This clinical trial evaluates the impact of a writing-based intervention, called EASE, on distress related to fears and concerns in patients with metastatic cancer. Some adults with cancer report imagined worst-case scenarios related to their cancer, ranging from fearing their cancer’s progression, having to undergo difficult treatments, not being able to be there for loved ones, or fearing the process of dying itself. People may report feeling fearful or haunted by these imagined scenarios in a way that causes them distress and lowers their quality of life. The EASE intervention uses a writing-based exposure therapy approach to address an individual’s worst-case scenario about cancer toward the goal of reducing their fear and distress.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06042400.
PRIMARY OBJECTIVES:
I. Evaluate the acceptability and feasibility of EASE with anxious adults with metastatic cancer or actively treated blood cancer.
II. Assess fear of cancer progression and cancer-related trauma symptoms session-by-session to determine the trajectory of improvement and to assess whether future versions of the intervention may be able to be shortened.
III. Evaluate the preliminary efficacy effects of EASE on targeted psychosocial outcomes of cancer-related trauma symptoms and fear of cancer progression (primary outcomes), anxiety and depression symptoms, fear of dying, hopelessness, fatigue, pain interference, and valued living (secondary outcomes) and acceptance and avoidance-based coping and self-compassion (process measures).
OUTLINE:
Patients participate in 6 weekly writing exercises coached through one-on-one online video sessions with a trained therapist and complete surveys throughout study. Patients may optionally participate in an interview on study.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Colorado – Boulder
Principal InvestigatorJoanna Arch