Addressing Non-Initiation of Recommended Adjuvant Endocrine Therapy With a Culturally Informed-Intervention
Phase: NA
Conditions: Breast Cancer, Survivorship, Treatment Compliance, Treatment Adherence, Treatment Refusal
Sponsor: Massachusetts General Hospital

PROTCOL TITLE:
Addressing Non-Initiation of Recommended Adjuvant Endocrine Therapy with a Culturally Informed 
Intervention
PRINCIPAL INVESTIGATOR:
Jamie M. Jacobs, PhD
Center for Psychiatric Oncology and Behavioral Sciences 
617-643-1777
jjacobs@mgh.harvard.edu
VERSION NUMBER:
6.0
DATE:
9/5/2024

2
SECTION 1: Phase 2 RCT Study Protocol Schema
Screening patients who have delayed starting 
AET or report hesitancy to start AET
Recruitment
RCT (up to N=35)
Baseline Assessment
Initiate Intervention
(Arm A, up to N=35)
2 one-hour videoconference 
sessions with a trained NP
1-month post-baseline assessment
3-months post-baseline assessment

3
SECTION 2: Body of Protocol
1.0
Introduction .......................................................................................................................................................5
1.1
Overview ........................................................................................................................................................5
1.2
Background and Rationale .............................................................................................................................5
1.3
Preliminary Studies ........................................................................................................................................7
1.4
Innovation of Proposed Study ........................................................................................................................7
2.0
Objectives ...........................................................................................................................................................8
3.0
Research Subject Selection ...............................................................................................................................8
3.1
Partial waiver of HIPAA Authorization .........................................................................................................8
4.0
Research Subject Entry.....................................................................................................................................9
4.1
Patient Recruitment, Pre-Screening, and Enrollment Procedures..................................................................9
4.2
The Informed Consent Process ....................................................................................................................11
4.3
Registration...................................................................................................................................................12
4.4
Participant Communication Methods...........................................................................................................12
5.0
Study Design and Methods..............................................................................................................................13
5.1
Design/Study Type.......................................................................................................................................13
5.2
Selection of Instruments...............................................................................................................................13
5.3
Description of Proposed Study Intervention ................................................................................................16
5.4
Data Collection and Provisions to Protect the Privacy Interests of Subjects................................................16
5.5
Description of Study Process........................................................................................................................17
5.6
Adverse Reactions and Their Management..................................................................................................18
6.0
Provisions to Monitor the Data to Ensure the Safety of Subjects .................................................................19
7.0
Statistical Analyses..........................................................................................................................................22
7.1
Primary and Secondary Endpoints ...............................................................................................................22
7.2
Sample Size..................................................................................................................................................22
7.3
Early Stopping Rules....................................................................................................................................22
7.4
Definition of Allowance in Design for Unevaluable/Ineligible Participants................................................23
7.5
Analysis Plan................................................................................................................................................23
7.6
Handling of Missing Data in the Analysis ...................................................................................................23
8.0
References........................................................................................................................................................24
9.0
Appendices.......................................................................................................................................................27
9.1
Suggested Clinician Email Template: Request to Approach .......................................................................28

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9.2
Clinician Handout.........................................................................................................................................29
9.3
Rally Recruitment Portal Advertisement......................................................................................................30
9.4
Rally Recruitment Portal Advertisement - Spanish .....................................................................................31
9.5
Suggested Recruitment and Eligibility Phone Script ...................................................................................32
9.6
Suggested Recruitment and Eligibility Phone Script - Spanish ...................................................................33
9.7
Suggested Recruitment Voicemail Script ....................................................................................................35
9.8
Suggested Recruitment Voicemail Script - Spanish.....................................................................................36
9.9
Patient Screening Question ..........................................................................................................................37
9.10
Patient Screening Question - Spanish ..........................................................................................................38
9.11
Recruitment Flyer.........................................................................................................................................39
9.12
Recruitment Flyer – Spanish ........................................................................................................................40
9.13
Suggested Email Template for Sending a Copy of the Verbal Consent and HIPAA Authorization............41
9.14
Suggested Email Template for Sending a Copy of the Verbal Consent and HIPAA Authorization - Spanish
......................................................................................................................................................................42
9.15
Participant Locator Form– English ..............................................................................................................43
9.16
Participant Locator Form– Spanish..............................................................................................................44
9.17
Suggested Participant Email Reminder Templates ......................................................................................45
9.18
Suggested Participant Email Reminder Templates - Spanish ......................................................................46
9.19
Suggested Participant SMS Text Reminder Templates................................................................................47
9.20
Suggested Participant SMS Text Reminder Templates - Spanish................................................................48
9.21
INITIATE Welcome Letter – English .........................................................................................................49
9.22
INITIATE Welcome Letter – Spanish.........................................................................................................50
9.23
Participant Road Map...................................................................................................................................51
9.24
Participant Road Map - Spanish...................................................................................................................52
9.25
INITIATE Manual........................................................................................................................................53
9.26
Interventionist Post-session Survey..............................................................................................................54
9.27
Semi-structured Interview Guide .................................................................................................................55
9.31
Remuneration Form......................................................................................................................................57
9.32
Source Documentation Certified Copy Cover Sheet....................................................................................58
9.33
Suggested Social Media posts (Facebook, Instagram, Twitter, Reddit).......................................................59

