Cultural and Linguistic Adaptation of a Telephone-Based Intervention to Treat Depression and Anxiety in Hispanic Cancer Survivors
Phase: NA
Conditions: Survivorship, Cancer, Depression, Anxiety
Sponsor: Wake Forest University Health Sciences

Cultural and Linguistic Adaptation of a Telephone-Based Intervention to Treat 
Depression and Anxiety in Hispanic Cancer Survivors 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 01220 
ClinicalTrials.gov:  NCT04430335
Protocol version date 3/15/21 
Page 1 of 31 
Co-Principal Investigators: 
Suzanne C. Danhauer, Ph.D., Associate Professor 
Division of Public Health Sciences  
Department of Social Sciences & Health Policy 
Gretchen A. Brenes, Ph.D., Professor 
Department of Internal Medicine, Section on Gerontology & 
Geriatric Medicine 
Biostatistician: 
Janet A. Tooze, Ph.D, Professor 
Comprehensive Cancer Center of Wake Forest 
Division of Public Health Sciences  
Department of Biostatistics & Data Sciences 
Co-Investigator(s): 
Dianna S Howard, MD 
Comprehensive Cancer Center of Wake Forest 
Department of Internal Medicine 
Section on Oncology and Hematology 
Alexandra Thomas, MD 
Comprehensive Cancer Center of Wake Forest University 
Department of Internal Medicine 
Section on Oncology and Hematology 
Karen A. Winkfield, MD, PhD 
Comprehensive Cancer Center of Wake Forest, 
Department of Radiation Oncology 
Study Coordinator& 
Regulatory Contact  
Meg O’Mara, MHA 
Department of Social Sciences and Health Policy 
Division of Public Health Sciences 
Wake Forest School of Medicine 
Medical Center Boulevard, Winston-Salem, NC 27157 
Study Therapists: 
Jessica Garcia, MSW, LCSW 
El Futuro 
2020 Chapel Hill Road, Suite 23 
Durham, NC 27707 
Dayhana Ray, M.S, LCMHC-A 
El Futuro 
2020 Chapel Hill Road, Suite 23 
Durham, NC 27707 
Protocol Editor: 
Kathy Walker 
Comprehensive Cancer Center of Wake Forest 
Wake Forest School of Medicine 
Medical Center Blvd 

Cultural and Linguistic Adaptation of a Telephone-Based Intervention to Treat 
Depression and Anxiety in Hispanic Cancer Survivors 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 01220 
 
 
Protocol version date 3/15/21 
 
 
 
 
 
Page 2 of 31 
 
Winston-Salem, NC 27157 
 
 
 
 
 
 
 
Participating Institution(s):  
Wake Forest University Health Sciences  
 
Version Date: March 15, 2021 
 
 
 

Cultural and Linguistic Adaptation of a Telephone-Based Intervention to Treat Depression and Anxiety 
in Hispanic Cancer Survivors 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 01220 
 
Protocol version date 3/15/21 
 
 
 
 
 
Page 3 of 31 
 
Table of Contents 
SCHEMA ............................................................................................................ Error! Bookmark not defined. 
1.0 
Introduction and Background ................................................................................................................. 7 
2.0 
Objectives .............................................................................................................................................. 7 
2.1 
Primary Objective(s) ........................................................................................................................... 7 
2.2 
Exploratory Objective(s) ..................................................................................................................... 7 
3.0 
Patient Selection .................................................................................................................................... 8 
3.1 
Inclusion Criteria ................................................................................................................................ 8 
3.2 
Exclusion Criteria ............................................................................................................................... 8 
3.3 
Inclusion of Women and Minorities ..................................................................................................... 9 
4.0 
Registration Procedures ......................................................................................................................... 9 
5.0 
Study Outcomes and Study Measures ................................................................................................... 8 
5.1 
Primary Outcome ............................................................................................................................. 10 
6.0 
Intervention Plan .................................................................................................................................. 10 
6.1 
Study-Related Activities ................................................................................................................... 11 
6.2 
Supportive Care Guidelines ........................................................................................................... 134 
6.3 
Duration of the Intervention .............................................................................................................. 14 
6.4  
Duration of Follow-Up .................................................................................................................... 116 
6.5 
Criteria for Removal from Study ..................................................................................................... 126 
7.0 
Adverse Events List and Reporting Requirements ............................................................................. 156 
8.0 
Data Management ............................................................................................................................... 18 
9.0 
Statistical Considerations ..................................................................................................................... 19 
9.1 
Analysis of Primary Objective ........................................................................................................... 19 
9.2 
Analysis of Secondary Objective ...................................................................................................... 19 
9.3 
Sample Size Justification ................................................................................................................. 19 
9.4 
Estimated Accrual Rate .................................................................................................................... 19 
9.5 
Estimated Study Length ................................................................................................................... 19 
References ...................................................................................................................................................... 20 
Appendix A – Eligibility Checklist ................................................................................................................... 223 
Appendix B – Protocol Registration Form ...................................................................................................... 245 
Appendix C -STRC Serious Adverse Event (SAE) Notification SOP  ............................................................... 26 
 

Cultural and Linguistic Adaptation of a Telephone-Based Intervention to Treat Depression and Anxiety 
in Hispanic Cancer Survivors 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 01220 
 
Protocol version date 3/15/21 
 
 
 
 
 
Page 4 of 31 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Enrollment on the study  
12-week telephone-based CBT intervention: 
A 12-chapter workbook that provides information about different techniques for 
managing anxiety and depression. Each chapter has an assignment (15 minutes daily 
to complete exercises) that helps the participant apply the technique in daily life  
Confidential 1-on-1, weekly 45-minute sessions delivered by telephone with a licensed 
bilingual mental health provider (study coach) for 12 weeks. The participant and study 
coach will review the assigned chapter and assignments during weekly telephone 
sessions. 
Referral to the study meeting the following criteria:  
• 
age≥18 years 
• 
self-identify as Hispanic ethnicity 
• 
History of (1) treated (newly diagnosed or recurrent) solid tumor cancers (Stage I, II, 
or III); (2) any stage lymphoma (Hodgkin’s or non-Hodgkin’s); (3) acute leukemia in 
remission for more than a year; (4) chronic myelogenous leukemia with stable disease 
(chronic phase disease); or (5) chronic lymphocytic leukemia (CLL) not requiring 
treatment or a change in treatment for more than 6 months. 
• 
6 months to 5 years post-treatment  
(surgery, chemotherapy, radiation therapy). The timeframe applies to the most recent 
completion of treatment if a participant had a cancer recurrence. It is acceptable to be 
on hormonal/maintenance therapies. 
• 
speak/read/understand Spanish or English 
• 
resides in North Carolina 
Consent and Screen with PHQ-9 and GAD-7 
• 
score ≥10 on the GAD-7 and/or ≥8 on the PHQ-9 
If ≤10 on the GAD-7 and 
≤8 on the PHQ-9 
 
Not eligible  
If score ≥10 on the GAD-7 
and/or ≥8 on the PHQ-9 
 
Eligible 

Cultural and Linguistic Adaptation of a Telephone-Based Intervention to Treat Depression and Anxiety 
in Hispanic Cancer Survivors 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 01220 
 
Protocol version date 3/15/21 
 
 
 
 
 
Page 5 of 31 
 

Cultural and Linguistic Adaptation of a Telephone-Based Intervention to Treat Depression and Anxiety 
in Hispanic Cancer Survivors 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 01220 
 
Protocol version date 3/15/21 
 
 
 
 
 
Page 6 of 31 
1.0 
Introduction and Background 
 
Psychological concerns are among the most commonly reported unmet needs among post-treatment 
cancer survivors.1 Up to 54% of post-treatment cancer survivors report clinically significant distress,2,3 
which is associated with multiple adverse outcomes, including mortality.4,5 Hispanic cancer survivors 
have a disproportionately higher risk of experiencing anxiety and depressive symptoms relative to non-
Hispanic whites,6-11 even up to 5 years after diagnosis.9 Further, Hispanic cancer survivors are less 
likely to receive psychosocial services than non-Hispanic whites.12 Cognitive-behavioral therapy (CBT) 
has a large evidence base demonstrating its efficacy in reducing distress, 13 anxiety, 14,15 and 
depressive symptoms14-21 among Hispanics.  
 
