Adaptation and Implementation of an Evidence-Based Patient Navigation Intervention for Adolescent and Young Adult Cancer Survivors
Phase: NA
Conditions: Breast Cancer, Ovarian Cancer, Cervical Cancer, Testicular Cancer, Colon Rectal Cancer, Melanoma (Skin Cancer), Endometrial Cancer, Sarcoma, Thyroid Cancer
Sponsor: Kaiser Permanente

NIH Protocol Template for Behavioral and Social Sciences Research Involving Humans 
Navigation Intervention for Adolescent and Young Adult 
Cancer Survivors * 
 Protocol Number*: UG3CA297705 
National Clinical Trial (NCT) Identified Number:  <Number, once assigned by 
CT.gov> 
Principal Investigator*: Erin E. Hahn, PhD, MPH 
Sponsor: Kaiser Permanente Southern California, Department of Research and 
Evaluation 
Grant Title: Adaptation and Implementation of an Evidence-Based Patient 
Navigation Intervention for Adolescent and Young Adult Cancer Survivors 
Grant Number*: 1UG3CA297705-01A1 
Funded by: National Cancer Institute (NCI) 
Version Number:  v.1.0 
27 January 2026 
 
 

NIH Protocol Template for Behavioral and Social Sciences Research Involving Humans 
Summary of Changes from Previous Version: 
 
 
 
 
CONFIDENTIALITY STATEMENT 
This document is confidential communication. Acceptance of this document constitutes agreement by the 
recipient that no unpublished information contained herein will be published or disclosed without prior 
approval of the Principal Investigator or other participating study leadership and as consistent with the 
NIH terms of award.  
 
Affected Section(s) 
Summary of Revisions Made 
Rationale 
Not applicable; this is the first 
version of the protocol 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table of Contents 
STATEMENT OF COMPLIANCE ............................................................................................................................. 1 
INVESTIGATOR’S SIGNATURE .............................................................................................................................. 1 
1 
PROTOCOL SUMMARY ............................................................................................................................... 2 
1.1 
Synopsis ................................................................................................................................................ 2 
1.2 
Schema ................................................................................................................................................. 5 
1.3 
Schedule of Activities .......................................................................................................................... 6 
2 
INTRODUCTION ............................................................................................................................................ 6 
2.1 
Study Rationale .................................................................................................................................... 6 
2.2 
Background........................................................................................................................................... 7 
2.3 
Risk/Benefit Assessment .................................................................................................................... 9 
2.3.1 
Known Potential Risks ..................................................................................................... 9 
2.3.2 
Known Potential Benefits .............................................................................................. 10 
2.3.3 
Assessment of Potential Risks and Benefits .............................................................. 10 
3 
OBJECTIVES AND ENDPOINTS .............................................................................................................. 10 
4 
STUDY DESIGN ........................................................................................................................................... 13 
4.1 
Overall Design .................................................................................................................................... 13 
4.2 
Scientific Rationale for Study Design.............................................................................................. 14 
4.3 
Justification for Intervention ............................................................................................................. 15 
4.4 
End-of-Study Definition ..................................................................................................................... 15 
5 
STUDY POPULATION ................................................................................................................................ 15 
5.1 
Inclusion Criteria ................................................................................................................................ 16 
5.2 
Exclusion Criteria ............................................................................................................................... 16 
5.3 
Lifestyle Considerations .................................................................................................................... 16 
5.4 
Screen Failures .................................................................................................................................. 17 
5.5 
Strategies for Recruitment and Retention ...................................................................................... 17 
6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ............................................ 18 
6.1 
Study Intervention(s) or Experimental Manipulation(s) Administration ...................................... 18 
6.1.1 
Study Intervention or Experimental Manipulation Description ................................. 18 
6.1.2 
Administration and/or Dosing ....................................................................................... 18 
6.2 
Fidelity ................................................................................................................................................. 19 
6.2.1 
Interventionist Training and Tracking .......................................................................... 19 
6.3 
Measures to Minimize Bias: Randomization and Blinding ........................................................... 20 
6.4 
Study Intervention/Experimental Manipulation Adherence.......................................................... 20 
6.5 
Concomitant Therapy ........................................................................................................................ 20 
6.5.1 
Rescue Therapy ............................................................................................................. 20 
7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL ......................................................................................... 20 
7.1 
Discontinuation of Study Intervention/Experimental Manipulation ............................................. 20 
7.2 
Participant Discontinuation/Withdrawal from the Study ............................................................... 21 
7.3 
Lost to Follow-Up ............................................................................................................................... 21 
8 
STUDY ASSESSMENTS AND PROCEDURES ..................................................................................... 22 
8.1 
Endpoint and Other Non-Safety Assessments .............................................................................. 22 
8.2 
Safety Assessments .......................................................................................................................... 22 
8.3 
Adverse Events and Serious Adverse Events ............................................................................... 23 
8.3.1 
Definition of Adverse Events ........................................................................................ 23 
8.3.2 
Definition of Serious Adverse Events .......................................................................... 23 

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8.3.3 
Classification of an Adverse Event .............................................................................. 23 
8.3.4 
Time Period and Frequency for Event Assessment and Follow-Up ....................... 24 
8.3.5 
Adverse Event Reporting .............................................................................................. 25 
8.3.6 
Serious Adverse Event Reporting ............................................................................... 25 
8.3.7 
Reporting Events to Participants ................................................................................. 25 
8.3.8 
Events of Special Interest ............................................................................................. 25 
8.3.9 
Reporting of Pregnancy ................................................................................................ 25 
8.4 
Unanticipated Problems .................................................................................................................... 25 
8.4.1 
Definition of Unanticipated Problems .......................................................................... 26 
8.4.2 
Unanticipated Problems Reporting .............................................................................. 26 
8.4.3 
Reporting Unanticipated Problems to Participants ................................................... 26 
9 
STATISTICAL CONSIDERATIONS .......................................................................................................... 27 
9.1 
Statistical Hypotheses ....................................................................................................................... 27 
9.2 
Sample Size Determination .............................................................................................................. 27 
9.3 
Populations for Analyses .................................................................................................................. 27 
9.4 
Statistical Analyses............................................................................................................................ 27 
9.4.1 
General Approach .......................................................................................................... 27 
9.4.2 
Analysis of the Primary Endpoint(s) ............................................................................ 28 
9.4.3 
Analysis of the Secondary Endpoint(s) ....................................................................... 28 
9.4.4 
Safety Analyses .............................................................................................................. 28 
9.4.5 
Baseline Descriptive Statistics ..................................................................................... 28 
9.4.6 
Planned Interim Analyses ............................................................................................. 28 
9.4.7 
Sub-Group Analyses ..................................................................................................... 28 
9.4.8 
Tabulation of Individual Participant Data .................................................................... 28 
9.4.9 
Exploratory Analyses ..................................................................................................... 28 
10 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .............................. 29 
10.1 
Regulatory, Ethical, and Study Oversight Considerations ........................................................... 29 
10.1.1 
Informed Consent Process ........................................................................................... 29 
10.1.2 
Study Discontinuation and Closure ............................................................................. 30 
10.1.3 
Confidentiality and Privacy ........................................................................................... 30 
10.1.4 
Future Use of Stored Specimens and Data ............................................................... 31 
10.1.5 
Key Roles and Study Governance .............................................................................. 31 
10.1.6 
Safety Oversight ............................................................................................................. 32 
10.1.7 
Clinical Monitoring .......................................................................................................... 33 
10.1.8 
Quality Assurance and Quality Control ....................................................................... 34 
10.1.9 
Data Handling and Record Keeping ............................................................................ 34 
10.1.10 
Protocol Deviations ........................................................................................................ 35 
10.1.11 
Publication and Data Sharing Policy ........................................................................... 35 
10.1.12 
Conflict of Interest Policy .............................................................................................. 37 
10.2 
Additional Considerations ................................................................................................................. 37 
10.3 
Abbreviations and Special Terms ................................................................................................... 37 
10.4 
Protocol Amendment History ........................................................................................................... 39 
11 
REFERENCES ............................................................................................................................................. 40 
 

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STATEMENT OF COMPLIANCE 
 
(1) [The trial will be carried out in accordance with International Council on Harmonisation Good 
Clinical Practice (ICH GCP) and the following:  
 
• 
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 
46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812).  
 
National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are 
responsible for the conduct, management, or oversight of NIH-funded clinical trials have 
completed Human Subjects Protection and ICH GCP Training. 
 
The protocol, informed consent form(s), recruitment materials, and all participant materials will 
be submitted to the IRB for review and approval. Approval of both the protocol and the consent 
form(s) must be obtained before any participant is consented. Any amendment to the protocol 
will require review and approval by the IRB before the changes are implemented to the study. All 
changes to the consent form(s) will be IRB approved; a determination will be made regarding 
whether a new consent needs to be obtained from participants who provided consent, using a 
previously approved consent form.] 
INVESTIGATOR’S SIGNATURE 
The signature below constitutes the approval of this protocol and provides the necessary assurances 
that this study will be conducted according to all stipulations of the protocol, including all statements 
regarding confidentiality, and according to local legal and regulatory requirements and applicable US 
federal regulations and ICH guidelines, as described in the Statement of Compliance above. 
 
Principal Investigator or Clinical Site Investigator: 
Signed: 
Date: 
01/29/2026 
 
Name*:  Erin E. Hahn, PhD, MPH 
 
Title*:  Research Scientist / Associate Professor 
 
Investigator Contact Information 
Affiliation*:  Kaiser Permanente Southern California, Department of Research and Evaluation / Kaiser 
Permanente Bernard J. Tyson School of Medicine, Department of Health Systems Science 
Address: 100 S. Los Robles, 2nd Floor, Pasadena, CA 91101 
Telephone: 626-564-3505 
Email: Erin.E.Hahn@kp.org 

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1 
PROTOCOL SUMMARY 
 
1.1 
SYNOPSIS  
 
Title: 
Adaptation and Implementation of an Evidence-Based Patient Navigation 
Intervention for Adolescent and Young Adult Cancer Survivors 
Grant Number: 
1UG3CA297705-01A1 
Study Description: 
We propose to: 1) Adapt an evidence-based cancer-focused patient 
navigation program to the AYA survivor population; and 2) Plan and 
conduct a pragmatic stepped wedge hybrid type 2 effectiveness-
implementation trial of this program within Kaiser Permanente Southern 
California. PLEASE NOTE: This study is awarded in two phases. The 
UG3 phase has been awarded for the first two years; upon successful 
completion of this phase by meeting pre-defined milestones, the 
National Cancer Institute will provide funding for the second phase 
of the study (Years 3-6), which will allow our team to conduct a 
pragmatic stepped wedge hybrid 2 effectiveness-implementation trial 
of the patient navigation intervention. Here we are focused on the 
initial UG3 phase and will update the protocol for the UH3 trial upon 
successful completion of the UG3 milestones and receipt of the UH3 
award.  
 
Objectives*: 
 
Primary Objectives (UG3): 
The primary objectives in the UG3 phase of the study are to adapt and 
tailor an existing patient navigation program to meet the needs of AYA 
cancer survivors and the local clinical context via (a) qualitative 
research involving key stakeholders (patients, clinicians, administrators) 
and (b) guidance from our AYA Primary Care Survivorship Council. 
We will conduct a prospective, single-arm pilot study of the adapted 
navigation program and refine the program to enhance acceptability to 
patients and clinicians, enhance feasibility and effectiveness, and 
develop and pilot pragmatic trial evaluation tools and methods prior to 
the start of the UH3 phase of the trial, which will be a pragmatic stepped 
wedge prospective trial. Objectives will be updated for the UH3 phase 
once awarded. 
 
Secondary Objectives: N/A 

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Endpoints*: 
Primary Endpoints: For the pilot test of the patient navigation program 
contained in the UG3 phase, we will survey patient and clinician 
participants. Patient survey outcomes will include patient self-efficacy, 
measures of care coordination and communication, barriers to care, and 
appropriateness and acceptability of the program. Clinician outcomes 
include integration of the navigation program as well as the 
appropriateness, acceptability, and feasibility of implementation of the 
program.  The primary outcomes for the UH3 phase will be incorporated 
once awarded.    
  
