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

4 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

250

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Colorado
      • Aurora, Colorado, Stati Uniti, 80045
        • Reclutamento
        • University of Colorado Anschutz Medical Campus
        • Contatto:
      • Boulder, Colorado, Stati Uniti, 80309
        • Reclutamento
        • University of Colorado Boulder
        • Investigatore principale:
          • Joanna Arch, PhD
        • Contatto:
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: EASE (Written Exposure-Based Coping Intervention)
EASE intervention over 6 individual sessions.
Comportamentale: 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
Altro: Control: Usual Care
Usual Care (UC) consists of access to supportive care providers available at treatment sites.
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Fear of Progression Questionnaire, Short Form (with cancer as the disease)
Lasso di tempo: 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)
Lasso di tempo: 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).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Concerns About Recurrence Scale (CARS overall fear scale)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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).

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Valuing Questionnaire, Obstruction and Progress Scales
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Colorado, Boulder

Collaboratori

National Cancer Institute (NCI)
University of Colorado, Denver

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

4 maggio 2026

Completamento primario (Stimato)

1 marzo 2030

Completamento dello studio (Stimato)

1 maggio 2030

Date di iscrizione allo studio

Primo inviato

28 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

4 giugno 2026

Primo Inserito (Effettivo)

9 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 25-0367
  • 1R01CA300028 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Criteri di accesso alla condivisione IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • ICF

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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