The pilot work extends our current work by increasing our ability to serve a broader group of cancer 
survivors (including those who speak Spanish), addressing a disparity in supportive care services 
available to Hispanic cancer survivors. The work in this pilot grant targets the needs of Hispanic cancer 
survivors in our catchment area and broadens our ability to provide psychosocial care to Hispanic 
cancer survivors (regardless of language) by obtaining critical survivor and provider feedback to 
culturally adapt an existing evidence-based intervention. 
2.0 
Objectives 
 
Building on this study team’s current NCI-funded study of a telephone-based intervention targeting 
English-speaking rural cancer survivors (5R21CA198237, MPIs Danhauer/Brenes), this study proposes 
to culturally and linguistically adapt a telephone-based cognitive-behavioral therapy (CBT) intervention 
designed to reduce anxiety and depressive symptoms for use with Hispanic cancer survivors (Spanish- 
or English-speaking). Twelve participants will be recruited to participate in the tailored CBT intervention. 
They will provide content/process feedback on the intervention and undergo assessment of relevant 
future outcomes (to be used as pilot data). Participants with either moderate or severe distress (anxiety 
and/or depressive symptoms) will complete the telephone-based intervention that will consist of a CBT 
workbook with accompanying psychotherapy by a bilingual mental health provider. Each participant will 
choose whether (s)he prefers to complete the intervention in Spanish or English (at least half of the 
participants will complete the study in Spanish). 
2.1 
Primary Objectives 
 
2.1.1 To assess the feasibility (participation, accrual, retention, adherence) of administering 
the intervention in Hispanic cancer survivors. 
 
2.1.2 To culturally adapt an existing behavioral intervention for cancer survivors based on 
stakeholder feedback. 
 
2.2 
Exploratory Objectives 
 
2.2.1 To summarize emotional distress (anxiety, depressive symptoms) and fear of recurrence 
in these post-treatment Hispanic cancer survivors. 
 
2.2.2 To describe the therapy process in terms of satisfaction with treatment and the therapist-
participant relationship. 

Cultural and Linguistic Adaptation of a Telephone-Based Intervention to Treat Depression and Anxiety 
in Hispanic Cancer Survivors 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 01220 
 
Protocol version date 3/15/21 
 
 
 
 
 
Page 7 of 31 
3.0 
Patient Selection 
Participants with moderate or severe anxiety and/or depressive symptoms.  
3.1 
Inclusion Criteria  
• 
Inclusion: age≥18 years;  
• 
Self-identify as Hispanic ethnicity 
• 
score ≥10 on the GAD-7 and/or ≥8 on the PHQ-9; 
• 
History of (1) treated (newly diagnosed or recurrent) solid tumor cancers (Stage I, II, or III); 
(2) any stage lymphoma (Hodgkin’s or non-Hodgkin’s); (3) acute leukemia in remission for 
more than a year; (4) chronic myelogenous leukemia with stable disease (chronic phase 
disease); or (5) chronic lymphocytic leukemia (CLL) not requiring treatment or a change in 
treatment for more than 6 months. 
• 
6‐60 months post‐treatment (surgery, chemotherapy, and/or radiation therapy) for cancer (If 
only received active surveillance for prostate cancer or lymphoma with no other cancer 
treatment, participant is ineligible.) The timeframe applies to the most recent completion of 
treatment if a participant had a cancer recurrence. It is acceptable to be on 
hormonal/maintenance therapies. 
• 
Must be able to speak, read, and understand Spanish or English 
• 
Resides in North Carolina  
3.2 
Exclusion Criteria  
• 
Current psychotherapy [regular appointment(s) with a mental health provider within the last 
30 days] 
• 
Self-reported active alcohol or substance abuse within the last 30 days 
• 
Past history of prostate cancer or non-Hodgkin’s lymphoma with only active surveillance 
(i.e., no surgery, chemotherapy, or radiation therapy) 
• 
Progressive cancer 
• 
Global cognitive impairment based on self-reported diagnosis of dementia.  
• 
Self-reported psychotic symptoms in the last 30 days (Item in Screening Form: “Have you 
seen things that aren’t really there or have you heard voices when no one else was around 
within the last 30 days?”) 
• 
Active suicidal ideation with plan and intent 
• 
Any change in psychotropic medications within the last 30 days  
• 
Hearing loss that would preclude participating in telephone sessions (determined by brief 
hearing assessment administered by research staff). Individuals who can compensate for 
hearing loss through the use of a hearing device or TDD phone, and through the use of such 
devices are able to communicate with the study therapist by telephone, will be included. If 
the therapist cannot communicate with the participant by telephone, the participant will be 
excluded.  
• 
Failure/inability/unwillingness to provide names and contact information for two family 
members or friends to serve as emergency contacts during the course of the study 
 
 

Cultural and Linguistic Adaptation of a Telephone-Based Intervention to Treat Depression and Anxiety 
in Hispanic Cancer Survivors 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 01220 
 
Protocol version date 3/15/21 
 
 
 
 
 
Page 8 of 31 
3.3 
Inclusion of Women and Minorities 
 
Both men and women are eligible for this open pilot trial. The entire sample (N=12) will be 
Hispanic because this is our target population. Children will not be included because the 
research topic is not relevant to children. While children may experience depression and/or 
anxiety, the treatment approach would be different from the approach used in this study that has 
been developed for use with adults. 
4.0 
Registration Procedures 
 
All patients entered on any WFBCCC trial, whether treatment, companion, or cancer control trial, must be 
linked to the study in EPIC within 24 hours of Informed Consent. Patients must be registered prior to the 
initiation of treatment.   
 
You must perform the following steps in order to ensure prompt registration of your patient: 
 
1. Complete the Eligibility Checklist (Appendix A) 
2. Complete the Protocol Registration Form (Appendix B) 
3. Alert the Cancer Center registrar by phone, and then send the signed Informed Consent Form, 
Eligibility Checklist and Protocol Registration Form to the registrar, either by fax or e-mail. 
 
Contact Information: 
Protocol Registrar PHONE (336) 713-6767 
Protocol Registrar FAX (336) 713-6772 
Protocol Registrar E-MAIL (registra@wakehealth.edu) 
            
*Protocol Registration is open from 8:30 AM - 4:00 PM, Monday-Friday. 
 
4. Fax/e-mail ALL eligibility source documents with registration. Patients will not be registered without 
all required supporting documents. 
Note: If labs were performed at an outside institution, provide a printout of the results. Ensure that the 
most recent lab values are sent. 
 
To complete the registration process, the Registrar will register the patient on the study. 
5.0 
 Study Outcomes and Study Measures 
 
Participants will have the choice to complete all study measures in either English or Spanish. 
 