Secondary Endpoints: N/A 
Study Population: 
Patients: In the UG3 focus groups and pilot study of the navigation 
intervention, we will include patients of current age of 21-45 years who 
received  a diagnosis of breast, ovarian, cervical, testicular, colon/rectal, 
melanoma, endometrial, sarcoma, or thyroid cancer. Patients in the focus 
groups may have diagnosis years between 2019-2022, while those in the 
pilot test of the navigation intervention will be up to 36 months post-
diagnosis. Exclusion criteria: patients with a history of leukemia or 
lymphoma; patients with metastatic disease at diagnosis; and patients 
with less than 120 days of Kaiser Permanente Southern California 
(KPSC) insurance membership after diagnosis of primary cancer. 
 
Clinicians and Administrators: Physicians selected to participate in focus 
groups or survey must be Board Certified in Internal or Family Medicine, 
hold a valid and current MD and be employed by the Southern California 
Permanente Medical Group. Nurses or Advanced Care Practitioners must 
hold a valid license and be employed by KPSC. Department 
Administrators must be employed by KPSC.  
Phase* or Stage: 
Other 
 
Description of 
Sites/Facilities Enrolling 
Participants: 
The UG3 phase will be conducted in a community-based integrated 
healthcare system, KPSC.  
 
 

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Description of Study 
Intervention/Experimental 
Manipulation: 
In the UG3 phase, we will be adapting a patient navigation intervention 
to suit adolescent and young adult cancer survivors and conducting a 
single-site pilot test of the adapted intervention. In the UH3 phase, we 
will conduct a pragmatic stepped wedge hybrid effectiveness 
implementation trial evaluating (1) clinical effectiveness and (2) 
implementation outcomes, across a range of data sources. 
 
Intervention:  
Navigator-level: For the pilot test in the UG3 phase, we will provide 
navigation training for the adapted AYA patient navigation (PN) 
program to at least one navigator. We anticipate that navigators will 
undergo a comprehensive training curriculum that draws on existing 
KPSC PN program trainings (e.g., KP Motivational Interviewing for 
Clinicians, KPSC Panel Management) and includes primary care and 
cancer survivorship/surveillance components and established 
recommendations for cancer survivorship navigation from the American 
Society of Clinical Oncology (ASCO) and others. These resources 
include core navigation competencies for survivorship, patient 
assessment, scope of practice, etc. These trainings will be completed 
with additional focus areas/domains identified during the adaptation 
processes. Based on the structure of the existing PN program, we 
anticipate holding monthly review of navigation milestones and metrics 
(developed based on established recommendations and stakeholder 
input) with the study team.  
 
Patient-level: For the pilot test in the UG3 phase, we will identify 
eligible patients from a single clinical site within KPSC. We anticipate 
enrolling 15-25 patients in the pilot. Patients will receive a letter and 
brochure describing the adapted AYA PN program with a bio of their 
assigned navigator and how the program will help integrate primary care 
and cancer survivorship needs. We strongly anticipate navigation 
‘touches’ will include progressive steps via a combination of delivery 
modes as with the existing PN programs: 1) email: patients with KP.org 
patient portal accounts will receive email communication from 
navigators; 2) text: patients with registered mobile phone in KP 
membership files will receive text-based communications; 3) calls: 
patients will receive calls from their navigator to discuss scheduling, 
overdue recommended care, and motivational coaching; 4) letters: 
patients may receive letters if unable to be reached via email, text, and 
calls. Navigators will work with the electronic medical record (EMR) to 
identify need for recommended healthcare services and gaps in care, 
working with the care team to pend orders for physician review and 
work directly with the patient using motivational interviewing skills to 
encourage participation in care, address social needs, and identify care 
goals. PN program milestones, developed based on established 
recommendations for survivorship navigation metrics and the input from 
our adaptation processes, will likely include patients contacted, 
engagement activities, and pending orders for physician review for 
overdue services. 
 

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System-level: As part of the UG3 phase, we will work closely with our 
partners to adapt the PN program to suit existing clinical needs and 
workflows. We will convene 2-3 focus groups with care teams 
(nurses/physicians/advanced practice providers) and department 
administrators (DAs) using a semi-structured focus group format. These 
groups will provide feedback on the team-based care focus for the PN 
program, how to integrate seamlessly into existing clinical workflows, 
suggestions for use and/or expansion of existing KPSC information 
technology (IT) tools (e.g., the Complete Care Model tools), and clinical 
needs of the patient population. Using adapted health IT tools, flags may 
be created for patients due for recommended services.  
Study Duration*: 
In the UG3 phase, the study will open enrollment for the prospective 
single-arm pilot study by month 18, after focus group data and program 
adaptation is complete. Completion of data collection for the pilot is 
estimated at month 24.  
Participant Duration: 
In the UG3 phase, the patients in the single site pilot will complete all 
study tasks by 6 months.  
1.2 
SCHEMA  
 
 

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1.3 
SCHEDULE OF ACTIVITIES  
 
 
 
 
2 
 
INTRODUCTION 
 
2.1 
STUDY RATIONALE  
There is an urgent need to provide high-quality survivorship care to the rapidly growing population of 
adolescent and young adult (AYA) cancer survivors. Approximately 90,000 AYAs are diagnosed with cancer 
each year.1,2 AYAs, defined as those diagnosed between 15-39 years of age, are at unique developmental 
life stages regarding their emotional, cognitive, and social development, and cancer diagnosis and 
treatment is highly disruptive to completing education, establishing families, and/or starting 
employment.3,4 AYA cancer survivors have complex health care needs requiring coordinated care, 
including surveillance for cancer recurrence, management of long-term and late effects, and appropriate 
preventive care.5-7 However, serious gaps in care have been identified for AYA survivors, including 
underuse of guideline-recommended cancer surveillance (e.g., mammography, colonoscopy) and specific 
screenings based on cancer treatment exposures,8-14 as well as underuse of primary care services such as 
vaccinations and general disease screenings.15,16 AYA cancer survivors bear a high burden of morbidity 
associated with chronic conditions and premature mortality, and there is an urgent need to provide 
ongoing, high-quality survivorship care to this population.4 Our recent work found that one-quarter of AYA 
survivors had no oncology-related specialty visits within their first year after treatment despite guideline 
recommendations.17 AYA survivors also experience significant disparities in care and outcomes associated 
with race, ethnicity, and socioeconomic status.18,19 
High-quality, equitable, comprehensive AYA cancer survivorship care requires a team-based model of 
primary care with patient navigation. Cancer survivors actively managed in primary care that involved 
primary care received higher quality of care.20-25 Team-based primary care with patient navigation has 
been shown to improve receipt of cancer screening, surveillance, and primary care services, particularly 
in underserved populations at higher risk for gaps in care.26-32 Navigation programs address common 
barriers associated with health disparities (insurance and financial barriers, transportation, language, lack 
of social support),33 and can also reduce unnecessary and unplanned care (e.g., emergency department 
visits, hospitalizations).34 Unfortunately, primary care engagement can be low after AYA patients are 

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diagnosed with cancer14 and there are few, if any, primary care-based patient navigation models of 
survivorship care focused on AYA cancer survivors. 
 
Thus, despite the multitude of benefits shown by PN programs in the empirical literature, there are few, 
if any, primary care-based PN programs for AYA survivors, representing a critical gap. Our study will be 
one of the first to draw on implementation science methods to adapt and test a primary care-based PN 
program for AYA survivors. We will build on our expertise in cancer survivorship research, implementation 
and adaptation of evidence-based interventions, and pragmatic trial methods to apply a novel 
combination of frameworks, including RE-AIM,35 the Framework for Reporting Adaptations and 
Modifications-Expanded (FRAME),36 and Escoffery’s 11 steps of adaptation37 to adapt the existing 
navigation program in the UG3 phase of the study. In the UH3 phase, we will conduct a rigorous pragmatic 
stepped wedge hybrid type 2 trial of the program in 35 primary care clinics with a minimum of 850 AYA 
survivors, with pragmatic elements based on the PRECIS-2; the protocol will be updated appropriately 
upon award of the UH3 phase.38 
2.2 
BACKGROUND  
We are nearing three-quarters of a million AYA cancer survivors in the U.S, and the population is growing 
rapidly.39 Approximately 90,000 new cases of cancer in adolescents and young adults (AYAs) are diagnosed 
annually,2 with AYA defined by the National Cancer Institute (NCI) and others as those diagnosed with 
cancer between 15-39 years of age. Increased incidence of colorectal, breast, endometrial, and other 
cancers among individuals under 40 is well documented.1,2,40 Although causal mechanisms remain 
somewhat unclear, likely contributors to these increases include lifestyle factors, environmental factors, 
dietary and obesity trends, and changes in screening practices.1,41,42 As AYAs diagnosed with cancer are 
living longer than ever, with 5- year relative survival of 86%,43 the majority of these patients will enter into 
a prolonged post-treatment phase of care and are considered cancer survivors.44 Cancer survivors require 
coordinated, comprehensive care addressing several domains of survivorship as described by National 
Academy of Medicine (NAM), ASCO and others, including surveillance for recurrence, screening for new 
cancers, screening for long-term and late effects of treatment, symptom management, and primary and 
preventive care. 
AYA cancer survivors have multiple unmet healthcare needs and experience significant disparities in care. 
AYAs are at unique developmental and life stages regarding their emotional, cognitive, and social 
development, and cancer diagnosis and treatment is highly disruptive to establishing families, completing 
education, and/or starting employment.3 AYAs face multiple unique challenges to accessing high-quality 
survivorship care, both at the system-level (e.g., transitioning from pediatric to adult-focused care, the 
need for care outside of typical clinic hours) and individual-level socioeconomic barriers (e.g., 
uninsured/underinsured, limited paid leave, caregiving for young children).45-48 AYAs span diverse 
developmental life stages with varying needs; for example, younger AYAs report higher need for 
information and supportive care than older AYAs.49,50 Other needs, such as fertility counseling and access 
to reproductive health services, are acknowledged as critically important across the AYA age span.51 
However, AYA survivors often have low uptake of guideline-recommended cancer surveillance services 
such as annual mammograms for breast cancer survivors and treatment exposure-based screenings.14,52 
Additionally, AYA survivors experience delayed or interrupted return to primary care and have low uptake 
of preventive care, including influenza vaccination, screening for non-primary cancers, and screening for 
hypertension and lipid abnormalities.16,53 Health insurance and socioeconomic status have been shown to 
play a critical role in access to high-quality care and patient outcomes for AYA survivors.18 In a large cohort 
of AYA patients diagnosed with cancer, there were significant disparities in relative survival by 