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1.0 Introduction
1.1 Overview
The present protocol proposes to conduct a single-arm pilot trial to examine the feasibility and acceptability of a 
patient-centered, evidence-based, culturally competent, tailored intervention to encourage breast cancer 
survivors who have not begun taking adjuvant endocrine therapy (AET) to initiate the medication. Phase 1 (21- 
331) includes intervention development based on the literature, behavior change theory (described below), 
expert input from breast oncologists and nurses, and semi-structured interviews with a diverse sample of BCS 
who delayed AET initiation or are hesitant to start (N=10). In Phase 2 of the study, we are seeking to evaluate 
the feasibility and acceptability of the 2-session intervention that we develop with purposeful recruitment of 
racial/ethnic minorities. AET initiation will be measured by a self-report questionnaire. Participants will 
complete assessments at baseline, 1-month, and 3-months post-baseline measuring beliefs about AET necessity, 
satisfaction with patient-physician communication, perceived social support and quality of life. The proposed 
project is funded by an Electronic Space Systems Corporation (ESSCO) MGH Breast Cancer Research Fund 
Grant.
1.2 Background and Rationale
AET is critical for lowering risk of recurrence and preventing second primary breast cancers in stage 0- 
IIIB hormone sensitive breast cancer survivors (BCS). Female breast cancer is the most commonly 
diagnosed cancer in the U.S.; one in eight women (12%) will develop breast cancer in her lifetime.1 
Approximately 60-75% of breast malignancies are hormone sensitive1 and treated with AET to inhibit cancer 
growth, reducing recurrence and mortality by 50% and 29%, respectively.2 Surprisingly, despite overwhelming 
clinical benefits and life-saving potential, initiation of AET among BCS is suboptimal, with several failing to 
initiate3 or delaying initiation.4 On self-report, non-initiation rates range from 12.0%-19%,3,5 while objective 
measures such as pharmacy refill and medical record abstraction suggest that up to 30% of BCS do not initiate 
AET as recommended.6
BCS of a racial or ethnic minority are disproportionately less likely to initiate AET. African 
American/Black and Hispanic/Latina women have a higher mortality risk compared to Non-Hispanic Whites; 
with a 1.4-2.4-fold greater risk of breast cancer specific mortality.7 This disparity may be attributed, in part, to 
the disparity in AET initiation, with Black and Hispanic/Latina BCS being significantly less likely to initiate 
AET than White BCS.8,9,10 Although the risk of breast cancer mortality for Asian American women is variable 
and AET initiation in Asian American women is not well understood, some research has found that Asian 
American women are also less likely to initiate AET.9,10 AET use is critical and associated with a 29% relative 
risk reduction in mortality.1 Patient deviations from guideline concordant care with recommended AET are 
associated with recurrence, mortality, and poor patient-provider relationships. 11
AET initiation is a modifiable health behavior with established predictors, with some being more salient 
for minority BCS. Adherence to guideline concordant care is the single most modifiable factor that influences 
treatment outcomes for BCS.12 Modifiable factors associated with non-initiation of AET include (1) low 
perceived social support and poor communication with clinicians, (2) negative beliefs about treatment efficacy, 
and (3) fears of toxicities. First, BCS who report a lower quality of communication with their physicians, less 
social support and greater difficulty making decisions around AET treatment are less likely to initiate.3,13 
Notably, quality of communication about AET and clinician trust is rated lower among Black BCS than 
Whites.14 Among low-income Latina women, patient-centered communication may increase AET use.15 
Second, non-initiators are more likely to hold negative beliefs about therapeutic efficacy and less favorable 
attitudes towards AET.3 Across all racial and ethnic groups, discontinuation is associated with questions about 
“whether AET is helping.”16 Third, adverse effects (e.g., joint pain, hot flashes, sleep difficulties) are common 
with AET and patients who express greater fears about these side effects are less likely to initiate.3 While fears 
of side effects are present across all racial/ethnic groups, one study suggested that side effects were the most 
cited barrier to AET use among Hispanic patients.9 In addition, BCS who report receiving inadequate 
information about managing side effects are less likely to initiate.16 Ultimately, poor clinician-patient

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communication and social support, doubts about efficacy, and fears of side effects are modifiable contributors 
to AET initiation, and certain barriers are more pronounced in racial and ethnic minorities.
Interventions to improve initiation to AET are nonexistent, needed, and should be culturally sensitive. 
Despite some identified barriers to AET initiation, there are no existing interventions to increase initiation or 
address the racial/ethnic disparity in AET use. However, there is a small body of work investigating 
interventions to improve adherence (taking medication as directed) for patients already taking AET. A meta- 
analysis in 2019 identified four randomized controlled trials of interventions to improve AET adherence, with 
education delivery as the most common intervention and, not surprisingly, only one demonstrating a significant 
effect on adherence.17 Absolutely no studies targeting AET use have incorporated cultural modifications17, a 
necessity to ensure adaptation by racial and ethnic minority groups and to strengthen intervention effects on 
health behavior change.18 Another meta-analysis identified eight intervention studies to improve adherence to 
AET with an overall null effect across interventions.19 However, a sensitivity analysis showed that interventions 
using bidirectional communication were efficacious compared to those relying on one-way communication of 
information. This suggests that future interventions should enhance patient engagement and promote interactive 
discussion.
To be effective, interventions to improve initiation to AET for BCS should be multimodal, bidirectional, 
culturally competent, and convenient, targeting modifiable factors beyond the provision of information.20 
Most oncology clinicians will schedule a visit 3-4 months after prescribing AET in order to assess whether the 
patient has initiated AET and to discuss how they are tolerating the medication. It is at this visit that providers 
may discover that the patient has not started taking the medication. While this may be a helpful check-in for 
some, literature suggests that successful interventions should offer: a) support earlier on,13 b) bidirectional 
communication with clinicians,3,19 c) evidence-based techniques to address negative beliefs about AET efficacy,
d) information on expectations and management of side effects,3,16 and e) culturally-sensitive problem- 
solving.18 For example, in the breast cancer setting, encouraging patient participation has been shown to 
improve comprehension and treatment satisfaction.21 As cultural beliefs influence decisions to start AET, 
culturally competent communication and problem-solving should address these beliefs and barriers.22 In 
addition, treatment satisfaction, including communication with clinicians and nurses, predicts better adherence 
to oral anti-cancer therapy.23 Research also suggests that oncology nurses should be involved in implementing 
clinical interventions to manage barriers to AET adherence such as concerns about side effects,24 and that 
nursing involvement has the potential to prevent early disruptions in adherence to guideline concordant care25 
by facilitating shared decision-making,24 discussing benefits and concerns of AET, and providing side-effect 
coping strategies.26 In summary, to be efficacious, interventions targeting non-initiation should include 
oncology nurses, be culturally competent, and address modifiable barriers such as provider and social support, 
beliefs about therapeutic efficacy in recurrence prevention, and concerns about side effects.
To address this timely public health concern, the proposed study employs a two-phase mixed-methods 
design to develop and test a culturally competent, evidence-based, brief, two-session, nurse-led 
intervention to promote AET initiation in a diverse sample of early-stage, hormone receptor-positive BCS 
who have delayed initiation or are hesitant to start. Phase 1 (21-331) included intervention development 
based on the literature, behavior change theory (described below), expert input from breast oncologists and 
nurses, and semi-structured interviews with a diverse sample of BCS who delayed AET initiation or are hesitant 
to start (N=10). Phase 2 will be a single-arm pilot feasibility trial (up to N=35) of this intervention with 
purposeful recruitment of racial/ethnic minorities. AET initiation will be measured by a self-report 
questionnaire for the pilot study. Participants will complete assessments at baseline, 1-month, and 3-months 
post-baseline measuring beliefs about AET necessity, satisfaction with patient-physician communication, 
perceived social support, and quality of life.

