Trial of Written Exposure for Metastatic Cancer Patients (EASE)

Completed · Not applicable

Conditions studied: Metastatic Cancer, Solid Tumor Cancer, Lymphoproliferative Disorders, Anxiety, Post-traumatic Stress Symptoms, Fear of Cancer Progression

In brief

In the face of imminent loss, many adults with metastatic cancer report a range of mental health challenges, including cancer-related trauma symptoms, fear of cancer progression and dying/death, anxiety, depression, and hopelessness, as well as physical symptoms such as fatigue and pain. Cancer patients may report feeling upset or haunted by imagined scenarios in a way that causes them distress and lowers their quality of life. This study aims to look at the acceptability and feasability of a writing-based intervention for adults with late-stage or recurrent cancer, or actively treated blood cancer. The EASE study uses a writing-based approach to address an individual's worst-case scenario about cancer because previous studies have shown that similar approaches have shown promise in reducing fear in early-stage cancer survivors and among adults with PTSD (posttraumatic stress disorder). The EASE study represents a novel adaptation of this foundational work on written exposure therapy (WET) to address worst-case scenarios among adults with late stage cancers. The EASE study will include 5 weekly one-on-one online video sessions with a trained therapist where participants will be coached through writing exercises based on a worst-case scenario related to their cancer experience.

Key facts

Study ID

NCT06042400

Run by

University of Colorado, Boulder

People needed

30

Starts

2022-04-18

Expected to finish

2023-09-21

Last updated by the study team

2023-12-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 18 years of age
• English-speaking (able to speak, read, and write well in English)
• Diagnosed with solid tumor cancer at Stage III (locally metastatic) or Stage IV (distantly metastatic) or solid tumor cancer that has recurred, or actively treated lymphoproliferative cancer (e.g., non-solid tumor cancer)
• Report elevated cancer-related trauma symptoms or fear of cancer progression on the screening measures: IES-R, FoP-Q 12-item short version.
• No moderate to severe dementia reported by patient or seen during eligibility confirmation in the medical chart
• Are capable at time of consent of understanding and voluntarily consenting themselves to the study, attending EASE sessions, and completing the online sessions at home, confirmed by an Eastern Cooperative Group Performance Status Scale of 0 to 2. Given that the study does not require individuals to leave their home, we will make an exception for individuals endorsing an Eastern Cooperative Group Performance Status Scale score of 3 (confined to bed or chair for <50% of waking hours, able to do only limited selfcare) if they meet all other study criteria, including criteria 7.
• Report that they are able and willing to complete all study procedures, including the online assessments and the intervention itself, including being physically able to write by hand or type for 30 minutes at a time and do weekly hour-long EASE sessions by Zoom.
• Has access to a computer with internet connection or are willing to use a study-loaned computer tablet for the study duration, and are willing to conduct sessions via videoconferencing on a computer

You may not qualify if…

• Current moderate or high suicide risk evaluated by the Columbia Suicide Severity Rating Scale (CSSRS)

Where it is running

• University of Colorado Boulder — Boulder, Colorado, United States

Full record on ClinicalTrials.gov

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