Promoting Resilience in Women With Breast Cancer
Phase: NA
Conditions: Breast Cancer
Sponsor: University of Alabama at Birmingham

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Promoting Resilience in Women With Breast Cancer 
University of Alabama at Birmingham 
IRB #300011028 
NCT #06133348 
PI: Gabrielle Rocque, MD, MSPH 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Study/Protocol Title: Promoting Resilience in Women with Breast Cancer 
 
Table of Contents: 
1. Background and Significance……………………………………………………………….3 
2. Objective……………………...……………………………………………………………….3 
3. Approach……………………...……………………………………………………………….3 
4. Data and Safety Monitoring…………………………………………………………………10 
5. Benefits…………………………………………………………..……………………………10 
6. Risks…………………………………………………………..………………………………10 
7. Confidentiality…………………………………………………………...……………………11 
 
Principal Investigator: 
Gabrielle Rocque, MD, MSPH 
UAB Medicine, Division of Hematology & Oncology 
849 Boshell Building 
1080 7th Ave South 
Birmingham, AL 35294-3300 
Phone: (205) 996-9281 
Fax: (205) 934-7760 
 
UAB Investigators:  
Courtney Williams, DrPH (Statistical Lead) 
Andres Azuero, PhD (Statistician) 
Lily Gutnik, MD 
Ritu Aneja, PhD 
 
UAB Staff: 
Stacey Ingram, MEd 
Noon Eltoum, MBBS, MPH 
Keynosis Hildreth, MPH 

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Etzael Ortiz, BS 
D’Ambra Dent, MBA  
Nicole E. Caston, MPH 
 
 

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1. Background and Significance 
Patients with breast cancer often deal with persistent psychological distress. Fear of recurrence 
is associated with difficulties in performing daily and social activities, higher depression and 
anxiety, and lower quality of life.1,2 These fears are not always unfounded. For example, among 
women with a substantial amount of residual disease after neoadjuvant chemotherapy, 40% will 
have recurrence of breast cancer by five years.3 Fear of recurrence is more common in women 
with cancer who are younger, have children, and/or have fewer social supports.4 Additionally, 
fear of recurrence is intensified among Black mothers with breast cancer compared to White 
mothers with breast cancer.5 Furthermore, Black women are known to have a higher allostatic 
load (i.e., biological marker of stress),6 which is associated, not only with higher likelihoods of 
breast cancer recurrence, but with overall worse quality of life during and after cancer-therapy.7,8 
Recent findings suggest that positive psychosocial experiences, including psychotherapeutic 
interventions and therapeutic mind-body protocols can modulate the inflammatory response by 
reducing the expression of genes/proteins associated with inflammation and stress-related 
pathways.9  Interventions are urgently needed to support women at risk for recurent fear and 
distress, particularly marginalized populations who are vulnerable to experiencing disparate 
outcomes (e.g., progression, disability, death).  
The PRISM (Promoting Resilience in Stress Management) intervention is an evidence-based 
program that builds resilience. This program was developed in adolescent and young adult 
oncology, and utilizes centrally-administered skills-based coaching to bolster positive 
psychological tools known as resilience resources. These resources include stress 
management, goal-setting, and positive reframing. Previous studies using this intervention have 
found PRISM to be successfully administered remotely and it has improved resilience, 
psychological distress, hope, and quality of life.10 Among adult caregivers, PRISM has shown to 
improve resilience, self-efficacy, and engagement with medical care.11 While PRISM 
successfully targets distress and associated downstream consequences known to be 
experienced by breast cancer survivors, it has not been utilized in adults with cancer or in 
marginalized communities. Adapting this intervention to this context will require the testing of the 
intervention and, importantly, tailoring to meet the needs of women with breast cancer, 
particularly those of marginalized populations who may uniquely benefit from this intervention. 
 
2. Objective 
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the 
PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on 
elements for future adaptation or expansion to meet the unique needs of women with breast 
cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress 
for patients with breast cancer receiving the PRISM intervention.  
3. Hypothesis:  
We hypothesize that PRISM will be feasible, acceptable, and appropriate for individuals with 
breast cancer.  
 
