Meaning-Centered Psychotherapy for Cancer Caregivers Study protocol of a randomized controlled trial

Background Caregivers of patients with advanced cancer shoulder immense responsibilities as they care for patients, including symptom and medication management, providing emotional support, and navigating healthcare treatment and decision-making. Due to the heavy toll of these responsibilities, caregivers are at high risk for profound mental health challenges, including anxiety, depression, and posttraumatic stress disorder. A key driver of this heightened risk for psychopathology in caregivers is existential distress, manifesting as a loss of meaning and purpose, decreased spiritual well-being, and hopelessness. Historically, psychosocial interventions targeting distress in cancer caregivers have neglected to address existential distress. Meaning-Centered Psychotherapy for Cancer Caregivers, a 7-session structured intervention, was developed to address this gap. In a pilot randomized controlled trial, the approach led to enhancements in personal meaning, benefit finding, and spiritual well-being. Here, we present a large, multi-site trial that aims to definitively examine the efficacy of Meaning-Centered Psychotherapy for Cancer Caregivers in an adequately powered study. Method This randomized controlled trial will evaluate the efficacy of Meaning-Centered Psychotherapy for Cancer Caregivers versus Supportive Psychotherapy for Cancer Caregivers on primary (personal meaning and spiritual well-being) and secondary (anxiety, depression, sense of meaning in caregiving, benefit finding, caregiver burden, social support) outcomes at baseline, post-treatment, and at 6- and 12-months follow-up. It will also evaluate the role of sense of meaning in life as a mediator of secondary outcomes, as well as the impact of Meaning-Centered Psychotherapy for Cancer Caregivers on pre-and post-loss bereavement outcomes. Two hundred caregivers of patients with advanced (stage III/IV) solid tumor cancers from Memorial Sloan Kettering Cancer Center, Sylvester Comprehensive Cancer Center, and the community will be enrolled. Discussion Meaning-Centered Psychotherapy for Cancer Caregivers has the potential to help alleviate existential suffering in caregivers as they manage the multifaceted demands of caring for patients with advanced cancer. This trial seeks to evaluate the efficacy of this intervention in a more robust and representative trial of cancer caregivers, and extends prior research to explore mediators of improvement and the impact of the intervention on pre- and post-loss bereavement outcomes. Trial registration : This trial is registered at ClinicalTrials.gov, NCT06307535, registered on 03/05/2024