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race/ethnicity, poverty level, and insurance type.19 Other studies have shown disparities in AYA survival 
by race/ethnicity;54,55 for example, Black AYA patients diagnosed with colon cancer between 20-49 years 
had smaller increases in relative survival compared to White patients over time.56 It is clear that 
improvements in access to and receipt of high-quality care are critically needed—and this is particularly 
acute for traditionally underserved populations.3 Compounding these issues, our current oncology 
workforce is insufficient to care for the rapidly growing population of cancer survivors,57-61 with a shortage 
of oncology physicians predicted by 202562 and concomitant oncology nursing shortage.63 The current 
approach to delivering survivorship care, which is typically with oncology specialists with limited or no 
coordination with primary care providers or patient navigators, is inadequate and fails to meet the unique 
healthcare and psychosocial needs of AYA survivors.64 
High-quality, equitable, and comprehensive AYA survivorship care requires patient navigation with team-
based primary care. Primary care-based, coordinated survivorship care is critically important for provision 
of high-quality care to AYA cancer survivors.65 Primary care-based teams are well-positioned to counsel 
survivors regarding lifestyle choices such as physical activity,66 disease prevention,67 screening for 
psychosocial health needs,68 and tobacco cessation.69 Recent studies have found that the majority of 
healthcare received by cancer survivors comes from primary care,70 and that primary care teams feel they 
have a significant role to play in cancer survivorship.71-73 However, there are considerable barriers to time- 
pressed primary care physicians involvement in survivorship, including resources, knowledge, and 
systems- level support, and it is not sustainable to continually ask our primary care physicians to simply 
“do more.”74-78 A team-based approach with comprehensive patient navigation offers demonstrated 
potential for optimizing AYA survivor outcomes. Patient navigation (PN) is defined as individualized 
assistance offered to patients and families to help overcome barriers to care and optimize health 
outcomes, and navigators have been described as “catalysts to mitigate cancer disparities.”79 A rich PN 
literature has been developed over the past two decades including multiple systematic reviews and meta-
analyses,26-30 demonstrating PN can improve a variety of clinical outcomes, particularly in underserved 
populations at higher risk for gaps in care.31 Primary care-based PN programs have been shown to improve 
patient access and connection to appropriate clinicians, improve patient-provider communication, 
increase interaction and links with the health system, increase patient employment, reduce financial 
stresses, and improve insurance coverage.80,81 PN also improves cancer-related care, including symptom 
management,28,82,83 increases timely cancer diagnostic resolution and follow-up, and leads to higher 
completion rates for cancer screenings and treatment as well as higher rates of attending medical 
appointments.34,84 PN addresses common barriers to access associated with health disparities, 
coordination, transportation, language, and lack of social support.33 A recent review concluded that PN 
also reduces unnecessary or unplanned care (e.g., emergency department utilization, hospitalization), can 
reduce burden for physicians, and are cost-effective.34 Although limited in number, PN survivorship 
programs have shown improvements in guideline-recommended cancer surveillance services and health-
reported quality of life.85-87 Navigators use elements of care coordination and can be considered a type of 
coordinator, based on the definition from the Alliance to Advance Patient-Centered Cancer Care (“Patient 
navigation represents an evidence-based health care intervention designed to enhance patient-centered 
care and care coordination”)88 as well as recent meta-analyses and reviews of the navigation and 
coordination literature.27,89 Given this large body of research, PN is clearly an evidence-based intervention 
suitable for widespread implementation. Recent in-depth qualitative work from our research group 
focused on developing a comprehensive model of AYA survivorship found that AYA survivors strongly 
encourage use of PN programs tailored to their needs.90 However, only a small number of PN studies have 
focused on the AYA survivor population, mainly centered around preferences for PN programs rather than 
adaptation, implementation, or sustainment.51,91,92  

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Results from this study will yield valuable evidence on the effectiveness and mechanisms of effect of a 
scalable, adaptable primary care-based patient navigation program targeting AYA cancer survivors, 
addressing the critical need to improve the quality of care for this unique patient population. 
 
2.3 
RISK/BENEFIT ASSESSMENT  
 
2.3.1 KNOWN POTENTIAL RISKS  
 
For this study, a waiver of informed consent and HIPAA authorization waiver will be required to identify 
KPSC AYA cancer survivors by condition who are eligible for enrollment into the adapted PN program pilot 
and focus group recruitment sample (UG3 phase). We do not foresee any risks to potential participants 
by not directly consenting them to participate for identification by condition. It will be prohibitive to 
contact patients directly for identification by condition and this study poses no more than minimal risk to 
privacy and confidentiality of study participants. Survivorship cancer care will be performed as part of 
routine medical care that is consistent with guidelines from professional societies and organizations. The 
pilot adapted PN program will focus on directing enrolled AYA patients to guideline-recommended 
services that already exist, essentially bridging service gaps for this population. In addition, participation 
in the adapted PN program (UG3 phase) will be voluntary. We also believe that such a waiver of consent 
is not only widely recognized as necessary and appropriate, but also scientifically necessary and ethically 
justifiable under the “Common Rule” for protection of research participants (45 CFR 46.116d) – (e.g., 1) 
the research involves no more than minimal risk to the subjects; 2) the waiver of alteration will not 
adversely affect the rights or welfare of the subjects; 3) the research could not practicably be carried out 
without the waiver of alteration; and 4) whenever appropriate, the subjects will be provided with 
additional pertinent information after participation in the form of a summary sheet of survey findings 
after completion of the study). Throughout the study phases, we will work closely with our Institutional 
Review Board (IRB), clinical chiefs, and operational leaders to ensure patient safety, with regular review 
and reporting of adverse events and protocol deviations. 
Patients, clinicians and administrators will be individually recruited for focus groups and surveys and we 
will obtain written or oral consent from all participants, unless we obtain approval from the KPSC IRB for 
a waiver of written informed consent for these specific study-related activities. 
 
A rare but serious harm that could occur is loss of confidentiality of personal health information (PHI), but 
every effort will be made to protect PHI. Specifically, each focus group and survey participant will be given 
a unique alpha-numeric identification number. No data collection form will be linked to an actual 
participant name. Any document linking the participant's name to an identification number will be kept 
in a locked file separate from data collection files. All records from the study will be kept in locked files. 
Identifying information will be removed from the final data sets and stored in a linked file to which only 
the Principal Investigator (PI) or designee has access. Individual participants will not be identified in any 
reports. Additionally, study reports will be aggregated so that individual participants are not identified. All 
investigators and research staff at participating sites will be required to maintain up-to-date training in 
human subject protection and good clinical practice through Collaborative Institutional Training Initiative 
(CITI; https://about.citiprogram.org/) and HIPAA training. Additional security precautions include 
encryption, digital certification, audit logs, and firewall protection. 
 

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2.3.2 KNOWN POTENTIAL BENEFITS  
There are no direct benefits to the participants in this proposed study. There are potential societal benefits 
from our findings. Our study is innovative, among the first to draw on implementation science methods 
to adapt and test a primary care-based PN program for AYA survivors. Despite recognition of the unique 
needs of AYA survivors and critical gaps in primary, preventive, and surveillance care, there has been little 
rigorous investigation of barriers and methods for adaptation and implementation of primary care-based 
PN programs for AYA survivors. Several initiatives are underway to improve awareness of AYA survivor 
needs and provide education to clinicians and survivors about recommended care, many of which rely of 
mHealth solutions; however, recent reviews have highlighted that these studies have been small, single-
arm studies mainly focusing on feasibility.93-96 Our proposed study will add to the evidence base for 
primary care-based navigation services tailored for AYA cancer survivors, potentially leading to policy 
decisions regarding coverage and reimbursement from private insurers and Medicaid as well as care 
delivery decisions by capitated healthcare delivery systems. 
Ultimately, results from this study will yield valuable evidence on the effectiveness and mechanisms of 
effect of a scalable, adaptable primary care-based patient navigation program targeting AYA cancer 
survivors, addressing the critical need to improve the quality of care for this unique patient population. 
 
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  
 
There are minimal physical, psychological, social, legal, privacy or other risks from participating in this 
study. Individual patients and clinicians will not be recruited for enrollment into the adaptive PN pilot 
(UG3 phase) or the stepped-wedge trial (UH3), thus there is minimal risk to loss of privacy or 
confidentiality; any demographic, clinical and utilization data will be collected from the EMR and/or claims 
data with no participant interaction. A rare but serious harm that could occur is loss of confidentiality of 
PHI. However, participant confidentiality will be maintained at all times using the specific steps and 
procedures for enrollment, focus groups and surveys, as outlined in Section 2.31 above. 
 
3 
OBJECTIVES AND ENDPOINTS  
 
We have defined measurable, feasible milestones for both the UG3 and UH3 phases of the study. The UG3 
phase has been awarded for two years; upon successful completion of this phase, the NCI will provide 
funding for the second phase of the study, which will allow our team to conduct the pragmatic stepped 
wedge hybrid 2 effectiveness-implementation trial outlined in this protocol (UH3 phase). Herein we are 
focusing on the UG3 phase, with reference for future protocol versions that incorporate the UH3 phase 
once awarded.  
 
We will engage in a three-step process to achieve our goals for the UG3 phase: 
 
1. Intervention refinement via context assessment including multilevel barriers and facilitators to guide 
adaptation; adaptation and tailoring to local contexts. 
2. Demonstrate feasibility of program implementation with pilot testing of recruitment, data collection, 
evaluation plans and methods, and data sources. 

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3. Develop and demonstrate the feasibility of logistical and administrative arrangements for conducting 
the pragmatic trial in the UH3 phase including finalizing agreements with sites, IRB approvals, and 
development of a manual of operations for the trial. 
 
In step 1, we plan for rigorous exploration and documentation of adaptation processes via a combined 
use of implementation and adaptation frameworks, representing a significant contribution to the field. 
Intentional adaptation provides an opportunity for implementation flexibility, potentially improving the 
overall fit of an evidence-based intervention to a new population and/or context,97 such as AYA survivors 
care in the primary care setting. Several adaptation frameworks have been proposed over the past 
decade, with a collective recognition of the importance of rigorous research on adaptation processes and 
the distinction between the function (e.g., core elements) and form (e.g., delivery type) of evidence-based 
interventions.98 We will follow the overarching steps of adaptation processes as described by Escoffery et 
al.,37 consisting of eleven discrete steps, with extensive stakeholder engagement throughout. We will 
supplement this with a novel application of the RE-AIM framework for guidance on the ‘who, why, how’ 
of adaptation a nascent and exciting application of RE-AIM to adaptation processes. We will use the 
FRAME to guide thorough documentation of adaptation activities throughout the eleven steps. This blend 
of Escoffery’s eleven steps, RE-AIM, and FRAME provides a stepwise, thoughtful approach for capturing 
the rationale for adaptation, the internal and external context of adaptation, and for cataloguing 
adaptation elements (see Section C.5.3 for adaptation process details). Recent work from leaders in the 
field have combined RE-AIM with adaptation frameworks,99,100 although not in this specific combination 
which is more appropriate to address our research questions. We propose a multilevel adaptation 
process, tailoring PN program components to meet the needs of AYA cancer survivors, primary care 
teams, and the organizational setting (and leveraging available supportive resources). We will be adapting 
KPSC’s existing PN program for patients newly diagnosed with cancer, which includes KPSC’s robust 
‘Complete Care’ model and health IT tools shown to be effective at managing cancer (diagnosis and initial 
treatment) and other chronic conditions.101,102 In step 2, we will conduct a pilot study of the adapted PN 
program with a single clinic, collecting patient, clinician, and clinic-level data and iteratively refining the 
PN program as appropriate. Following Escoffery’s Eleven Steps of Adaptation, we will: 1) assess 
community, 2) understand the intervention (patient navigation program), 3) select the appropriate 
program structure, 4) consult with experts, 5) consult with stakeholders, 6) decide on needed adaptations, 
7) adapt, 8) train staff, and 9) pilot test the adapted materials. Lastly, in step 3 we will develop our trial 
manual of operations and obtain administrative and other approvals so that the trial is set to launch at 
start of Year 3. 
 
In the UH3 phase, we will conduct a pragmatic stepped wedge hybrid type 2 effectiveness-implementation 
trial with extensive quantitative and qualitative process evaluation activities to examine mechanisms of 
effect, moderators and other contextual factors.103 This protocol will be updated once the UH3 phase is 
awarded.  
 
Primary Outcomes: UG3 
We will conduct a prospective, single-arm pilot study of the adapted AYA PN program at a 
participating clinic site in Southern California, focusing on the perceptual implementation outcomes of 
acceptability, appropriateness, and feasibility (the behavioral implementation outcomes including 
adoption, penetration, fidelity and sustainment will be measured in the UH3 pragmatic trial) and the 
hypothesized PN program outcomes of increased motivation, capability, and opportunity for care. The 
pilot will also include testing of patient enrollment/engagement methods, clinical workflow, survey 
recruitment methods, and health IT elements (e.g., access, ease of use). We anticipate enrolling 15-25 
AYA survivors. 

