Clinical trial NCT03459781: Compassion Meditation for Cancer Survivor-Caregiver Dyads
Official title: Compassion Meditation for Cancer Survivor-Caregiver Dyads: Feasibility and Preliminary Efficacy of Cognitively-Based Compassion Training (CBCT®) for Solid Tumor Cancer Survivors and Their Informal Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cancer Survivors
Informal Cancer Caregivers (Family and Friends of Cancer Survivors)
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2018-03-09
Enrollment: 82
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Over the course of the study we will randomize 20 survivor-caregiver dyads to CBCT®, and 20 dyads to the CHE. We will conduct the study in several cohorts, with 4-10 dyads randomized to CBCT® and 4-10 dyads randomized with CHE in each cohort.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Survivors of solid tumor cancers and their informal caregivers (family, friends) experience impairments in health-related quality of life (HRQOL) including disruptions in psychological, physical, social, and spiritual well-being. Our prior work demonstrates that impairments in depression, anxiety, fatigue, and negative affect experienced by cancer survivors across time are interdependent those experienced by their informal caregivers. These findings suggest that interventions directed simultaneously toward both members of the cancer survivor-caregiver dyad may be especially impactful in improving HRQOL in cancer survivors and informal caregivers. Although a number of interventions have been developed and tested to support the survivor or the caregiver, few have attempted to simultaneously intervene with both to improve HRQOL within the collective survivor-caregiver dyad. CBCT®, Cognitively-Based Compassion Training (already piloted by members of this team with breast cancer survivors, is an 8-week manualized meditation-based program that starts with attention and mindfulness training and builds to contemplation about compassion for the self and others. The proposed pilot feasibility study builds upon this work to intervene with caregivers in addition to survivors of solid tumor cancers. The major aim of the proposed project is to test the feasibility and acceptability of CBCT® for survivors of solid tumor cancer and their informal caregivers after the end of cancer treatment. The project will also determine in a preliminary manner whether or not CBCT® (compared to a cancer health education \[CHE\] comparison group) has a positive impact on different measures of HRQOL (e.g. features of depression and anxiety, fatigue, social isolation), stress-related biomarkers of inflammation and cortisol, and assessments related to healthcare utilization.

IMPORTANT READER NOTE: ==\> A prior version of this study protocol on clinicaltrials.gov incorrectly stated information about interpretation of scores of the Morisky Medication Adherence Scale-8 (MMAS-8). ==\> Individuals interested in using the MMAS-8 are directed to https://morisky.org for information about the scale, as well as for licensing and other requirements for using the MMAS-8 in their research or clinical practice. Dr. Pace and his colleagues sincerely regret any incorrect information posted previously about the MMAS-8 on this clinicaltrials.gov trial website.

Detailed description: The overarching purpose of this research is to determine the feasibility, acceptability, and preliminary efficacy of Cognitively-Based Compassion Training (CBCT®) compared to a cancer health education (CHE) attention on dimensions of health-related quality of life (HRQOL), biomarkers of inflammation and diurnal cortisol rhythm, and healthcare utilization-related endpoints including healthcare-related patient activation. To address this goal the study will be conducted to address four specific aims:

Aim 1: To obtain evidence of preliminary efficacy of CBCT® versus CHE for survivors of solid tumor cancer and their informal caregivers to improve health-related quality of life outcomes. The objective of this aim is to estimate effect sizes for the differences between CBCT® and CHE at weeks 9 and 13 on HRQOL-related outcomes including psychological (depression\*, anxiety, positive affect), physical (fatigue), social (empathy, feelings of social connection/isolation, dyadic function), and spiritual (self-compassion) domain as well as global well-being. The noted endpoint (\*) is considered primary, and the others are secondary. We predict that CBCT® will result in better primary and secondary outcomes than CHE at weeks 9 and 13 (Study Hypothesis 2).

Aim 2: To obtain preliminary evidence of efficacy of CBCT® versus CHE for survivors of solid tumor cancer and their informal caregivers to influence stress-related biomarkers of inflammation and diurnal cortisol rhythm. The objective of this aim is to estimate group differences at weeks 9 and 13 on stress-related biomarkers of inflammation (plasma IL-6, IL-1β, TNF-α), as well as diurnal saliva cortisol rhythm in survivor-caregiver dyads randomized to CBCT® compared to survivor-caregiver dyads randomized to CHE. For this aim we predict that CBCT® will result in lower proinflammatory cytokines (decreased IL-6, IL-1β, TNF-α) than CHE at weeks 9 and 13 (Study Hypothesis 3). We also predict that CBCT® will result in steeper slope (i.e. more dynamic diurnal cortisol rhythm) than CHE at weeks 9 and 13 (Study Hypothesis 4).

