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
Phase: PHASE1
Conditions: Cancer Survivors, Informal Cancer Caregivers (Family and Friends of Cancer Survivors)
Sponsor: Thaddeus Pace

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Official Title: Compassion Meditation for Cancer Survivor-Caregiver Dyads
NCT number: NCT03459781
Document Date: February 10, 2022

Project Title:
Compassion Meditation for Cancer Survivor Dyads: Feasibility and Preliminary 
Efficacy of Cognitively-Based Compassion Training® for Solid Tumor Cancer 
Survivors and Their Informal Caregivers 
Investigator Information
Principal Investigator Name, 
Degree(s):
Thaddeus Pace, PhD
Affiliation
 UA             B–UMG            
Principal Investigator UA NetID
twwpace
Status/Rank:
Associate Professor
Center:
 
Department:
Community and System Health Science
College:
College of Nursing
Contact phone: 
520-626-3520 / 
404-513-3111
Official Institutional Email:
twwpace@email.arizona.edu
Advisor contact information (Required for all students and residents)
Name, Degree(s), UA NetID:
Contact phone: 
Official University Email:
Alternate/Coordinator or Co-PI contact information
*This individual will receive copies of all correspondence on the study
Name, UA NetID:
Bettina Hofacre
Contact phone: 
520-626-4994
Official University Email:
bhofacre@email.arizona.edu

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SECTION 1: REQUIRED SIGNATURES
1. Principal Investigator
I will 
conduct my study according to the University of Arizona HSPP policies and 
procedures for research with human subjects.
November 20, 
2017
Thaddeus Pace, PhD
Signature
Date
Print Name
2. Advisor (for all students and residents acting as the pi)
I will oversee the student researcher according to the University of Arizona HSPP policies and procedures for research with 
human subjects.
Signature
Date
Print Name
3. Scientific/Scholarly Review (See HSPP Guidance on requirements for Scientific/Scholarly Assessment  - include documentation for 
options A and B with submission materials.)
a.  Nationally based, federal funding organization (NIH, NSF) subject to full peer review
b.  Nationally based, non-federal funding organization (March of Dimes, Amer Academy of Pediatrics) subject to peer 
review
c.  Locally constituted peer review (signature required) 
Signature
Date
Print Name
4. Department/Center/Section Review
I have reviewed this application and determined that all departmental requirements are met and that the investigator has 
adequate resources to conduct the Human Research.
Signature
Date
Print Name/Email
5. Responsible Physician (projects involving medical procedures which the pi is not authorized to conduct)
I am a physician licensed by the State of Arizona (or US license for the SAVAHCS). I will be responsible for ensuring that all 
procedures that are part of this project and that require the attendance of a licensed physician will have a suitable physician 
present during the procedures. If at any time this is not possible, I will inform the IRB before any procedures are conducted.
Signature
Date
Print Name

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SECTION 2: GENERAL INFORMATION
1. How many Human Research studies does the PI have open?
2
2. How many research staff will be involved in the Human Research?
3
3. What is the expected length of this project?  
1.5 years
4. Will the University of Arizona be the coordinating center for a multi-site study?
  No  
 Yes- Complete Appendix C- Multi-Site study
5. Retention of study materials before, during, and after completion of the project: 
a. Where will original signed consent and PHI Authorization documents be stored (building name 
and room)?  Location: Office of Nursing Research, CON room 410
b. How long will consents be maintained after conclusion of the project?
              6 years (UA standard)      6 years after child reaches 18     Other (explain):
6. Is or will the project be funded by an external funding source e?   No   Yes- Complete below:
a. Funding PI: Thaddeus Pace, PhD
b. Proposal Title: Wellness interventioFns and stress-immune mechanisms in cancer survivors 
and their caregivers
c.
Funder Name: Estate of Jack Challem
d. Total funding amount OR per subject amount: $50,000
e. UAccess Account Information  Provide one of the following below:
i.
Institutional Proposal #: 
ii. Award #: 
Submit complete copy, cover-to-cover, of grant or award. If you need help locating any of the UAccess 
numbers please call Sponsored Projects at 626-6000.
7. Is the project funded by a For-profit industry sponsor?   No   Yes- Complete required below:
a. IRB Payment eDoc #:
Please review HSPP Guidance, Fees for Human Research, for more information. 
8. Conflict of Interest (COI):
The Principal Investigator hereby affirms that ALL individuals who meet the definition of 
investigator for this project in the current Policy on Investigator Conflict of Interest in Research 
have completed the mandatory Conflict of Interest training and Disclosure of Significant Financial 
Interests.
 Yes 
 No (explain):     

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9. Additional requirements:
Certain types of research require additional regulatory documentation. Please identify which of the 
following apply to your project. Complete the appropriate Appendix and submit as part of the 
submission materials.
 Appendix A – Children (subjects under 18) 
 Appendix B – Drugs/Devices (A clinical investigation of a drug or device) 
 Appendix C – Multi-Site study (The UA IRB will review research activities for an investigator or 
research staff not affiliated with the UA who is ‘engaged in the research’ (e.g. consenting, 
collecting data, or analyzing identifiable information) 
 Appendix D – Pregnant Women/Neonates 
 Appendix E – Prisoners
 Appendix F – Waivers of consent, waiver of a signature, or waiver or alteration of PHI
 Appendix G – Exception From Informed Consent (EFIC) 
 Appendix H – Native American or International Indigenous populations
 None apply to the proposed study
10. Research Site:
Location (Explain):
All procedures for the proposed research will take place at the College of Nursing at the University 
of Arizona. No UACC resources will be used, including access to the electronic medical record. 
Participants for this study will be recruited from across Tucson and will either be individuals who 
have completed their cancer treatments a minimum of 3 months before enrollment in the study, 
or their informal caregivers (i.e. wives, husbands, adult children, and close friends). We will not 
recruit participants who are current patients at Banner UMC or the UACC for their cancer 
treatments.
If research is taking place at B–UMG or AZCC please check the appropriate boxes below:
Banner – University Medicine Group:
 Phoenix Campus
 Biological specimens
 Clinical Data
 Tucson Campus     
 Biological specimens
 Clinical Data
 South Campus
 Biological specimens
 Clinical Data
*Submit a copy of the UAHS Research feasibility review approval
University of Arizona Cancer Center:
 North Campus
 Biological specimens
 Clinical Data
 Orange Grove Clinics 
 Biological specimens
 Clinical Data
 Phoenix
 Biological specimens
 Clinical Data
*Submit a copy of the Scientific Review Committee letter
SECTION 3.  PROJECT NARRATIVE

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1) Background
Advancements in early detection and treatments have dramatically improved the prognosis for 
the majority of patients diagnosed with solid tumor cancers. Indeed, recent trend data show that 5-
year survival rates are improving for those diagnosed with and treated for colorectal (66%), lung 
(18.7%), prostate (99%), and breast cancer (women, 90%).1 Despite these gains, health-related 
quality of life (HRQOL) impairments remain a significant concern for cancer patients during and after 
treatment. For example, survivors of different cancers are likely to experience increased depressive 
symptoms (e.g. colorectal: 28%,2 lung: 8-31%, ADDIN EN.CITE 3,4 prostate: 18%,5 and breast: 10-
25%, ADDIN EN.CITE 6,7), fatigue (23-73%, ADDIN EN.CITE 2,8 98%,9 12-21%,10 and 30-80%, 
ADDIN EN.CITE 11-13 respectively) as well as anxiety. ADDIN EN.CITE 3,14-18
Although the focus of interventions to improve HRQOL is usually on the experiences of cancer 
survivors, close family members and friends who provide supportive care (i.e. informal caregivers) 
also experience significant HRQOL impairments during and after the time when their loved ones 
undergo cancer treatment. ADDIN EN.CITE 19,20 Informal caregivers are not just passive 
bystanders, but instead provide significant supportive care (as much as 60%) to their loved one. 
ADDIN EN.CITE 21-23 A nascent literature (including work by us) suggests that impairments in 
caregivers’ HRQOL, in addition to directly affecting perceptions of quality of care,23 are strongly 
interdependent with and possibly causally linked with the HRQOL impairments experienced by their 
loved ones who are cancer survivors. For example, work by our group has shown that increased 
depressive symptoms, anxiety, symptom distress (including fatigue), and negative affect that breast 
cancer survivors experience are interdependent with the same impairments that their informal 
caregivers experience.24 We have found the same interdependence/ causal linkage of HRQOL 
impairments in prostate cancer survivors and their informal caregivers.25 Together these findings 
suggest that informal caregivers are much more than a "social backdrop" to cancer and its 
treatment.24 Instead, HRQOL is shared by both members of a cancer survivor dyad by way of 
"emotional contagion," or the multilevel phenomenon whereby stimuli from one individual results in
a complimentary emotional or behavioral state in another individual.26 The scientific premise of the 
interdependence between a survivor’s and caregiver’s HRQOL demands that interventions be 
developed and tested that are directed at both members of the dyad. One such intervention, CBCT® 
(Cognitively-Based Compassion Training) has been tested by us in cancer survivors (see justification 
and feasibility) and will now be extended to informal caregivers.
CBCT® is an established 8-week meditation-based program developed by Lobsang Tenzin Negi, 
PhD at Emory University that has already been shown by us to have HRQOL benefits for breast 
cancer survivors.27 CBCT® cultivates empathy and prosocial capacity and enhances perceptions of 
social connection and positive emotions for others. CBCT® is an iterative program, in that skills 
learned each week build upon each other. The program begins by teaching mindfulness practices for 
mental stability and non-reactive awareness, but then goes on to facilitate self-compassion, positive 
emotions, and feelings of social connectivity through compassion-based techniques of actual of 
imagined experiences of desired emotional states. Effectiveness of CBCT® was found in several 
different populations, with multiple health-related outcomes. ADDIN EN.CITE 27-33 We have 
already shown in a published pilot study that CBCT® had beneficial effects on dimensions of HRQOL 
in breast cancer survivors including symptoms of depression, fear or cancer recurrence, and vitality 
(related to the inverse of fatigue).27 Pilot data with CBCT® in breast cancer survivors were obtained 
from a 2-arm trial conducted by our group (Dodds and Pace).27 Breast cancer survivors who 
completed cancer treatments except for aromatase inhibitors or tamoxifen were randomized to 
CBCT® (n=16) or a wait list control (n=17). In favor of acceptability and feasibility of CBCT® for cancer 

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survivors, retention in CBCT® over 8 weeks was 75%, and 100% of those who attended CBCT® 
completed the post-intervention assessments.27 Compared to controls at post-intervention, the 
CBCT® group showed significant improvements in depressive
symptoms (CES-D-10), functional impairment associated 
with fear of cancer recurrence, and vitality as well as 
avoidance of intrusive thoughts and mindfulness (Figure 1). 
These preliminary findings suggest that CBCT® is feasible and
may promote positive change with respect to key aspects of 
HRQOL in cancer survivors. We are now proposing to extend
these findings to survivors of others cancers, and to pilot the
program in a form where cancer survivors will take part in 
the CBCT® program in training sessions along with their 
informal caregivers. We plan to determine the acceptability 
and feasibility of CBCT® for cancer survivor-caregiver dyads, 
assess changes in HRQOL (as we did in our study with only 
survivors) in both survivors and caregivers, and also assess in
a preliminary manner how CBCT® for survivor-caregiver 
dyads may have a beneficial effect on stress-related 
biomarkers of inflammation and cortisol, and healthcare 
adherence.  
There is good justification for examining stress-related 
physiological function by way of stress biomarkers in cancer 
survivor-informal caregiver dyads who are participating in a 
contemplative or behavior interventional study. 
Considerable evidence from research over the last two 
decades has linked HRQOL impairments in cancer survivors to changes in stress-related physiological 
function, including diurnal cortisol production as well as inflammation. Inflammation is measurable 
at multiple levels including circulating (i.e. blood concentrations) of inflammatory mediators such as 
cytokines (interleukin [IL]-1beta, IL-6 and tumor necrosis factor).34 Breast cancer survivors have been
found to have increased circulating concentrations of key inflammatory biomarkers that positively 
correlated with fatigue. ADDIN EN.CITE 35-41 Severity of major depression features have also been 
associated with inflammatory biomarkers, including IL-6, in cancer survivors.42 With further regard to
the ways that inflammation may drive the symptoms experienced by cancer survivors, a rich 
literature suggests that inflammatory cytokines undercut neurotransmitter metabolism and function in 
key brain regions, resulting in depression and fatigue. ADDIN EN.CITE 50,51 Taken together, these 
findings strongly suggest that inflammation plays an important role in the pathophysiological 
mechanisms of impairments in many dimensions of HRQOL experienced by cancer survivors. With 
respect to HRQOL impairments experienced by informal caregivers, there is also a rich science on how 
inflammation is causally linked with quality of life impairments experienced by non-survivors as well. Also
part of the rationale for examining inflammation in informal caregivers undergoing wellness 
interventions is that HRQOL impairments have been found to be linked between cancer survivors and 
informal caregivers.24 The same HRQOL impairments have been associated with inflammation.
Multiple studies suggest that increased inflammation may interact with abnormal cortisol activity
in the context of HRQOL impairments experienced by cancer survivors.52 Significant distress in breast
cancer survivors has been associated with dysregulation of the hypothalamic-pituitary adrenal (HPA) 
axis, most frequently manifested as reduced variation in cortisol from morning (when cortisol is 
Figure 1. Standardized effect sizes of 
differences between CBCT® and 
control for post-intervention outcomes 
in breast cancer survivors.1 

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normally high) to evening (when cortisol is normally low).53  Psychological distress has been found to 
be associated with flattening of the diurnal cortisol slope in numerous patient populations, including 
those with cancer. ADDIN EN.CITE 54-57  Previous research has documented that flatter cortisol 
slope, or abnormal diurnal cortisol rhythm (DCR), has been associated with fatigue58, tumor 
progression, reduced survival ADDIN EN.CITE 59,60, and depression, ADDIN EN.CITE 56,61 and in 
breast cancer, with negative psychosocial and disease outcomes. ADDIN EN.CITE 62-65   We have 
recently observed that a flatter cortisol rhytm across the day (lower cortisol in the morning and 
higher cortisol at night) is associated with greater fatigue in breast cancer survivors (Figure 2). 
Following psychosocial intervention, Giese-Davis and colleagues found that emotional expression 
within breast cancer therapy was associated with less aberrant cortisol slopes.55 Thus, treatments 
targeting psychological distress may result in a DCR comparable to that of individuals without cancer.
ADDIN EN.CITE 53,56  Regarding the role that cortisol system activity may play in HRQOL 
impairments experienced by cancer survivors, Thornton and colleagues found that stress-related 
neuroendocrine hormones including cortisol predicted pain, depression, and fatigue.66 Together 
these findings provide a strong rationale for choosing DCR as a marker of disease-relevant cortisol 
activity in the context of HRQOL impairments experienced by cancer survivors. Available evidence 
also suggests that DCR alterations (i.e. flattening of the cortisol slope) also associate with depression,
distress, and fatigue in non-survivors. In the current investigational study we will therefore 
investigate biomarkers of inflammation and DCR in both cancer survivors and informal caregivers 
undergoing CHE or CBCT®.
In addition to dimensions of HRQOL and stress-related physiological function, another concern 
about the well being of solid tumor cancer survivors is the degree to which cancer survivors adhere 
to healthcare recommendations (including following cancer survivorship plans). In a chronic illness 
model, cancer survivorship requires lifelong adherence to survivorship care, and adherence may 
consist of several dimensions including appropriate use of health services. In turn, health services 
utilization requires having access to available health care resources, but are further mediated by 
physical, psychological, psychosocial, and economic factors in the patient. For example, adherence 
may be challenged when other chronic, co-morbid conditions are present, when patients experience 
depression or anxiety, or when social support is limited. In addition, cancer survivors report that 
adequate health insurance coverage, a major barrier to service access and utilization, is one of their 
most important health care needs. 
Factors within the health care system may also affect adherence. For example, among cancer 
patients, receiving treatment summaries and survivorship care plans supports self-management 
while also providing information to primary care physicians involved in follow-up care. Studies show 
that receiving a verbal explanation of follow-up instructions is significantly associated with higher 
self-efficacy scores, and these in turn are significantly associated with lower emergency room visits 
and hospitalizations. This also holds true for other chronic diseases, such as diabetes or arthritis.
One psychological factor in adherence is a degree of patient motivation and activation. The 
importance of the patient as an active, engaged participant in their own cancer survivorship and 
chronic disease management has received growing attention in the past decade, so much that the 
US Centers for Medicare and Medicaid Services assessed patient activation and engagement in its 
recent evaluation of innovative Pioneer Accountable Care Organizations (ACOs).
Activated patients are those with the motivation, knowledge, skills, and confidence to make 
effective decisions in managing their health. Those with low activation are typically passive recipients
of care and do not believe in the need for an active patient role. Those who are highly activated are 
proactive about their health and engage in many recommended health behaviors. Activation, 

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however, is not either/or. A widely used developmental model of activation involves four stages: (1) 
believing the patient role is important, (2) having the confidence and knowledge necessary to take 
action, (3) actually taking action to maintain and improve one’s health, and (4) staying the course 
even under stress (Hibbard et al. 2004; Hibbard et al., 2005). See Figure 3.
Correlational studies have found patient activation to be related to healthy lifestyle behaviors 
(e.g. physical activity, eating fruits and vegetables), appropriate use of health care services (e.g. 
having fewer hospitalizations), and self-management of chronic conditions (e.g. diabetic eye 
examinations, 
recording blood 
pressure readings, 
HbA1c control). 
Other studies 
show patient 
activation to be a 
modifiable 
characteristic, and 
that interventions 
can increase self-
management 
capacities and 
health services 
use. For example, 
among patients in 
a community 
health center, a 
brief activation 
intervention 
helped patients 
have more 
effective encounters with physicians. Among community mental health clinic patients, a 3-session 
activation intervention improved health-related decision-making. Further, patients showed 
improvements in activation even when an intervention was delivered online.
In addition to HRQOL outcomes, in the current pilot study we will also explore patterns of and 
barriers to health care adherence in solid tumor cancer survivors and their informal caregivers. 
Exploration of this dimension is limited only because of the short time frame of the study and the 
high likelihood that participants will have too few scheduled appointments in that period with which 
to adequately assess health behavior change. Further, along with changes in dimensions of health-
related quality of life and on biomarkers of inflammation and diurnal cortisol rhythm, we AIM to 
determine the efficacy of CBCT® on improved patient activation, an important ingredient in chronic 
care management. This information will not only help us determine the efficacy of CBCT® on patient 
activation, but also the role of activation on health care adherence in a full-scale study with less 
restrictive time constraints in the future. 
2) Purpose
Figure 3. 

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The overarching purpose of the proposed research is to determine the feasibility, acceptability, 
and preliminary efficacy of Cognitively-Based Compassion Training (CBCT®) compared to a cancer 
health education (CHE) attention control 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, we present the following aims:
Aim 1: To determine the feasibility, acceptability, and obtain preliminary evidence of efficacy (as 
reflected by the effect sizes) of an 8-week CBCT® (Cognitively-Based Compassion Training) program
for survivors of solid tumor cancer and their informal caregivers to impact health-related quality of
life outcomes. The objective of this aim is to determine feasibility and acceptability of CBCT® for 
cancer survivor-caregiver dyads compared to CHE, and to also obtain preliminary measures of pre to 
post intervention change on HRQOL including psychological (depression features*, anxiety features, 
negative affect), physical (fatigue), social (empathy, feelings of social isolation, dyadic function), and 
spiritual (self-compassion) domain as well as global well-being. The endpoint noted above (*) is 
primary, all others are secondary.
Hypothesis 1: Randomization to CBCT® will result in greater changes/ improvement in domains of 
HRQOL from before to after the intervention programs than randomization to CHE.
Aim 2: To obtain preliminary evidence of efficacy (as reflected by the effect sizes) of an 8-week 
CBCT® program for survivors of solid tumor cancer and their informal caregivers on stress-
related biomarkers of inflammation and diurnal cortisol rhythm. The objective of this aim is to 
obtain preliminary measures of pre to post intervention change on stress-related biomarkers of 
inflammation (plasma interleukin [IL]-6, IL-1 beta, tumor necrosis factor (TNF)- alpha, as well as 
diurnal saliva cortisol change in survivor-caregiver dyads randomized to CBCT® compared to 
survivor-caregiver dyads randomized to CHE.
Hypothesis 2: Randomization to CBCT® will result in greater change in inflammatory cytokines 
(decreased IL-6, IL-1beta, TNF-alpha) from before to after the intervention program than 
randomization to CHE.
Hypothesis 3: Randomization to CBCT® will result in a greater dynamic change in saliva 
concentrations of cortisol from morning to evening (i.e. diurnal cortisol rhythm) from before to after 
the intervention programs than randomization to CHE.
Aim 3: To explore health care adherence in both survivors of solid tumor cancer and their informal 
caregivers, and obtain preliminary evidence of efficacy of the 8-week CBCT® program (as reflected 
by the effect sizes) on patient healthcare-related activation. The objective of this aim is to obtain 
preliminary measures of pre to post intervention change in healthcare activation (i.e. intent to use 
cancer-related survivorship plans [survivor] and management plans of other chronic conditions 
[survivor and caregiver) in survivor-caregiver dyads randomized to CBCT® compared to survivor-
caregiver dyads randomized to CHE.
Hypothesis 4: Randomization to CBCT® will result in greater patient activation than CHE from before 
to after the intervention programs.
Aim 4: To explore the interdependence of solid tumor cancer survivor and informal caregiver 
health-related quality of life from before to after CBCT® (Cognitively-Based Compassion Training). 

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The objective of this aim is to statistically determine the degree to which changes of HRQOL 
measures, biomarkers of inflammation, or diurnal cortisol rhythm  in survivors predicts changes in 
caregivers (or vice-versa). 
Hypothesis 5: Randomization to CBCT® will result in greater interdependence on study outcomes 
between survivors and caregivers than randomization to CHE.
3) Lay Summary (approximately 400 words)
Survivors of solid tumor cancers and their informal caregivers (family members or friends) experience
significant 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 strongly related
to, or interdependent with, 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. It differs from other meditation interventions in that it directly enhances self-
compassion, feelings of social connection, empathy for others, and equanimity and by doing so lessens
emotional suffering. Our recent findings suggest that CBCT® may reduce depressive symptoms, fear of
cancer recurrence, and improve vitality in breast cancer survivors. 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® 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 (patient
healthcare-related activation).  Using the actor-partner interdependence model, the project will also
explore the interdependence of the solid tumor cancer survivor and informal caregiver HRQOL
outcomes from before to after CBCT®. If feasibility and acceptability are established in this research, a
future larger trial will be warranted and appropriately powered to formally test the efficacy of this
dyadic CBCT® intervention. Evidence-based programs such as CBCT® may fill the gap in supportive
psychosocial oncology care directed toward both members of the survivor-caregiver dyad, as opposed
to programs directed at the either alone. We believe that CBCT® is a particularly promising program
because it may be effective at enhancing both the individual and the collective empathy shared by a
cancer survivor and his or her informal caregiver.
4) Setting of the Human Research
All procedures for the proposed research (except saliva collection) will be completed at the 
University of Arizona College of Nursing: including blood draws, self-report assessments, and the 8-
week intervention classes (CBCT® and CHE). The will be three assessment time points: before the 8-

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week interventions (T1), immediately after the 8-week intervention classes (T2), and then again 3 
months later (T3). Blood samples will be drawn in the Research Suite phlebotomy room (CON 418C), 
and paper Scantron questionnaires will be completed in the Research Suite conference room (CON 
418A). The weekly CBCT® sessions will take place in CON 349, and the weekly CHE sessions in CON 
416. 
Saliva collection will take place in participants’ homes per the Saliva Instructions form (attached).
5) Resources available to conduct the Human Research 
Facilities
All study procedures (assessments and interventions) will be completed at the University of Arizona 
College of Nursing where Dr. Pace (PI) is member of the faculty. Processing and analyses of all 
biological samples will take place in the Biological Core Laboratory at the College of Nursing, where 
Dr. Pace already conducts work for other projects according to biosafety and chemical safety 
protocol plans already approved at the University of Arizona.
 Research Personnel Training Plan
All study personnel have already undergone human subjects research training via the CITI Program. Dr.
Dodds has received training from the CBCT® Teacher Certification Program at Emory and takes part in
periodic refresher seminars. She also periodically consults with CBCT® program faculty and staff
including Dr. Negi, the creator of CBCT®, as well as Tim Harrison, Director of the CBCT® Training
Program. 
6) Study Population
This study will enroll survivors of solid tumor cancers who have completed cancer treatment 
(except for hormonal therapies) and their informal caregivers. Participants of both genders and all 
racial/ ethnic backgrounds will be included. 
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. 
Cancer survivor exclusionary factors: 1) diagnosis of major mental illness, 2) nursing home resident, 
and 3) ongoing compassion meditation practice (as determined by the Principle Investigator).

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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 compassion meditation practice 
(as determined by the Principle Investigator).
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) to be randomized to either intervention arm. 
 
 
The sample size for this feasibility study (N=48 dyads [96 participants total]; CBCT® about n=24, 
CHE attention control about n=24) is based on the number of cancer survivor-caregiver dyads that 
are projected to meet inclusion criteria for depressive and/or anxiety symptoms who will complete 
the entire study protocol. This feasibility study will not formally test hypotheses but will determine 
estimates of the effects sizes for future work, thus formal hypothesis-based sample size 
determination is not applicable. The proposed sample size will yield estimates of and the confidence 
intervals for the effect sizes for the improvements in primary outcomes in physical, psychological, 
and social HRQOL (depressive symptoms, anxiety, fatigue, negative affect, empathy, and dyadic 
function) for those randomized to CBCT® versus the CHE attention control. We will also estimate 
effect sizes for stress-related biomarker outcomes. The rigor of the proposed pilot RCT design (i.e. 
having the CHE attention control) will secure the attribution of the effects to the intervention.
7) Recruitment Methods and Consenting Process
a. Recruitment Process:
Participants for the study will be recruited by the PI (Pace) and the study coordinators (Hadeed/ 
Figueroa/ Hofacre) from cancer advocacy organizations in metropolitan Tucson. The PI, study 
coordinators, and others on the research team already have strong collaborative relationships 
with these advocacy organizations (see letters of support). 
We may use additional recruitment materials in the future, including a recruitment flyer (see 
Appendix). This flyer will be distributed to partnering cancer advocacy organizations (see letters 
of support) as well as at the University of Arizona Cancer Center.
A recruitment script (version already approved) will be read to prospective participants before 
they are presented with a consent form.
b. Informed Consent: 
Participants will be consented in person and with a printed consent form (see attached) by the 
study coordinators or the PI, either in the community or at the College of Nursing. If consented in
the community, a public place such as a coffee shop, restaurant, or community center may be 
used. If at the College of Nursing, a private conference will be used. During the consenting 
process participants will be made aware that the study involves an 8-week intervention and 
several self-report assessments, and blood sampling by venipuncture. 
8) Research procedures involved in the Human Research

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Over the course of the study we will randomize about 24 survivor-caregiver dyads to CBCT®, and 
about 24 dyads to the CHE attention control. We will conduct the study in 3-4 cohorts, with about 
equal number of dyads randomized to CBCT® and CHE in each cohort. Randomized dyads will include
cancer survivors and informal caregivers with at least mild depressive or anxiety symptoms (see 
Study Population, above). 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. 8-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 (centrifugation at 1,030 rcf at 4C 
for 10 minutes before freezing at -80C), or PBMCs (blood will be dilute 1:1 with sterile saline, 
loaded onto a ficol-hypque gradient before centrifugation at 1,500 rcf for 10 minutes at room 
temperature, followed by isolation of leukocytes (PBMCs), then washing of cells with 1 X PBS before 
storage in freezing serum [fetal bovine serum + 10% DMSO] at -80C). 
After completion of baseline self-report questionnaires (including demographics 
questionnaire with height and weight) and before departing the College of Nursing we will distribute 
to all survivor-caregiver dyads home saliva collection kits in order to assess cortisol diurnal rhythm. 
The saliva collection kits (see Appendix for kit Saliva Instructions form) will instruct survivors and 
caregivers to collect saliva in the home setting on two consecutive days in the morning at waking, 
and again in the evening after dinner and about 2 hours before bedtime. These samples will be 
returned to the lab at the College of Nursing, and will be batch analyzed for concentrations of 
cortisol to assess diurnal cortisol rhythm (see Laboratory Procedures below for assay details). 
After providing the saliva collection kit, 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)(those marked by a * are primary). Please see the Appendix for
the complete self-report packet. Each of the questionnaires are described immediately below:
Health-Related Quality of Life self-report instruments
Depressive* and anxiety symptoms (psychological HRQOL): PROMIS-short forms 8-items: 
depression and anxiety. These short forms are already in use by members of the study team (Pace) 
and like other PROMIS forms have evidence for reliability and validity. PROMIS measures were 
developed with various techniques including Item Response Theory (IRT). ADDIN EN.CITE 67-70 