Data Collection -- Self-Report (Qualitative) Measures. The research staff will obtain weekly feedback on the 
process and content of the intervention in brief (~5 minute) phone calls following the weekly telephone 
sessions. Study staff will also complete telephone assessments at baseline (Week 0), halfway through the 
intervention (Week 7), and upon completion of the intervention (Week 13). Additionally, upon completion of 
the intervention, a Q-PRO staff person will conduct a semi-structured in-depth interview designed to identify 
any issues (logistical, intervention feedback, feedback on how the process/content could work better for 
Hispanic cancer survivors) and maximize usability of the CBT workbook. These interviews will last up to 60 
minutes and be conducted over the phone. Interviews will be recorded with participants’ permission and then 

Cultural and Linguistic Adaptation of a Telephone-Based Intervention to Treat Depression and Anxiety 
in Hispanic Cancer Survivors 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 01220 
 
Protocol version date 3/15/21 
 
 
 
 
 
Page 9 of 31 
summarized. After the first 4 participants complete the intervention and in-depth interview, Q-PRO and the 
MPIs will review the data. Suggested changes will be made to the intervention and tested in the next 4 
participants. Remuneration for time will be provided. 
 
 
5.1 
Primary Outcomes  
5.1.1 Feasibility (participation, accrual, retention, adherence rates)  
To determine study feasibility, recruitment, accrual, retention, and adherence rates, 
which will be calculated as follows:  
Participation. To determine participation rate, we will track the total number of 
individuals approached, the number of individuals who met all eligibility criteria, and 
percent who agree to participate.  
Accrual. Accrual rates will be calculated by calculating the mean number of participants 
recruited per month.  
Retention. Study retention will be estimated by the proportion of participants who 
complete the Week 13 visit. Drop-out is defined as 100% minus the dropout %.  
Adherence. Intervention adherence will be estimated as the mean percentage of 
therapy or check-in sessions each participant completes. Participants must complete at 
least 9 of the 12 sessions (75%) to be considered adherent.  
5.2 
Secondary Outcomes 
5.2.1 Anxiety – GAD-7 
The GAD-753 is a self-report measure of DSM-IV symptoms of GAD. Participants rate 7 
questions on a scale of 0 (not at all) to 3 (nearly every day); one additional question 
assesses the interference of these symptoms with functioning. The first 7 questions are 
summed to create a total score. It has been validated for use in the general population70 
and in primary care.53 The GAD-7 has demonstrated good sensitivity (89%) and 
specificity (82%) in identifying GAD diagnoses when using a cut point of 10.53 It also has 
good internal consistency (alphas = 0.89-0.92) and test-retest reliability (intraclass 
correlation = .83).53,70 
5.2.2 Depressive Symptoms – PHQ-9 
The PHQ-9 is a self-report measure of DSM-IV symptoms of Major Depressive 
Disorder. Participants rate how often they have experienced nine symptoms over the 
past 2 weeks on a scale of 0 (not at all) to 3 (nearly every day). Responses are 
summed, with higher scores indicating greater depressive symptomatology. It has 
demonstrated good reliability and validity. The traditional cutoff for the PHQ-9 is a score 
≥10. However, ASCO guidelines recommend using a score ≥8, based on a study of 
cancer outpatients76 and a meta-analysis of use of the PHQ-9 for identifying depression 
in cancer patients.77 
5.2.3 Fear of Recurrence – Fear of Recurrence Inventory Severity Subscale 
The Fear of Cancer Recurrence Inventory55 (FCRI; severity subscale) will be used to 
measure self-reported fear of recurrence. This 9-item subscale measures the presence 
and severity of the intrusive thoughts or images associated with the fear of recurrence, 
and it can be used separately as a short form of the 42-item FCRI for the brief 
screening of fear of cancer recurrence. The measure is widely used and has strong 
reliability and validity (Cronbach’s α=0.75). 

Cultural and Linguistic Adaptation of a Telephone-Based Intervention to Treat Depression and Anxiety 
in Hispanic Cancer Survivors 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 01220 
 
Protocol version date 3/15/21 
 
 
 
 
 
Page 10 of 31 
6.0 
Intervention Plan 
 
Participants will have the choice to complete the intervention in either English or Spanish. 
 
Intervention Adaptation. Building on the feedback received from Aim 1 from key clinical, bilingual 
psychotherapist, and patient stakeholders (IRB00063774), we will iteratively refine the CBT workbook 
based on feedback from 12 cancer survivors receiving the intervention and completing relevant 
outcome and feasibility measures.   
 
Intervention. Participants with moderate or severe anxiety and/or depressive symptoms will participate in the 
telephone-based intervention that consists of the CBT workbook (15 minutes daily to complete exercises), 
plus psychotherapy delivered by telephone with a licensed bilingual mental health provider (45-50 minute 
sessions weekly). Two therapists who meet the following requirements have been hired to conduct the 
intervention. They meet the following qualifications: Master’s or doctoral degree in counseling, marriage and 
family therapy, psychology, or social work; licensed as an independent mental health provider in North 
Carolina; and experience with CBT. The therapists will complete study-specific training with Dr. Brenes that 
will cover study design, anxiety/depression in cancer survivors, principles of CBT, intervention delivery, and 
use of the workbook. The professionally-prepared CBT workbook focuses on cognitive-behavioral techniques 
for managing anxiety, depression, and distress. Chapters focus on the cognitive-behavioral model of 
depression and anxiety, relaxation techniques, cognitive restructuring, problem solving, worry control, 
exposure, behavioral activation, and relapse prevention. Workbook chapters target issues specific to cancer 
survivors, such as (a) fear of recurrence;2,3,29-41  (b) lasting effects of treatment on health, ongoing symptoms 
of fatigue and physiologic effects of cancer treatment;2,3,29,32,37,41,42  (c) late effects of cancer treatment (the 
possibility of developing other diseases);29,38,43  (d) concerns about reproductive ability42,44  and (e) distress 
related to changes in body image and sexuality.31,38,43 The sessions will supplement the participant's 
understanding of distress management techniques and include a review of the daily workbook exercises to 
assure understanding and maximize application in daily life. 
 
 

Cultural and Linguistic Adaptation of a Telephone-Based Intervention to Treat Depression and Anxiety 
in Hispanic Cancer Survivors 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 01220 
 
Protocol version date 3/15/21 
 
 
 
 
 
Page 11 of 31 
6.1 
Study-Related Flow Activities  
Screening and Consent Procedures 
Patients will be referred from oncology providers and the Hispanic patient navigator or from the community. 
 
 
      Pre-Visit 
We will obtain a limited HIPAA waiver to assess the potential participant’s name, contact information, and 
demographics. This information will be collected on a Pre-Visit Form that will be reviewed with potential 
participants during the screening phone contact to assess for eligibility.  
 
Informed Consent 
After making sure the patient clearly understands the study procedures and agrees to follow them, the 
patient will be asked to sign the informed consent form electronically (e.g., REDCap) or in person. If 
signed electronically, REDCap will allow the study team to access signed electronic consent forms 
immediately after signature. Patients will have the option to download a copy of the signed informed 
consent from REDCap, or a hard copy will be provided to the patient if needed.  
 
Screening 
The screening process will occur by telephone. Once a participant has signed the informed consent, 
emergency contact information will be collected and the participant will be screened for adequate hearing 
ability and additional screening criteria. The PHQ-9 and GAD-7 will be administered. If the participant is 
eligible based on the scoring of the PHQ-9 and GAD-7, then additional screening questions will be 
administered.   
 
The Screening Form will be reviewed with participants to confirm contact information, demographics, and 
chart information (eligibility criteria – type of cancer, month/year of diagnosis, cancer stage at time of 
diagnosis, time of last treatment, date of birth).  Additional questions will also be administered to assess 
additional eligibility criteria including an item to determine adequate hearing ability (please refer to the next 
paragraph for additional hearing ability information), telephone access, and language preference.   
 
To determine adequate hearing ability, the participant is asked to repeat the phrase, “I have a cat so all I 
need is a dog.”  If the participant is able to repeat this phrase correctly, staff will continue with screening.  
If the participant is unable to repeat the phrase correctly after a second attempt or if staff thinks hearing is 
a problem, the participant will be considered ineligible and will not be screened further.  Participants with a 
circumstance that could affect the ability to hear at the time of the call (illness, hearing aid problem, in 
process of obtaining hearing aid, etc.) can reschedule.   
 
We will also collect information from the participant’s medical chart, including type of cancer, month/year 
of diagnosis, cancer stage at time of diagnosis, time of last treatment. 
 
If a participant is not eligible or declines study participation at screening, screening information will be 
entered into RedCap up to the point the participant was no longer eligible or declined, and no further 
information will be collected. 
 
Baseline Testing 
If informed consent was administered by electronically/by phone, the site must receive the signed full 
informed consent prior to initiating baseline study activities. Baseline interviewer-administered measures 
and chart review must be administered and completed by study staff. Baseline measures may be 
completed over the phone with study staff or through REDCap. The baseline measure responses must be 
received within 30 days after screening with PHQ-9 and GAD-7. Replacement packets can be emailed at 

Cultural and Linguistic Adaptation of a Telephone-Based Intervention to Treat Depression and Anxiety 
in Hispanic Cancer Survivors 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 01220 
 
Protocol version date 3/15/21 
 
 
 
 
 
Page 12 of 31 
participant request. Study staff must receive the following self-administered completed forms from the 
participant prior to enrolling the participant.  
 
Baseline Measures: 
• 
Demographics 
• 
Fear of Recurrence Inventory--Severity Subscale 
 
Interviewer Administered Measures and Chart Review: 
 
Research staff will administer the following forms (see Appendices) by telephone (or in person if 
participant is in clinic) and enter the data in REDCap within 48 hours.  These forms are to be 
interviewer-administered whether the contact is by telephone or in person.  The PHQ-9 and GAD-7 
should have no missing data.   
• 
PHQ-9 (administer only if it has been >30 days since screening to reassess eligibility) 
• 
GAD-7 (administer only if it has been >30 days since screening to reassess eligibility) 
• 
Current Medication Use 
 
Chart Review: 
• 
Initial Cancer Diagnosis and Treatment Form 
• 
Additional Malignancy Diagnosis and Treatment Form 
• 
Cancer Relapse/Recurrence Form 
 
 
     Weekly 
 The study staff will obtain weekly feedback on the process and content of the intervention and 
completion of the study measures in brief (5-10 minutes) phone calls following the intervention 
sessions. The Project Manager will work to coordinate calls shortly after the end of weekly therapy 
sessions and enter responses into REDCap. 
 
Weeks 7 and 13:  
The participant will complete questionnaires and telephone interviews during week 7 and week 13 of 
the study. During week 7, the participant will complete the PHQ-9 and GAD-7. Study staff will obtain 
information about current medication use and adverse events. At week 13, patients will again 
complete the PHQ-9, GAD-7, Fear of Recurrence Inventory--Severity Subscale, client satisfaction 
item. Study staff will obtain information about cancer diagnosis and treatment information, current 
medication use, and adverse events.  
 After completing the intervention, a Q-PRO staff person will conduct a semi-structured in-depth 
interview designed to identify any issues (logistical, intervention feedback, feedback on how the 
process/content could work better for Hispanic cancer survivors) and maximize usability of the CBT 
workbook. Interviews will last up to 60 minutes and be conducted via telephone. Interviews will be 
recorded and summarized. After the first 4 participants, Q-PRO and the MPIs will review the data. 
Changes will be made and tested in the next 4 participants. Remuneration for time and transportation 
will be provided.  Individuals who are unable to afford a telephone may be provided with assistance to 
cover this expense. This will be determined on a case-by-case basis. 
Participant Enrollment  
The participant should not be enrolled until the participant is ready to start the intervention. Once 
the participant is enrolled, the study timeline begins.   
 
 
 

Cultural and Linguistic Adaptation of a Telephone-Based Intervention to Treat Depression and Anxiety 
in Hispanic Cancer Survivors 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 01220 
 
Protocol version date 3/15/21 
 
 
 
 
 
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Table 3. Study Measuresa 
Screen 
Baseline 
Wk 0 
Mid 
Wk 7 
Post 
Wk 13 
Eligibility Items 
X 
 
 
 
Hearing Screen 
X 
 
 
 
Emergency Contacts 
X 
 
 
 
Depressive Symptoms - PHQ-925,26 
X 
 
X 
X 
Anxiety Symptoms - GAD-727 
X 
 
X 
X 
Demographic 
 
X 
 
 
Fear of Recurrence Inventory Severity 
Subscale28 
 
X 
 
X 
Cancer Diagnosis & Treatment Information 
 
X 
 
X 
Current Medication Use 
 
X 
X 
X 
Adverse Event (AE) Form 
 
Complete as needed 
AE Ascertainment Form 
 
 
X 
X 
Intervention Feedback 
 
 
Weekly (Wks 1-12) 
Post-Intervention Interview 
 
 
 
X 
Client Satisfaction Item 
 
 
 
X 
Progress Notes/Session Information Form 
 
 
Weekly (Wks 1-12) 
Participant Status Change Form 
 
 
Complete as 
needed 
aIdeally all assessments will be completed within 2 weeks of when they are due, but must be completed within 6 weeks of 
the time that they are due  
6.2 
Supportive Care Guidelines-Crisis Protocol 
Anxiety is measured by the GAD-7 at baseline and weeks 7 and 13.  Depression is measured 
by the PHQ-9 at baseline and at weeks 7 and 13. When the data from either of these two forms 
are filled out, the study staff will document the scores to ensure participants have not indicated 
a significant worsening in anxiety or depression scores (1 standard deviation increase [rounded 
to the nearest integer) on the GAD-7 (Change≥4)75 or PHQ-9 (Change≥6)73 from baseline]. If 
there has been a significant change, the Project Manager will initiate the Crisis Protocol and 
complete a Crisis Protocol Event Form. During the course of a regularly scheduled participant 
contact, it may become evident that there is a need for immediate evaluation (e.g., active 
suicidal ideation, active psychotic symptoms, disorientation). Staff will be instructed to follow 
the Crisis Protocol and complete the Crisis Protocol Event Form. In both cases, the participant 
may be referred for mental health care by their primary care physician or by an emergency 
department physician.  
 
