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
Author
Pace, Thaddeus W WDodds, Sally E
Sikorskii, Alla
Badger, Terry A
Segrin, Chris
Negi, Lobsang Tenzin
Harrison, Timothy
Crane, Tracy E
Affiliation
Univ Arizona, Coll Nursing, Div Community & Syst Hlth SciUniv Arizona, Coll Med, Dept Psychiat
Univ Arizona, Coll Sci, Dept Psychol
Univ Arizona, Canc Ctr
Univ Arizona, Coll Social & Behav Sci, Dept Commun
Univ Arizona, Coll Nursing, Div Biobehav Healthsci
Issue Date
2019-04-29Keywords
Active controlCancer survivorship
Compassion meditation
Cortisol
Dyadic interdependence
Health-related quality of life
Inflammation
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BMCCitation
Pace, T. W., Dodds, S. E., Sikorskii, A., Badger, T. A., Segrin, C., Negi, L. T., ... & Crane, T. E. (2019). 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. Trials, 20(1), 247.Journal
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© The Author(s). 2019. Open Access. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/). The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.Collection Information
This item from the UA Faculty Publications collection is made available by the University of Arizona with support from the University of Arizona Libraries. If you have questions, please contact us at repository@u.library.arizona.edu.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 (R) (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 1month 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.Note
Open access journalISSN
1745-6215PubMed ID
31036091Version
Final published versionSponsors
The Jack Challem Trust [001]ae974a485f413a2113503eed53cd6c53
10.1186/s13063-019-3320-9
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Except where otherwise noted, this item's license is described as © The Author(s). 2019. Open Access. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/). The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.