Writing Content Predicts Outcomes in Written Exposure to Worst-Case Scenarios for Advanced Cancer.
Lauren B Finkelstein, Christopher P Wojdak, Jamie L Studts...
https://pubmed.ncbi.nlm.nih.gov/40510017/Actively Recruiting
Led by University of Colorado, Boulder · Updated on 2026-06-09
250
Participants Needed
2
Research Sites
8 weeks
Total Duration
This research focuses on adults with advanced solid tumor cancers who often experience significant fear of cancer progression FoP and related trauma symptoms. The study evaluates a novel behavioral intervention called EASE, based on written exposure therapy, aimed at reducing these fears and trauma symptoms. This trial is the first known randomized study in the United States to assess such an intervention delivered via telehealth, addressing gaps in supportive care for advanced cancer patients. Participants receive either the EASE intervention, which includes six individual telehealth sessions of structured writing focused on their cancer-related fears and coping strategies, or usual care involving access to supportive care providers like social workers and nurse practitioners. The sessions last about 60 minutes each and include identifying worst-case scenarios, engaging in exposure writing, and coping writing. Usual care participants continue with standard supportive services available at their treatment sites. Throughout the study, participants complete assessments before, during, and after the intervention, including fear of progression questionnaires and measures of trauma symptoms, anxiety, depression, hopelessness, and quality of life. Outcomes are evaluated at multiple time points, including a three-month follow-up. The study monitors participant progress and collects data on their use of supportive care resources. The total participation period extends from baseline through follow-up assessments, with careful monitoring to understand the interventions impact on emotional well-being.
CONDITIONS
The EASE Study: Randomized Trial of a Novel Approach to Addressing Fear of Progression in Advanced Cancer
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
University of Colorado, Boulder
Lead Sponsor
National Cancer Institute (NCI)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | EASE – Written Exposure-Based Coping Intervention | Usual Care |
|---|---|---|
| What it is | A six-session, telehealth-delivered writing program developed from Written Exposure Therapy. Sessions guide participants to confront worst-case scenarios related to their cancer, process trauma, and apply coping strategies. | Routine supportive care including access to clinical social worker and nurse practitioner, provided as requested. Use of outside supportive care tracked for all participants. |
| Role in the trial | Primary investigational intervention designed to reduce fear of progression and cancer-related trauma in advanced cancer. | Comparator arm representing supportive care as typically delivered at trial sites. |
| Primary use | To address psychological distress, including fear of cancer progression and trauma symptoms, in adults with advanced solid tumors by using structured exposure writing and coping strategies. | To provide emotional and supportive care through standard resources available at clinical sites for people with advanced cancer. |
| How it is given or performed | Delivered in six, approximately 60-minute telehealth sessions. Written exposure and coping exercises led 1:1 by a trained interventionist. | Participants may access supportive care providers upon request, with no structured session schedule, reflecting routine clinic practice. |
| Evidence status | Early-stage clinical evidence from pilot studies suggests written exposure interventions may decrease trauma symptoms and fear of progression in advanced cancer. Large, randomized studies like EASE are ongoing to establish effectiveness. | Emotional and psychosocial support has long-established value in advanced cancer, but structured trauma-focused interventions specifically for fear of progression remain under study. |
| Important limitations | The EASE intervention is novel in adult advanced cancer, with limited published evidence and no established guideline endorsement yet. Its effectiveness and safety for those with chronic trauma or cognitive impairment remain uncertain. | Usual supportive care varies across sites and is not standardized for trauma-focused coping or fear of progression. No structured exposure writing is provided. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening visit
Duration - 6 weeks
Participants receive either the EASE telehealth writing therapy over six weekly sessions or continue with usual supportive care at their treatment sites.
6 weekly telehealth sessions for EASE group; usual care as needed for control group
Duration - 3 months
Participants complete assessments of fear, trauma symptoms, anxiety, depression, and quality of life up to three months after the intervention ends.
Assessments at post-intervention and 3-month follow-up
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Lauren B Finkelstein, Christopher P Wojdak, Jamie L Studts...
https://pubmed.ncbi.nlm.nih.gov/40510017/Joanna J Arch, Elizabeth T Slivjak, Lauren B Finkelstein
https://pubmed.ncbi.nlm.nih.gov/38579139/Joanna J Arch, Mackenzie H Kirk, Lauren B Finkelstein
https://pubmed.ncbi.nlm.nih.gov/39710501/University of Colorado, Boulder
Lead Sponsor
National Cancer Institute (NCI)
Collaborating Sponsor