Status:
COMPLETED
Trial of Written Exposure for Metastatic Cancer Patients (EASE)
Lead Sponsor:
University of Colorado, Boulder
Collaborating Sponsors:
University of Colorado, Denver
Conditions:
Metastatic Cancer
Solid Tumor Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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, anxie...
Detailed Description
This single-arm pilot trial aims to look at the acceptability and feasibility of a writing-based intervention for adults with metastatic or recurrent cancer, or actively treated blood cancer. The EAS...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 1\. Current moderate or high suicide risk evaluated by the Columbia Suicide Severity Rating Scale (CSSRS)
Key Trial Info
Start Date :
April 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 21 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06042400
Start Date
April 18 2022
End Date
September 21 2023
Last Update
December 5 2023
Active Locations (1)
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1
University of Colorado Boulder
Boulder, Colorado, United States, 80309