4. Approach 
3.1 Study eligibility criteria, screening procedures, recruitment: There will be two cohorts in 
this study. Cohort 1 will include women undergoing chemotherapy for early-stage breast 
cancer. Cohort 2 will include women undergoing treatment for metastatic breast cancer. 
Patients who do not speak English will be excluded. The study team will identify 30 women 
with early-stage disease (Cohort 1) and 10 women (Cohort 2) with metastatic disease to 

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participate through the review of daily clinic lists, coupled with discussions with clinical 
teams. We anticiapte minimal drop-out since patients will still be in an active phase of 
cancer treatment in the initial year after diagnosis. However, if patients drop out of the 
study, they will be replaced to achieve a total number of patients for each cohort. Across 
the entire study, we will sample such that we include at least 20 women who are Black or 
African American, ten women living in areas of higher disadvantage (defined using Area 
Deprivation Index), and five women with dependent children. Given the intersectionality of 
these characteristics, patients may represent more than one target population. Women 
will be approached in clinic by a study coordinator who will explain the study and obtain 
informed consent.  
 
3.2 Study Procedures-Patient and Clinic Characteristics: A REDCAP database will be used to 
track patients approached, enrolled, and completing each portion of the study (blood/nail 
collection, patient reported outcomes (PROs), and intervention components). For patients 
enrolling in the study, a unique study ID will be created for each patients. The following 
patient and clinical characteristics of participants who enroll will be abstracted from the 
medical record: age at diagnosis, sex, race and ethnicity, insurance status, address, 
breast 
cancer 
stage, 
treatments 
received, 
BMI, 
blood 
pressure, 
prior 
diabetes/hypertension/cholesterol treatment. At the time of enrollment, a waist 
circumference will be captured using a tape measure (documented in cm).  
 
Table 1.  Promoting Resilience in Stress Management (PRISM) intervention content 
Session Focus* 
Details 
Format 
Stress and Coping 
Theory Constructs 
1. Getting to Know 
You 
Provide information about the 
logistics of the 
PRISM program, explain it in 
detail, and answer any questions 
the participant may have. 
1:1 (video) 
 
 
2. Stress 
Management 
Relaxation strategies (i.e., deep 
breathing), Mindfulness 
techniques 
1:1 (video) 
Situational factors 
 
3. Catching Your 
Thought 
Recognizing and reframing 
negative thoughts 
1:1 (video) 
Coping processes 
 
 
4. Goal Setting 
Setting SMART goals, planning 
for roadblocks 
1:1 (video) 
Situational factors 
 
5. Finding the 
Positives 
Identifying gratitude or meaning 
from illness experience 
1:1 (video) 
Coping processes 
 
 
6. Coming 
Together  
Discussion about what was 
learned, what worked, how loved 
ones can help (optional) 
Family 
meeting 
(video) 
Situational factors 
and Coping 
processes 
Advance Care 
Planning 
Discussion of advance care 
planning (optional) 
 
Skill Practice  
Between-session exercises to 
practice, further develop and track 
skills 
Digital app  
*Sessions 1-6 are delivered every 1-2 weeks.   

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3.3 Intervention: PRISM is a manualized, brief, skills-based intervention targeting four 
resilience resources (stress-management, goal-setting, cognitive-reframing, meaning-
making) consistently associated with improved psychosocial outcomes (Table 1).10-12 Its 
content has been validated with proof-of-concept and pilot studies in diverse populations, 
including Adolescents and Young Adults (AYAs) with cancer, diabetes, or cystic fibrosis; 
parents of children with cancer or diabetes; interdisciplinary health-care professionals 
during the COVID-19 pandemic; adults with congenital heart disease; and caregivers of 
adult patients from marginalized background who experience racism.79 The program has 
proven efficacy in randomized trials among these populations.11,12 The content is 
understandable and applicable across multiple stressful situations, thus creating the 
potential for broad, ground-breaking impact. Content will all be provided by video.  
 