Aim 3: To obtain preliminary evidence of efficacy of CBCT® versus CHE for survivors of solid tumor cancer and their informal caregivers to improve health care utilization and patient activation in both survivors of solid tumor cancers and their informal caregivers over 13 weeks of the study. The objective of this aim is to estimate effect sizes for the differences between CBCT® and CHE at weeks 9 and 13 on health care utilization (i.e. keeping appointments, use of preventive services, hospitalizations, and use of urgent care or emergency department services), and patient activation (i.e. motivation, knowledge, skills and confidence in managing personal health). For this aim, we predict that CBCT® will result in better healthcare utilization (lower hospitalizations, use of urgent care or emergency department services, greater keeping of the appointments and use of preventive services), and greater patient activation than CHE over weeks 1-9 and 10-13 of the study (Study Hypothesis 5).

Aim 4: To explore the interdependence of solid tumor cancer survivor and informal caregiver health-related quality of life from before to after CBCT®. The objective of this aim is to determine the degree to which HRQOL measures, biomarkers of inflammation, or diurnal cortisol rhythm in survivors predict the corresponding outcomes in caregivers (and vice-versa).

Over the course of the study we will randomize 20 cancer survivor-caregiver dyads to CBCT®, and 20 dyads to the CHE attention group. We will conduct the study in several cohorts, with 4-10 dyads randomized to CBCT® and 4-10 dyads randomized with CHE in each cohort. The research procedures are elaborated below in chronological order of when they will occur for each study cohort. The study will consist of four major phases after recruitment/ screening/ consent:

1. Baseline (pre-intervention) assessments
2. Intervention phase
3. 9-week (post-intervention) assessments
4. 3-month (post intervention) assessments

Assessments - Baseline (pre-intervention)

After successful recruitment, screening, and consent we will invite solid tumor cancer survivor-informal caregiver dyads to the College of Nursing for the baseline assessment. Shortly after arrival blood will be collected from participants before starting self-report questionnaires. Blood will be drawn in order to obtain plasma and peripheral blood mononuclear cells (PBMCs). Blood (2 X 7 milliliters) will be collected by venipuncture into EDTA-coated vacutainer tubes by the (TBA) study phlebotomist, and then immediately processed to obtain plasma or PBMCs.

After blood sampling at the baseline assessment is complete we will next ask survivor-caregiver dyads to complete self-report assessments. Self-report instruments to be completed will assess different dimensions of health-related quality of life (HRQOL) and healthcare adherence/ utilization.

Interventions

Within 2 weeks of the baseline assessment study participants will begin either 8 weeks of CBCT® or 8 weeks of CHE, depending on randomization. Study group will be revealed to study participants and study staff after the completion of the baseline assessment.

Upon randomization to either the CBCT® or CHE groups participants will be given a booklet, "Survivorship and Surveillance Guidelines", and another booklet, "Healthy Behaviors for a Healthier Life." Although these booklets will not be referred to directly throughout CBCT® or CHE, participants will be encouraged review them and ask questions about the content of these booklets throughout the study. Participants with questions after reviewing these booklets will be referred to Dr. Badger, clinical co-I. These booklets are being included because they may have an indirect effect on measures of health care adherence/ utilization in both the CBCT® and CHE groups.

Assessments - 9 weeks

Within a week of concluding the study interventions we will schedule all survivor-caregiver dyads to return to the College of Nursing for the 9-week assessment. The 9-week assessment will mirror the baseline assessment except for the healthcare utilization questionnaire, which will use an 9-week version of this questionnaire.

Assessments - 3 months

About 4 weeks later we will have all survivor-caregiver dyads visit the College of Nursing for the final, 3-month assessment time point. As with the 8-week assessment, this visit will mirror the baseline assessment except for a different healthcare utilization questionnaire, which will use a 3-month version of this questionnaire.

IMPORTANT READER NOTE: ==\> A prior version of this study protocol on clinicaltrials.gov incorrectly stated information about interpretation of scores of the Morisky Medication Adherence Scale-8 (MMAS-8). ==\> Individuals interested in using the MMAS-8 are directed to https://morisky.org for information about the scale, as well as for licensing and other requirements for using the MMAS-8 in their research or clinical practice. Dr. Pace and his colleagues sincerely regret any incorrect information posted previously about the MMAS-8 on this clinicaltrials.gov trial website.

