Grant Number:	1R01CA276035-01A1 Interpret this number
Primary Investigator:	Milbury, Kathrin
Organization:	University Of Tx Md Anderson Can Ctr
Project Title:	Psycho-Spiritual Management for Patients with Advanced Cancer and Their Family Caregivers
Fiscal Year:	2023

PROJECT SUMMARY/ABSTRACT Given the generally incurable nature of metastatic cancer, patients and their family caregivers are at high risk of experiencing depressive symptoms and spiritual distress (e.g., lack of meaning and peace, despair, alienation). As caregivers struggle with their own fears and stressors, providing quality support and care to the patient may be difficult. Moreover, psychospiritual distress is interdependent in families coping with cancer suggesting the need for a dyadic approach to psychospiritual supportive care. Despite accumulating evidence that highlights the value of positive psychology interventions in improving depressive symptoms and spiritual wellbeing, evidence-based dyadic interventions are limited in the palliative care setting. To address critical knowledge gaps and build upon our pilot work, we propose an adequately powered efficacy trial of a 4-session family-focused meditation (FFM) intervention targeting psychospiritual outcomes. Patient-family caregiver dyads will be randomized to either the FFM intervention, a usual care (UC) control group or a dose-matched attention control (AC) group receiving a social support intervention. To enhance accessibility and scalability for future dissemination, the FFM and AC interventions will be delivered via videoconferencing. To increase generalizability of our findings, we will use a multi-site enrollment strategy and recruit families from a community hospital caring for a diverse including underserved patient population. We will administer all study procedures including the Patients and caregivers will complete assessments at baseline (prior to randomization) and then again 6, 12, and 24 weeks later. Guided by our exciting pilot findings, we propose a multi-method assessment strategy to uncover a priori intervention mechanisms. In addition to self-reports, at baseline and the 6-week follow-up, patients and caregivers will wear a device called the Electronically Activated Recorder (EAR), an innovative, in vivo naturalistic observation tool that will allow us to objectively assess changes in observed behaviors in daily life as a function of group assignment to evaluate mechanisms of intervention efficacy. We propose depressive symptoms as the primary outcome given the prognostic value of depression in the survival of metastatic cancer patients and family caregivers; and spiritual wellbeing as the secondary outcome as it protects against the desire for a hastened death, hopelessness, and suicidal ideation independent of depression in patients with metastatic cancer. For families who transition to end of life care over the course of the study, we seek to explore their experiences with this transition and if the FFM program improves patient and caregiver psychospiritual adjustment at this crucial timepoint. The knowledge gained from this randomized controlled trial will advance the science of behavioral medicine, and, ultimately, inform the clinical care of a vulnerable and understudied patient-caregiver population. intervention in English or Spanish based on participant preference.





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