Specifically, PRISM is delivered by trained intervention staff (called “coaches” within the 
PRISM program).  Each coach receives >8 hours of standardized training, including role-
playing and trouble-shooting, to demonstrate competency and mastery of the program 
script. Each PRISM session is audio-recorded to monitor for script-fidelity; the senior 
coach training reviews and scores each recording for fidelity using a standardized tool.  In 
cases where coaches do not receive a score of 80% or higher, they receive additional 
training and supervision. In the history of the PRISM program’s experience and >500 
program deliveries, to date, no such remediation has yet been necessary.   
Intervention sessions are described in detail in the attached Appendix A (PRISM manual).  
They are scheduled approximately weekly to every-other-week, depending on participant 
preference to optimize feasibility and completion.  Briefly, for each session, coaches (i) 
ensure a private video conference to enable participation and conversation; (ii) review 
session content and format; (iii) teach and practice a particular resilience skill; and (iv) 
plan opportunities to practice the skill. Session 1, Stress-Management, involves mini-skills 
such as deep breathing, guided imagery, and mindfulness.  Session 2, Goal-Setting, 
involves deconstructing and reconstructing goals to make them “SMART” (Specific, 
Measurable, Actionable, Realistic, and Time-Dependent). The session also includes 
exercises to plan for challenges and alternative strategies.Session 3, Cognitive 
Restructuring, involves recognizing negative self-talk and reframing impressions of 
negative experiences to make them feel more manageable.  Session 4, Meaning-Making, 
involves exercises to find gratitude and purpose in the context of adversities like cancer.  
Session 5 (optional), Coming Together, is optional and involves the participant and their 
loved ones discussing the program and lessons-learned. Session 6 (optional) involved 
advance care planning to discuss future goals related to medical care.  
Throughout the program, participants will have access to the award-winning PRISM 
smartphone app. This program provides practice opportunities for all of the skills, plus an 
embedded journal to catalogue goals, lessons-learned, and gratitudes; a library of related, 
evidence-based resources; tracking tools to monitor one’s own stress and resilience.   
The total PRISM intervention lasts 6-8 weeks, and the app is available thereafter, 
indefinitely. 
3.4 Study Procedures-Surveys: Following enrollment, the participants will be asked to 
complete baseline surveys at the time of consent. The research coordinator will register 
the patient, providing the study ID, patient phone number, and email address for survey 
completion to the PRO Core team at the University of North Carolina. Surveys will be 

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completed electronically, when possible, but paper and telephone-based options will be 
available for patients not able to complete electronically. Baseline surveys should be 
completed within 90 days of completion of definitive therapy (chemotherapy, radiation, or 
surgery) for Cohort 1 (early stage) and at any time post metastatic diagnosis for Cohort 2 
(metastatic). We will allow people to enroll during ongoing maintenance therapy with 
non-cytotoxic therapies including endocrine therapy, targeted therapy (e.g. Her2-
targeted therapy) or immunotherapy. Patients will be asked to complete a follow-up 
survey after completion of the PRISM intervention, with a goal completion of within 60 
days. We will make up to 5 attempts to reach patients if they do not complete their 
survey. The survey includes 114 questions at baseline and 106 questions at follow-up on 
feasibility, acceptability, appropriateness, recent stressors, fear of recurrence, anxiety, 
depression, social determinants of health, spirituality, resilience, posttraumatic growth, 
patient activation, and quality of life (Table 2). The survey is expected to take 
approximately 30-40 minutes to complete.  
Survey responses will be captured using a database hosted by the University of North 
Carolina PRO Core. The staff at PRO Core will contact participants once prior to each 
survey due-date, and up to 4 times thereafter for missed surveys. PRO Core will oversee 
data monitoring and quality. PRO Core adheres to best practices for data security and 
privacy. PRO Core is accessed through a web interface using a secure, authenticated 
login. Data are stored in a secure enterprise-level Oracle database; the databases and 
web servers are hosted by the UNC Center for Bioinformatics. Data transmitted between 
the server and end-users are encrypted using SSL, and all databases are encrypted. 
PRO Core will story patient data in a secure database identified by a coded study ID. 
Upon study conclusion, the de-identified dataset will be transferred to UAB via secure 
transfer and stored in a password protected file for analysis.  
3.5 Study Procedures- Biological Specimens (Cohort 1 Early Stage Breast Cancer Patients 
Only):  
Blood samples:  
Blood samples will be collected at baseline and approximately 6 months after surgery 
(post PRISM intervention, aligned with standard of care appointment where possible).  
 
A trained phlebotomist will draw 25 mL of blood per draw (5 teaspoons) via standard 
venipuncture performed at pre and post assessments. A maximum of five 5 mL vials will 
be drawn from each participant per phlebotomy session. Samples will be labeled with a 
study ID and date of collection. Serum preparation analyses will  use collection tubes with 
clot activators (ie.- red top tubes). Blood will be centrifuged at 4°C for approximately 10 
minutes and sera will be aliquoted. Samples will be designated with study participant label 
only for specified analyses and stored in -80C until assays are performed.  
 