Eligibility criteria: Inclusion Criteria:

Cancer survivor inclusion criteria: 1) age 21 or older, 2) have a solid tumor cancer diagnosis, 3) have completed treatments (surgery, radiation, chemotherapy) except for hormonal therapies (e.g. aromatase inhibitors, androgen suppression therapy) a minimum of 3 months and a maximum of 10 years before starting CBCT® or CHE, 4) able to speak and understand English, and 5) able to travel to a centralized location to attend CBCT® or attention control classes.

Informal caregiver inclusion criteria will be: 1) named by the cancer survivor, 2) age 21 or older, 3) able to speak and understand English, 4) cognitively oriented in time, place, and person, and 5) able to travel to a centralized location to attend intervention classes with their solid tumor cancer survivor. Informal caregivers will be excluded if they have ongoing or past regular compassion meditation experience in the last 4 years.

In addition to these criteria, either the cancer survivor or the informal caregiver must report at least mild anxiety (PROMIS anxiety 4-item raw score \> 6) and/ or mild depressive symptoms (PROMIS anxiety 4-item raw score \> 6).

Exclusion Criteria:

Cancer survivor exclusionary factors: 1) diagnosis of major mental illness, 2) nursing home resident, and 3) have ongoing or past regular compassion meditation experience in the last 4 years (i.e. more than two compassion meditation session \[completed or attempted\] per year, either with a group or individually).

Informal caregiver exclusionary factors: 1) diagnosis of major mental illness, 2) nursing home resident, and 3) have ongoing or past regular compassion meditation experience in the last 4 years (i.e. more than two compassion meditation session \[completed or attempted\] per year, either with a group or individually).

Primary outcomes:
measure: change in depression features
timeFrame: change from baseline depression score at 9 weeks
Secondary outcomes:
measure: change in negative affect
timeFrame: change from baseline 10-item Positive and Negative Affect Schedule score at 9 weeks
measure: change in negative affect
timeFrame: change from baseline 10-item Positive and Negative Affect Schedule score at 3 months
measure: change in dyadic function
timeFrame: change from baseline Relationship Assessment Scale score at 9 weeks
measure: change in dyadic function
timeFrame: change from baseline Relationship Assessment Scale score at 3 months
measure: change in self-compassion
timeFrame: change from baseline Self-Compassion Scale score at 9 weeks
measure: change in self-compassion
timeFrame: change from baseline Self-Compassion Scale score at 3 months
measure: change in global well-being
timeFrame: change from baseline Quality of Life Index score at 9 weeks
measure: change in global well-being
timeFrame: change from baseline Quality of Life Index score at 3 months
measure: change in inflammatory biomarkers
timeFrame: change from baseline inflammation markers at 9 weeks
measure: change in inflammatory biomarkers
timeFrame: change from baseline inflammation markers at 3 months
measure: change in diurnal saliva cortisol rhythm
timeFrame: change from baseline diurnal saliva cortisol rhythm at 9 weeks
measure: change in diurnal saliva cortisol rhythm
timeFrame: change from baseline diurnal saliva cortisol rhythm at 3 months
measure: change in healthcare activation / utilization
timeFrame: change from baseline healthcare activation/ utilization at 9 weeks
measure: change in healthcare activation / utilization
timeFrame: change from baseline healthcare activation/ utilization 3 months
measure: change in depression features one month after the end of the intervention
timeFrame: change from baseline depression score at 3 months
measure: change in anxiety features one month after the end of the intervention
timeFrame: change from baseline anxiety score at 3 months
measure: change in fatigue one month after the end of the intervention
timeFrame: change from baseline fatigue score 3 months
measure: change in empathy one month after the end of the intervention
timeFrame: change from baseline IRI total score 3 months
measure: change in feelings of social isolation / connection one month after the end of the intervention
timeFrame: change from baseline Social Connectedness Scale-Revised score 3 months
measure: change in anxiety features
timeFrame: change from baseline anxiety score at 9 weeks
measure: change in fatigue
timeFrame: change from baseline fatigue score at 9 weeks
measure: change in empathy
timeFrame: change from baseline IRI total score at 9 weeks
measure: change in feelings of social isolation / connection
timeFrame: change from baseline Social Connectedness Scale-Revised score at 9 weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: University of Arizona
name: Thaddeus Pace, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pace TWW, Dodds SE, Sikorskii A, Badger TA, Segrin C, Negi LT, Harrison T, Crane TE. 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. 2019 Apr 29;20(1):247. doi: 10.1186/s13063-019-3320-9.