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Conceptual Framework
The proposed aims are based on National Institutes of Health (NIH) guidelines for behavioral intervention 
development: The Obesity-Related Behavioral Intervention Trials (ORBIT) Model. The ORBIT model 
emphasizes 1) designing the intervention based on drivers of behavior that are treatment targets and refining 
practical intervention aspects (i.e., mode of delivery, duration) using mixed-methods such as qualitative (semi- 
structured interviews) in addition to quantitative data (satisfaction measures); and 2) conducting a feasibility 
pilot study to justify an efficacy trial. The Social Ecological Model, which maintains that factors at the 
individual, interpersonal, and community, and societal level influence health behaviors, will provide a 
framework for developing an intervention that addresses culture-specific barriers to AET initiation.27
1.3 Preliminary Studies
A subgroup of BCS does not initiate recommended AET. Dr. Jacobs is currently conducting a National 
Cancer Institute-funded study to develop and test an evidence-based, psychosocial, telehealth intervention for 
adherence, symptom management, and distress in early-stage BCS taking AET.28 The current RCT enrollment 
rate is 72%. A review of the Electronic Health Record (EHR) in the context of our current study revealed 75 
BCS who had not initiated recommended AET. Documentation indicated that women did not start due to 
concerns about side effects or fears of long-term health consequences. These BCS are ineligible for the 
adherence study, and would be eligible for the proposed study.
Adherence is strongly associated with satisfaction with clinician communication. In a prospective 
longitudinal study, our research group identified factors associated with adherence to oral anti-cancer therapy 
over time including improved satisfaction with clinician communication and treatment (B = 0.73; 95% CI, 0.49 
to 0.98), reduced perceived burden on others (B = -0.92; 95% CI, -1.76 to -0.09), and reduced symptom distress 
(B = -0.79; 95% CI, -1.41 to -0.18).23
Adherence to oral anti-cancer therapy is associated with symptom burden. In a subsequent RCT funded by 
the Patient Centered Outcomes Research Institute (PCORI), we reported that patients (N=181) took only 85.6% 
of their oral therapy according to an electronic pill cap and bottle, and that patients with greater cancer-related 
symptom severity (e.g., fatigue, sleep, memory problems, distress) had lower adherence (r=-0.20, p=.020) and 
worse quality of life (r=-.67, p<.0001), highlighting the importance of enhancing adherence and managing 
symptoms and side effects.29
Interventions to foster initiation and adherence to AET are lacking. To assess the need for interventions to 
improve adherence to oral anti-cancer therapy, we published a systematic review which revealed only three 
RCTs targeting AET adherence and no efficacious interventions.30
Patients with early-stage breast cancer can benefit from interventions. Dr. Jacobs’s previous work 
demonstrates that a skills-based intervention such as Cognitive-Behavioral Stress Management can improve 
long-term clinical outcomes,31 depression, and QOL for BCS.32 Approximately one third of this sample was a 
racial or ethnic minority.
Summary. There is a subset of BCS that does not initiate AET as recommended. We know that adherence is 
related to modifiable factors including clinician communication, symptom severity, and concerns about side 
effects. Interventions are needed to improve patient adherence to guideline concordant care with AET, and we 
have had success in administrating skills-based interventions targeting modifiable behaviors in early-stage 
breast cancer with diverse patients. The current study proposes to build on this evidence by developing and 
testing a brief, individualized nurse-led intervention to increase initiation of AET in early-stage, hormone 
sensitive BCS.
1.4 Innovation of Proposed Study
This research project aims to reduce risk of recurrence and prevent second primary breast cancer by increasing 
initiation of AET for BCS who have failed or delayed AET initiation or are hesitant to start, with particular

8
attention to Black, Hispanic/Latina and Asian American BCS. The data from this Phase 2 single-arm pilot trial 
to test a behavioral intervention developed using feedback from Phase 1 (21-331) to improve initiation, will be 
used to apply for an NIH grant to conduct a full-scale efficacy trial of the intervention. This is an area of 
important clinical investigation that does not necessitate a new treatment or technology, but rather points to the 
critical need to improve how and whether patients engage with an efficacious, life-saving therapy. In the short- 
term, this study has the potential to improve understanding of AET need and efficacy and increase initiation by 
mitigating barriers and enhancing self-efficacy. To minimize burden and increase access, we propose to deliver 
the intervention via ZOOMTM, a HIPAA-secure Massachusetts General Hospital (MGH)-approved software.
The study staff may also administer these sessions in person of via phone if necessary. This intervention has 
minimal risk and is likely to improve patient satisfaction with communication with clinicians and management 
of AET-related side effects. In the long-term, this study may improve patient outcomes by preventing second 
primary tumors, recurrence, and disease-related mortality while promoting the quality of life of BCS and 
reducing the racial and ethnic disparity in breast cancer outcomes.
2.0 Objectives

Aim 1: To examine the feasibility and acceptability of the brief nurse-led intervention in BCS who have 
delayed initiation of AET or are hesitant to start (up to N=35) and refine the intervention using 
qualitative and quantitative feedback.
Hypothesis: The study will be feasible, defined by enrollment (rate>50%), retention (completion 
rate>70%) and attendance (≥70% of participants completing at least one session). The study will be 
acceptable as demonstrated by >75% of participants reporting average satisfaction scores greater than 
the mid-point of the Client Satisfaction Questionnaire (CSQ).

