The EASE Study: Randomized Trial of a Novel Approach to Addressing Fear of Progression in Advanced Cancer (EASE)
4. června 2026 aktualizováno: 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.
Přehled studie
Postavení
Postavení
Nábor
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Typ studie
Typ studie
Intervenční
Zápis (Odhadovaný)
Zápis
250
Fáze
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Colorado
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Aurora, Colorado, Spojené státy, 80045
- Nábor
- University of Colorado Anschutz Medical Campus
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Kontakt:
- Joanna Arch, PhD
- Telefonní číslo: 720-897-1850
- E-mail: ease@colorado.edu
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Boulder, Colorado, Spojené státy, 80309
- Nábor
- University of Colorado Boulder
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Vrchní vyšetřovatel:
- Joanna Arch, PhD
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Kontakt:
- Sarah Genung
- Telefonní číslo: 720-897-1850
- E-mail: ease@colorado.edu
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Kontakt:
- Elliot Sandberg
- Telefonní číslo: 720-897-1850
- E-mail: ease@colorado.edu
-
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Počet zbraní
2
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
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Experimentální: EASE (Written Exposure-Based Coping Intervention)
EASE intervention over 6 individual sessions.
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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
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Jiný: Control: Usual Care
Usual Care (UC) consists of access to supportive care providers available at treatment sites.
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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.
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Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Fear of Progression Questionnaire, Short Form (with cancer as the disease)
Časové okno: 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).
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Assesses fear of cancer progression.
Higher scores = higher fear of progression.
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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).
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Impact of Events Scale-Revised (with cancer as the event)
Časové okno: 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).
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Cancer-related trauma symptoms.
Higher scores = higher symptom levels.
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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).
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Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Concerns About Recurrence Scale (CARS overall fear scale)
Časové okno: 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).
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Fear of cancer recurrence/progression.
Higher scores = higher fear of recurrence/progression.
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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).
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Generalized Anxiety Disorder-7
Časové okno: 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).
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Anxiety symptoms.
Higher scores = higher anxiety symptoms.
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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).
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Patient Health Questionnaire-8
Časové okno: 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).
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Depression symptoms.
Higher scores = higher depression symptoms.
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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).
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Hopelessness Assessment in Illness Questionnaire
Časové okno: 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).
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Hopelessness regarding one's illness.
Higher scores = higher hopelessness.
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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).
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Functional Assessment of Cancer Therapy-General-7 item version (FACT-G7)
Časové okno: 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).
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Quality of life with cancer.
Higher scores = higher quality of life.
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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).
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Další výstupní opatření
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Valuing Questionnaire, Obstruction and Progress Scales
Časové okno: 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).
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Measures movement towards values and goals.
Higher scores = greater movement towards values and goals.
Theorized process variable.
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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).
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Death Attitude Profile Revised (DAP-R), Death Avoidance and Fear of Death Scales
Časové okno: 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).
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Measures rigidly avoidance of all thinking about dying; fear of dying.
Higher scores = higher avoidance and fear.
Theorized process variable.
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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).
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Coping Orientation to Problems Experienced Inventory (COPE) - Behavioral and Emotional Disengagement Scale and Emotion Approach Coping Scale
Časové okno: 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).
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Measures use of avoidance-based coping strategies.
Higher scores = higher use of coping strategies.
Theorized process variable.
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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).
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Intolerance of Uncertainty (IUS-4)
Časové okno: 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).
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Measures behavioral reactions to ambiguous or uncertain situations.
Higher scores = greater levels of intolerance of uncertainty.
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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).
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Positive and Negative Affect Schedule (PANAS)
Časové okno: 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).
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Measures emotional state.
Higher scores = higher intensity of affect.
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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).
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Positive and Negative Valence Systems Scale (PVSS)
Časové okno: 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).
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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).
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Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale - Short Form Version 1.0
Časové okno: 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).
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Measures fatigue and lack of vitality.
Higher scores = higher levels of fatigue and higher lack of vitality.
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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).