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These forms will minimize participant burden relative to more traditional scales (e.g. CES-D). 
Negative affect (psychological HRQOL): 10-item Positive and Negative Affect Schedule (PANAS). 
The PANAS contains positive and negative affect subscales. Reliability is good (0.86-0.90 for positive 
scale, 0.84-0.87 for the negative scale).71 
Fatigue (physical HRQOL): PROMIS: fatigue will be used to capture physical and emotional 
components of fatigue. The BFI is a self-report instrument containing 9 items designed for the rapid 
assessment of fatigue in cancer patient and takes <5 minutes to complete.72  
Empathy (social HRQOL): Interpersonal Reactivity Index (IRI). The IRI was designed to assess 
empathy, defined as the reactions of one individual to the observed experiences of another. The IRI 
comprises four sub-scales that measure a component of empathy: perspective-taking, empathic 
concern, personal distress, and fantasy. The IRI has demonstrated good validity and reliability and has 
been used widely since its creation.73-75
Social connection (social HRQOL): Social Connectedness Scale, Revised (SCS-R). The SCS-R is based 
on the original Social Connectedness Scale that was developed to measure perceived social 
connectedness.76 The revised scale, SCS-R, addresses psychometric limitations in the original and 
consists of 20 items.77
Dyadic function (social HRQOL): Relationship Assessment Scale (RAS). Quality of relationship will 
be measured using the RAS, a 7-item scale designed to measure general relationship satisfaction. 
Respondents answer each item using a 5-point scale ranging from 1 (low satisfaction) to 5 (high 
satisfaction).78 
Self-compassion (spiritual HRQOL): Neff Self-Compassion Scale (NSCS). The NSCS measures the 
construct of self-compassion, defined as being kind to oneself instead of harshly critical in situations of 
pain or failure; perceiving experiences as part of the larger human condition; and being aware of 
painful thoughts and feelings without over-identifying with them.79 This 26-item scale has good test-
retest reliability (0.93).80
Global HRQOL: Defined as subjective well-being related to life happiness/ satisfaction, global HRQOL 
will be measured using the Quality of Life Index (QLI) developed by Ferrans and Powers and is 
suitable for cancer and non-cancer populations. Generic version will be used for caregivers, and 
cancer version will be used for survivors.81 The QLI reflects both satisfaction and importance of 
various aspects of life, using 30 items for each. Importance ratings are used to weight satisfaction 
responses, so scores reflect satisfaction with aspects of life that are valued by the individual. Total 
score summarizes multiple HRQOL domains. 
Healthcare adherence self-report instruments
Health services utilization: We operationalize health services utilization as appointment-keeping 
for oncologic, primary care, and non-cancer specialty care (if needed). Dimensions assessed on the 
Healthcare Utilization Self-Report Questionnaire, developed by us, follow approaches used in 
previous studies of cancer survivors (Kirchhoff et al., 2012) and of chronic care patients (Lorig et al., 
2001) and include:

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o Access to care:
Having adequate health insurance coverage and the ability to meet out of pocket (OOP) 
health expenses;
Having designated, identifiable providers for cancer care, primary care, and other non-
cancer specialty care; and,
Having received a cancer survivorship care plan (for the survivor).
o Health service appointment-keeping:
Appointments made and kept in the prior 2 months with 3 types of health providers, 
cancer care providers, primary care providers, and other non-cancer medical specialists. If 
unable to keep an appointment(s), respondents select from a list of common reasons.
o Receipt of routine preventive services:
In the past year, receipt of an annual physical exam; screenings for hypertension, 
osteoporosis (women), mammogram (women), Papanicolaou/PAP test (women), prostate 
cancer (men); flu shot; and, dental check-up or dental care
o Urgent Care, Emergency Room, and Hospital Services
Receipt of services in the past 2 months at an urgent care center, a hospital emergency 
room (ER), or inpatient admission to a hospital for at least one night.
Biological Core Laboratory Procedures.
Plasma and PBMCs will be batch analyzed later (i.e. after collection of all samples from a given 
cohort / across all time points [baseline, 8-week, and 3-month; see below]). Concentrations of 
interleukin (IL)-6, IL-1beta, and TNF-alpha in plasma will be determined using a high-sensitivity 
magnetic bead multiplex from R&D Systems. The PI's laboratory at the College of Nursing has 
experience with multiplex assays for cytokines and has found good agreement between cytokines 
concentrations determined using multiplex assays and high-sensitivity ELISA. There is no genetic 
analyses part of this study. This study will not involve genetic tests of any kind, including gene 
expression of gene polymorphisms analyses. 
Saliva concentrations for cortisol will be determined using ELISA kits from Salimetrics (State 
College, PA) according to manufacturer instructions. 
 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. Sealed envelopes will be used in 
order to obtain dyad group assignment immediately at the conclusion of the baseline assessments.
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. These booklets are being included because they may have an indirect effect on measures 

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of health care adherence/ utilization in both the CBCT® and CHE groups. 
CBCT® (Cognitively-Based Compassion Training)
CBCT® was designed at Emory University by Lobsang Tenzin Negi, PhD. CBCT® is a secular 
adaptation of techniques derived from traditional Tibetan Buddhist methods for cultivating 
compassion known as lo-jong.82 Translated as “thought transformation”, lo-jong is considered to be 
an analytical meditation, one that actively incorporates intellectual analysis into meditation practice 
with a goal of complete reorientation away from egoistic self-centeredness (i.e., “self-cherishing”) 
toward altruism or “other-cherishing”.83 From the lo-jong perspective, self-centered thought and 
behavior cause suffering for oneself and others, while other-centered, altruistic thoughts, emotions, 
and actions benefit oneself and others. Over the course of 8 weeks there will a total of 8 CBCT® 
sessions, one session per week, led by the CBCT® instructor (Dodds). Participating dyads will attend 
the weekly CBCT® classes together, which we believe will be critical to make concepts and empathy 
salient for survivor and informal caregiver in each dyad. Each weekly session will last for 120 minutes
and will begin with brief meditation to focus attention. This will be followed by a didactic phase in 
which the instructor will articulate content and goals of the current week, after which a group 
discussion led by the instructor will take place. A session will end with a 20-30 minute meditation 
guided by the instructor. Of note, the instructor (Dodds) has worked with cancer survivors 
previously,27 and is a cancer survivor herself. In between weekly meetings, dyads will be encouraged 
to practice a minimum of 10 minutes per day at home, and together as a dyad if possible. Our 
previous work suggests that participants who practice an average of 3.1 sessions per week (10 
minutes minimum per session) tend to exhibit meaningful changes in various outcomes including 
depressive symptoms, self-compassion, and inflammatory markers. ADDIN EN.CITE 27-33 Home 
practice will be encouraged by providing dyads with printed narrative summaries of weekly lessons, 
as well as guided meditation audio recordings created by the Emory CBCT® program. Participants will
be asked to complete a CBCT practice log (see attached CBCT Practice Log form) in order to 
encourage practice, and to gather information on their engagement with CBCT. Below is a summary 
of topics/work (by week) of the CBCT® protocol. This program has been studied previously with 
other populations, including breast cancer survivors: ADDIN EN.CITE 27-33 
The course is divided into six modules, taught across 8 sessions that meet for 120 minutes, plus time 
for personal practice between sessions.   All sessions combine lecture, discussion, experiential 
exercises, and reflective practice.  
 Class Meeting 1 – Introduction and Foundational Practice
In the first session, the instructor presents an introduction and overview, which informs the 
participants about the following:

Develop a working definition of compassion (as distinct from empathy) and how it can be 
cultivated systematically with a skill-building approach.

