Cognitively-Based Compassion Training versus cancer health education to improve health-related quality of life in survivors of solid tumor cancers and their informal caregivers: study protocol for a randomized controlled pilot trial

• Type of Material: Article
• Authors: Thaddeus Pace, Emory University; Sally E. Dodds, University of Arizona; Alla Sikorskii, University of Arizona; Terry A. Badger, University of Arizona; Chris Segrin, University of Arizona; Geshe Lobsang Tenzin Negi, Emory University; Timothy Harrison, Emory University; Tracy E. Crane, University of Arizona
• Language: English
• Date: 2019-04-29
• Publisher: BMC (part of Springer Nature)
• Publication Version: Final Published Version
• Copyright Statement: © 2019 The Author(s).
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1186/s13063-019-3320-9
• Title of Journal or Parent Work: Trials
• ISSN: 1745-6215
• Volume: 20
• Issue: 1
• Start Page: 247
• End Page: 247
• Grant/Funding Information: This study is supported by a gracious gift from the Jack Challem Trust (the Trust); although SED is a trustee of the Trust, she has no role in the collection of study data, is not involved in any way with implementation of the CHE (attention control) group, has not had contact with CHE participants, and is not/will not be involved in the interpretation of study findings.
• Keywords: Life Sciences & Biomedicine; Science & Technology; MAJOR DEPRESSION; METASTATIC BREAST-CANCER; Health-related quality of life; COLORECTAL-CANCER; Medicine, Research & Experimental; Cancer survivorship; C-REACTIVE PROTEIN; DIURNAL CORTISOL RHYTHM; PROSTATE-CANCER; BEHAVIORAL-RESPONSES; INFLAMMATORY BIOMARKERS; Research & Experimental Medicine; INNATE IMMUNE; Inflammation; FATIGUE; Dyadic interdependence; Cortisol; Active control; Compassion meditation
• Research Categories: Psychology, Cognitive; Religion, Philosophy of

Abstract

Background: Cancer survivors and their informal caregivers (family members, close friends) often experience significant impairments in health-related quality of life (HRQOL), including disruptions in psychological, physical, social, and spiritual well-being both during and after primary cancer treatment. The purpose of this in-progress pilot trial is to determine acceptability and preliminary efficacy (as reflected by effect sizes) of CBCT® (Cognitively-Based Compassion Training) compared with a cancer health education (CHE) attention control to improve the primary outcome of depressive symptoms and secondary outcomes of other HRQOL domains (e.g., anxiety, fatigue), biomarkers of inflammation and diurnal cortisol rhythm, and healthcare utilization-related outcomes in both cancer survivors and informal caregivers. Methods: Forty dyads consisting of solid tumor survivors who have completed primary treatments (chemotherapy, radiation, surgery) and their informal caregivers, with at least one dyad member with ≥ mild depressive symptoms or anxiety, will be recruited from Tucson, Arizona, USA. Survivor-caregiver dyads will be randomized together to complete either CBCT or CHE. CBCT is a manualized, 8-week, group meditation-based intervention that starts with attention and mindfulness and builds to contemplative practices aimed at cultivating compassion to the self and others. The goal of CBCT is to challenge unexamined assumptions about feelings and behaviors, with a focus on generating spontaneous self-compassion and increased empathic responsiveness and compassion for others. CHE is an 8-week, manualized group intervention that provides cancer-specific education on various topics (e.g., cancer advocacy, survivorship wellness). Patient-reported HRQOL outcomes will be assessed before, immediately after (week 9), and 1 month after CBCT or CHE (week 13). At the same time points, stress-related biomarkers of inflammation (e.g., plasma interleukin-6) and saliva cortisol relevant for survivor and informal caregiver wellness and healthcare utilization will be measured. Discussion: If CBCT shows acceptability, a larger trial will be warranted and appropriately powered to formally test the efficacy of this dyadic intervention. Interventions such as CBCT directed toward both survivors and caregivers may eventually fill a gap in supportive oncology care programs to improve HRQOL and healthcare utilization in both dyad members. Trial registration: Clinicaltrials.gov, NCT03459781. Prospectively registered on 9 March 2018.