Aim 2: To assess intervention-related changes in primary and secondary outcomes at one- and three- 
months post-baseline.
Hypothesis: Following the intervention, BCS will be more likely to have started their AET. We will 
explore changes in satisfaction with patient-physician communication, perceived social support, self- 
efficacy for symptom management, and quality of life.
3.0 Research Subject Selection
3.1 Partial waiver of HIPAA Authorization
We request a partial waiver of HIPAA Authorization in order for our team to perform an initial screening 
process that requires review of the electronic medical record. This partial waiver is being requested to allow the 
research team to screen the oncology clinic schedules and identify potential study participants from a minimal 
chart review. In accordance with the DF/HCC policy: (1) this Waiver is being sought solely to review Protected 
Health Information as necessary to prepare a research protocol; (2) the Waiver will not include removing 
Protected Health Information from the Covered Entity by the researcher, and (3) the Protected Health 
Information for which we are requesting access is necessary for research purposes.
For individuals who provide verbal consent to participate in the study, we will obtain HIPAA authorization, as 
described in section 4.2 (Informed Consent Process).
Table 1. 
Inclusion Criteria
1. Female
2. Age 21 or older

9
3. Diagnosis of early-stage (Stage I-IIIB), hormone receptor-positive breast cancer
4. Recommended to start AET at least 3 weeks prior and not currently taking AET OR 
recommended to start AET in the future and reports hesitations to start AET as determined 
by a score of >/= 4 (range =0-10) when asked "How hesitant are you about starting your 
recommended hormonal therapy? (0=Not at all hesitant and 10 = Extremely hesitant)"
5. Ability to read and respond in English or Spanish
6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
7. For at least 10 participants, identify as a member of a racial or ethnic minority 
community per self-report
Exclusion criteria
1. Uncontrolled psychosis, active suicidal ideation, psychiatric hospitalization within the 
past year
2. Cognitive impairment that prohibits participation in the study
3. Undergoing primary treatment for other cancer (i.e., advanced stage cancer)
4. Participating in a clinical trial involving AET
5. Diagnosis of Stage 0 (DCIS) breast cancer
Eligibility criteria (Table 1) will maximize homogeneity, reflect study focus, enhance rigor, and consider 
limitations. The intervention targets barriers to non-initiation of adjuvant endocrine therapy identified in 
women, as male patients face different challenges. While patients with metastatic cancer are also treated with 
endocrine therapy, there are different facilitators and barriers to initiation with incurable disease. Therefore, the 
focus on early-stage patients preserves the intervention scope.
Study staff will screen the EHR mentioning uncontrolled psychosis, suicidal ideation, psychiatric 
hospitalization within the past year, or cognitive impairment. If a note mentions any of the items in this 
criterion, study staff will refrain from approaching the patient. If this is not clearly documented in the EHR, the 
study staff will confer with the PI and/or discuss with the treating oncologist for further clarification and 
permission to approach.
We will aim to have at least 1/3 of the participants identifying as a racial or ethnic minority, in order to enroll a 
representative sample of experiences and concerns about AET to develop the culturally-informed intervention. 
With Spanish-speaking study staff, we will be able to enroll both English and Spanish-speaking participants. All 
materials have been translated and back-translated into Spanish with best practices for translation and quality 
control using Native Spanish speakers and an approved translation company, Linguistics Systems, Inc.
4.0 Research Subject Entry
4.1 Patient Recruitment, Pre-Screening, and Enrollment Procedures
Study staff will recruit BCS from the MGH Cancer Center and satellite sites MGH North Shore, MGH 
Waltham, MGH Cancer Center at Emerson Hospital, and MGH Cancer Center at Newton-Wellesley Hospital as 
well as the Dana-Farber Cancer Institute (DFCI) and satellite sites Milford, South Shore, Londonderry, Steward 
St. Elizabeth’s Medical Center, Merrimack Valley, and Foxborough. While screening for our current study for 
adherence to AET, we identified at least 75 BCS at MGH main and satellite clinics that did not initiate AET as 
recommended. Therefore, we anticipate there will be sufficient potentially eligible patients to meet the accrual 
goal of up to 35 participants.
We will be enriching for participants of an ethnic or racial minority background. We will be doing this by 
reaching out directly to providers for referrals.

10
The following recruitment procedures will be executed by the lead site study staff, MGH Boston, for all MGH- 
affiliate study sites and DFCI sites. The three MGH-affiliate sites and all DFCI sites will not have any 
responsibilities regarding recruitment or enrollment. All study sites will be open through the DF/HCC IRB as 
the IRB of record.
We will complete a privacy waiver with our protocol submission to the Institutional Review Board (IRB) to 
allow study staff to screen the breast oncology clinic schedules and identify patients for study participation. 
We will also use this information to describe the enrolled sample.
Multiple recruitment methods detailed below have been strategically designed to ensure successful reach and 
engagement of this population while maintaining patient safety and research compliance:

Proactive Electronic Health Record (EHR) Screening: Study staff will screen the breast cancer clinic 
schedules for demographic and clinical eligibility criteria to identify potentially eligible patients (under 
the use of a HIPAA waiver, submitted to the DF/HCC IRB). We will also use this information to 
describe the enrolled sample. Recommended AET start date will be determined from the progress note 
(e.g., patients prescribed AET prior to radiation are usually not expected to start until after radiation 
completion) and verified with the treating oncologist when necessary. If a patient is potentially eligible 
from EHR screening, study staff will request permission from the oncology clinician to approach 
patients. Specifically, study staff will email the cancer care team (i.e., oncologist, nurse practitioner) to 
inquire if they have any reservations about the study staff approaching the patient for study participation 
(Appendix 9.1). This email will also include an informative handout for clinicians to familiarize 
themselves with study aims and relevant procedures (Appendix 9.2).

Rally Recruitment Portal: Study staff will submit a recruitment advertisement to the MGB Rally 
Recruitment Portal (Appendix 9.3, 9.4). Through this portal, interested and potentially eligible patients 
will be able to send their contact information to the study staff. The study staff will then preliminarily 
assess eligibility in the EHR, and study staff will reach out to interested patients, using the study 
screening and telephone scripts to assess fit and eligibility for the study (Appendices 9.5, 9.6).

Provider and Self-Referral: Patients may be referred to contact study staff by receiving a study flyer 
(Appendices 9.11, 9.12), seeing a study flyer posted at MGH, or by hearing about the study from an 
oncology provider. Study staff will provide clinicians at other cancer institutions (e.g., Memorial Sloan 
Kettering Cancer Center, Moffitt Cancer Center, Sylvester Cancer Center (University of Miami), Tisch 
Cancer Institute (Mt. Sinai)) with recruitment materials (i.e., flyers) that can be shared with patients.