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RAND Short Form Health Survey (RAND-SF 36), 2-items
Časové okno: 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).
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Measures perceived health.
Higher scores = lower perceived health.
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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).
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Adverse Childhood Experience Questionnaire for Adults
Časové okno: Assessed once with parallel timing in the control group: prior to the intervention (Pre).
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Measures childhood exposure to trauma.
Higher scores = higher levels of exposure to trauma.
Theorized moderator/predictor.
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Assessed once with parallel timing in the control group: prior to the intervention (Pre).
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Demographics, Short Cancer History Questionnaire, History of journaling/creative writing
Časové okno: Assessed once with parallel timing in the control group: prior to the intervention (Pre).
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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
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Assessed once with parallel timing in the control group: prior to the intervention (Pre).
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Client Satisfaction Questionnaire-8
Časové okno: Assessed twice in intervention group only: within one week after the end of the weekly intervention (Post), and at 3-month follow-up (FU).
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Measures client satisfaction with the intervention.
Higher scores = higher satisfaction.
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Assessed twice in intervention group only: within one week after the end of the weekly intervention (Post), and at 3-month follow-up (FU).
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Sharing of Scenario
Časové okno: 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).
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Item assessing whether participant has discussed their scenario with anyone else.
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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).
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Reflection Questions
Časové okno: Assessed pre and post- each 30-minute writing block in EASE Sessions 1-5, in the intervention group only.
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Description of experience of writing.
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Assessed pre and post- each 30-minute writing block in EASE Sessions 1-5, in the intervention group only.
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Sponzor
Spolupracovníci
Spolupracovníci
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- Arch JJ, Kirk MH, Finkelstein LB. Patient-Reported Worst-Case Scenarios in Advanced Cancer: Presence, Contents, and Predictors. Psychooncology. 2024 Dec;33(12):e70039. doi: 10.1002/pon.70039.
- Finkelstein LB, Wojdak CP, Studts JL, Arch JJ. Writing Content Predicts Outcomes in Written Exposure to Worst-Case Scenarios for Advanced Cancer. J Palliat Med. 2025 Dec;28(12):1648-1653. doi: 10.1089/jpm.2024.0463. Epub 2025 Jun 12.
- Arch JJ, Slivjak ET, Finkelstein LB. A Novel Intervention to Reduce Fear of Progression and Trauma Symptoms in Advanced Cancer Using Written Exposure to Worst-Case Scenarios. J Palliat Med. 2024 Aug;27(8):1009-1017. doi: 10.1089/jpm.2023.0658. Epub 2024 Apr 5.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
4. května 2026
Primární dokončení (Odhadovaný)
Primární dokončení
1. března 2030
Dokončení studie (Odhadovaný)
Dokončení studie
1. května 2030
Termíny zápisu do studia
První předloženo
První předloženo
28. května 2026
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
4. června 2026
První zveřejněno (Aktuální)
První zveřejněno
9. června 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
9. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
4. června 2026
Naposledy ověřeno
Naposledy ověřeno
1. června 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Urogenitální onemocnění
- Onemocnění genitálií
- Onemocnění endokrinního systému
- Urogenitální novotvary
- Novotvary podle místa
- Ženské urogenitální onemocnění
- Ženské urogenitální onemocnění a těhotenské komplikace
- Novotvary podle histologického typu
- Onemocnění pohlavních orgánů, ženy
- Novotvary endokrinních žláz
- Novotvary, žlázové a epiteliální
- Onemocnění vaječníků
- Adnexální onemocnění
- Genitální novotvary, ženy
- Gonadální poruchy
- Astrocytom
- Gliom
- Novotvary, neuroepiteliální
- Neuroektodermální nádory
- Novotvary, zárodečné buňky a embryonální
- Novotvary, nervová tkáň
- Novotvary
- Novotvary vaječníků
- Glioblastom
Další identifikační čísla studie
Další identifikační čísla studie
- 25-0367
- 1R01CA300028 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu 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.
Kritéria přístupu pro sdílení 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.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- ICF
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .