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

June 4, 2026 updated by: Joanna Arch, University of Colorado, Boulder
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Anschutz Medical Campus
        • Contact:
      • Boulder, Colorado, United States, 80309
        • Recruiting
        • University of Colorado Boulder
        • Principal Investigator:
          • Joanna Arch, PhD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: EASE (Written Exposure-Based Coping Intervention)
EASE intervention over 6 individual sessions.
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
Other: Control: Usual Care
Usual Care (UC) consists of access to supportive care providers available at treatment sites.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fear of Progression Questionnaire, Short Form (with cancer as the disease)
Time Frame: 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.
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).
Impact of Events Scale-Revised (with cancer as the event)
Time Frame: 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.
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).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Concerns About Recurrence Scale (CARS overall fear scale)
Time Frame: 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).
Fear of cancer recurrence/progression. Higher scores = higher fear of recurrence/progression.
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).
Generalized Anxiety Disorder-7
Time Frame: 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).
Anxiety symptoms. Higher scores = higher anxiety symptoms.
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).
Patient Health Questionnaire-8
Time Frame: 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).
Depression symptoms. Higher scores = higher depression symptoms.
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).
Hopelessness Assessment in Illness Questionnaire
Time Frame: 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).
Hopelessness regarding one's illness. Higher scores = higher hopelessness.
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).
Functional Assessment of Cancer Therapy-General-7 item version (FACT-G7)
Time Frame: 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).
Quality of life with cancer. Higher scores = higher quality of life.
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).

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Valuing Questionnaire, Obstruction and Progress Scales
Time Frame: 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).
Measures movement towards values and goals. Higher scores = greater movement towards values and goals. Theorized process variable.
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).
Death Attitude Profile Revised (DAP-R), Death Avoidance and Fear of Death Scales
Time Frame: 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).
Measures rigidly avoidance of all thinking about dying; fear of dying. Higher scores = higher avoidance and fear. Theorized process variable.
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).
Coping Orientation to Problems Experienced Inventory (COPE) - Behavioral and Emotional Disengagement Scale and Emotion Approach Coping Scale
Time Frame: 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).
Measures use of avoidance-based coping strategies. Higher scores = higher use of coping strategies. Theorized process variable.
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).
Intolerance of Uncertainty (IUS-4)
Time Frame: 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).
Measures behavioral reactions to ambiguous or uncertain situations. Higher scores = greater levels of intolerance of uncertainty.
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).
Positive and Negative Affect Schedule (PANAS)
Time Frame: 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).
Measures emotional state. Higher scores = higher intensity of affect.
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).
Positive and Negative Valence Systems Scale (PVSS)
Time Frame: 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).
Measures reward sensitivity. Higher scores = higher reward sensitivity.
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).
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale - Short Form Version 1.0
Time Frame: 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).
Measures fatigue and lack of vitality. Higher scores = higher levels of fatigue and higher lack of vitality.
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).
RAND Short Form Health Survey (RAND-SF 36), 2-items
Time Frame: 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).
Measures perceived health. Higher scores = lower perceived health.
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).
Adverse Childhood Experience Questionnaire for Adults
Time Frame: Assessed once with parallel timing in the control group: prior to the intervention (Pre).
Measures childhood exposure to trauma. Higher scores = higher levels of exposure to trauma. Theorized moderator/predictor.
Assessed once with parallel timing in the control group: prior to the intervention (Pre).
Demographics, Short Cancer History Questionnaire, History of journaling/creative writing
Time Frame: Assessed once with parallel timing in the control group: prior to the intervention (Pre).
Demographics and cancer treatment history - Relevant cancer diagnostic and treatment history items will be confirmed via medical chart review, Single item about history of journaling or use of writing to process emotion
Assessed once with parallel timing in the control group: prior to the intervention (Pre).
Client Satisfaction Questionnaire-8
Time Frame: Assessed twice in intervention group only: within one week after the end of the weekly intervention (Post), and at 3-month follow-up (FU).
Measures client satisfaction with the intervention. Higher scores = higher satisfaction.
Assessed twice in intervention group only: within one week after the end of the weekly intervention (Post), and at 3-month follow-up (FU).
Sharing of Scenario
Time Frame: Assessed three times with parallel timing in the control group: following session 3 of the intervention (Mid), within one week after the end of the weekly intervention (Post), at 3-month follow-up (FU).
Item assessing whether participant has discussed their scenario with anyone else.
Assessed three times with parallel timing in the control group: following session 3 of the intervention (Mid), within one week after the end of the weekly intervention (Post), at 3-month follow-up (FU).
Reflection Questions
Time Frame: Assessed pre and post- each 30-minute writing block in EASE Sessions 1-5, in the intervention group only.
Description of experience of writing.
Assessed pre and post- each 30-minute writing block in EASE Sessions 1-5, in the intervention group only.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Boulder

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)
University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 4, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 25-0367
  • 1R01CA300028 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified study survey data and associated documentation will be made available to the research community free of charge through the Cancer Data Service (CDS), maintained by the National Cancer Institute under the Cancer Research Data Commons (CRDC) infrastructure for storing cancer research data generated by NCI funded programs.

IPD Sharing Access Criteria

Data will be available by controlled access only. Data will be made available by a data repository only after approval by the PI, with input from the full research team.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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