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Survey Measures. While there is no single measure of PN programs, there are several measures that 
address the theorized PN mechanisms of motivation, capability, and opportunity for care; these 
domains are commonly conceptualized as patient satisfaction with care, receipt of care, barriers and 
facilitators to care, and self- efficacy or ‘health competence.’ As described over a decade ago by 
Fiscella et al there are several patient- reported outcomes appropriate for measuring the impact of PN 
programs. Based on those specific recommendations for measuring cancer survivorship PN programs, 
patient surveys will include a validated measure of self-efficacy (the Perceived Health Competence 
Scale), measures of care coordination and communication from the Care Coordination Quality 
Measures developed by the Agency for Healthcare Research and Quality (AHRQ), and measures of 
barriers to care (e.g., non-adherence due to cost, access issues) and provider communication from the 
Medical Expenditure Panel Survey (MEPS). The MEPS patient-provider communication scale evaluates 
discussions about: 1) cancer follow-up care; 2) late or long- term treatment effects; 3) lifestyle 
recommendations; and 4) emotional or social needs. While other measures may offer more 
comprehensive scales of these domains, we wish to be mindful of participant time and likelihood of 
participation based on survey length and will therefore limit to these most highly relevant measures. 
Patient surveys will also include questions on ways to improve or change the PN program elements as 
well as contact and engagement methods for patients.  
Clinician and administrator surveys will include questions on ease of clinical workflow integration, 
familiarity with the PN program, and open-ended questions on ways to improve the PN program from 
a clinical or administrative perspective. Both patient and clinician/administrative surveys will include 
validated measures of acceptability, appropriateness, and feasibility of the PN program, developed by 
Weiner et al, as well as questions about survey contact methods and reasons for participation and 
hypothesized reasons for non-participation (e.g., “Why do you think someone would decide not to 
participate in this survey?”). This will help refine the survey outreach for the UH3 pragmatic trial. 
Survey Recruitment Methods. We will invite all AYA survivors contacted as part of the pilot as well as 
clinical team members and the clinic’s administrative team to participate in survey after their 
introduction to the PN program. We will use Dillman’s Tailored Design Method104 to guide all survey 
activities with goals to: 1) Minimize all possible sources of survey error; 2) Tailor to the survey 
population; and 3) Use procedures that create positive social exchange and encourage response. We 
designed our REDCap-based recruitment procedures to encourage response and minimize 
nonresponse by using multiple modes of contact, multiple modes of response (e.g., direct link to web 
survey, paper survey), and incentives. Patient participants will receive a $20 gift card for completing 
the survey, as evidence suggests this is one of the best ways to improve response rates and increase 
representativeness.104,105 Mixed-mode strategies such as the one we propose have been shown to be 
effective and help minimize total survey error. We will engage our Advisory Board to refine 
recruitment materials. 
Data Collection and Analysis. We will invite AYA patients contacted by the program and clinical staff 
and administrators to complete brief electronic surveys. We will collect demographic information 
(e.g., age, race, ethnicity, census-level education and income) and clinical information (e.g., date of 
cancer diagnosis, age at diagnosis, disease stage, cancer treatment type, tumor genomics) from the 
EMR and tumor registry for all participants. We will collect for clinician variables such as gender, race, 
and years in practice from the EMR. Sex as a potentially important biologic factor will be included in all 
analyses. Use of existing data in the EMR can other databases is in alignment with the highly 
pragmatic nature of the trial. 
We will create descriptive summary tables of results. We did not do a formal power analysis for the 
pilot data, as this will be only one clinic site and the purpose is to identify areas needing additional 
refinement prior to the launch of the pragmatic trial. 

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4 
STUDY DESIGN 
 
4.1 
OVERALL DESIGN 
 
The purpose of the study is to: 1) Adapt an evidence-based cancer-focused patient navigation program to 
the AYA survivor population; and 2) Plan and conduct a pragmatic stepped wedge hybrid type 2 
effectiveness-implementation trial of this program within KPSC. We will apply a novel combination of 
frameworks, including RE-AIM, the Framework for Reporting Adaptations and Modifications-Expanded 
(FRAME), and Escoffery’s  steps of adaptation to adapt the existing navigation program and conduct a 
rigorous pragmatic stepped wedge hybrid type 2 trial of the program with pragmatic elements based on 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
PUTATIVE 
MECHANISMS 
OF ACTION 
Primary 
 
 
 
UG3 Phase. Adapt a 
navigation program to suit 
the needs of the AYA 
cancer survivor population. 
 
Conduct a prospective 
single arm pilot study of 
the adapted AYA PN 
program. 
Patient outcome measures taken pre/post 
entry into the navigation program include self-
efficacy, care coordination and 
communication from the Care Coordination 
Quality Measures developed by the Agency for 
Healthcare Research and Quality, and 
measures of barriers to care (e.g., non-
adherence due to cost, access issues) and 
provider communication from the Medical 
Expenditure Panel Survey. 
 
Clinician and administrator surveys will 
include questions on ease of clinical workflow 
integration, familiarity with the PN program, 
and open-ended questions on ways to 
improve the PN program from a clinical or 
administrative perspective.  
 
Both patient and clinician/administrative 
surveys will include validated measures of 
acceptability, appropriateness, and feasibility 
of the PN program (perceptual 
implementation outcomes).  
 
We hypothesize that 
the patient navigation 
program will increase 
patient capability, 
motivation and 
opportunity to 
connect to the 
healthcare system. 
Thus, we include 
measures of self-
efficacy, perceived 
care coordination, and 
communication.  
 
Other survey 
measures will help 
guide the refinement 
of the program for the 
UH phase.  
 
Secondary 
 
 
 
 
 
 
 

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the PRECIS-2. Here we describe the initial funded phase of the study (the UG3 phase) which is a 2-year 
adaptation process and single-arm prospective pilot study of the adapted patient navigation program.  
 
UG3 Aim 1. Adapt and tailor an existing patient navigation program to meet the needs of AYA cancer 
survivors and the local clinical context via (a) qualitative research involving key stakeholders (patients, 
clinicians, administrators) and (b) guidance from our AYA Primary Care Survivorship Council. 
 
UG3 Aim 2. Pilot and refine the program to enhance acceptability to patients and clinicians, enhance 
feasibility and effectiveness, and develop and pilot pragmatic trial evaluation tools and methods. 
 
The pilot study will focus on AYA patients 3-36 months post-diagnosis, allowing for the PN program to 
reach patients coming into early post-treatment survivorship as well as those who have completed 
treatment within the past 12-24 months (assuming an average treatment time of 6-18 months for these 
tumor types). Thus, we will prospectively identify AYA cancer patients with 10 disease types and 
diagnosed with local/regional disease undergoing treatment or in survivorship at study start. The top 10 
most diagnosed local and regional solid tumors in the AYA age range, based on data from the KPSC SEER-
affiliated cancer registry: breast, ovarian, cervical, testicular, colon/rectal, melanoma, endometrial, 
sarcoma, and thyroid cancers. In line with the pragmatic design, we have kept a very broad eligibility 
criteria and minimized exclusions to enhance the generalizability of results. There are no exclusions based 
on sex, race/ethnicity, comorbidity status, lifestyle factors (e.g., tobacco and alcohol use), or other patient 
demographics. We will not include leukemia and lymphoma patients as these patients are often cared for 
in the inpatient setting and/or transferred to tertiary cancer centers for transplant. We also exclude 
patients with metastatic disease at diagnosis, as these patients are cared for within an integrated palliative 
care/oncology/social work team structure starting at diagnosis, and the addition of the PN program would 
be providing duplicative services. Lastly, we will exclude patients with less than 120 days of Kaiser 
Permanente insurance membership after diagnosis of primary cancer, as we would not be able to follow 
the patient into their cancer survivorship phase. 
 
4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
 
Following the structure of the NCI two-phase cooperative agreement, we propose to: 1) Adapt an existing 
evidence-based, cancer-focused PN program to the AYA survivor population and to the clinical setting; and 
2) Conduct a pragmatic stepped wedge hybrid type 2 effectiveness-implementation trial within a large 
integrated healthcare system, KPSC. As described in established program theory for patient navigation, 
we hypothesize that the adapted PN program will lead to increased uptake of high-quality, guideline-
recommended primary care and cancer surveillance services for AYA survivors (clinical outcomes), and 
high levels of acceptability, appropriateness, feasibility, adoption, penetration, fidelity, and sustainment 
(Proctor’s implementation outcomes). In the UG3 phase, we will focus on three areas derived from the 
scientific literature on navigation and adaptation of evidence-based interventions:  
1. Intervention refinement via context assessment including multilevel barriers and 
facilitators to guide adaptation; adaptation and tailoring to local contexts. 
2. Demonstrate feasibility of program implementation with a prospective single-arm pilot 
study. 
3. Develop and demonstrate the feasibility of logistical and administrative arrangements for 
conducting the pragmatic trial in the UH3 phase including finalizing agreements with sites, 
IRB approvals, and development of a manual of operations for the trial. 

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4.3 
JUSTIFICATION FOR INTERVENTION 
There is a rich body of evidence from over 2 decades of scientific inquiry demonstrating the effectiveness 
of patient navigation (PN) on improving patient outcomes, increasing access to and receipt of care 
(particularly in underserved populations), and lowering costs,26-30 experts have called for greater focus on 
PN programs specifically for cancer survivors. A recent systematic review of cancer PN programs notes 
that 50% of programs focused on cancer screening only and an additional 27% on cancer diagnosis only.84 
As noted in a recent editorial on community navigation programs for cancer patients, despite the evidence 
of success of PN programs, deploying these complex multilevel interventions is challenging and a 
successful program requires adaptation and tailoring to meet cultural, economic, patient, and health-
system needs.106  
High-quality, equitable, comprehensive AYA cancer survivorship care requires a team-based model of 
primary care with patient navigation. Cancer survivors actively managed in primary care that involved 
primary care received higher quality of care.20-25 Team-based primary care with patient navigation has 
been shown to improve receipt of cancer screening, surveillance, and primary care services, particularly 
in underserved populations at higher risk for gaps in care.26-32 Navigation programs address common 
barriers associated with health disparities (insurance and financial barriers, transportation, language, lack 
of social support),33 and can also reduce unnecessary and unplanned care (e.g., emergency department 
visits, hospitalizations).34  
Thus, despite the multitude of benefits shown by PN programs in the empirical literature, there are few, 
if any, primary care-based PN programs for AYA survivors, representing a critical gap. This paucity of high-
quality implementation research, particularly in community-based settings, seriously limits our ability to 
implement policy or practice decisions regarding optimal survivorship care delivery for the growing AYA 
survivor population.  Our study will be one of the first to draw on implementation science methods to 
adapt and test a primary care-based PN program for AYA survivors. Medicare recently announced 
payment changes including offering reimbursement for navigation services given the strong evidence of 
benefit from PN programs.107 Although limited to older adults, this demonstrates the power of high-
quality research to affect policy decisions. Thus, our program of research to adapt and test an evidence-
based PN program for AYA cancer survivors is highly justified and has a high likelihood of success.  
 
4.4 
END-OF-STUDY DEFINITION 
 
In the UG3 phase, a participant is considered to have completed the study if he or she has: 
 
•  Participated in a one-time focus group; or 
•  Participated as a patient in the prospective, single-arm pilot study for 6 months and completed the 
associated survey; or 
•  Participated as a clinician and/or administrator in the one-time survey about the navigation program. 
•  For patient data, truncated person-time will be accounted for in case of membership end or death 
during the pilot study.  
5 
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5.1 
INCLUSION CRITERIA 
 
Patient Population Selection for UG3: 
Patient Identification for Focus Group Recruitment. KPSC AYA cancer survivors who fit study eligibility will 
be identified from our KPSC cancer registry. 
 
Clinician and Administrator Focus Groups. Nurses, physicians, advanced practice providers and 
administrators will be identified from the primary care teams at our participating five sites.  
 
Inclusion Criteria: 
 
Patient Focus Groups. Inclusion criteria: (1) Aged 15-39** years old at time of cancer diagnosis; (2) a 
diagnosis of breast, ovarian, cervical, testicular, colon/rectal, melanoma, endometrial, sarcoma, or thyroid 
cancers; and (3) up to 6 years post-treatment.  
 
Clinician and Administrator Focus Groups. Physicians selected to participate must be Board Certified in 
Internal or Family Medicine, hold a valid and current MD and be employed by the Southern California 
Permanente Medical Group. Nurses or Advanced Care Practitioners must hold a valid license and be 
employed by Kaiser Permanente Southern California. Department Administrators must be employed by 
Kaiser Permanente Southern California. 
 
Single-arm prospective pilot study: 
Inclusion criteria: (1) Aged 15-39** years old at time of cancer diagnosis; (2) a diagnosis of breast, ovarian, 
cervical, testicular, colon/rectal, melanoma, endometrial, sarcoma, or thyroid cancers; and (3) up to 36 
months post-diagnosis. 
 
**While we will be identifying patients from our cancer registry that were diagnosed with cancer between 15-39 
years of age, for the pilot (Phase 1) and potential future trial (Phase 2) we will be focusing only on those patients who 
are now over the age of 21; therefore we will not be enrolling patients under the age of 18 years nor including them 
in focus groups or surveys. The rationale is that younger patients tend to stay within pediatric oncology for extended 
periods and would not likely benefit from our intervention. 
 