Explain researched-based and theoretical benefits of compassion, including improved empathic 
accuracy, increased happiness and activation of the brain’s pleasure circuitry, a multitude of 
health benefits, and increased patient outcomes and satisfaction.

Delineate the core concepts of the Emory University protocol CBCT® (Cognitively-Based 
Compassion Training), including sustained attention, self-compassion, equanimity, impartiality, 
interdependence, and gratitude.

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
What “cognitively-based” means and how the program may differ from other types of 
meditation/cognitive retraining participants may have engaged in.

Foundational Practice: Resting in a Moment of Nurturance
 Class Meeting 2 – Module I: Attentional Stability and Clarity
This class presents Module I: Developing Attentional Stability and Clarity.  The initial practice trains 
attentional stability in order to improve mental stability and clarity; typically, this is done by placing 
and retaining focus on the unfolding sensations of the breath and by learning to relate to distractions
with greater equanimity.
 Class Meeting 3 - Module II: Cultivating Insight into the Nature of Mental Experience
Still rooted in the present moment, the focus shifts to how mental experience unfolds from moment 
to moment.  The goal is to pay attention without pushing away this mental activity or becoming 
overly involved in it.  This practice develops a flexible responsiveness to inner experience, insight into
habitual mental patterns, and increased calmness of mind.
 Class Meetings 4 and 5 -- Module III: Self-compassion
Using insights from Module II, this practice looks closely at how mental patterns and inner 
perspectives contribute to a sense of well-being.  Lasting relief from difficult life circumstances is 
often possible by shifting one’s inner attitudes and by reducing unrealistic expectations and 
unhelpful reactions.  When the practitioner engages these tendencies with a view of kindness 
toward one’s self, these practices work to strengthen the determination to replace negative and 
damaging thought patterns with more constructive and realistic viewpoints. 
 Class Meeting 6 -- Module IV: Cultivating Impartiality
Humans are intrinsically social creatures, so attitudes toward others are of great importance.  By 
examining the tendency to place people into in-groups and out-groups based on temporary and 
subjective criteria, practitioners consider how such categories are both artificial and fluctuating.  By 
contemplating that people – on the most basic level – share a common humanity, the practitioner 
learns to see that the desire for personal fulfillment and the wish to avoid distress and dissatisfaction
is a shared aspiration.
 Class Meeting 7 -- Module V: Appreciation and Affection for Others
This module begins by recognizing that everything that helps one to thrive and flourish is dependent 
upon countless others, and this understanding inspires appreciation for those responsible.  By 
attuning to this interconnected ecosystem, a sense of gratitude toward others is engendered.  The 
practitioner moves away from the narrow view of independence and isolation that maintains a self-
centered mindset.  Through reflection on the daily and long-term gifts of the broader society, and 
the drawbacks of self-focused attitudes and actions, deep affection is cultivated for others.
 Class Meeting 8 - Module VI: Empathy and Engaged Compassion
With the perspectives of seeing each person as equally deserving of happiness and as having great 
value in their own right, practitioners place their attention on the difficulties and distress 
experienced by so many, which naturally invokes an empathic response.  When supported by the 
inner strength developed in earlier modules, this empathy leads to the strong wish to see others free
of difficulties and distress and to orient one’s core motivation toward the alleviation of the suffering 

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of others.
Cancer Health Education (attention control)
The cancer health education (CHE) intervention is an adaptation of the in-person attention control 
program called Health Discussion, a protocol used by our group previously.31 The CHE will focus on 
relevant topics to health and cancer including 1) cancer advocacy, 2) health and cancer biology, 3) 
nutrition, 4) lifestyle interventions such as physical activity and goals for physical activity, 5) the 
importance of good sleep, 6) the impact of stress, and 7) mental health and social support. CHE will 
also discuss current events related to cancer (e.g. “cancer in the news”), trends about cancer 
diagnoses, and the latest science and research about cancer (e.g. the Cancer Moonshot).
 
Over the course of 8 weeks there will be a total of 8 sessions, one session per week, similar to CBCT®.
Each session will last for approximately 90 minutes. We will train a public health graduate student to 
administer the cancer health education attention control per established protocol used previously by
prior members of the study team (Badger & Segrin). ADDIN EN.CITE 84,85  Through previous 
experience with the Health Discussion group, we found that public health graduate students have 
the communication skills, enthusiasms, and scholarly background to teach rigorous attention control 
groups.31 
 Assessments - 8 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 8-week assessment. The 8-week assessment will mirror 
the baseline assessment except for the healthcare utilization questionnaire, which will use an 8-week
version of this questionnaire (see Appendix).
 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 an 3-
month version of this questionnaire (see Appendix). At this assessment we will also ask participant to
complete and height and weight questionnaire form.
Statistical Analytic Plan
Questionnaire total scores, biomarker data, and other relevant endpoints (e.g. class attendance) will 
be entered into the study database and managed in SPSS. 
Feasibility will be measured by rates of consent and retention of dyads. Acceptability will be 
measured weekly at each CBCT® session by adherence to program engagement requirements (class 
attendance, home practice) by both dyadic members. Satisfaction and what participants consider 
strengths and weaknesses of the program will be assessed immediately post the 8-week 
intervention. 

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We will also assess different dimensions of health-related quality of life (HRQOL) before, after, and 
again 8 weeks after either CBCT® or the cancer health education (CHE) control. The randomized 
design will yield estimates of the effect sizes for improvements in primary outcomes of physical, 
psychological, and social HRQOL (depressive symptoms, anxiety, negative affect, fatigue, empathy, 
and dyadic function) for each member of the dyad for CBCT® versus the control.
The Actor-Partner Interdependence Model will be used to guide exploration of the interdependence 
over time of the primary outcomes of psychological, physical, and social well-being as well as stress 
biomarkers in cancer survivors and their informal caregivers.
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Bierhaus A, Wolf J, Andrassy M, Rohleder N, Humpert PM, Petrov D, Ferstl R, von Eynatten M, 
Wendt T, Rudofsky G, Joswig M, Morcos M, Schwaninger M, McEwen B, Kirschbaum C, 
Nawroth PP. A mechanism converting psychosocial stress into mononuclear cell activation. 
Proceedings of the National Academy of Sciences of the United States of America. 
2003;100(4):1920-1925.
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Steptoe A, Hamer M, Chida Y. The effect of acute psychological stress on circulating 
inflammatory factors in humans: a review and meta-analysis. Brain, Behavior, & Immunity. 
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Segerstrom SC, Miller GE. Psychological stress and the human immune system: a meta-analytic 
study of 30 years of inquiry. Psychol Bull. 2004;130(4):601-630.

