The Online Adaptation of Managing Cancer and Living Meaningfully (iCALM): A Phase II Randomized Controlled Trial

Summary: 

Individuals and families living with advanced cancer face multiple challenges related to the disease and its treatment. These include managing distressing symptoms and side effects, navigating a complex healthcare system, making difficult treatment decisions, and planning for the future and end of life. Distress in patients with cancer is profound, with up to 25% at any point in time experiencing clinically significant depression. Depressive symptoms not only adversely affect quality of life, but also impair compliance with medical treatment. Cancer treatment tends to be more focused on the disease and physical symptoms. To address this gap, a brief psychotherapeutic intervention referred to as Managing Cancer and Living Meaningfully (CALM) was developed and showed preliminary effectiveness in patients with advanced cancer. However, there are barriers to access including economic factors, impaired mobility, and geographic distance from cancer centers. This phase II study will assess the feasibility and acceptability of iCALM versus usual care in patients with advanced or metastatic cancers. The program, iCALM, is a 9-week online adaptation of CALM and is the first online intervention of this kind allowing global access to psychological care for patients with advanced cancers.

Trial Registration: ClinicalTrials.gov Identifier: NCT04757155