When ready for analysis, serum samples will be delivered by the research coordinator to 
the Bio-Analytical Redox Biology (BARB) Core at UAB for mDAMPs analysis and to the 
NORC metabolic core at UAB for the blood based biomarkers in allostatic load analysis 
respectively. In addition, blood samples will be mailed to Eve technologies for analysis of 
inflammatory cytokines. .  
 
Patients will also be asked if they are willing to have blood stored for future biomarker and 
omics evaluation. Additional sample preparation may be done on those blood samples, in 

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order to cryopreserve blood in appropriate forms for epigenetics, proteomics & 
transcriptomics evaluation. If patient declines, remaining biospecimens will be discarded.  
 
Serum analyses:  
1. Serum analyses for mtDNA DAMPs an nail cortisol will be performed at the Bio-
Analytical Redox Biology (BARB) Core, UAB.  
2. Serum analysis for allostatic load will be conducted at NORC metabolic core, UAB. 
These samples will be tested for serum cortisol, CRP, homocysteine, creatinine, 
albumin, lipid panel, and Hgb A1C. 
3. Serum analysis of inflammatory markers IL-6 and TNF-alpha will be performed by the 
NORC metabolic core.  
 
Nail sample collection and analysis: Cortisol measurements will also be derived from nail 
samples. Nail samples will be provided by participants using fingernail trimming clippers. 
They will be sent to the Bio-Analytical Redox Biology (BARB) Core at UAB for further 
analysis. Fingernails and toenails will be cut and stored independently until processed 
using the procedure previously described. Briefly, nail samples will be washed twice with 
2 mL isopropanol and dried overnight. The dried nail samples will be added to a pre 
weighed tube containing three 5 mm steel grinding balls (Retsch) and ground using a 
TissueLyser II (Qiagen Venlo, Netherlands) at 30 Hz for 9 min. 1 mL of methanol will be 
added per 50 mg of powdered nail (w/v) and placed on a rotator for 18 h at room 
temperature to extract the cortisol. Samples were then centrifuged at 10,000 x g for 5 min. 
800 μL of supernatant was transferred to a clean tube and evaporated under 
nitrogen gas in a certified fume hood. The evaporated sample will be resuspended in 400 
μL of phosphate buffered saline per 50 mg of ground sample (w/v). Cortisol will be assayed 
using 25 μL of sample according to manufacturer’s protocol (Salimetrics, Salivary Cortisol 
Enzyme Immunoassay Kit, 1-3002, State College, PA). 
 
3.5 Study Procedures- Intervention (Both Cohorts): Following baseline survey and 
biospecimen collection, participants will schedule their PRISM sessions with study staff, 
who will also connect them with their coach. Staff and coaches will verify best contact 
methods and confirm timelines with participants. Coaches will provide a calendar of 
sessions as appointments.  Staff and/or coaches will provide session reminders via phone, 
email, and/or text, based on participant preference, one day and 15-minutes prior to each 
session.    
 
3.6 Study Procedures- Post-intervention Interview (Both Cohorts) Upon completion of the 
whole intervention, participants will participate in a 30 minute to 1-hour semi-structured 
interview (Appendix B) to elicit perspectives on psychological state, intervention feasibility 
and acceptability, and areas for expansion of the intervention to better meet the needs of 
women with breast cancer, all the while with a focus on equity. A semi-structured interview 
will be conducted by a trained qualitative interviewer either in person or virtually using 
Zoom or by phone based on patient choice. Interviews will be audio recorded, transcribed 
verbatim, and stored in a secure, password-protected folder. Participants who do not 
complete the intervention or complete surveys will also be asked to participate in 
interviews to explore barriers to completion and opportunities for improvement. 
 

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*Only administered to patients with early stage breast cancer 
3.7 Compensation: Participants who complete biomarker and survey portions of the study will 
receive a $50 gift card upon completion. Patients who complete the interview will receive 
an additional $50 upon completion ($100 total for Cohort 1, $50 for Cohort 2). 
 