Social Media Posts: Study staff can post study advertisements on social media outlets (Facebook, 
Instagram, Twitter, Reddit) for recruitment purposes. Suggested language and postings are found in 
Appendix 9.30.
For patients meeting initial eligibility criteria and with clinician permission to approach, trained study staff will 
approach the patient at a clinic visit or by telephone to initiate the informed consent discussion and explain the 
study procedures. The study staff will first introduce the study to patients and ask if they have started taking 
their AET. If the patient indicates that they are not interested in the study, or are currently taking AET, study 
staff will collect the reason for refusal for the purposes of documentation and future study reporting. Depending 
on their reasons for refusal, study staff may request permission to re-approach some patients in the future, such 
as for later phases of this study.
For patients who engage via social media or are at other cancer institutions, they will self-report their age, 
diagnosis/staging, hormone receptor status, and ECOG score. We will aim to maximize recruitment of 
participants of a racial/ethnic minority via this method.
If the patient indicates that they are interested in the study and have not started taking their AET, the study staff 

11
will screen the potentially eligible patient. Patients will be eligible if they have been recommended AET and 
have not started taking it within three weeks of the proposed start date, or if they are recommended to start AET 
in the future (e.g., post-radiation completion) and they have significant hesitancies about starting AET. 
Hesitancy to start AET will be indicated by a score of >/=4 on the question, “how hesitant are you to start 
AET?” with 0 = not at all hesitant, and 10 = extremely hesitant. Once eligibility has been confirmed, the study 
staff will initiate the informed consent process verbally (if approached by telephone) or in-person (if 
approached in-clinic).
4.2 The Informed Consent Process
We will follow the DF/HCC Policy CON-100: Informed Consent Process to obtain and document informed 
consent. Study staff can review the study details, offer study participation, and obtain informed consent in- 
person or verbally. Both the written and the verbal consent forms describe all study procedures, information 
about potential risks and benefits of participation, and information regarding who they can contact for further 
questions. The forms also state that participation is voluntary, that participants can refuse to answer any 
questions, that they can withdraw from the study at any time, and that study participation is in no way related to 
their medical care. Study participants who do not provide consent will be asked the reason why they prefer to 
not participate in the study.

Verbal Consent Process: We are requesting an alteration of HIPAA to allow for a waiver of Written 
Documentation of Consent. This study meets the requirements for a waiver as it is a Minimal Risk 
study, and all study procedures can be communicated verbally. This Waiver will allow study staff to 
recruit participants remotely to address barriers to study enrollment including infrequent in-person visits, 
lack of space in clinic, and patients’ time constraints. Verbal consent allows for greater flexibility while 
assuring patient safety in response to changing healthcare practices. Study staff will contact potential 
participants via telephone to guide them through verbal consent forms that describe all study procedures, 
information about potential risks and benefits of participation, and information regarding who they can 
contact for further questions. The participant will be given ample opportunity to ask questions and take 
their time to consider their participation. All patients who provide verbal consent will receive an 
unsigned copy of the written informed consent. The study staff may contact eligible patients to obtain 
verbal consent using the HIPAA-compliant verbal consent form. If the patient does not answer the 
phone study staff may leave a voicemail (Appendix 9.7, 9.8).

Spanish-speaking Consent Process: Patients who speak Spanish will have all study procedures and 
information regarding risks, benefits and study contacts explained to them via the use of an interpreter 
(in-person or remotely) or a Spanish-speaking study staff member with a witness present. Study staff 
will sign the English verbal consent form and document interpreter information when necessary.

For all patients who provide consent, we will obtain HIPAA authorization. This may be done remotely 
through the REDCap platform by the patient typing their name and checking an assurance confirming 
that the typed name acts as an electronic signature or in person.

12
4.3 Registration
Participants who meet eligibility criteria and provide informed consent will be registered in the Clinical Trials 
Management System (CTMS) OnCore, as required by per DF/HCC SOP REGIST-101. Registration will occur 
once the participant has completed the baseline assessment. Study staff will complete the protocol-specific 
eligibility checklist, verifying that the participant meets all inclusion and exclusion criteria.
4.4 Participant Communication Methods
It is important to access and maintain contact with participants through communication methods they are most 
comfortable with, including phone, text, and email correspondence. During the informed consent process, study 
staff will elicit patient preferences about methods of study contact to facilitate participation (e.g., scheduling 
study intervention sessions, sending reminders, etc.). The limitations of each method will be described to them 
in detail by the research coordinator. Specifically, patients may opt to pursue communication with study staff 
via phone, text, or email correspondence. Phone and email communication have been successful strategies to 
communicate with patients in prior psychosocial studies, and email and SMS text templates intended for study 
use can be found in Appendices 9.17, 9.18, 9.19, 9.20.
SMS Messaging. Participants may elect to provide a personal mobile phone number and provide 
permission to receive SMS messages via an online service (GoogleVoice) regarding the study 
that the study staff will monitor. Before doing so, participants will be informed of the limitations 
of using GoogleVoice, particularly emphasizing that it is not HIPAA-compliant and thus does 
not offer protection over their personal health information. Additionally, participants will be 
informed that this phone number is not monitored regularly and should not be used for urgent or 
emergency purposes. Participants will be advised that, in the case of an emergency, they should 
contact their care team or emergency services. In the event participants still prefer the use of text 
messaging, study staff will send brief messages containing limited information regarding 
intervention session reminders. Participants will be provided with the number for SMS study- 
related communications. Study staff will follow the templates as outlined in Appendix 9.19 and 
9.21 for SMS communication. Under the discretion of trained study staff and extenuating 
circumstances, study staff may stray from the following templates to address 
scheduling/reminder situations not covered by the message templates. Under no circumstances 
will study staff ever screen or discuss personal medical history, exchange personal health 
information, or other sensitive information via SMS message. If a participant introduces 
sensitive information, including but not limited to the examples just listed, into a SMS message 
conversation, the study staff member will direct the participant to call them to discuss it further 
over the phone.

Send Secure Email. Participants will be provided with the Partners Privacy language regarding 
encrypted emails and given the opportunity to opt-out of Send Secure emails. In previous 
psychosocial studies, participants have articulated difficulties with accessing encrypted emails 
and prefer the option to opt-out of such method of encrypted communication.

