Abstract
BackgroundCancer 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.MethodsForty 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.DiscussionIf 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 registrationClinicaltrials.gov, NCT03459781. Prospectively registered on 9 March 2018.
Highlights
Cancer survivors and their informal caregivers 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
If Cognitively-Based Compassion Training (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
We have found that CBCT improves a number of different HRQOL dimensions in breast cancer survivors, including symptoms of depression, fear of cancer recurrence, and vitality [30]
Summary
Allocation procedures, and blinding This interventional study uses a randomized controlled trial design to compare CBCT with CHE to determine effect sizes in study outcomes (see below). Once every 6 months, the DSMB will review a report from the study that includes: 1) the number of participants who signed consent for the study; 2) the number of dropouts; 3) reasons for these dropouts; 4) any safety concerns or adverse events (i.e., solicited and spontaneously reported adverse events and other unintended effects of trial interventions or trial conduct); 5) an up-to-date consent form; and 6) measures taken to protect confidentiality (e.g., data storage, use of coded ID numbers, etc.) After reviewing this information, the DSMB will issue its own report summarizing any serious and unexpected adverse events or other unanticipated problems that involve risk to study participants, and whether these appear related to the study-based research assessment protocol. Analyses guided by hypotheses noted above will only take place after all participants have completed the study protocol
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