Study staff will follow the steps outlined in the Crisis Protocol and participants will receive 
information about safety precautions and procedures to follow in the event of a crisis (i.e., the 
participant becomes imminently suicidal). Because active suicidal ideation is an exclusion 
criterion for the study, we anticipate that the risk of participants becoming suicidal during the 
study will be minimal. Further, in our prior studies, no participants randomized into the study 
became imminently suicidal. All study staff (therapists, research staff) will receive training on 
the Crisis Protocol and coping with participant distress that may be experienced during the 
consent, assessment and treatment procedures. In addition, there will be regular study team 
meetings to discuss clinical issues. Dr. Brenes will review the status and progress of 
participants with the study therapists on a regular (at least monthly) basis. All participants will 
be contacted at Week 7 and Week 13 to assess the primary outcomes and depressive 

Cultural and Linguistic Adaptation of a Telephone-Based Intervention to Treat Depression and Anxiety 
in Hispanic Cancer Survivors 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 01220 
 
Protocol version date 3/15/21 
 
 
 
 
 
Page 14 of 31 
symptoms. Additionally, study therapists will attempt to reach participants who miss a session 
by calling the participant twice in a one-week period. If the therapist is unable to contact the 
participant by phone, the therapist will send the participant a letter with a request that the 
participant contact the therapist regarding interest in continuing the study sessions.  
6.3 
Duration of the Intervention 
CBT Intervention. CBT will consist of 12 individual weekly psychotherapy sessions with a 
study therapist by telephone and an accompanying workbook.  We have used this treatment 
in 4 previous RCTs.  The 12-chapter workbook focuses on techniques that have 
demonstrated efficacy in treating adults with an anxiety disorder and is currently being used 
in an ongoing for rural post-treatment cancer survivors.45,4647-51  
 
All participants receive 12 identical chapters according to their language preference. To tailor the 
intervention to anxiety and depressive symptoms, participants are instructed to choose 2 chapters 
from a menu of 5 chapters (e.g. pain, more focused information on changing behavior related to 
anxiety or depression, etc.).  Workbook chapters target issues specific to cancer survivors, such as 
(a) fear of recurrence (most commonly reported source of distress in survivors across different 
types of cancer);8,9,13,24,38–48 (b) lasting effects of treatment on health, ongoing symptoms of fatigue 
and physiologic effects of cancer treatment;38,39,42,44,48–50 (c) late effects of cancer treatment (the 
possibility of developing other diseases);14,38,45 (d) concerns about reproductive ability and higher 
risk of cancer for their children;50,51 and (e) distress related to changes in body image and 
sexuality.14,41,45  
 
There will be weekly telephone sessions with the study therapist that will last 45 to 50 
minutes. The participant and therapist will review the assigned chapter and assignments 
during weekly telephone sessions. In order to ensure privacy, every participant will be asked 
if he/she needs to reschedule the appointment due to a lack of privacy.  
 
Coach training and supervision. Study coaches will be bilingual licensed mental health 
providers who have the ability to conduct therapy in both English and Spanish.  Training will 
include use of the treatment manual, didactic presentations, readings, and role plays.  The 
competency of coaches in delivering CBT-T will be evaluated with a measure developed 
and used by Dr. Melinda Stanley.47,48  Coaches who fail to demonstrate competency (mean 
competency score < 6 on a scale of 1 to 8) will receive additional training and exposure to 
role play exercises until competency is demonstrated. Also, coaches must achieve ≥80% 
adherence across the sessions before contacting any potential participants. If any coach 
fails to achieve this level, the PI will determine if there are specific components across 
sessions that are routinely omitted or implemented incorrectly and will retrain the coach in 
the identified treatment components.   The PI will meet with the coaches weekly to discuss 
cases, review adherence and competence ratings, and answer any questions regarding the 
administration of the protocol.  Any areas of non-adherence will be reviewed with the 
coaches.   
 
 

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Wake Forest Baptist Comprehensive Cancer Center 
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6.4 
Duration of Follow Up 
Participants will be involved in a 12-week intervention and will complete the follow-up assessment 
immediately upon completion of the intervention.  
6.5 
Criteria for Removal from Study 
Participants will be removed from study for the following reasons: the protocol intervention and any 
protocol-required follow-up period is completed, serious adverse event, lost to follow-up, withdraw 
consent, PI removes from study, or death. Participants also have the option to discontinue the 
intervention but continue in the study for follow-up purposes. For subjects who are enrolled, site 
staff must contact the subject at the next study visit with at least 5 attempts.  After 5 documented 
contact attempts the subject will be considered lost to follow-up.  Site staff must complete a 
Participant Status Change Form in RedCap. 
7.0 
Adverse Events List and Reporting Requirements 
REPORTING ADVERSE AND SERIOUS ADVERSE EVENTS 
Reportable Adverse Events 
An adverse event (AE) is defined as any untoward or unfavorable medical occurrence in a human 
subject, including any clinically significant abnormal sign (for example, abnormal physical exam or 
laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the 
research, whether or not considered related to the subject’s participation in the research. The burden of 
collecting and reporting data on every possible AE is excessive and therefore, study staff will report all 
serious adverse events (SAEs) and selected described below.  
 
SAEs and AEs will be ascertained by study staff for all participants at Weeks 7 and 13. Study staff will 
administer the Adverse Event Ascertainment Form to specifically query participants about safety events 
at weeks 7 and 13. In addition, adverse events may also be reported to study staff spontaneously 
through telephone calls, emails or other correspondence. In addition to local reporting requirements, all 
SAEs and selected AEs will be recorded on the Adverse Event Form by clinic staff.  
 
AEs will be assessed according to the grade associated with the CTCAE term. AEs that do not have a 
corresponding CTCAE term will be assessed according to the general guidelines for grading used in 
the CTCAE v5.0.. A copy of the CTCAE can be found at 
http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm  
 
Serious Adverse Events  
 
Definition: Regulations at 21 CFR §312.32 (revised April 1, 2014) define an SAE as any untoward 
medical occurrence that at any dose or intervention level has one or more of the following outcomes:  
A Serious Adverse Event (SAEs) is defined if it results in ANY of the following outcomes:  
• 
Death  
• 
Life-threatening  
• 
Results in inpatient hospitalization or prolongation of existing hospitalization for ≥ 24hours  
• 
A persistent or significant incapacity or substantial disruption of the ability to conduct normal 
life functions  
• 
A congenital anomaly/birth defect  

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• 
Important Medical Event (IME) that may not result in death, be life threatening, or require 
hospitalization may be considered serious when, based upon medical judgment, they may 
jeopardize the patient or subject and may require medical or surgical intervention to prevent 
one of the outcomes listed in this definition. (FDA, 21 CFR 312.32; ICH E2A and ICH E6).  
 
Reporting Requirements for above Study Descriptions:  
• 
All unexpected hospitalizations regardless of grade  
• 
All Grade 5 toxicities (deaths-expected and unexpected)  
• 
All unexpected Grade 4 toxicities  
• 
All additional reporting requirements as outlined in the protocol  
 
 
Selected Adverse Events  
A select list of adverse events include suicide attempts, psychosis, worsening anxiety, worsening 
depression, and suicidal ideation, should be reported as an adverse event, regardless of whether they 
resulted in an ER visit or hospitalization.  
 
Definition of Worsening Anxiety or Depression  
An adverse event form should be completed for any participant who indicates a significant worsening in 
anxiety or depression scores (1 standard deviation increase (rounded to the nearest integer) on the 
GAD-7 (Change≥4) 75 or PHQ-9 (Change≥6)73,74,51 from baseline). If there is a need for immediate 
treatment (e.g., active suicidal ideation, active psychotic symptoms, disorientation, and active 
substance abuse) at any point in time, staff persons will notify the co-PIs. In both cases, the participant 
may be referred for psychiatric care. 
 
Data and Safety Monitoring:  As adverse event reports are collected, all adverse events will be 
identified and reported to the co-principal investigators. The co-principal investigators are responsible 
for the review of all adverse event reports and determining whether any changes in the study protocol 
or informed consent are required to insure subject safety and welfare.  
 
Clinical Monitoring: The co-PIs will meet with the study staff weekly to provide supervision and review 
the clinical status of all participants. Study staff will also notify at least one supervisor immediately if a 
patient shows the need for urgent treatment (e.g., suicidal intent, active psychosis). This type of 
information will be communicated immediately, with consultation about an appropriate course of action.  
 
The Data Safety Monitoring Committee (DSMC) is responsible for reviewing SAEs for WFBCCC Institutional 
studies as outlined in Appendix D. All Adverse Events that occur during protocol intervention and are coded as 
either 1) unexpected grade 4, 2) unplanned inpatient hospitalization ≥ 24 hours (regardless of grade), or grade 
5 (death) must be reported to the DSMC using the using the SAE console in WISER.  
 