3.8 Quantitative Analysis: Cohorts will be analyzed both separately and together. The primary 
outcome is feasibility, which will be defined as 70% of women completing all intervention 
components and 70% of survey time points (baseline, post-surgery, post intervention) 
 
 
Table 2. Primary and secondary outcomes.  
Domain 
Instrument or 
Source 
Baseline 
Follow-up 
Number 
of items 
Expected 
length of time 
to complete 
Demographics 
Study-specific 
quesionairre 
X 
 
9 
2 minutes 
Social 
determinents of 
health 
CMS Health 
Related Social 
Needs 
X 
 
11 
2-3 minutes 
Spirituality 
FACIT-SP 
X 
X 
12 
2-3 minutes 
Fear of cancer 
recurrence* 
Fear of Cancer 
Recurrence 
Inventory Short 
Form (FCRI- 
SF)13 
X 
X 
12 
2-3 minutes 
Depression 
Patient Health 
Questionnaire 
depression 
scale14 
X 
X 
8 
2 minutes 
Anxiety 
General Anxiety 
Disorder-715 
X 
X 
7 
2 minutes 
Resilience 
Connor 
Davidson 
Resilience 
Scale -10 16 
X 
X 
10 
2-3 minutes 
Post-traumatic 
growth 
Post-Trumatic 
Growth 
Inventory17 
X 
X 
21 
3-4 minutes 
Patient activation 
Patient 
Activation 
Measure (PAM) 
18 
X 
X 
13 
2-3 minutes 
Quality of life 
PROMIS Global 
Short Form19 
X 
X 
10 
2-3 minutes 
Life stressor 
question 
Study Specific 
Survey 
X 
X 
1 
30 seconds 
Acceptability  
Acceptability of 
Intervention 
Measure (AIM) 
20  
 
X 
4 
1-2 minutes 
Appropriateness  
Intervention 
Appropriateness 
Measure (IAM) 
20  
 
X 
4 
1-2 minutes 
Feasibility  
Feasibility of 
Intervention 
Measure (FIM)20  
 
X 
4 
1-2 minutes 

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being completed. Secondary endpoints will include implementation outcome measures by 
Weiner, which will evaluate the acceptability, appropriateness, and feasibility (survey-
based) of interventions.20 Acceptability of Intervention Measure (AIM), Intervention 
Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) are 
implementation measures with four-items each, and a response scale ranging from 1 to 5 
(1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = 
Completely agree).20 Scores for each measure are calculated by averaging responses.20 
An average of 4 or greater on each measure (AIM, IAM, FIM) will be considered 
acceptable, appropriate, and/or feasible.  
 
We will also capture the following measures for future comparative efficacy trial:  
- 
Fear of recurrence will be measured using the Fear of Cancer Recurrence Inventory 
Short Term (FCRI_SF) which is scored from 0 to 4 (0 = Not at all, 1 = A little, 2 = 
Somewhat, 3 = A lot, 4 = A great deal)13.  
- 
Patient depression will be measured using the Patient Health Questionnaire 
depression scale14, which is a 2 questions screener with 6 addional questions for an 8 
question scale with a cut-point of greater than or equal to 10 being defined as current 
depression.  
- 
Patient anxiety will be measured using the General Anxiety Disorder-7 scale,15 which 
is a 7 item scale with scores of 0-4 signifying minimal anxiety, 5-9 mild anxiety, 10-14 
moderate anxiety, and greater than 15 severe anxiety.   
- 
Resilience using the Connor-Davidson Resilience scale which has 10 items each 
carry a 5 point range (0 = Not true at all, 1 = Rarely true, 2 = Sometimes true, 3  = 
Often true, and 4 = True nearly all of the time; total scores range from 0-40, and higher 
score indicate higher resilience)16 
- 
Post-traumatic growth will be measured using the Post-Traumatic Growth Inventory 
(PTGI), which is a 21 item questionnaire with each item scored from 0-5 with 5 being 
greater degree of change.17 
- 
Social determinants of health will be measured using the CMS Health Related Social 
Needs, which is a 11 question survey. 
- 
Spirituality will be measured using the FACIT-SP is 12 question instrument.  
- 
Patient activation using the Patient Activation Measure scores of which range from 0 
to 100 with four corresponding levels [level 1 (0.0 - 47.0), level 2 (47.1 – 55.1), level 3 
(55.2 – 72.4), and level 4 (72.5 – 100) which indicates the highest level of activation]18; 
- 
Quality of life using the PROMIS Global Scale which is a 10-item measure that is 
scored from 1 to 5 (1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, 5 = Always).19 
(Table 2)  
- 
Recent life stressors: We will use a single open-ended questions asking “Have you 
had any additional life stressors in the last 3 months (in addition to your breast cancer 
diagnosis and treatment)?” 
Descriptive survey statistics will be calculated using frequencies and percentages for 
categorical variables and medians and interquartile ranges for continuous variables. Data 
will be analyzed in aggregate, by race, by residence in high vs. low resource census 
blocks, and by presence of dependent children in the home. Pre-post changes in survey 
scores will be examined using mixed models repeated measures analysis with two points 
of data capture: surveys capturing data at baseline (T1) and after PRISM intervention (T2). 
Linear contrasts will be used to estimate average change in survey scores between 
timepoints and compute 95% confidence intervals. The modeling approach uses all 
available data. Patterns of missing data will be examined and if necessary, models will be 