13
5.0 Study Design and Methods
5.1 Design/Study Type
The present protocol proposes to examine the single-arm pilot trial to examine feasibility and acceptability of a 
patient-centered, evidence-based, culturally competent, tailored intervention to encourage breast cancer 
survivors who have not begun taking adjuvant endocrine therapy to initiate the medication, enriching for Black, 
Hispanic/Latina, and Asian American BCS. AET initiation will be measured by a self-report questionnaire.
Participants will complete assessments at baseline (within 14 days of consent), 1-month, and 3-months post- 
baseline measuring beliefs about AET necessity, satisfaction with patient-physician communication, perceived 
social support and quality of life.
5.2 Selection of Instruments
Instrument/Measure
Screening
Baseline 
(14-day 
window)
1-month 
follow-up 
(+/- 7 day)
3-month 
follow-up 
(+/- 7 day)
Chart Review
X
Screening Questions 
(AET initiation)
X
Demographics
X
AET Initiation Question
X
X
X
Functional Assessment of 
Chronic Illness Therapy- 
Treatment Satisfaction-Patient 
Satisfaction (FACIT-TS-PS)
X
X
X
Beliefs about Medicines 
Questionnaire – Adjuvant 
Endocrine Therapy 
(BMQ-AET)
X
X
X
Multidimensional Scale of 
Perceived Social Support 
(MSPSS)
X
X
X
Functional Assessment of Cancer 
Therapy-Breast
(FACT-B)
X
X
X
Hospital Anxiety and Depression 
Scale (HADS)
X
X
X
Self-Efficacy for Managing 
Symptoms Questionnaire 
(Self-Efficacy for Symptoms)
X
X
X
Measure of Current Status – Part 
A (MOCS)
X
X
X
Client Satisfaction Questionnaire 
(CSQ)
X
Screening:
EHR Factors: The following information will be collected from participant EHR: MGH Main vs Affiliate site vs 
DFCI sites, demographic information, breast cancer stage, treatment (e.g., surgery, chemotherapy, radiation), 
AET type, approximate recommended AET start date, and medical or psychological co-morbidities.

14
AET Initiation questions: A question will be administered asking patients whether they have started taking their 
daily AET (yes vs. no). Patients who have not yet started AET will be considered eligible for study 
participation. Patients will also be asked how hesitant they are about starting their recommended hormonal 
therapy medication on a scale of 0-10.
Outcome Measures:
Demographics Questionnaire: Participants will self-report their age, gender, race/ethnicity, marital status, 
education level, and relationship status.
AET Initiation Question: This one item instrument will ask patients: At different times throughout your 
participation this study, you may or may not be taking/have started taking your hormonal therapy. “At this time, 
are you currently taking your hormonal therapy (e.g., Tamoxifen, Anastrozole/Arimidex, 
Exemestane/Aromasin, Letrozole/Femara)?” Patients will self-report their initiation of endocrine therapy.
Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-Patient Satisfaction (FACIT-TS- 
PS):33 This thirty-item questionnaire will be administered to patients to assess satisfaction with communication 
with clinicians and nurses and consists of items such as “Did you doctor show genuine concern for you?”. Each 
item is measured on a Likert-type scale of 0 (No, not at all) to 3 (Yes, and as much as I wanted). Subscale 
scores are computed by summing each individual item, multiplying the sum by the number of items in the 
subscale and dividing by the number of items answered. Over 50% of items in a subscale must be completed to 
receive a valid score. Subscales include physician communication (0-36 score range), treatment staff 
communication (0-12), technical competence (0-9), nurse communication (0-9), and confidence and trust (0-
12).
Beliefs about Medicines Questionnaire – Adjuvant Endocrine Therapy (BMQ-AET):34 This 10-item 
questionnaire will be administered to assess the perceived need for AET versus concerns about side effects or 
other negative consequences (i.e., Necessity-Concerns framework). The BMQ-AET has been used in studies 
measuring endocrine therapy adherence. This study will use one of the two scales, which is computed 
measuring perceived need for medication and concerns about disruptive medication effects. Items are measured 
on a Likert-type scale of 1 (strongly agree) to 5 (strongly disagree). Total scores are calculated by finding the 
sum of subscales that range 10-50.
Multidimensional Scale of Perceived Social Support (MSPSS):35,36 This 12-item questionnaire will be 
administered to patients to assess patients’ perceived social support. The validated and reliable scale consists of 
items, such as “my family really tries to help me,” and is measured on a 7-point Likert scale. The item is 
divided into 3 subscales: family, friends, and significant other and the range of the total scale is 1-7.
Functional Assessment of Cancer Therapy-Breast (FACT-B):37 The FACT-B is a validated measure used to 
assess multidimensional quality of life in patients with breast cancer. The measure captures five domains: 
physical well-being, social/family well-being, emotional well-being, functional well-being, and additional 
concerns. Each item is answered on a Likert-type scale of 0 (not at all) to 5 (very much). Subscale scores are 
computed by summing each individual item, multiplying the sum by the number of items in the subscale and 
dividing by the number of items answered. Total FACT-B scores can range from 0-148.
Hospital Anxiety and Depression Scale (HADS):38, 39 The HADS is a valid self-report measure for assessing 
anxiety and depressive symptoms among patients in non-psychiatric hospitals. The 14-item measure contains 
seven questions to assess depressive symptoms and seven questions to assess anxiety symptoms to distinguish 
between the two. Patients indicate how they have been feeling on average over the past week. Each item is 
answered on a scale of 1 to 4. The four possible answer choices vary and adjust for each question. Total 
subscale scores range from 0-21.

15
Self-Efficacy for Managing Symptoms Questionnaire (Self-Efficacy for Symptoms):40 The Self-Efficacy for 
Symptoms Questionnaire is a modified version of the self-efficacy scale to assess patient self-efficacy in 
managing symptoms related to their endocrine therapy medication. The measure asks patients to rate their 
confidence on a scale of 1 (not at all confident) to 10 (very confident) in their ability to decrease or control the 
side effects of their medication. This is an 8-item scale, and total scores range from 1-10.
Measure of Current Status (MOCS):41 The MOCS is a 13-item scale which measures patients’ current self- 
perceived ability on several skills. Examples of targeted content areas are ability to relax, restructure 
maladaptive thoughts, and choose appropriate coping responses. Each of the 13 items is answered on a scale of 
0 (I cannot do this at all) to 4 (I can do this extremely well).
Other demographic and treatment-related factors affecting initiation will be collected from the EHR and 
examined as covariates.
Intervention Acceptability:
Client Satisfaction Questionnaire (CSQ):42 The CSQ is a 3-item, validated measure to assess satisfaction with 
services provided to the patient, and asks questions such as, “to what extent has our program met your needs?” 
Each item is answered on a scale of 1-4. This will be administered at the 1-month assessment to evaluate 
intervention participants only to examine intervention acceptability. The total score range is 3-12.