5.2 
EXCLUSION CRITERIA 
 
Exclusion criteria for UG3:  
 
• 
Patients with a history of leukemia or lymphoma. 
• 
Patients with metastatic disease at diagnosis 
• 
Patients with less than 120 days of Kaiser Permanente insurance membership after diagnosis of 
primary cancer 
 
5.3 
LIFESTYLE CONSIDERATIONS 
 
N/A 

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5.4 
SCREEN FAILURES 
 
The study focuses on  patients diagnosed with local and regional solid tumors in the AYA age range, based 
on data from the KPSC SEER-affiliated cancer registry: breast, ovarian, cervical, testicular, colon/rectal, 
melanoma, endometrial, sarcoma, and thyroid cancers. In line with the pragmatic design, we have kept a 
very broad eligibility criteria and minimized exclusions to enhance the generalizability of results. There 
are no exclusions based on sex, race/ethnicity, comorbidity status, lifestyle factors (e.g., tobacco and 
alcohol use), or other patient demographics.  
 
We will prospectively identify AYA cancer patients with the 10 disease types described above and 
diagnosed with local/regional disease undergoing treatment or in survivorship at study start. We will use 
our comprehensive pathology database, Co-Path, combined with an EMR text-information extraction 
system and cancer registry data to identify eligible patients. Breast cancer patients may be receiving 
ongoing HER-2 directed therapy or endocrine therapy and be considered eligible for the PN program. 
 
Screen failures are defined as participants misidentified either by age at diagnosis (i.e., not diagnosed 
within the AYA age range) or by disease stage—those who did not have local or regional disease at time 
of diagnosis (i.e., metastatic disease at diagnosis).  Misidentified patients will be considered screen 
failures, will be excluded from the study, and will receive their survivorship care under usual care 
conditions.  
 
5.5 
STRATEGIES FOR RECRUITMENT AND RETENTION 
Recruitment UG3 phase  
A waiver of the requirement for informed consent will be requested for enrollment into the PN program 
for the pilot study. We believe that such a waiver of consent is not only necessary and appropriate, given 
the proven track record and evidence base of PN programs, but is also scientifically necessary and ethically 
justified given the minimal risk of the proposed research based on the Common Rule, 45 CFR 46.116d 
(e.g., use of routine care practices, no investigational drugs or devices, little risk of physical or 
psychological harm).This also allows for the AYA PN program to be integrated into usual care processes 
for the clinic, simplifying the research participation processes and maximizing our patient contact, 
engagement, and generalizability of results. 
Patient Focus Groups. Using a REDcap recruitment and tracking database, we will send an initial 
recruitment email to a batch of the potential participants (approximately 25-30) describing the study and 
invite the recipients to participate in the focus group. Follow-up contacts will be made using multi modal 
outreach (e.g., emails, texts, letters). We will randomly select the initial batch of patients using a SAS-
generated algorithm. Once we have exhausted the initial batch without reaching our recruitment goal, 
we will identify a second batch of potential participants (approximately 25-30) and continue with batches 
until our recruitment goals are reached. Focus groups will be conducted either online or in person at the 
Kaiser Permanente clinical research center (Pasadena, CA) equipped with a focus group facility or at a 
professional focus group room rented in the community. 
Provider and Administrator Focus Groups. For clinicians and administrators, we will follow a similar 
recruitment protocol although we will restrict recruitment outreach to email contact. Our studies that 
have involved clinicians and administrators in qualitative research have found that this group responds to 

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email contact attempts but are much less likely to respond to letter or phone recruitment contacts. Focus 
groups will be conducted either online (e.g., Microsoft TEAMS) or in-person. 
Estimated participant time commitment: 
We estimate a total time commitment for both AYA patients and providers participating in focus groups 
to be approximately 4 hours. 
Compensation amount and type: 
Patient Focus Groups. Patients will receive a $150 gift card upon completion of the focus group. 
If focus groups are conducted in person, food and beverages will also be provided. 
Clinician and Administrator Focus Groups. Clinicians and administrators will not receive 
renumeration for their participation in the focus group. However, if focus groups are conducted in 
person, food and beverages will be provided. 
 
6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) 
 
6.1 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ADMINISTRATION 
6.1.1 STUDY INTERVENTION OR EXPERIMENTAL MANIPULATION DESCRIPTION 
Intervention for UG3 pilot study. The intervention for this phase of the study will be based on the adapted 
AYA PN program developed under the UG3 initial phase activities. The proposed multilevel adaptations 
will be based on the existing KPSC PN program for patients newly diagnosed with cancer, which was 
developed using PN program theory and incorporates the core functions of enhancing patient capability, 
motivation, and opportunity for care. However, the current KPSC PN cancer program does not extend 
into cancer survivorship; rather, it focuses on guiding newly diagnosed patients through the initial steps 
of diagnostic procedures (e.g., imaging, labs), scheduling and referral for cancer treatment (surgery, 
medical oncology), and provision of education and support through the initial stages of cancer treatment. 
Therefore, the adapted AYA PN cancer survivorship program will adhere to these core functions, but we 
anticipate that the adapted PN program will have refinements to the forms of these core functions, 
including mode of delivery, outreach timing and tone, clinical workflow, and survivorship domains of care 
(e.g., cancer surveillance, screening for late effects). For the AYA PN program, we will adapt the current 
health IT tools highlight or flag the relevant National Comprehensive Cancer Network (NCCN) and USPSTF 
guideline recommendations. The navigation intervention may also use existing IT tools such as the 
Proactive Office Encounter (POE) which is the EMR alert system for overdue recommended care, and the 
KPSC ‘cancer tracker’ system for newly diagnosed patients. These tools will allow for close collaboration 
between navigators and oncology and primary care teams, addressing gaps in care without duplication of 
effort. We will establish a shared-care protocol to ensure that services are not duplicated. 
6.1.2 ADMINISTRATION AND/OR DOSING 
 
Intervention: Navigators 

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Navigators will undergo a comprehensive training curriculum that draws on existing KPSC trainings and 
includes 
primary 
care 
and 
cancer 
survivorship/surveillance 
components 
and 
established 
recommendations for cancer survivorship navigation from ASCO and others. These resources include core 
navigation competencies for survivorship, patient assessment, scope of practice, etc. These trainings will 
be completed with additional focus areas/domains identified during the adaptation processes. Based on 
the structure of the existing PN program, we anticipate holding monthly review of navigation milestones 
and metrics (developed based on established recommendations and stakeholder input) with the study 
team, and at least quarterly with the primary care team within the clinic. 
 
Intervention: Patients 
All eligible patients at a single clinical site will be passively enrolled in the PN pilot study. Patients will 
receive a letter and brochure describing the adapted AYA PN program at the start of the assigned stepped 
wedge phase, with a bio of their assigned navigator and how the program will help integrate primary care 
and cancer survivorship needs. We strongly anticipate navigation ‘touches’ will include progressive steps 
via a combination of delivery modes as with the existing PN programs: 1) email: patients with KP.org 
patient portal accounts will receive email communication from navigators; 2) text: patients with 
registered mobile phone in KP membership files will receive text-based communications; 3) calls: patients 
will receive calls from their navigator to discuss scheduling, overdue recommended care, and motivational 
coaching; 4) letters: patients may receive letters if unable to be reached via email, text, and calls. 
Navigators will work with the EMR to identify need for recommended healthcare services and gaps in 
care, working with the care team to pend orders for physician review and work directly with the patient 
using motivational interviewing skills to encourage participation in care, address social needs, and identify 
care goals.  
 
Intervention: System-level 
We will work closely with care teams in our participating service areas and clinics to adapt the PN program 
to suit clinical needs and workflows. We will include department administrators (DAs), who oversee 
staffing, IT needs, clinic management, and organizational goals. To deepen these insights, we will convene 
2-3 focus groups with primary care teams (nurses/physicians/advanced practice providers) and DAs using 
a semi-structured focus group format. These groups will provide feedback on the team-based care focus 
for the PN program, how to integrate seamlessly into existing clinical workflows, suggestions for use 
and/or expansion of existing KPSC IT tools (e.g., the Complete Care Model tools), and clinical needs of the 
patient population. 
 
Using adapted health IT tools, flags will be created for patients due for recommended services. Flags will 
also be created for unplanned hospitalizations and emergency department utilization to allow the 
navigators to connect with patients to offer support and assistance with care coordination during 
unplanned care episodes. These tools will allow for close collaboration between PCPs, navigators, and 
oncology teams. 
 
6.2 
FIDELITY 
 
6.2.1 INTERVENTIONIST TRAINING AND TRACKING 
 

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For the UG3 pilot study, navigator training will be overseen by the study team. Subsequent navigation 
activities will include the development of relevant PN program milestones, developed based on 
established recommendations for survivorship navigation metrics and the input from our adaptation 
processes. These will likely include patients contacted, timing of contacts, engagement activities (e.g., use 
of motivational interviewing, PMT documentation in the EMR), pending orders for physician review for 
overdue services (e.g., labs, imaging related to cancer surveillance or primary care needs). Monthly review 
of navigation milestones and metrics will be discussed in study team meetings, and navigators will meet 
at least quarterly with the care team in the clinic to review patient metrics. 
 
6.3 
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
 
N/A 
 
6.4 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE 
 
For the UG3 pilot study, we will track patient participant contacts with the navigator (e.g., emails, phone 
calls). While there is no set number of ‘correct’ patient contacts, we anticipate all patients to have at least 
one contact to be considered adherent. Patient participation in the survey will be tracked and  response 
rates calculated, although survey participation will not be required to participate in the navigation 
program.. 
 
6.5 
CONCOMITANT THERAPY 
 
N/A 
6.5.1 RESCUE THERAPY 
N/A 
 
7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
 
7.1 
DISCONTINUATION OF STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
 
When a subject discontinues from the AYA PN cancer survivorship program but not from the study, 
remaining study procedures will be completed as indicated by the study protocol. If a clinically significant 
finding is identified after enrollment, the investigator or qualified designee will determine if any change 
in participant management is needed. Any new clinically relevant finding will be reported as an adverse 
event (AE). 
 
The data to be collected at the time of study intervention discontinuation will include the following: 
 

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•  The reason(s) for discontinuing the participant from the intervention, and methods for determining 
the need to discontinue 
•  Where the participant will be receiving survivorship care. 
7.2 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
 
Participants are free to withdraw from participation in the pilot study at any time. An investigator may 
discontinue a participant from the study for the following reasons: 
 
•  Significant study intervention non-compliance, unless varying compliance is an aspect of the study 
objectives; 
•  Lost-to-follow up; unable to contact subject (see Section 7.3, Lost to Follow-Up) 
•  Any event or medical condition or situation occurs such that continued collection of follow-up study 
data would not be in the best interest of the participant or might require an additional treatment that 
would confound the interpretation of the study; 
•  The participant meets an exclusion criterion (either newly developed or not previously recognized) 
that precludes further study participation. 
 
The reason for participant discontinuation or withdrawal from the study will be recorded on the Case 
Report Form (CRF). Subjects who receive the study intervention, and subsequently withdraw, or are 
discontinued from the study, will not be replaced. 
7.3 
LOST TO FOLLOW-UP 
 
We will track all utilization within KPSC until disenrollment from KP health insurance or death. 
 
For focus groups and surveys, a participant will be considered lost to follow-up if he or she does not 
respond to multiple contacts to complete the survey and/or focus group after agreeing to do so. 
 
The following actions must be taken if a participant fails to complete the focus group interview or return 
the survey: 
 
•  The site will attempt to contact the participant or resend the survey, and ascertain if the participant 
wishes to and/or should continue in the study. 
•  Before a participant is deemed lost to follow-up, the investigator or designee will make every effort 
to regain contact with the participant. These contact attempts will be documented in the participant’s 
study file. 
•  Should the participant continue to be unreachable, he or she will be considered to have withdrawn 
from the study aim with a primary reason of lost to follow-up. 
 
For the pilot study, a patient will be considered lost to follow-up if the following: 
 
• 
We attempt to contact the participant, reschedule the missed contacts, counsel the participant 
on the importance of maintaining the assigned visit schedule and ascertain if the participant 
wishes to and/or should continue in the study. 