All WFBCCC Clinical Protocol and Data Management (CPDM) staff members assisting a Principal Investigator 
in investigating, documenting and reporting an SAE qualifying for DSMC reporting are responsible for informing 
a clinical member of the DSMC as well as the entire committee via the email notification procedure of the 
occurrence of an SAE.  
 
 

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Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 01220 
 
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8.0 Data Management 
The PHQ-9 and GAD-7 must be entered into RedCap within 48 hours of being administered.  The 
Crisis Protocol form must be entered into RedCap at the time the form is completed with the participant. 
All other assessments must be completed within the designated study visit windows then data entered 
into RedCap by designated site staff or designated study therapist within 14 days from the date 
assessments are completed.   
 
Informed consent document 
EPIC 
Protocol registration form 
WISER/OnCore 
Depressive Symptoms - PHQ-925,26 
RedCap 
Anxiety Symptoms - GAD-727 
RedCap 
Demographic Information 
RedCap 
Fear of Recurrence Inventory Severity 
Subscale28  
RedCap 
Cancer Diagnosis & Treatment Information 
RedCap 
Current Medication Use 
RedCap 
Adverse Event (AE) Form 
WISER/OnCore 
AE Ascertainment Form 
RedCap 
Client Satisfaction Item 
RedCap 
Weekly Intervention Feedback 
RedCap 
Post-Intervention Interview 
Files on a Secure Server 
Progress Notes/Session Information Form  
RedCap 
Participant Change Status Form 
RedCap 
 
 

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Wake Forest Baptist Comprehensive Cancer Center 
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9.0 
Statistical Considerations 
9.1 
Analysis of Primary Objective 
Objective 2.1.1will provide data on feasibility, including participation, accrual, adherence, 
and retention rates. We will calculate 95% confidence intervals for each feasibility measure 
to determine the range of estimates consistent with our data. We will track the number 
approached for screening, number screened, number eligible, and the percent who agree to 
participate. For those not meeting eligibility criteria, reasons will be summarized. The 
proportion of participants and corresponding 95% CI for participants who participated in the 
intervention sessions and those who completed all assessments will be computed; we will 
also calculate the percent who complete the Week 13 visit to assess retention. We will use 
one-sample tests of binomial proportions to compare participation, adherence, and retention 
rates to the hypothesized values of 50%, 75%, and 75%, respectively.  
 
Qualitative Analyses. Interview transcripts and field notes will be reviewed independently by 
two staff members of the Q-PRO Shared Resource who will provide an integrative 
summary/synthesis of the interviews (identification of key points, potential themes, areas 
needing further exploration). The qualitative and quantitative analyses will be evaluated in a 
mixed-methods framework for consistency and discrepancies to refine the intervention for 
future studies.  
 
9.2 
Analysis of Secondary Objective 
 
8.2.1 Analysis of Exploratory Objectives 
 
In exploratory analyses, we will summarize the variables of interest (anxiety, depressive 
symptoms) fear of recurrence, satisfaction, and the therapist-participant relationship) by visit 
using descriptive statistics.  Because this is a small pilot study, this information will be used to 
estimate variability for future study planning purposes, but not to estimate effect size or to test 
hypotheses, and the analyses will be considered exploratory. 
 
9.3 
Sample Size Justification 
An N=12 sample size is quite standard for qualitative analyses to achieve thematic saturation.  
With 12 people, we will be able to calculate two-sided 95% confidence intervals around 
proportions of interest within 28%. Power is not applicable for this study in the absence of 
hypothesis testing. 
 
9.4 
Estimated Accrual Rate 
We will enroll 12 participants over six months at a rate of 2 participants per month. 
9.5 
Estimated Study Length 
The study will span one year in duration.   
9.6 
Interim Analysis Plan 
None planned.  

Cultural and Linguistic Adaptation of a Telephone-Based Intervention to Treat Depression and Anxiety 
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Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 01220 
 
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Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 01220 
 
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Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 01220 
 
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Appendix A – Eligibility Checklist 
 
 
IRB Protocol No.  
WFBCCC Protocol No. 
Study Title: Cultural and Linguistic Adaptation of a Telephone-Based Intervention to Treat Depression and Anxiety in 
Hispanic Cancer Survivors 
Principal Investigators:  Suzanne Danhauer, PhD & Gretchen Brenes, PhD 
 
Inclusion Criteria 
(as outlined in study protocol) 
Criteria 
is met 
Criteria is 
NOT met 
Source Used to Confirm * 
(Please document dates and lab results) 
Age≥18 years;  
 
□ 
□ 
 
Self-identify as Hispanic ethnicity 
 
□ 
□ 
 
Score ≥10 on the GAD-7 and/or ≥8 on the 
PHQ-9; 
 
□ 
□ 
 
History of (1) treated (newly diagnosed or 
recurrent) solid tumor cancers (Stage I, II, or III); 
(2) any stage lymphoma (Hodgkin’s or non-
Hodgkin’s); (3) acute leukemia in remission for 
more than a year; (4) chronic myelogenous 
leukemia with stable disease (chronic phase 
disease); or (5) chronic lymphocytic leukemia 
(CLL) not requiring treatment or a change in 
treatment for more than 6 months. 
□ 
□ 
 
6‐60 months post‐treatment (surgery, 
chemotherapy, and/or radiation therapy) for 
cancer (If only received 
active surveillance for prostate cancer or 
lymphoma with no other cancer treatment, 
participant is ineligible.) The timeframe applies to 
the most recent completion of treatment if a 
participant had a cancer recurrence. It is 
acceptable to be on hormonal/maintenance 
therapies. 
 
□ 
□ 
 
Must be able to speak, read, and understand 
Spanish or English 
□ 
□ 
 
Resides in North Carolina 
□ 
□ 
 
Exclusion Criteria 
(as outlined in study protocol) 
Criteria 
NOT 
present 
Criteria is 
present 
Source Used to Confirm * 
(Please document dates and lab results) 
Current psychotherapy [regular 
appointment(s) with a mental health provider 
within the last 30 days] 
 
□ 
□ 
 

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Wake Forest Baptist Comprehensive Cancer Center 
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Self-reported active alcohol or substance 
abuse within the last 30 days 
 
□ 
□ 
 
Past history of prostate cancer or non-
Hodgkin’s lymphoma with only active 
surveillance (i.e., no surgery, chemotherapy, 
or radiation therapy) 
 
□ 
□ 
 
Progressive cancer 
 
□ 
□ 
 
Global cognitive impairment based on self-
reported diagnosis of dementia.  
 
□ 
□ 
 
Self-reported psychotic symptoms in the last 
30 days (Item in Screening Form: “Have you 
seen things that aren’t really there or have 
you heard voices when no one else was 
around within the last 30 days?”) 
 
□ 
□ 
 
Active suicidal ideation with plan and intent 
 
□ 
□ 
 
Any change in psychotropic medications 
within the last 30 days  
 
□ 
□ 
 
Hearing loss that would preclude participating 
in telephone sessions (determined by brief 
hearing assessment administered by 
research staff). Individuals who can 
compensate for hearing loss through the use 
of a hearing device or TDD phone, and 
through the use of such devices are able to 
communicate with the study therapist by 
telephone, will be included. If the therapist 
cannot communicate with the participant by 
telephone, the participant will be excluded.  
 