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50.
Dantzer R, O'Connor JC, Freund GG, Johnson RW, Kelley KW. From inflammation to sickness 
and depression: when the immune system subjugates the brain. Nature reviews neuroscience. 
2008;9(1):46-56.
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Bower JE. Cancer-related fatigue--mechanisms, risk factors, and treatments. Nat Rev Clin Oncol. 
2014;11(10):597-609.
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Fagundes C1, 3,LeRoy A4, Karuga M5. Behavioral sympotms after breast cancer treatment: A 
biobehavioral approach. Journal of Perspective Medicine. 2015;5(3):280-295.
53.
Spiegel DG-D, J. Depression and cancer: Mechanisms and Disease Progression. Society of 
Biological Psychiatry. 2003;54:269-282.
54.
Spiegel D, Giese-Davis J, Taylor CB, Kraemer H. Stress sensitivity in metastatic breast cancer: 
analysis of hypothalamic-pituitary-adrenal axis function. Psychoneuroendocrinology. 
2006;31(10):1231-1244.
55.
Giese-Davis J, Spiegel D. Emotional expression and cancer progression. Handbook of affective 
sciences. 2003(Journal Article):1053–1082.
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Giese-Davis J, Wilhelm FH, Conrad A, Abercrombie HC, Sephton S, Yutsis M, Neri E, Taylor 
CB, Kraemer HC, Spiegel D. Depression and stress reactivity in metastatic breast cancer. 
Psychosomatic medicine. 2006;68(5):675-683.
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Giese-Davis J, Collie et al. . Decrease in depression symptoms is associated with longer survival 
in patients with metastatic breast cancer: A secondary analysis. Journal of clinical oncology. 
2010;29(4):413-420.
58.
Bower JE GP, Dickerson SS, Peterson L, Azia N,  & Fahey JL. Diurnal cortisol rhythm and 
fatigue in breast cancer survivors. PsychoNeuroendocrinology. 2005;30:92-100.
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Sephton SE, Sapolsky RM, Kraemer HC, Spiegel D. Diurnal cortisol rhythm as a predictor of 
breast cancer survival.[see comment]. Journal of the National Cancer Institute. 2000;92(12):994-
1000.
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Chida Y, Hamer M, Wardle J, Steptoe A. Do stress-related psychosocial factors contribute to 
cancer incidence and survival? Nat Clin Pract Oncol. 2008;5(8):466-475.
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Jarcho MR SG, Tylova-Stein H, Wolkowitz OM, Burke HM. Dysregulated diurnal cortisol pattern
is associated with glucocorticoid resistance in women with major depressive disorder. . Biological 
Psychology. 2013;93(1):150-158.
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Spiegel D, Giese-Davis, J., Taylor, C.B., & Kraemer, H. Stress sensitivity in metastatic breast 
cancer: Analyisis of the hypothalmic-pituitary-adrenal axis function. PsychoNeuroendocrinology. 
2006;31:1231-1244.
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Giese-Davis J, Sephton SE, Abercrombie HC, Duran RE, Spiegel D. Repression and high anxiety 
are associated with aberrant diurnal cortisol rhythms in women with metastatic breast cancer. 
Health Psychology. 2004;23(6):645-650.
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Abercrombie HC, Giese-Davis J, Sephton S, Epel ES, Turner-Cobb JM, Spiegel D. Flattened 
cortisol rhythms in metastatic breast cancer patients. Psychoneuroendocrinology. 2004;29(8):1082
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Turner-Cobb JM, Sephton SE, Koopman C, Blake-Mortimer J, Spiegel D. Social support and 
salivary cortisol in women with metastatic breast cancer. Psychosomatic Medicine. 
2000;62(3):337-345.
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Thornton LM AB, Blakely WP. The pain, depression, and fatigue symptom cluster in advanced 
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PROMIS. Adult Depression version 1.0 short form: a breif guide to the 8-item PROMIS Short 
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PROMIS. Adult satisfaction with participation in social roles profile short forms. 2013. 2013.
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Rose M, Weinfurt K, Hays R. The Patient-Reported Outcomes Measurement Information System 
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2005-2008. J Clin Epidemiol. 2010;63(11):1179-1194.
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Lee RM, Draper M, Lee S. Social connectedness, dysfunctional interpersonal behaviors, and 
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Negi LT. Emory Compassion Meditation Protocol: Cognitively-Based Compassion Training 
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Ozawa-de Silva B, Dodson-Lavelle B, Raison CL, Negi LT. Compassion and ethics: Scientific 
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being. . Journal of Healthcare, Science, and the Humanities. 2012;11(1):145-157.
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Badger TA, Segrin C, Figueredo AJ, Harrington J, Sheppard K, Passalacqua S, Pasvogel A, 
Bishop M. Psychosocial interventions to improve quality of life in prostate cancer survivors and 
their intimate or family partners. Qual Life Res. 2011;20(6):833-844.
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Badger TA, Segrin C, Hepworth JT, Pasvogel A, Weihs K, Lopez AM. Telephone-delivered 
health education and interpersonal counseling improve quality of life for Latinas with breast 
cancer and their supportive partners. Psychooncology. 2013;22(5):1035-1042.
9) Cost to subjects
There are no costs to be in this study, except for subjects’ time. The total time commitment will be 
about 14 hours, over a 3 month period.  

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10) Risks to subjects
Subjects may be uncomfortable discussing their cancer and its treatment and how they cope with 
their cancer diagnosis and treatment. If they become too anxious or upset by discussing cancer 
treatment or its side effects, they will be able to stop at any time.  To minimize risk, subjects will be 
asked to inform study staff if their levels of emotional distress increase during the telephone 
assessments. They will not have to answer any questions that upset them.
The questions subjects answer during the assessments will contain personal information. There is a 
risk that this information could become public, or fall into the hands of someone not associated 
with the study. We will take steps to prevent this from happening (see below). 
We will refer to the appropriate social service agency or cancer advocacy organization in the 
community. 
There are also risks associated with blood sampling by venipuncture. These risks include discomfort
and a slight risk for infection, bruising and/or bleeding at the blood draw site. To minimize risks 
associated with the blood draw, the procedure will be done in a sterile manner by a phlebotomist 
trained and experienced in venipuncture. 
11) Potential benefits to subjects and/or society
Participants may benefit from the intervention programs that are part of this study. Both CHE and 
CBCT® are designed to impart useful skills to program participants (see interventions descriptions 
above). The participation of subjects may also ultimately help improve psychosocial health care for 
women who are survivors of breast cancer by investigating the benefits of two programs that could 
eventually be made available to all cancer survivors and informal caregivers.
12) Provisions to protect the privacy of subjects and the confidentiality of data
a. Protection of subject privacy: The identity of subjects will be protected during recruitment 
and consenting by holding meetings at location that are reasonably private, although they 
may be public buildings, for example a quiet area at a community center. Participants will be 
asked to only complete study assessments (baseline, 8-week, 3-month) while in a private 
setting at the College of Nursing. 
b. Protection of data confidentiality: All study material including source documents and 
casebooks will be stored in a secured room (either Dr. Pace’s office, College of Nursing 443, 
Ms. Figueroa’s office, College of Nursing 441, or the Office of Nursing Research, College of 
Nursing 410) or on a secure computer server or personal computer that are HIPAA compliant 
and can only be accessed by study researchers. Data collected during the telephone 
assessments and the research center visit will be stored by study number, not by subject 
name. A paper copy list linking subject names to their subject numbers will be stored in a 
locked drawer located inside Dr. Pace’s office at the College of Nursing.