16
5.3 Description of Proposed Study Intervention
Our proposed intervention will be constructed within the aforementioned theoretical framework, using existing 
literature to incorporate strategies to reduce modifiable barriers to endocrine therapy initiation. Dr. Jacobs 
developed the intervention outline with expertise from co-investigators Drs. Jennifer Temel and Dr. Beverly 
Moy who are experts in cancer outcomes research and breast oncology and health equity, respectively. The data 
gathered from the semi-structured interviews has informed the intervention and be instrumental in refining it to 
optimize patient-centeredness.
The nurse-led intervention will be a brief, two-session, culturally competent, evidence-based intervention via 
videoconferencing software administered by a breast oncology nurse practitioner. The sessions will begin once 
baseline assessments and enrollment are complete, and the sessions will be approximately 2 weeks apart. Both 
sessions will aim to take place prior to the planned and agreed upon AET start date per the treatment plan with 
their oncology team. Study staff will work with patients on a case-by-case basis to schedule the sessions in a 
timeline that aligns with their treatment plan. Patients have the option to request attending these sessions via 
phone or in person.
The intervention and study materials will be translated into Spanish and delivered by nurse practitioner, Kathryn 
Post, PhD, in either English or Spanish. An interpreter will be present either in person or remotely for the 
intervention for patients who speak Spanish only. Both sessions will take place within one month of the baseline 
assessment. The intervention will target known modifiable barriers to AET initiation, including support and 
communication with clinicians, perceived therapeutic efficacy of AET, and managing expectations of symptoms 
and side effects, but will be primarily driven by barriers identified by the patient. Therefore, the session will 
begin by probing and identifying the individual and culture-specific barriers to initiation in multiple domains.
The interventionist and patient will then problem-solve barriers to initiation through motivational interviewing, 
cognitive-behavioral techniques, and medication education. The intervention is informed by the Health Belief 
Model (HBM), the Cognitive Model of Adjustment to Cancer, and Motivational Interviewing Techniques. First, 
the intervention will address perceived risk and medication efficacy in line with the HBM, which maintains that 
the health behavior (i.e., initiating AET) will be adopted if the patient perceives (a) risk for a condition, (b) that 
the medication will reduce risk, (c) that benefits outweigh costs, and (d) self-efficacy for taking medication.
Second, driven by the Cognitive Model of Adjustment to Cancer, the intervention will include strategies for 
enhancing coping with side effects, reframing cognitive self-talk about AET efficacy, and identifying and 
enhancing social support. CBT is effective in helping patients manage concerns, fears, and actual cancer-related 
side effects. Finally, Motivational Interviewing techniques will help the patient explore and resolve 
ambivalence with attention to their readiness for change. Sessions will be audio-recorded and at least 10% will 
be reviewed for treatment fidelity. Intervention acceptability will be evaluated using the CSQ.
5.4 Data Collection and Provisions to Protect the Privacy Interests of Subjects
Participants will be given the option to complete the above instruments either on paper, over a secure REDCap 
portal or over the telephone. Study staff will send assessments to participants at the start of their timepoint 
window and will follow-up periodically throughout to ensure receipt and completion of assessments.
Assessments that are completed on paper will be entered into the secure REDCap database by study staff.
Patients will receive an Intervention Manual which has been informed by the Qualitative Phase of this study 
(21-331) (Appendix 9.25).
Patients will additionally receive a copy of the Intervention Manual and a welcome letter with study 
expectations (Appendix 9.21, 9.22), and a study timeline document (Appendix 9.23, 9.24). As detailed in the 
Data Safety Monitoring Plan (Section 6.0), all subjects will receive a confidential number identifier. All 
participants will be identified on study assessments by their number identifier.

17
Identifiers, such as name, will only be used during the initial data retrieval process and can be destroyed 
once all data records have been obtained and data analysis has been completed as discussed previously.
5.5 Description of Study Process
After completing the baseline assessment and enrollment, we will schedule the patient’s intervention sessions. 
Sessions will take place via videoconferencing software (Zoom). If a patient prefers, these sessions can also be 
held in person or over the phone. Each session will last approximately 60 minutes. Participants will be reminded 
that they can decline to discuss any topic that is presented during the sessions. Interventionists will complete a 
post-session survey following each session (Appendix 9.26). 80% of sessions will be audio-recorded and at 
least 10% randomly selected, stratified by interventionist, and reviewed with study staff for treatment fidelity.
Content fidelity will be assessed by calculating the percentage of key intervention topics addressed out of total 
topics, with a goal of 90%. Feedback will be given to interventionists to enhance adherence to the protocol.
The nurse-led intervention will be administered by trained study staff (under direct supervision and guidance 
from the PI) and study sessions will be conducted in English or Spanish using an intervention manual. This 
manual will be finalized after the completion of Phase I of this study with input from Dr. Jennifer Temel, Dr. 
Beverly Moy, and Kathryn Post, PhD. Following the intervention, we will offer participants optional semi- 
structured interviews to gather feedback on the sessions (Appendix 9.27). We will then modify the intervention 
iteratively to reflect participants’ feedback in order to best address the needs of patients who have not started or 
are hesitant to initiate their AET medication. The study materials, including consent forms, recruitment 
materials, patient-facing materials and study measures, not otherwise available in Spanish from their licensor, 
will be translated (forwards and backwards) into Spanish by Linguistic Systems, Inc and Spanish-speaking 
investigators and coordinators in our Cancer Outcomes Research and Education Program (CORE). This group 
has extensive experience providing translation services for researchers at Harvard Medical School and Beth 
Israel Deaconess Medical Center. After the translation, a second linguist will edit the Spanish-language 
materials for quality assurance, following best practices in the translation industry.
Special Concerns
We do not anticipate any major complications with this study. To reduce burden, participants will be offered the 
opportunity to complete the intervention sessions via Partners approved videoconferencing software (Zoom). If 
a patient prefers, these sessions can also be held in person or over the phone. If a participant expresses distress 
during the study sessions, they will be reassured that they can stop the session and they are not required to 
respond to any topics presented during the sessions which they find upsetting. They will also be reminded that 
study participation is voluntary. If a participant remains distressed, the principal investigator, a psychologist, 
will offer a referral to supportive care services in the Psychiatric Oncology Service in the MGH Cancer Center, 
and assess safety prior to terminating the intervention session.
Participants may experience some discomfort talking about some of the topics brought up during the sessions or 
answering study assessment questions; however, they may choose not to discuss topics or answer questions that 
are distressing. Participants may also experience some discomfort being audio recorded, for the purposes of 
qualitative data collection. Confidentiality will be detailed on the consent form and discussed in detail so that 
participants are fully informed of their right to request information and to withdraw from the study at any time 
without impacting their care. We will also discuss the importance of maintaining confidentiality at the 
beginning of each session.
Breach of confidentiality is a concern in all studies with human subjects. Patient participants will be completing 
individual intervention sessions that will be audio-recorded; thus, safeguards will be put in place to ensure that 
participant information is kept private and confidential. Participants’ data will be kept on Lab Archives, a Mass 
General Brigham electronic secure research lab notebook, and Business Dropbox, a cloud-based storage that is 
compliant with Mass General Brigham’s policies and procedures. Data stored on Lab Archives and Dropbox

