Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07636200

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, 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Advanced Solid Tumor Cancer Adnexal Diseases Astrocytoma Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Glioblastoma Glioma Gonadal Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Ovarian Diseases Ovarian Neoplasms Small Cell Lung Cancer Extensive Stage Stage III Ovarian Cancer Stage IV Cancer (Solid Tumors Only) Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Written Exposure-Based Coping Intervention (EASE)

Behavioral

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

Usual Care Control Condition

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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

  11. 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.

  12. 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.

  13. 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Boulder

Other

Collaborators

  • National Cancer Institute (NCI)
  • University of Colorado, Denver

Registry information

Acronym: EASE

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jun 9, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.