□ 
□ 
 
Failure/inability/unwillingness to provide 
names and contact information for two family 
members or friends to serve as emergency 
contacts during the course of the study 
 
□ 
□ 
 
 
This subject is      
 eligible /  ineligible     for participation in this study. 
 
OnCore Assigned PID: ___ ___ ___ ___ ___ ___ ___ ___ ___ 
 
 
 
 
 
 
 
 
Signature of research professional confirming eligibility: _______________________  
 
Date: ___ ___ / ___ ___ / ___ ___ 
 

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Wake Forest Baptist Comprehensive Cancer Center 
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Appendix B – Protocol Registration Form 
 
DEMOGRAPHICS 
Patient: Last Name: _____________________ First Name: ___________________________ 
MRN:          ___ ___ ___ ___ ___ ___ ___ ___ DOB (mm/dd/yy): ___ ___ / ___ ___ / ___ ___ 
ZIPCODE:  ___ ___ ___ ___ ___ 
 
 
SEX:   
  Male      Female 
Ethnicity (choose one):   Hispanic 
Non-Hispanic 
Primary Diagnosis: ____________________________________________________________ 
Date of Diagnosis: ___ ___ /___ ___/___ ___ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Protocol Registrar can be contact by calling 336-713-6767 between 8:30 AM and 4:00 PM, Monday – Friday. 
 
Compete the eligibility checklist in WISER and then give the completed Eligibility Checklist and Protocol Registration Form 
must be hand delivered, faxed or e-mailed to the registrar at 336-713-6772 or registra@wakehealth.edu, respectively. 
 
 
 
 
PROTOCOL INFORMATION 
Date of Registration: 
___ ___ / ___ ___ / ___ ___ 
MD Name (last) : 
______________________       
Date protocol treatment started: 
___ ___ / ___ ___ / ___ ___ 
Informed written consent: 
(consent must be signed prior to registration) 
 YES  NO 
 
Date Consent Signed: 
___ ___ / ___ ___ / ___ ___ 
 
PID # (to be assigned by OnCore): 
___ ___ ___ ___ ___ ___ ___ ___ ____ 
 

Cultural and Linguistic Adaptation of a Telephone-Based Intervention to Treat Depression and 
Anxiety in Hispanic Cancer Survivors 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 01220 
 
 
 Appendix C – STRC Reporting Requirements 
  
  
  
Data and Safety Monitoring 
Committee (DSMC) Serious Adverse 
Event (SAE) Notification SOP 
Date: 02/11/2021 
 
Mandatory DSMC SAE Reporting Requirements in WISER 
This document describes reporting requirements of adverse events from WFBCCC Investigator 
Initiated interventional trials to the Data and Safety Monitoring Committee (DSMC). A trial is 
considered a WFBCCC Investigator Initiated interventional trial if the following criteria are met: 
 
1) The Principal Investigator (PI) of the trial is a member of a department at the Wake Forest 
University Baptist Medical Center. 
2) WFBCCC is considered as the primary contributor to the design, implementation and/or 
monitoring of the trial. 
3) The trial is designated as “Interventional” using the Clinical Research Categories 
definitions provided by the NCI in the Data Table 4 documentation. 
(https://cancercenters.cancer.gov/GrantsFunding/DataGuide#dt4) 
 
There are two distinct types of WFBCCC Investigator Initiated interventional trials based on where 
patient enrollment occurs.  These include: 
 
1) Local WFBCCC Investigator Initiated interventional trials defined as trials where all patients are 
enrolled from one of the WFBCCC sites. These include the main outpatient Cancer Center 
clinics (located in Winston-Salem) as well as WFBCCC affiliate sites located in Bermuda Run 
(Davie Medical Center), Clemmons, Lexington, High Point, or Wilkesboro. 
2) Multi-Center WFBCCC Investigator Initiated interventional trials defined as trials where 
patients are enrolled from other sites in addition to WFBCCC sites.   
There are three types of trials that are included in this category: 
a. Trials sponsored by the NCI Community Oncology Research Program (NCORP) that are 
conducted at multiple sites where the PI is a member of a department at the Wake 
Forest University Baptist Medical Center. 
b. Trials sponsored by Industry that are conducted at multiple sites and the PI is a 
member of a department at the Wake Forest University Baptist Medical Center. 
c. Trials sponsored by WFBCCC that are conducted at multiple sites and the PI is a 
member of a department at the Wake Forest University Baptist Medical Center. 
 
All Adverse Events (AEs) and Serious Adverse Events (SAEs) that occur on any patients enrolled on WFBCCC 
Investigator Initiated Interventional trials must be entered into the WISER system. The only exception to 
this requirement is for patients enrolled on NCORP trials at non- WFBCCC sites. AEs and SAEs for NCORP 
patients enrolled at WFBCCC sites must be entered into the WISER system. Once these AEs and SAEs are 
entered in WISER, certain actions must be taken regarding the reporting of specific Adverse Events to the 
DSMC. 

Cultural and Linguistic Adaptation of a Telephone-Based Intervention to Treat Depression and 
Anxiety in Hispanic Cancer Survivors 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 01220 
 
 
All Adverse Events that occur during protocol intervention (defined below) and are coded as either 1) 
unexpected grade 4, 2) unplanned inpatient hospitalization > 24 hours (regardless of grade), or grade 
5 (death) must be reported to the DSMC using the using the SAE console in WISER. 
 
A research nurse or clinical research coordinator when made aware that an adverse event meets one 
of the above criteria has occurred on a WFBCCC Investigator Initiated interventional trial, is responsible 
for informing a clinical member of the DSMC by phone (or in-person) about the adverse event. The 
nurse/coordinator should contact the treating physician prior to calling the DSMC clinical member to 
obtain all details of the SAE, as well as all associated toxicities to be recorded along with the SAE. In 
addition, this nurse or coordinator is responsible for entering the adverse event information into the 
SAE console in WISER.  Once the adverse event has been entered into the SAE console an email 
informing the entire DSMC will be generated. 
 
THESE REPORTING REQUIREMENTS APPLY TO any staff member on the study team for a WFBCCC Institutional 
Interventional trial. Ultimately, the protocol PI has the primary responsibility for AE identification, 
documentation, grading and assignment of attribution to the investigational agent/intervention. However, 
when an AE event as described above is observed, it is the responsibility of the person who observed the event 
to be sure that it is reported to the DSMC. 
 
What is considered during protocol intervention? 
During protocol intervention is considered to be the time period while a patient is on study treatment or 
during the time period within 30 days of last study treatment (even if patient begins a new (non-study) 
treatment during the 30 days). This window of 30 days should be the standard window to be used in all 
protocols unless a specific scientific rationale is presented to suggest that a shorter window can be used 
to identify events. If it is a trial sponsored by Industry and the sponsor requires a longer window for 
monitoring of SAEs, then the longer window of time specified by the sponsor should be followed. 
 
What is considered as an Unexpected Grade 4 event? 
Any grade 4 event that was not specifically listed as an expected adverse event in the protocol should be 
considered as unexpected. A grade 4 adverse event can be considered to be unexpected if it is an event 
that would not be expected based on the treatment being received or if it is unexpected based on the 
health of the patient. In either case, if there is any uncertainty about whether a grade 4 adverse event is 
expected or unexpected it should be reported to DSMC. 
 