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• 
Before a participant is deemed lost to follow-up, the investigator or designee will make every 
effort to regain contact with the participant (where possible, 3 telephone calls and, if necessary, 
a certified letter to the participant’s last known mailing address or local equivalent methods). 
These contact attempts will be documented in the participant’s medical record or study file.  
• 
Should the participant continue to be unreachable, he or she will be considered to have 
withdrawn from the study with a primary reason of lost to follow-up. 
 
8 
STUDY ASSESSMENTS AND PROCEDURES 
 
8.1 
ENDPOINT AND OTHER NON-SAFETY ASSESSMENTS 
 
UG3 pilot study 
Patients will complete brief surveys of key domains relating to patient navigation services: self-efficacy 
(the Perceived Health Competence Scale), measures of care coordination and communication from the 
Care Coordination Quality Measures developed by AHRQ, and measures of barriers to care (e.g., non-
adherence due to cost, access issues) and provider communication from the MEPS. The MEPS patient-
provider communication scale evaluates discussions about: 1) cancer follow-up care; 2) late or long- 
term treatment effects; 3) lifestyle recommendations; and 4) emotional or social needs. While other 
measures may offer more comprehensive scales of these domains, we wish to be mindful of participant 
time and likelihood of participation based on survey length and will therefore limit to these most highly 
relevant measures. Patient surveys will also include questions on ways to improve or change the PN 
program elements as well as contact and engagement methods for patients.  
Clinician and administrator surveys will include questions on ease of clinical workflow integration, 
familiarity with the PN program, and open-ended questions on ways to improve the PN program from 
a clinical or administrative perspective.  
Both patient and clinician/administrative surveys will include validated measures of acceptability, 
appropriateness, and feasibility of the PN program, developed by Weiner et al, as well as questions 
about survey contact methods and reasons for participation and hypothesized reasons for non-
participation (e.g., “Why do you think someone would decide not to participate in this survey?”). This 
will help refine the survey outreach for the UH3 pragmatic trial. 
Navigation activities will be tracked with number of contacts, mode of contact, timing of contact, number 
of pended orders, and other metrics reviewed monthly and consolidated.  
 
8.2 
SAFETY ASSESSMENTS 
 
Collection of observational data from administrative and clinical databases, self-reported demographics 
from the PRO surveys, and intervention activities at the KPSC medical centers will be collected and 
discussed at weekly project meetings. During monthly investigator meetings, data and recruitment 
summary reports of demographic and clinical information will be presented. Recruitment strategies will 
be brainstormed for optimization as needed. Recruitment success by racial/ethnic categories will be 
monitored closely and reported in National Institutes of Health (NIH) progress reports and to the Project 
Officer (PO) and/or Safety Monitoring Board (DSMB) no less than annually. 

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8.3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
 
8.3.1 DEFINITION OF ADVERSE EVENTS 
 
We believe this study poses no more than minimal risk to subjects and the protocol uses the definition of 
adverse event (AE) from the KPSC IRB: (a) any unfavorable medical or psychological events experienced 
by a study participant during clinical research, including: a) a new symptom; b) worsening of an existing 
condition; or a clinically significant abnormal lab finding. AEs are considered a reportable unanticipated 
problem (UP) -- e.g., reportable to the KPSC IRB -- if they meet all three criteria for an unanticipated 
problem: 
 
• 
Unexpected in nature, severity, or frequency 
• 
Related or possibly related to participation in the research 
• 
Suggests greater risk to participants or others than previously known 
 
Patients with local and regional cancer who survived their cancer therapy and are at least 1 year out 
from diagnosis will be enrolled in the pilot study. The pilot study time interval is quite short (estimated 6 
months) and the intervention is unrelated to a drug or device; thus, it is unlikely that many patient 
participants will have a significant adverse event related to the pilot study.  
 
In the event that an AE is determined, it must be reported to the IRB within 10 business days and at the 
continuing review period. 
 
AE/SAE Attribution Scale. We will calculate overall rates of occurrence of SAEs (number of SAEs per 
person-month) by extracting EMR/administrative data monthly to identify signals that might indicate 
potential harm. 
8.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS 
 
As defined by the KPSC IRB, a serious adverse event (SAE) includes: 
 
•  Death 
•  Life threatening condition/situation 
•  An enduring or significant incapacity or substantial disruption of the ability to conduct normal life 
functions 
•  The delivery of a child with congenital anomaly or birth defect 
•  Other medical events that the PI determines require intervention to prevent the above outcomes 
 
8.3.3 CLASSIFICATION OF AN ADVERSE EVENT 
8.3.3.1 SEVERITY OF EVENT 
 

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The PI must take action to protect the study participant(s) or others from the unexpected risk of harm. 
For AEs not included in the protocol defined grading system, the following guidelines will be used to 
describe severity: 
 
•  Mild - Events require minimal or no treatment and do not interfere with the participant’s daily 
activities. 
•  Moderate – Events result in a low level of inconvenience or concern with the intervention measures. 
Moderate events may cause some interference with functioning. 
• 
Severe – Events interrupt a participant’s usual daily activity and may require systemic drug therapy or 
other treatment. Severe events are usually potentially life-threatening or incapacitating. Of note, the 
term “severe” does not necessarily equate to “serious 
8.3.3.2 RELATIONSHIP TO STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
 
All AEs will have their relationship to study procedures, including the intervention, assessed by an 
appropriately trained clinician based on temporal relationship and his/her clinical judgment. The degree 
of certainty about causality will be graded using the categories below. 
 
•  Related – The AE is known to occur with the study procedures, there is a reasonable possibility that 
the study procedures caused the AE, or there is a temporal relationship between the study 
procedures and the event. Reasonable possibility means that there is evidence to suggest a causal 
relationship between the study procedures and the AE. 
•  Not Related – There is not a reasonable possibility that the study procedures caused the event, 
there is no temporal relationship between the study procedures and event onset, or an alternate 
etiology has been established. 
8.3.3.3 EXPECTEDNESS  
 
The PI will determine if the event or incident is unexpected in nature, severity, or frequency, taking into 
consideration: 
 
•  The protocol-related documents, including: 1) IRB-approved research protocol or research 
application; or 2) other sources of information 
•  The PI’s knowledge of the characteristics of the study population 
•  The expected progression of any underlying diseases or conditions of the participants 
•  The participant’s pre-existing conditions and risk profile for the event 
8.3.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
 
The occurrence of an AE or SAE may come to the attention of study personnel from review of electronic 
medical record data or from a study participant contacting the patient navigator.  
 
All AEs, not otherwise precluded per the protocol, will be captured on the appropriate CRF. Information 
to be collected includes event description, time of onset, clinician’s assessment of severity, relationship 
to study procedures (assessed only by those with the training and authority to make a diagnosis), and 
time of resolution/stabilization of the event. All AEs occurring while on study will be documented 
appropriately regardless of relationship. All AEs will be followed to adequate resolution. 

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Any medical or psychiatric condition that is present at the time that the participant is screened will be 
considered as baseline and not reported as an AE. However, if the study participant’s condition 
deteriorates at any time during the study, it will be recorded as an AE. 
 
Changes in the severity of an AE will be documented to allow an assessment of the duration of the event 
at each level of severity to be performed. Documentation of onset and duration of each episode will be 
maintained for AEs characterized as intermittent. 
 
The PI and/or project manager will record events with start dates occurring any time after informed 
consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study 
participation. 
8.3.5 ADVERSE EVENT REPORTING  
 
The PI will report AEs that are determined to be unanticipated problems to the KPSC IRB within 10 
business days of discovery and at the continuing review period. 
8.3.6 SERIOUS ADVERSE EVENT REPORTING  
 
The PI will be responsible for conducting an evaluation of a SAE based on the unanticipated problem 
analysis and shall report the results of such evaluation to the NIH and the KPSC IRB as soon as possible, 
but no event later than 10 working days after the investigator first learns of the event. In the event of the 
death of a study participant, reporting will fall under one of the following pathways: 
 
(1) Death of an intervention study participant + unanticipated problem determination – the PI will 
report to the Institutional Review Board within 1 business day of discovery and at continuing 
review 
(2) Death of an intervention study participant + NOT an unanticipated problem – the PI will report at 
continuing review 
(3) Death of a non-interventional study participant – the event is not reportable 
8.3.7 REPORTING EVENTS TO PARTICIPANTS  
 
N/A 
8.3.8 EVENTS OF SPECIAL INTEREST  
 
N/A 
8.3.9 REPORTING OF PREGNANCY  
 
N/A 
 
8.4 
UNANTICIPATED PROBLEMS 

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8.4.1 DEFINITION OF UNANTICIPATED PROBLEMS 
 
As per the definition provided by the KPSC IRB we will consider any AE under this protocol a reportable 
unanticipated problem (UP) if the event meets all three criteria: 
 
•  Unexpected in nature, severity, or frequency 
•  Related or possibly related to participation in the research 
• 
Suggests greater risk to participants or others than previously known 
 
Corrective actions or changes that may be considered in response to a UP are: 
 
•  Modification of inclusion or exclusion criteria to mitigate the newly identified risks 
• 
Implementation of additional safety monitoring procedures 
•  Suspension of consenting/enrollment of new participants or halting of study procedures for 
consented/enrolled participants 
•  Modification of informed consent documents to include a description of newly recognized risks 
• 
Provision of additional information about newly recognized risks to previously consented/enrolled 
participants 
 
8.4.2  UNANTICIPATED PROBLEMS REPORTING  
 
The PI will report UPs to the reviewing KPSC IRB. The UP report will include the following information: 
 
•  Protocol identifying information: protocol title and number, Principal Investigator’s name, and the IRB 
project number 
•  A detailed description of the event, incident, experience, or outcome 
• 
An explanation of the basis for determining that the event, incident, experience, or outcome 
represents an UP 
•  A description of any changes to the protocol or other corrective actions that have been taken or are 
proposed in response to the UP 
 
To satisfy the requirement for prompt reporting, UPs will be reported using the following timeline: 
 
•  UPs that are SAEs will be reported to the IRB and the study funding agency within 10 business days of 
the investigator becoming aware of the event; within one day in the event of the death of a participant 
if determined a UP. 
•  Any other UP will be reported to the IRB and to the funding agency within 10 business days of the 
investigator becoming aware of the problem 
 
8.4.3 REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS  
 
N/A 
 
 

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9 
STATISTICAL CONSIDERATIONS  
 
9.1 
STATISTICAL HYPOTHESES 
 
As the UG3 phase focuses on adaptation of existing navigation programs, we do not have formal 
hypotheses for these aims.  
 
9.2 
SAMPLE SIZE DETERMINATION 
 
Qualitative data collection does not require power analysis. The focus groups have a target sample size of 
6-8 participants per group, as recommended as best practice.  
 
The single-arm pilot study will target 15-25 patient participants with estimates based on a reasonable 
number of participants to test the adapted navigation methods (e.g., patient contacts, navigation goals) 
and to provide insights into their care experiences within the program via patient survey. Similarly, 
clinicians/administrators at the pilot study site will be asked to complete a survey on their experiences 
with the program. Power analyses are not appropriate for these aims.  
 
9.3 
POPULATIONS FOR ANALYSES 
 
N/A 
 
9.4 
STATISTICAL ANALYSES 
9.4.1 GENERAL APPROACH 
 
UG3 phase: Focus groups and surveys 
Focus groups: Each group session will last approximately 1.5-2 hours and will be audio-recorded with 
an experienced notetaker present; recordings will be transcribed by a professional transcription 
vendor.  
We will use NVivo qualitative software to guide the analysis. Using a team coding approach relying on 
multiple coders (e.g., 2-3 research staff with qualitative research experience), we will generate initial 
coding categories from the preliminary research questions to create a start list of codes. Using the 
constant comparative method, coders will independently review the transcripts, applying the start lists 
of codes to the text, as well as generating their own emergent coding categories and analytical memos 
We will incorporate the FRAME into the qualitative analyses to identify both processes and reasons for 
adaptation (e.g., who participated, goals, contextual adaptations). 
Survey Data Collection and Analysis. We will collect demographic information (e.g., age, race, 
ethnicity, census-level education and income) and clinical information (e.g., date of cancer diagnosis, 
age at diagnosis, disease stage, cancer treatment type, tumor genomics) from the EMR and tumor 
registry for all participants. We will collect for clinician variables such as gender, race, and years in 

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practice from the EMR. Sex as a potentially important biologic factor will be included in all analyses. 
Use of existing data in the EMR can other databases is in alignment with the highly pragmatic nature 
of the trial. 
We will create descriptive summary tables of results. We did not do a formal power analysis for the 
pilot data, as this will be only one clinic site and the purpose is to identify areas needing additional 
refinement prior to the launch of the pragmatic trial. 
 
