The EASE Study: Randomized Trial of a Novel Approach to Addressing Fear of Progression in Advanced Cancer (EASE)
2026年6月4日 更新者：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.
調査の概要
状態
募集
研究の種類
介入
入学 (推定)
250
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Colorado
-
Aurora、Colorado、アメリカ、80045
- 募集
- University of Colorado Anschutz Medical Campus
-
コンタクト：
- Joanna Arch, PhD
- 電話番号：720-897-1850
- メール：ease@colorado.edu
-
Boulder、Colorado、アメリカ、80309
- 募集
- University of Colorado Boulder
-
主任研究者：
- Joanna Arch, PhD
-
コンタクト：
- Sarah Genung
- 電話番号：720-897-1850
- メール：ease@colorado.edu
-
コンタクト：
- Elliot Sandberg
- 電話番号：720-897-1850
- メール：ease@colorado.edu
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：EASE (Written Exposure-Based Coping Intervention)
EASE intervention over 6 individual sessions.
|
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
|
|
他の：Control: Usual Care
Usual Care (UC) consists of access to supportive care providers available at treatment sites.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Fear of Progression Questionnaire, Short Form (with cancer as the disease)
時間枠：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)
時間枠：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).
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Concerns About Recurrence Scale (CARS overall fear scale)
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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).
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Valuing Questionnaire, Obstruction and Progress Scales
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年5月4日
一次修了 (推定)
2030年3月1日
研究の完了 (推定)
2030年5月1日
試験登録日
最初に提出
2026年5月28日
QC基準を満たした最初の提出物
2026年6月4日
最初の投稿 (実際)
2026年6月9日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月9日
QC基準を満たした最後の更新が送信されました
2026年6月4日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 25-0367
- 1R01CA300028 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。