Compassion Meditation for Cancer Survivor-Caregiver Dyads

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, NF-κB pathway activation), 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) and lower PBMC NF-κB (NF-κB) 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.

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).