9.4.2 ANALYSIS OF THE PRIMARY ENDPOINT(S) 
  
As described above. 
 
9.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
 
N/A 
 
9.4.4 SAFETY ANALYSES 
 
N/A 
 
9.4.5 BASELINE DESCRIPTIVE STATISTICS 
 
N/A 
 
9.4.6 PLANNED INTERIM ANALYSES  
 
N/A 
 
9.4.7 SUB-GROUP ANALYSES 
 
N/A 
 
9.4.8 TABULATION OF INDIVIDUAL PARTICIPANT DATA 
 
N/A 
 
9.4.9 EXPLORATORY ANALYSES 
 
N/A 
 

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10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
 
10.1.1 INFORMED CONSENT PROCESS 
 
10.1.1.1 CONSENT/ASSENT 
AND 
OTHER 
INFORMATIONAL 
DOCUMENTS 
PROVIDED 
TO 
PARTICIPANTS 
 
For this study, a waiver of informed consent will be required to identify KPSC AYA cancer survivors by 
condition who are eligible for enrollment into the adapted PN program pilot study and inclusion in the 
focus group recruitment sample. We do not foresee any risks to potential participants by not directly 
consenting them to participate for identification by condition. This study poses minimal risk to AYA cancer 
survivors because survivorship cancer care will be performed as part of routine medical care that is 
consistent with guidelines from professional societies and organizations. The pilot adapted PN program 
will focus on directing enrolled AYA patients to guideline-recommended services that already exist, 
essentially bridging service gaps for this population. In addition, participation in the adapted PN program 
will be voluntary. We also believe that such a waiver of consent is not only widely recognized as necessary 
an appropriate, but also scientifically necessary and ethically justifiable under the “Common Rule” for 
protection of research participants (45 CFR 46.116d). We also requested a HIPAA authorization waiver for 
the identification of KSPC AYA cancer survivors for potential enrollment into the pilot adapted PN program 
and inclusion in the focus group recruitment sample. It will be prohibitive to contact patients directly for 
identification by condition and this study poses no more than minimal risk to privacy and confidentiality 
of study participants. 
 
For patient, clinician, and administrator focus groups and surveys: 
 
• 
For the UG3 phase patient focus groups, we will submit modifications to the KPSC IRB that include 
consenting and HIPAA procedures and forms before conducting the interviews. In addition, we will 
request a waiver of informed consent for the clinician and administrator focus groups.  
• 
Should the UG3 phase of the study be successful and we receive funding for the UH3 trial phase, we 
will submit all necessary focus group and survey recruitment and consenting procedures, including 
patient-, clinician, and administrator-facing written consent forms/oral consent procedures, 
recruitment scripts, etc. to the KPSC IRB for approval. We will update this protocol at the time these 
forms and procedures are approved by the KPSC IRB.  
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
 
Consent procedures and documentation for all patient, clinician, and administrator focus group and 
survey activities for the UG3 and UH3 phases of this study will be approved via future modifications to the 
KPSC IRB PRIOR to the conduct of any of these activities with participants. Updates to this protocol will 

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be made at the time we receive approval from the KPSC IRB for any modification requests related to 
consenting and documentation procedures for the focus group and survey activities.   
 
10.1.2 STUDY DISCONTINUATION AND CLOSURE 
 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause. Written notification, documenting the reason for study suspension or termination, will be provided 
by the suspending or terminating party to study participants, investigator, funding agency, and regulatory 
authorities. If the study is prematurely terminated or suspended, the Principal Investigator (PI) will 
promptly inform study participants, the KPSC IRB, and sponsor/funding agency and will provide the 
reason(s) for the termination or suspension. Study participants will be contacted, as applicable, and be 
informed of changes to study visit schedule. 
 
Circumstances that may warrant termination or suspension include, but are not limited to: 
 
•  Determination of unexpected, significant, or unacceptable risk to participants 
•  Demonstration of efficacy that would warrant stopping 
•  Insufficient compliance to protocol requirements 
•  Data that are not sufficiently complete and/or evaluable 
•  Determination that the primary endpoint has been met 
•  Determination of futility 
 
The study may resume once concerns about safety, protocol compliance, and data quality are addressed, 
and satisfy the funding agency, KPSC IRB, or other relevant regulatory or oversight bodies (OHRP, DSMB).] 
 
10.1.3 CONFIDENTIALITY AND PRIVACY  
 
Participant confidentiality will be maintained at all times. Each focus group and survey participant will be 
given a unique alpha-numeric identification number. No data collection form will be linked to an actual 
participant name. Any document linking the participant name to an identification number will be kept in 
a locked file separate from data collection files. All records from the study will be kept in locked files within 
the KPSC Department of Research and Evaluation. Identifying information will be removed from the final 
data sets and stored in a linked file to which only the Principal Investigator or designee(s) have access. 
Individual participants will not be identified in any reports. Additionally, study reports will be aggregated 
so that individual participants are not identified. Quotes from qualitative data will be reported using no 
name or identifying descriptors or will use pseudonyms. All investigators and research staff at 
participating sites will be required to maintain up-to-date training in human subject protection and good 
clinical practice through Collaborative Institutional Training Initiative (CITI; https://www.citiprogram.org) 
and HIPAA training. Additional security precautions include encryption, digital certification, audit logs, and 
firewall protection. 
 
The study monitor, other authorized representatives of the sponsor or funding agency, or representatives 
of the KPSC IRB may inspect all documents and records required to be maintained by the investigator, 
including but not limited to, medical records (office, clinic, or hospital) for the participants in this study. 

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The clinical study site will permit access to such records. At the end of the study, all records will continue 
to be kept in a secure location for as long a period as dictated by the KPSC IRB. 
 
Measures Taken to Ensure Confidentiality of Data Shared per the NIH Data Sharing Policies. The PI will 
ensure all mechanisms used to share data will include proper plans and safeguards for the protection of 
privacy, confidentiality, and security for data dissemination and reuse (e.g., all data will be thoroughly de-
identified and will not be traceable to a specific study participant; see Section 10.1.4 for details). Plans for 
archiving and long-term preservation of the data will be implemented as appropriate. A Certificate of 
Confidentiality is not required for this study. 
 
10.1.4 FUTURE USE OF STORED SPECIMENS AND DATA  
 
We are committed to the open and timely dissemination of study data and research outcomes to the 
broader community of health care providers, investigators, patients, health care systems, and public 
health personnel. The investigators agree to abide by the principles for sharing research resources as 
described by the National Cancer Institute’s Cancer Moonshot public access and data sharing policy. 
Publications based on the study will adhere to the NIH Public Access Policy. Study data will be de-identified 
and made available for use in subsequent studies by other investigators to the extent feasible, pursuant 
to details as outlined below. 
 
The study will also produce deliverables that will be freely available to the cancer care community 
including protocols for the interventions as well as EMR algorithms (e.g., risk-stratification), and clinician 
and patient educational tools. We will engage in presentation and publication of findings, and have 
structured each Aim to have publishable results, with an expectation of multiple opportunities for 
scientific presentations and manuscripts. 
 
Our plan to support efforts by other researchers to replicate this study in other oncology settings and 
practices, as well as for other healthcare systems that wish to test and/or implement the resulting 
products, includes: 1) sharing of a complete, detailed study protocol; 2) sharing of intervention tools 
developed during the study; and 3) sharing of de-identified datasets to the extent possible and in 
accordance with KSPC Department of Research and Evaluation policies for sharing data.* Each of these 
activities will ensure transparency as well as replication so that other researchers will be able to apply the 
same study procedures, measures and analytic approaches to similar or novel populations. Our sharing of 
de-identified data will allow researchers to consider additional or associated questions or as a basis for 
collecting new data using this study design. 
 
*Qualitative Data: Only de-identified, anonymous, thematic qualitative data will be available with no PHI 
(e.g., may include anonymous quotations). EMR Data: Only de-identified aggregated or summarized data 
(i.e., tables, graphs, summary descriptions) will be available including self-report survey data with no PHI. 
 
Metadata, other relevant data, and associated documentation: Documentation to be made available to 
the research community will include: study protocol published on ClinicalTrials.gov; semi-structured 
interview guides developed for the focus groups and interviews (provided in portable document format); 
tables of ICD/CPT codes. 
 
10.1.5 KEY ROLES AND STUDY GOVERNANCE 

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We will convene an AYA and Primary Care Survivorship Council consisting of our local Chiefs of Service for 
family and internal medicine for our 5 target Southern California medical service areas with the highest 
proportions of traditionally underserved populations. We will include our Regional Chief of Oncology and 
Regional Oncology Department Administrator, and representatives from the KPSC Complete Care 
program. We will also include our external advisors representing the lived AYA cancer survivor experience, 
AYA clinical programs, and working with underserved populations. We will recruit AYA cancer survivors 
from KPSC and from the Cactus Cancer Society to be representatives on the Council to provide feedback 
on the structure and development of the PN program. We will rely on stakeholder engagement strategies 
we have used in the past to ensure that our work is relevant and responsive. Collectively, we will develop 
a shared vision for a collaborative, team-based, patient-focused, system-enabled PN program for AYA 
patients diagnosed with cancer. At completion of the focus groups, the Council will be presented with the 
integrated findings and the draft PN program outline. The study team will create a PN program mock-up 
with the suggested adaptations and tailored components based on our qualitative data collection, PN 
program theory, and organizational resources. Council meetings will be held bimonthly with a highly 
structured approach including pre-session communication including brief polls and executive summaries 
of relevant scientific literature and program development progress, and in-meeting presentations on 
adaptation, followed by discussion and consensus measurement. Council recommendations will be 
integrated into the PN program for the study and communicated to KPSC leadership as appropriate for 
program investment, development, and scale up/sustainment. 
 
10.1.6 SAFETY OVERSIGHT 
 
The Data and Safety Monitoring Plan (DSMP) for this study includes monitoring recruitment procedures 
and potential adverse events resulting from data collection (observational data from clinical and 
administrative databases, qualitative data from focus groups and/or individual interviews, and survey 
data) and from the intervention. There are minimal physical, psychological, or other risks associated with 
the proposed research based on the Common Rule, 45 CFR 46.116d, because this study involves the use 
of routine care practices, no investigational drugs or devices, and poses little risk of physical or 
psychological harm to patients in either the patient navigation program or usual care. 
 
Therefore, we have considered our options to provide an independent review for safety; namely, 
employing either a Safety Officer (SO) or DSMB. Given the generally low risk faced by participants in this 
study, we believe that this trial can be monitored by the PI in the role of SO and the KPSC Institutional 
Review Board IRB. 

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Monitoring the Progress of Trials and the Safety of Participants.  Demographic information (e.g., age, race, 
ethnicity, census-level education and income) and clinical information (e.g., date of cancer diagnosis, age 
at diagnosis, disease stage, cancer treatment, endocrine therapy) will be collected from the electronic 
medical record (EMR) for all participants. We will collect primary care clinician variables such as clinician 
gender, race, and years in practice from the EMR.  
 
For the future pragmatic trial (UH3), we will prospectively identify adolescent and young adult (AYA) 
cancer survivors across our participating clinics using our comprehensive pathology database, Co-Path, 
combined with a text-information extraction system (a process we have used successfully in the past to 
identify newly diagnosed and on-treatment cancer patients). We will identify the end of active treatment 
(surgery, chemotherapy, and/or radiation) using our treatment databases (e.g., Beacon chemotherapy, 
Mosaiq radiation) and EMR data. This will ensure that we identify appropriate AYA cancer survivors to be 
included in the study. 
 