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13) Access to Private Information 
a. Access to medical records (HIPAA): n/a. This study will not access medical records of 
participants, electronic or otherwise.
14) Subject compensation
Participant dyads (cancer survivors and informal partners) will receive $20 for each intervention 
session they attend, as well as $20 for each assessment visit attended. The maximum compensation 
that a dyad can receive in this study is $220.
15) Medical care and compensation for injury 
In the event of injury we will arrange for emergency care, and at the nearby Banner UMC if 
necessary. A participant and/or their insurance company will be billed for the cost of this care.  We 
have not set aside any funds to compensate participants for illness or injury.  The exception would be
if it is proven that the illness or injury in a participant was a direct result of negligence (not fulfilling a 
standard duty) on the part of a University of Arizona employee.
16) Monitoring for subject safety 
It is possible that some of the participants may develop psychiatric and/or medical problems from 
screening to enrollment to after study end (up to 3 months later). Also, although not expected, it is 
possible that blood draws may result in adverse events for some participants.  For these reasons we 
have elected to use the Data Safety Monitoring Board (DSMB) at the University of Arizona College of 
Nursing for this study. The purpose of the UACoN DSMB is to provide UA researchers easier access to
and utilization of a data and safety monitoring board for investigator-initiated human research 
studies for which there is not a DSMB already appointed. This DSMB will provide independent 
oversight to further promote the protection of human subjects and the overall integrity of the study. 
The DSMB will meet once every six months. This protocol will be submitted to the DSMB 
simultaneously with this initial submission to the University of Arizona IRB. The DSMB will review the
research protocol and plans for data and safety monitoring. Once every 6 months the DSMB will 
review a report from the study’s data manager (Dr. Szalacha) that includes: the number of 
participants who signed consent for the study, the number of dropouts, reasons for these dropouts, 
and any safety concerns, adverse events, an up-to-date consent form, and measures taken to protect
confidentiality (e.g., data storage, use of coded ID numbers, etc.). The DSMB will also review the 
Principal Investigator’s summary of any new data or evidence that might alter the risk/benefit ratio 
for participating in the study (e.g., newly published studies, 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. There will be regular, ongoing communication 
between the PI, the University of Arizona IRB, and the DSMB. The PI will take responsibility for 
reporting any serious and unexpected adverse events or other unanticipated study problems to the 
University of Arizona IRB within 24 hours, and the sponsor according to standard regulations. A copy 

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of this correspondence will be sent to the DSMB. Actions taken by the IRB or the study sponsor in 
response to adverse event reports will be immediately reported to the DSMB.
17) Withdrawal of subjects
Subjects may withdraw whenever they wish, and they may be removed from the study at the 
discretion of the Principle Investigator if they are found to not meet inclusion/ exclusion criteria, or if
they experience excessive medical or psychological distress. The PI will be available in the event that 
withdrawal is necessary, and will refer subjects to appropriate care resources including nearby 
medical facilities. We will continue to follow-up with subjects if withdrawal is necessary to make sure
they have received appropriate care.
18) Sharing of results with subjects 
If requested by subjects, we will share their study information with them, as well as overall study 
findings/ manuscripts/ publications that contain aggregate information but no identifiable 
information from other study subjects.
19) Future use and long-term storage of data or specimens
Data will not be kept beyond the study period, including blood samples that will be collected. 
20) Information management 
Not applicable.
21) Clinical Trials.gov Information
ClinicalTrials.gov "NCT" number for this trial (provide): NCT03459781
Registration pending
Clinical trial does not require registration (explain):
22) Gases
Not applicable
SECTION 4: LIST OF ATTACHMENTS FOR THIS SUBMISSION (REQUIRED) (Items listed here are
expected to be attached as separate documents. These documents will appear in the UA HSPP IRB
approval letter as 'documents submitted concurrently' with the review.)
Document Name
Version Date
See HSPP website for submission requirements.

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Items needed for approval:

Word Versions of Application, Consents, Recruitment and Data Collection 

F107: Verification of Training Form

Current PI/Co-PI CVs or biosketch, if not included with copy of grant application

Informed Consent/Permission/Assent Form(s) – including study specific release of information documents, DHHS 
approved sample consent forms.  If consent will not be documented in writing, a script of information to be provided
orally to subjects
Other Items as applicable:

Appendix A - Children

Appendix B - Drug/Device

Appendix C- Multi Site Research

Appendix D- Pregnant Women and Neonates

Appendix E- Prisoners

Appendix F- Waiver of Consent/ PHI

Appendix G- Exception from Informed Consent (EFIC)

Appendix H- Native American

Biosafety Review letter (for UA - Institutional Biosafety Committee)

Certificate of Confidentiality

Compressed Gases Review letter (for UA – Research Instrumentation)

Contract – complete or draft copy of contract including budget

Data Collection Tools – surveys, questionnaires, diaries not included in the protocol, data abstraction form for 
records review

Data Monitoring Charter and Plan 

Drug/Device information – Investigator's Brochure, drug product sheet, device manual, user's manual, instructions 
for use, package insert, IND/IDE documentation, FDA 1572 form, 510k indication, FDA exemption, sponsor 
determination of device risk, etc.

Export Control Review

Grant Application(s) – cover-to-cover copy of grant, regardless of home institution or funding agency, and a copy of 
the Notice of Grant Award.  

Multi-site information (for sites engaged in research where the UA is the IRB of record) 
o
Copy of any approvals granted from that site (including determinations if this site has an IRB of its own)
o
Site-specific F107
o
Copy of the site's human subjects training policy
o
CV and medical license (if applicable) of site PI

Other Approval letters (e.g., school districts, Tribal, other IRB approvals)

Participant Materials – written materials to be provided to or meant to be seen or heard by subjects (e.g. study 
newsletter, physician to participant letter, wallet cards, incentive items, holiday/birthday cards, certificates, 
instructional videos/written guides, calendars, certification of achievement, etc.)

Payer coverage analysis

PHI Authorization Form(s)

Protocol – including all amendments/revisions, sub- or extension-studies

Radiation Safety Review letter- needed regardless if the radiation device is approved and used standard of care

Recruitment Materials – telephone scripts, flyers, brochures, websites, email texts, radio/television spots, 
newspaper advertisements, press releases, etc.

Scientific Review Committee letter (for cancer related projects – AZCC SRC; other units as applicable if the unit has a
scientific review committee)

Site Authorizations for research purposes and/or access to administrative records/samples
o
External sites (such as schools, other hospitals or campuses, etc.)
o
UAHS Research Portal feasibility review approval

Travel Authorization documentation (for UA – Office of Global Initiatives)

Use of retrospective research samples and/or data – IRB approval letter, original consent under which 
samples/data were collected, letter allowing access to samples