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adjusted with covariates associated with missingness. Normality of residuals will be 
examined, and if found to be non-normal, generalized linear modeling will be used. 
No formal power calculation is needed for this pilot study as feasibility is defined by patient 
participation and completion of surveys. Following NIH guidelines, no formal testing will 
be conducted. Uncertainty of pre-post change estimates will be measured with 95% 
confidence intervals. Assuming 70% completion in the full sample (N=40), a standardized 
outcome, and intra-subject correlation values 0.5, 0.6, and 0.7, the upperbound half-widths 
of 95% confidence intervals for pre-post change are 0.38, 0.35, and 0.30, respectively. 
These provide reasonable ranges for potential values of change that can be expected in 
a future project (computations in PASS 23 software).  
3.9 Biomarker evaluation: Data from biomarkers and ePROs will be merged with demographic 
data data using a study ID and date of collection. We will assess the relationship between 
biomarker outcomes and patient-reported outcomes. We will assess for correlational 
trends that would support evaluation in a larger cohort. We will examine distribution and 
ranges of biomarker data and determine whether variance stabilizing transformations are 
needed such as a natural logarithm, prior to analysis. As described above, we will employ 
a similar quantitative approach to compare pre/post intervention differences in assessed 
levels of cortisol, allostatic load, DAMPs and inflammatory response biomarkers 
(cytokines).  
 
3.10 Data linkage: Both ePRO data and the data from biospecimens will be labeled using a 
Study ID. A separate tracking log will be kept with Study ID and MRN at UAB. This tracking 
log will be used to link datasets for analytic purposes.  
 
3.11 Qualitative Analysis: The analytic strategy is informed by content analysis, which 
classifies text into categories that represent key concepts.21 In the initial stages of coding, 
two independent coders will read the transcripts and develop an open coding scheme.22 
This initial coding scheme will consider the complexities of the lived experience of women 
with breast cancer, with particular emphasis on the wide range of factors that contribute 
to their experience of recurrence and generalized stress in their daily lives. The intention 
here is to construct a grounded, emic measure of vulnerability that can be directly 
compared to outcome variables within the study and accurately identifies areas within the 
PRISM intervention that require adjustment for this population. Analytic codes 
constructed in the context of open coding are provisional and will be grounded within the 
data.23 The final version of the coding schema will be reviewed and finalized by the 
multidisciplinary team, which will include the interviewer, two primary coders, and the 
study PI, all having experience in oncology, anthropology, and/or implementation 
science. The two primary coders will subsequently use Dedoose to conduct “focused 
coding,” which includes a detailed analysis of themes identified during open coding. 
Discrepancies will be resolved by a third coder. The process will be repeated until 
thematic saturation is reached, where no new categories or relevant themes emerge.24 
Data will be analyzed in aggregate, by race, by residence in low resource areas, and by 
presence of dependent children in the home. During coding, we will consult regularly with 
the research team for multiple perspectives and discrepancy resolution through 
consensus. The coders will also code 20% of the transcripts to evaluate interrater 
reliability using a kappa statistic. If the kappa statistic is <0.7, the coders will discuss 
discrepancies, refine the code book, and complete another 20% of transcripts until the 

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kappa reaches 0.7.25 Summaries will be reviewed with the research team and key 
partners for the future R01 to plan for next steps in the research. 
 
