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

Thaddeus Wesley Warren Pace, Sally E Dodds, Alla Sikorskii, Terry A Badger, Chris G Segrin, Lobsang Tenzin Negi, Timothy Harrison, Tracy E. Crane

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Article number247
JournalTrials
Volume20
Issue number1
DOIs
StatePublished - Apr 29 2019

Fingerprint

Health Education
Caregivers
Survivors
Randomized Controlled Trials
Quality of Life
Neoplasms
Hydrocortisone
Anxiety
Biomarkers
Depression
Inflammation
Delivery of Health Care
Mindfulness
Meditation
Ego
Quality of Health Care
Circadian Rhythm
Saliva
Fatigue
Interleukin-6

Keywords

  • Active control
  • Cancer survivorship
  • Compassion meditation
  • Cortisol
  • Dyadic interdependence
  • Health-related quality of life
  • Inflammation

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

@article{dc35f0e8145f4383a57a573c8c5ee5f8,
title = "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",
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{\circledR} (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.",
keywords = "Active control, Cancer survivorship, Compassion meditation, Cortisol, Dyadic interdependence, Health-related quality of life, Inflammation",
author = "Pace, {Thaddeus Wesley Warren} and Dodds, {Sally E} and Alla Sikorskii and Badger, {Terry A} and Segrin, {Chris G} and Negi, {Lobsang Tenzin} and Timothy Harrison and Crane, {Tracy E.}",
year = "2019",
month = "4",
day = "29",
doi = "10.1186/s13063-019-3320-9",
language = "English (US)",
volume = "20",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central",
number = "1",

}

TY - JOUR

T1 - 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

T2 - Study protocol for a randomized controlled pilot trial

AU - Pace, Thaddeus Wesley Warren

AU - Dodds, Sally E

AU - Sikorskii, Alla

AU - Badger, Terry A

AU - Segrin, Chris G

AU - Negi, Lobsang Tenzin

AU - Harrison, Timothy

AU - Crane, Tracy E.

PY - 2019/4/29

Y1 - 2019/4/29

N2 - 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.

AB - 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.

KW - Active control

KW - Cancer survivorship

KW - Compassion meditation

KW - Cortisol

KW - Dyadic interdependence

KW - Health-related quality of life

KW - Inflammation

UR - http://www.scopus.com/inward/record.url?scp=85065228480&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85065228480&partnerID=8YFLogxK

U2 - 10.1186/s13063-019-3320-9

DO - 10.1186/s13063-019-3320-9

M3 - Article

VL - 20

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

M1 - 247

ER -