Collection of observation data from administrative and clinical databases, self-reported demographics 
from the surveys, and intervention activities at the KPSC medical centers will be collected by the study 
programmer and/or statistician and discussed at weekly project meetings with the PI. During monthly 
investigator meetings, data and recruitment summary reports of demographic and clinical information 
will be presented. We will review utilization of services to assess for potential harm to the intervention 
participants, including examining time to detection of cancer recurrence which will be identified using 
validated algorithms for clinical data.  Recruitment strategies for the surveys will be brainstormed for 
optimization as needed to address discrepancies in response by age, gender, and race/ethnicity. 
Recruitment success by racial/ethnic categories will be monitored closely and reported in NIH progress 
reports and to the SO/DSMB no less than annually.  
 
Participant confidentiality. A Certificate of Confidentiality is not needed. IRB mandated procedures for the 
protection of confidentiality of subject data will be carefully followed. We will use medical record numbers 
to link individual-level data across clinical and administrative databases, and these medical record 
numbers will be replaced with unique study identifiers once these linkages are made. Survey participants 
will be given a unique alpha-numeric identification number that will be retained for all data collection 
forms. All data will be stored on secured shared drives accessed only using password-protected 
computers. We will minimize emailing patient data among project team members at KPSC; no patient 
identifying information from KPSC will be sent outside KPSC. Furthermore, study team members and 
clinicians will only use KPSC email accounts to send encrypted emails, ensuring that the sender and the 
recipient can verify the identity of the sender and/or recipient. In addition, confidentiality will be a topic 
of discussion in the meetings between investigators and research staff, as well as across collaborating 
medical centers.   
 
Plans for assuring compliance with requirements regarding the identification and reporting of adverse 
events (AE) and unanticipated problems (UP) are outlined in Sections 8.3-8.4.  
 
10.1.7 CLINICAL MONITORING 
 
N/A 
 

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10.1.8 QUALITY ASSURANCE AND QUALITY CONTROL 
 
Quality control (QC) procedures will be implemented as follows: 
 
Informed consent  
• 
Aim 1: See consent procedures for focus groups; we will request a waiver of documented informed 
consent (but use of a study information sheet) and HIPAA for the focus groups.  
• 
Aim 2: We will request a waiver of documented informed consent (but use of a study information 
sheet) for the pilot study and associated surveys.   
 
Source documents and the electronic data --- Data for this study are obtained from clinical and 
administrative databases and participant self-report for the surveys.  
Intervention Fidelity — We will assess compliance with the study protocol monthly, with review of 
relevant data. We will collect utilization of navigation services for the pilot study. Clinical EMR data on 
utilization has a high degree of accuracy but will be reviewed at regular intervals to ensure quality and 
accuracy (e.g., chart review of outliers).  Interim data checks will be done in aggregate, with means, 
median, and range checks performed quarterly.  
Protocol Deviations – Throughout the study phases, we will work closely with our Institutional Review 
Board, clinical chiefs, and operational leaders to ensure patient safety, with regular review and reporting 
of adverse events and protocol deviations. 
 
Should independent monitoring become necessary, the PI will provide direct access to all trial related 
sites, source data/documents, and reports for the purpose of monitoring and auditing by the 
sponsor/funding agency, and inspection by local and regulatory authorities. 
 
10.1.9 DATA HANDLING AND RECORD KEEPING  
 
10.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
 
Demographic and clinical information will be collected from the EMR for all participants by study 
programmers under the oversight of the PI. Self-reported demographics will be collected from those who 
participate in the surveys. Transcripts of interviews will be collected from those who participate in the 
focus groups. We will collect clinician variables such as clinician gender, race, and years in practice from 
the EMR. Clinical EMR data on utilization will be reviewed at regular intervals to ensure quality and 
accuracy (e.g., chart review of outliers). Interim data checks will be done in aggregate, with means, 
median, and range checks performed quarterly. All investigators and research staff at participating sites 
will be required to maintain up-to-date training in human subject protection and good clinical practice 
through Collaborative Institutional Training Initiative (CITI; https://www.citiprogram.org) and Health 
Insurance Portability and Accountability Act (HIPAA) training. Additional security precautions include 
encryption, digital certification, audit logs, and firewall protection. 

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10.1.9.2 STUDY RECORDS RETENTION  
 
Study documents will be retained for a minimum of 2 years after cessation of study analyses. These 
documents should be retained for a longer period, however, if required by local regulations or additional 
studies using these data and resources. 
10.1.10 
PROTOCOL DEVIATIONS   
 
This protocol uses the KPSC definition of protocol deviation: a protocol deviation is a departure from the 
IRB approved research plan that – a) does not place the safety, rights, or welfare of one or more study 
participants at risk AND b) does not impact the integrity of the study. As a result of deviations, corrective 
actions will be developed by the site and implemented promptly. 
 
It will be the responsibility of the PI to use continuous vigilance to identify and report deviations at the 
next continuing review period of identification of the protocol deviation. All deviations will be addressed 
in study source documents, reported to the KPSC IRB for review per their policies. The site investigator 
will be responsible for knowing and adhering to the KPSC IRB requirements. 
 
10.1.11 
PUBLICATION AND DATA SHARING POLICY  
 
This study will be conducted in accordance with the following publication and data sharing policies and 
regulations: 
 
NIH Public Access Policy, which ensures that the public has access to the published results of NIH funded 
research. It requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds 
to the digital archive PubMed Central upon acceptance for publication. 
 
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded 
Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As 
such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be 
submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed 
journals. Data from this study may be requested from other researchers up to 5 years after the completion 
of the primary endpoint by contacting the PI. Considerations for ensuring confidentiality of these shared 
data are described in Sections 10.1.3 and 10.1.4. 
 
Details of data sharing include but are not limited to: 
 
(1) Sharing of a complete, detailed study protocol and publications 
 
We will ensure our study protocol is registered on ClinialTrials.gov prior to initiation of enrollment 
procedures. At the end of the study, we will provide an updated, detailed study protocol describing all 

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aspects of the study including the following: a) description of the study population, risk-stratification, 
sampling methods and resulting study sample; b) study design; recruitment and enrollment procedures; 
and primary care intervention components and implementation; c) data collection including programming 
algorithms to extract CPT-based utilization data; and d) copies of survey measures and data collection 
schedules and procedures. Our grant application becomes the initial draft of this protocol. This protocol 
will be updated at the end of the study planning phase to ensure that it provides a concrete, detailed, and 
specific step-by-step manual to allow replication. For reproducibility and for full transparency, any code 
or tools developed will be published along with the manuscript either through the journal website and/or 
GitHub or Open Science Framework website, which is hosted by the Center for Open Science (funded in 
part by the NIH and the National Science foundation) and is open to the public. We will also seek to publish 
this protocol in a relevant scientific journal. This and other publications generated from this study will: 
 
(1) Be deposited in PubMed Central with proper tagging of metadata after acceptance by a journal; 
(2) Will be published under the Creative Commons Attribution 4.0 Generic License or an equivalent 
license, or otherwise dedicated to the public domain; 
(3) To the extent feasible, underlying primary data will be shared simultaneously with the publication. 
 
2. Sharing of de-identified data for replication and additional studies 
 
For this study, the Investigators will provide these research data in a controlled manner to outside 
researchers who are willing to enter into formal research relationships to ensure that the data will be used 
for scientific purposes in the public interest, that patient privacy will be protected, and that all other risks 
to participants will be minimized. All such requests will be reviewed by the Investigators for scientific 
merit, human subjects considerations, and KPSC legal obligations. Primary data will reside locally within 
the Kaiser Permanente Department of Research and Evaluation. After approval of the request, a data 
sharing agreement will be created, approved, and signed. Conditions may be placed on the use of the 
data, including but not limited to, no distribution to third parties, a KPSC researcher included on the study 
team, proper acknowledgement and citation of the data providers (as indicated in the data sharing 
agreement) and the NIH grant funding, exclusive use by the data recipient in connection with a specific 
research project, for which the recipient has sole responsibility and which is explicitly described, and 
agreement not to use the data in any effort to establish the identity of the study subjects. The data 
recipient will be subject to applicable federal, state, and local laws or regulations and institutional policies 
providing additional protections for human subjects. 
 
De-identification of data: In order to protect the privacy rights of participants and confidentiality of their 
data, we will de-identify all data according to the standards set forth in the Health and Human Services 
Regulations for the Protection of Human Subjects; primary data will also be stripped of identifiers 
according to the HIPAA Privacy Rule. With input from the KPSC IRB, we will assess consent materials to 
determine whether data may be shared as contemplated in this policy. 
 
If de-identified data can be shared, the following process and procedures is to be followed: 
 
1.  Requests will be evaluated individually by the PI of this study in conjunction with the Senior Director 
of Research and/or the Executive Committee of the Department of Research and Evaluation. 
a.  Requests must be from a qualified, doctorate-level researcher; 

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b.  Requests must have a stated, achievable purpose and detailed plan that is of value to the 
clinical and/or research community. 
2.  
A data use agreement and/or data transfer agreement must be executed for all requests. This must 
include: 
a.  What data elements are to be included; 
b.  How the data will be used; 
c.  Details of any subsequent disclosure and prohibition of additional disclosure without an 
amendment; 
d.  How long the data can be used; 
e.  What will happen to the data when the project is complete 
f.  
Opportunity for review and comment. 
3.  De-identified datasets to be made available under this Plan must: 
a.  Follow the definitions of de-identification as outlined by Health and Human Services 
Regulations for the Protection of Human Subjects and the HIPAA Privacy Rule; 
b.  Use relative dates and round birth dates/ages; 
c.  De-identify entity/site of care to be to the extent possible; 
d.  Only include data to support publication. 
4.  An approval process will be in place, with required approvals from: 
a.  SCPMG practice leader (typically Regional Chief of relevant specialty) 
b.  SCPMG Area Medical Director 
c.  Senior Director of Research, Department of Research and Evaluation 
5.  There will be no associated fees. 
10.1.12 
CONFLICT OF INTEREST POLICY 
 
Any actual conflict of interest of persons who have a role in the design, conduct, analysis, publication, or 
any aspect of this trial will be disclosed and managed. Furthermore, persons who have a perceived conflict 
of interest will be required to have such conflicts managed in a way that is appropriate to their 
participation in the design and conduct of this trial. The study leadership in conjunction with NCI has 
established policies and procedures for all study group members to disclose all conflicts of interest and 
will establish a mechanism for the management of all reported dualities of interest. 
 
10.2 ADDITIONAL CONSIDERATIONS 
 
N/A 
 
10.3 ABBREVIATIONS AND SPECIAL TERMS 
 
AE 
Adverse Event 
AHRQ 
Agency for Healthcare Research and Quality 
ASCO 
American Society of Clinical Oncology 
AYA 
Adolescent and Young Adult 
COC 
Certificate of Confidentiality 
CRF 
Case Report Form 

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DAs 
Department Administrators 
DSMB 
Data Safety Monitoring Board 
DSMP 
Data Safety Monitoring Plan 
EMR 
Electronic Medical Record 
FRAME 
Focus, Reach, Ask, Model, and Encourage 
HIPAA 
Health Insurance Portability and Accountability Act  
IRB 
Institutional Review Board 
IT 
Information Technology 
KPSC 
Kaiser Permanente Southern California 
MD 
Medical Doctor 
MEPS 
Medical Expenditure Panel Survey 
NAM 
National Academy of Medicine 
NCCN 
National Comprehensive Cancer Network 
NCI 
National Cancer Institute 
NIH  
National Institutes of Health 
PHI 
Protected Health Information 
PN 
Patient Navigator or Patient Navigation 
PO 
Project Officer 
POE 
Proactive Office Encounter 
PRECIS-2 
Pragmatic-Explanatory Continuum Indicator Summary-2 
PI 
Principal Investigator 
RE-AIM 
Reach, Effectiveness, Adoption, Implementation and Maintenance 
REDcap 
Research Electronic Data Capture 
SAE 
Serious Adverse Event 
SO 
Safety Officer 
UP 
Unanticipated Problem 
US 
United States 
USPSTF 
U.S. Preventive Services Task Force 
 
 
 

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10.4 PROTOCOL AMENDMENT HISTORY 
 
 
Version 
Date 
Description of Change  
Brief Rationale 
1.0 
1/27/2026 
N/A; First Version 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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