An interventional study of Written Exposure-Based Coping Intervention (EASE) and Usual Care Control Condition in Advanced Solid Tumor Cancer, Stage IV Cancer (Solid Tumors Only) and Glioblastoma, sponsored by University of Colorado, Boulder. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by University of Colorado, Boulder · Not applicable, Interventional, and Supportive care
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.
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Exclusion Criteria:
EASE intervention over 6 individual sessions.
Behavioral: Written Exposure-Based Coping Intervention (EASE)
Usual Care (UC) consists of access to supportive care providers available at treatment sites.
Behavioral: Usual Care Control Condition
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 (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.
Fear of Progression Questionnaire, Short Form (with cancer as the disease)
Assesses fear of cancer progression. Higher scores = higher fear of progression.
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).
Impact of Events Scale-Revised (with cancer as the event)
Cancer-related trauma symptoms. Higher scores = higher symptom levels.
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).
Concerns About Recurrence Scale (CARS overall fear scale)
Fear of cancer recurrence/progression. Higher scores = higher fear of recurrence/progression.
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).
Generalized Anxiety Disorder-7
Anxiety symptoms. Higher scores = higher anxiety symptoms.
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).
Patient Health Questionnaire-8
Depression symptoms. Higher scores = higher depression symptoms.
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 Assessment in Illness Questionnaire
Hopelessness regarding one's illness. Higher scores = higher hopelessness.
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).
Functional Assessment of Cancer Therapy-General-7 item version (FACT-G7)
Quality of life with cancer. Higher scores = higher quality of life.
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).
Valuing Questionnaire, Obstruction and Progress Scales
Measures movement towards values and goals. Higher scores = greater movement towards values and goals. Theorized process variable.
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).
Death Attitude Profile Revised (DAP-R), Death Avoidance and Fear of Death Scales
Measures rigidly avoidance of all thinking about dying; fear of dying. Higher scores = higher avoidance and fear. Theorized process variable.
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).
Coping Orientation to Problems Experienced Inventory (COPE) - Behavioral and Emotional Disengagement Scale and Emotion Approach Coping Scale
Measures use of avoidance-based coping strategies. Higher scores = higher use of coping strategies. Theorized process variable.
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).
Intolerance of Uncertainty (IUS-4)
Measures behavioral reactions to ambiguous or uncertain situations. Higher scores = greater levels of intolerance of uncertainty.
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).
Positive and Negative Affect Schedule (PANAS)
Measures emotional state. Higher scores = higher intensity of affect.
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).
Positive and Negative Valence Systems Scale (PVSS)
Measures reward sensitivity. Higher scores = higher reward sensitivity.
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).
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale - Short Form Version 1.0
Measures fatigue and lack of vitality. Higher scores = higher levels of fatigue and higher lack of vitality.
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).
RAND Short Form Health Survey (RAND-SF 36), 2-items
Measures perceived health. Higher scores = lower perceived health.
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).
Adverse Childhood Experience Questionnaire for Adults
Measures childhood exposure to trauma. Higher scores = higher levels of exposure to trauma. Theorized moderator/predictor.
Time frame: Assessed once with parallel timing in the control group: prior to the intervention (Pre).
Demographics, Short Cancer History Questionnaire, History of journaling/creative writing
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
Time frame: Assessed once with parallel timing in the control group: prior to the intervention (Pre).
Client Satisfaction Questionnaire-8
Measures client satisfaction with the intervention. Higher scores = higher satisfaction.
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).
Sharing of Scenario
Item assessing whether participant has discussed their scenario with anyone else.
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).
Reflection Questions
Description of experience of writing.
Time frame: Assessed pre and post- each 30-minute writing block in EASE Sessions 1-5, in the intervention group only.
Plan to share: Yes — 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.
Supporting information: Study protocol, Icf
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