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Author Notes:

Correspondence: twwpace@email.arizona.edu

Thaddeus Pace ORCID: https://orcid.org/0000-0002-0686-1413

TWWP conceived of the study, is Principal Investigator of the trial, and lead author of the protocol.

All authors read and approved the final report.

SED co-conceived the study, is a certified CBCT instructor and responsible for implementing CBCT for the trial, adapted CBCT for use with solid tumor cancer survivors and their informal caregivers, composed the description of CBCT for the manuscript, and reviewed and approved the final manuscript.

AS, TAB, CS, and TEC co-conceived the study, helped to develop the study protocol, and reviewed and approved the final report.

LTN is the creator of CBCT, helped to develop the study protocol, and reviewed and approved the final manuscript.

TH advised TWWP and SED on implementation of CBCT, and reviewed and approved the final report.

The authors would like to thank Sana Khan for her excellent work to implement CHE, and Karolina Pahlitzsch for her logistical support for the CBCT group.

The authors would also like to thank Maria Figueroa for her critical assistance with recruitment efforts early in the trial, and Graciela Silva, PhD, MPH, for her kind work to generate the allocation sequence for study dyads.

Finally, the authors strongly commend and thank Bettina Hofacre for her kind work to coordinate multiple aspects of the trial.

The authors declare that they have no competing interests.

Subjects:

Research Funding:

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:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Medicine, Research & Experimental
  • Research & Experimental Medicine
  • Cancer survivorship
  • Health-related quality of life
  • Compassion meditation
  • Dyadic interdependence
  • Inflammation
  • Cortisol
  • Active control
  • METASTATIC BREAST-CANCER
  • DIURNAL CORTISOL RHYTHM
  • C-REACTIVE PROTEIN
  • COLORECTAL-CANCER
  • INFLAMMATORY BIOMARKERS
  • BEHAVIORAL-RESPONSES
  • MAJOR DEPRESSION
  • PROSTATE-CANCER
  • INNATE IMMUNE
  • FATIGUE

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

Tools:

Journal Title:

Trials

Volume:

Volume 20, Number 1

Publisher:

, Pages 247-247

Type of Work:

Article | Final Publisher PDF

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.

Copyright information:

© 2019 The Author(s).

This is an Open Access work distributed under the terms of the Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/).
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