3.12 Sample size considerations: Using a sample of 30 patients for breast cancer (10 MBC, 
30 EBC) will provide initial data on feasibility, while larger studies will be needed for 
formally testing outcomes. Sampling for qualitative inquiries is sequential and targeted to 
individuals who can provide insights on the processes under study. Typically, qualitative 
approaches require <30 participants to reach thematic saturation. If thematic saturation 
is not reached, we will engage additional participants in the intervention and continue 
interviews until thematic saturation is reached. 
 
3.13 Mixed methods analysis: We will validate our findings using both quantitative and 
qualitative methodologies that will be analyzed independently through side-by-side 
comparisons and thoroughly integrated using grounded measures derived from the 
interviews themselves. This mixed methodology will ensure that study findings are 
grounded in the appropriate context and will provide a comprehensive view of both study 
feasibility and necessary adaptations prior to conducting a future comparative efficacy 
trial. 
 
4 Dissemination: We will utilize the descriptive data from the biomarker and patient-reported 
outcomes evaluation in combination with existing literature to generate a lecture for patients 
and physicians on stress in breast cancer.  
 
5. Data and Safety Monitoring 
Access to patient data will be limited to the medical care teams and relevant study staff. 
Data will be de-identified when possible and encrypted to enhance security. Data files sent 
between members of the research team will be de-identified. When unique patient identifiers 
(unrelated to any patient characteristics) are required to track patient-level outcomes, the 
files will be sent via secure transfer and stored on secure encrypted network drives. All 
qualitative data from participant interviews will be de-identified and securely stored on 
password-protected, encrypted network drives. 
 
Multiple measures will be taken to ensure that the use of structured electronic medical 
record (EMR) data and manually abstracted EMR data involves the highest security 
precautions so that risks to individuals are limited. The data storage facility is located in a 
building with 24-hour security. The computers and data files are only accessible via a private 
gigabit-speed local area network to which only research team and clinical staff are 
connected. No routine traffic (e-mail, web, or other non-study services) travels on this 
network. All data are transmitted to investigators’ workstations in an encrypted state. Only 
members of the research team and clinical staff will have access to identifiable data. All 
research team members will be trained in data security. All quantitative analyses reported 
from this study will contain only aggregate data. The qualitative data (e.g. quotes) from 
individual participants will be anonymously reported. The quality of the data will be 
monitored on a regular basis by members of the research team under the supervision of the 
Principal Investigator (Rocque) and statistician. 
 
6. Benefits 
Study participants may benefit from the intervention by improving resilience and 
psychological distress not only as it relates to their fear of cancer recurrence but skills 
learned in this intervention can be applied to multiple areas of their lives. Our findings could 

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benefit future patients with cancer by equipping patients with the knowledge and skills to 
improve stress management, resilience, and engagement with health care team. 
7. Risks 
Participants will not receive any pharmacologic treatment as part of this study, minimizing 
physical risks. This project will make use of health and other personal information about the 
study participants. The primary risk to the participants will be loss of confidentiality leading to 
potential psychological, financial, or legal consequences. However, using the data access 
and protection plan described above, we believe that the likelihood of confidentiality breach 
is very low.  An additional risk that some PRISM sessions explore stressors, in turn 
prompting additional awareness of stress and corresponding distress. All coaches are 
trained in distress-recognition and suicide prevention; in >500 PRISM deliveries, there has 
been a single participant who endorsed significant distress prompting immediate coach 
intervention and referral (see Appendix Manual for procedures). In any case where coaches 
are concerned about participant distress, they will immediately contact the PI and the on-call 
social worker. In our experience, stress and distress during the sessions is short-lived and 
self-limited. Finally, there may be risk of discomfort from blood draws, although these will be 
completed in conjuction where possible with routine lab evalautions to prevent the need for 
additional venupuncture.  
 
8. Confidentiality 
Patients included in this study will be adult women receiving cancer care at UAB. The major 
risk for the study will be the risk of breach of data confidentiality. This will be minimized as 
described above in the data and safety monitoring section. 
 
9. Clinical Trial Registration:   
• 
Following initial IRB approval, this trial will be registered on ClinicalTrials.gov.  All protocol 
revisions and estimated timelines will be reported within the system immediately following 
Institutional Review Board (IRB) approval.   
• 
Results information will be submitted to ClinicalTrials.gov as outlined in the website’s 
policy and according to the specific timelines stated therein. 
• 
Informed consent documents for the clinical trial(s) will include a specific statement 
relating to posting of clinical trial information at ClinicalTrials.gov.   
 
 

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14
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