randomized trial in the United States of a behavioral intervention for FoP and cancer-related trauma symptoms among adults with advanced cancer. This 2-arm trial (N=250) will compare EASE delivered by telehealth with Usual Care (UC). We aim to compare EASE to UC on FoP and cancer-related trauma symptoms (primary outcomes) and anxiety, depression, hopelessness, and quality of life, at post-intervention (Aim 1) and follow-up (Aim 2). We will evaluate mechanisms for EASE relative to UC (Aim 3). Offering EASE in both English and Spanish, and by telehealth, increases access. Simple content increases scalability. Rigorous evaluation of EASE has the potential to provide a paradigm-shifting intervention ready for dissemination and to inform evidence-based care guidelines for distressed adults with advanced cancer.

Conditions

• Advanced Solid Tumor Cancer
• Stage IV Cancer (Solid Tumors Only)
• Glioblastoma
• Stage III Ovarian Cancer
• Small Cell Lung Cancer Extensive Stage

Interventions

BEHAVIORAL

Written Exposure-Based Coping Intervention (EASE)

The EASE intervention includes 6-sessions of structured writing designed to reduce fear of progression (FoP) and cancer-related trauma symptoms in adults with advanced cancer. Adapted from Written Exposure Therapy (WET), EASE will be delivered via telehealth by trained interventionists through 1:1 sessions. Each session will last approximately 60 minutes. The first session begins with an assessment, where participants identify their worst-case scenario related to their cancer. In the next three sessions, participants engage in structured exposure writing about this imagined scenario, focusing on vivid, sensory-rich descriptions and thoughts and feelings. The final two sessions involve coping writing, where participants re-evaluate the realism of their scenario. If deemed unlikely, they write about a more realistic outcome and how to cope with it; if likely, they focus on coping strategies for the original scenario

BEHAVIORAL

Usual Care Control Condition

Usual Care (UC) consists of access to a clinical social worker and nurse practitioners for supportive visits at patient request. To account for individual and site differences in use/availability of UC resources, patients in both arms will report use of non-study cancer supportive care using piloted trackers.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• University of Colorado, Denver

  collaborator OTHER

• University of Colorado, Boulder

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-04

Primary Completion

2030-03-31

Completion

2030-05-31

Countries

• United States

Study Locations