DSMC notification responsibilities of the person (e.g., nurse) handling the reporting/documenting of the SAE in 
WISER: 
1. Make a phone call (or speak in person) to the appropriate clinical member of the DSMC 
according to the schedule as listed below (page if necessary). 
2. Enter a new SAE into the SAE module that is located in the Subject>> CRA Console in WISER 
WITHIN 24 HOURS of first knowledge of the event. Information can be entered and saved, but 
the DSMC members will not be notified until a date is entered into the  DSMC Notification Date 
Field. This will ensure that all persons that need to be made aware of the event (i.e., PI, study 
team members and DSMC members) will be notified; remember to file a copy of the 
confirmation. 
3. Document that the appropriate person(s) on the DSMC has been contacted. Indicate the name of 

Cultural and Linguistic Adaptation of a Telephone-Based Intervention to Treat Depression and 
Anxiety in Hispanic Cancer Survivors 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 01220 
 
 
the DSMC clinician that was contacted and the date and time contacted in the Event Narrative 
field in the SAE console of the particular subject. 
4. Document whether or not the protocol should be suspended based on the discussion with the 
DSMC clinician. This is the major function of the email notification. Enter whether the protocol 
should be suspended in the Event Narrative Field. 
5. Follow up/update the clinical member(s) of DSMC regarding any new developments or 
information obtained during the course of the SAE investigation and reporting process. 
 
Elements needed to complete the SAE form in the Subject Console in WISER (see Screen Shot 3): 
1. Event Date 
2. Reported Date 
3. Reported by 
4. If Grade 5, enter Death Date 
5. If Grade 5, enter Death occurred: within 30 days 
6. Event Narrative: Brief description (include brief clinical history relevant to this event, including 
therapies believed related to event). Begin narrative with the DSMC clinician who was notified and 
Date/Time notified. In addition, state attribution by DSMC clinician as either “Unrelated”, 
“Unlikely”, “Possibly”, “Probably”, or “Definitely”.  Always include the following here: 
i. DSMC clinician name, date/time contacted and comments 
ii. Date of last dose before the event 
iii. Is suspension of the protocol needed? Y/N 
7. Treating Physician comments 
8. PI comments, if available 
9. Protocol Attribution after discussion with DSMC clinician 
10. Outcome (Fatal/Died, Intervention for AE Continues, Migrated AE, Not Recovered/Not Resolved, 
Recovered/Resolved with Sequelae, Recovered/Resolved without Sequelae, Recovering and 
Resolving) 
11. Consent form Change Required? Y/N 
12. SAE Classification *This is required in order for the email notification to be sent* 
13. Adverse Event Details – Enter all details for each AE associated with the SAE. 
a. Course start date 
b. Category 
c. AE Detail 
d. Comments 
e. Grade/Severity 
f. Unexpected Y/N 
g. DLT Y/N 
h. Attributions 
i. Action 
j. Therapy 
k. Click ADD to attach the AE Detail to the SAE. 
14. Enter Date Notified DSMC -- *This is required for the email notification to be sent* 
15. Click Submit. The auto-generated notification email will disseminate within 5 minutes. If you do 
not receive an email within 5 minutes, check that you have entered the “Date Notified DSMC” and 

Cultural and Linguistic Adaptation of a Telephone-Based Intervention to Treat Depression and 
Anxiety in Hispanic Cancer Survivors 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 01220 
 
 
the “SAE Classification”. If these have been entered and the email still has not been received, take 
a screen shot of the SAE in WISER and immediately email it out to all of the DSMC members listed 
in this SOP. In the subject line, indicate that this is a manual transmission of the SAE in lieu of the 
auto-generated email. It is required that a notification goes to the DSMC members immediately so 
that their assessment can be obtained within the 24 hour period requirement. Contact the Cancer 
Center Programmer/Analyst to alert that there is an issue with the auto-generated email. 
 
The Clinical Members of DSMC to Notify by Phone or Page: 
 
Monday 
Tuesday 
Wednesday Thursday 
Friday 
Saturday Sunday 
Lesser 
Hughes 
Goodman 
Reed 
Porosnicu Seegars 
Lesser 
Hughes 
Goodman 
Reed 
Porosnicu 
Seegars 
Lesser 
Hughes 
Goodman 
Reed 
Porosnicu 
Seegars 
Lesser 
Hughes Goodman 
Reed 
Porosnicu 
Seegars 
Lesser 
Hughes Goodman 
Reed 
Porosnicu 
Seegars 
Lesser 
Hughes 
Goodman 
Reed 
Porosnicu
Seegars 
Lesser 
Hughes 
Goodman 
Reed 
Porosnicu Seegars 
 
Glenn Lesser, MD – Hematology Oncology  
Mercedes Porosnicu, MD-- Hematology Oncology  
Ryan Hughes, MD – Radiation Oncology  
Michael Goodman, MD -- Hematology Oncology  
Daniel Reed, MD -- Hematology Oncology  
Mary Beth Seegars, MD -- Hematology Oncology  
 
 
Definition of Unavailable: 
As a general guideline if the first clinician that is contacted does not respond to the phone call or page 
within 30 minutes, then initiate contact with the next DSMC clinician listed in the table above on the 
particular day the SAE is being reported. Allow up to 30 minutes for the new DSMC clinician to respond to 
a phone call or page before contacting the next member in the table. These times (30 minutes) are a 
general guideline. Best judgment as a clinical research professional should be used giving considerations 
of the time of day, severity of the SAE, and other circumstances as to when it is appropriate to contact 
backup clinicians. If the event occurs near the end of day, then leave messages (voice or email) as 
appropriate and proceed with submitting the DSMC notification form. It is important to take reasonable 
steps and to document that some type of contact has been initiated to one or more of the clinical 
members of DSMC. 
 
DSMC CLINICAN RESPONSIBILITY: 
It is the responsibility of the DSMC clinician to review all reported events, evaluate the events as they are 
reported; and communicate a response to the Investigator, event reporter and the members of DSMC. 
The review will include but not be limited to the information reported; there may be times when 
additional information is needed in order for an assessment to be made and further communication 
directly with the investigator may be warranted. DSMC reserves the right to disagree with the 
Investigator's assessment. If DSMC does not agree with the Investigator, DSMC reserves the right to 
suspend the trial pending further investigation. If there is any immediate danger or harm that could be 
present for a future patient based on the information provided in the DSMC report then an immediate 

Cultural and Linguistic Adaptation of a Telephone-Based Intervention to Treat Depression and 
Anxiety in Hispanic Cancer Survivors 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 01220 
 
 
suspension of enrollment should be considered. 
 
 
AMENDMENTS TO PREVIOUS REPORTS 
If all pertinent information is unavailable with the initial submission, once the additional information is 
available do not submit a new report. Rather, go to the original email that was sent to the DSMC and 
using that email “reply to all”. Entitle this new email “Amendment for (list date of event and patient ID)” 
this will avoid duplications of the same event. List the additional information being reported. This 
information needs to be entered into WISER as well. To do this, go to the Subject console and click SAEs 
on the left column. Click on the appropriate SAE number that needs updating. Then click Update. This 
will allow additional  information to be added. 
 
 
Acronyms 
AE – Adverse Event 
DSMC-Data and Safety Monitoring Committee 
SAE-Serious Adverse Event 
WFBCCC – Wake Forest Baptist Comprehensive Cancer Center 
NCI-National Cancer Institute 
WISER –Wake Integrated Solution for Enterprise Research 
 
Screen Shots: 
 
The following screen shots come from the SAE Console within the Subject Console in WISER. 
Screen Shot 1: 
 
 
 
 
Screen Shot 2: 

Cultural and Linguistic Adaptation of a Telephone-Based Intervention to Treat Depression and 
Anxiety in Hispanic Cancer Survivors 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 01220 
 
 
 
Screen Shot 3: 
 
Screen Shot 4: 
 
 

Cultural and Linguistic Adaptation of a Telephone-Based Intervention to Treat Depression and 
Anxiety in Hispanic Cancer Survivors 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 01220