18
will only be accessible to the Principal Investigator and IRB-approved study staff. Data will not be shared with 
individuals other than study staff and any identifiable information about study participants will be destroyed 
after all data analyses are complete.
Compensation
Participants will not endure any additional costs as part of their participation in this research study. As 
such, we do not anticipate any financial burden on study participants. The study intervention visits will 
not be billed.
We will remunerate participants $10 for each assessment packet completed for up to $30 total.
Handling of Study Documents
Study source documents, including but not limited to signed informed consent forms, completed eligibility 
checklists, and participant questionnaires, will be scanned and stored digitally as certified copies on a secure 
drive only available for access to trained study staff working with the documents. The drive will be only 
accessible with proper invitation to the drive by the Principal Investigator through their Partners account, which 
will require personal username and password information to access. Trained study staff will follow specific 
standard operating procedures for handling source documents and certifying each copy appropriately. The 
procedures are as follows. After source documentation is filled out by the participant, study staff will collect the 
original source document. The study staff member scanning documents will be kept as consistent as possible 
throughout the duration of the study to ensure uniformity among source documentation handling. Location, 
time, and date of the scanning of the document will be recorded at the time of scanning. Study staff will fill out 
the Source Documentation Certified Copy Cover Sheet (Appendix 9.29) and include this as the first page of the 
electronic version of the source document. After the source document is scanned and the corresponding 
electronic document is confirmed to be legible, all facing the correct direction, and together as a single 
document, it will be collected and destroyed immediately. Study staff will destroy the original copy of the 
source document by following MGH procedures of destroying documents with Personal Health Information 
(PHI). Electronic versions of source documents will allow study staff to access these documents regardless of 
where the original copy is stored, which may be inconvenient, increase study staff burden, and study cost if 
storage of documents is far from the location where research activities will be conducted or required to be 
placed in long term storage. This process has been developed streamlined, and successfully implemented in 
DF/HCC Protocol #18-603.
5.6 Adverse Reactions and Their Management
Reporting Adverse of Unanticipated Events
We do not anticipate any harm with our study procedures. While some topics probed in study assessments and 
the intervention may be sensitive in nature, our study staff has extensive experience conducting social 
behavioral intervention on sensitive topics without any adverse events. No adverse or unanticipated events 
occurred in previous studies of psychological interventions conducted by our research group. Reportable 
adverse events would include a breach of confidentiality. Should adverse or unanticipated events occur during 
the study, a trained study staff member will report the events to the IRB as soon as they are discovered.
Anticipated Reactions
As Phase 2 of this study consists of a 2-session, in-person or virtual intervention with 3 study surveys, there are 
no ingested medications and no biomedical procedures. It is unlikely that participants will be at any risk for 
physical harm because of study participation. Participants may find some of the questions to be emotionally 
upsetting, and if so, they may experience some distress.
Reaction Management

19
A detailed consent form will be signed by study staff after the participant provides consent, following the 
explanation by study staff. The consent form will include all study procedures, information about potential risks 
and benefits of participation, and information regarding whom the participant can contact for further questions. 
It will also state that participation is voluntary, that participants can refuse to answer any questions, that they 
can withdraw from the study at any time, and that study participation is in no way related to their medical care. 
All study staff will complete the required human subjects training before they can work on any human subject 
aspects of the study.
If a participant expresses distress during the psychological intervention visits, they will be reassured by 
the clinician or study staff member conducting the intervention session that they can stop at any time 
and that they do not need to continue participating in content or discuss any intervention 
topics/questions which they find upsetting. They will also be reminded that study participation is 
voluntary. If participants remain distressed, they will be offered an opportunity to meet with a 
psychologist in the Psychiatric Oncology Service at the MGH Cancer Center to help address their 
distress.
For all participant assessments given throughout the study, study staff will review assessments upon receipt 
from participants for completion and to assess distress. On the HADS, patients who endorse ≥11 on even items 
for a more severe range for depression will be called by qualified study staff (e.g., Dr. Jacobs, a licensed clinical 
psychologist, as well as trained clinical psychology practicum fellows). If a participant completes the distress 
assessment online through the secure REDCap portal, a study staff member will check the responses and notify 
the PI for follow-up if needed within 72 hours of receipt. If a participant completes assessments on paper, study 
staff will check the responses and notify the PI for follow-up if needed within 72 hours of receipt. If a 
participant completes assessments over the phone, study staff will notify the PI for follow-up if needed within 
72 hours of receipt. If the patient needs further outpatient services for depression, including pharmacotherapy, 
or is at risk for self-harm requiring hospitalization, study staff will make the necessary referrals for treatment.
For example, for patients who are distressed but in no danger to self or others, study staff will refer either to the 
MGH Oncology Social Work Service or to the MGH Outpatient Psychiatry Department (617-724-5600), 
including the Cognitive-Behavioral Therapy Program. If suicidality or risk of harm to others is otherwise 
discovered at any study visit, the participant will be referred to appropriate services. Specifically, in the case 
that hospitalization is required, study staff will contact and escort the patient to the MGH Acute Psychiatry 
Service (617-726-2995), with the aid of the MGH Police & Security if necessary (617-726-2121). If a referral 
for outpatient services is made, or the patient requires escort to the MGH Acute Psychiatry Service, study staff 
will notify the health care team, including the primary oncologist.
The PI and trained study staff will meet weekly to review study progress, ensure properly implementation of the 
intervention, and review any adverse reactions that occur. The PI and the research assistant will review consents 
and collected data to ensure proper adherence to study protocol.
6.0 Provisions to Monitor the Data to Ensure the Safety of Subjects
Data and Safety Monitoring Plan
The purpose of the data and safety monitoring plan is to establish standards that will ensure that 
this protocol complies with Federal Regulations, Health Insurance Portability and Accountability 
Act (HIPAA) requirements, and applicable Dana-Farber Harvard Cancer Center (DF/HCC) 
Standard Operating Procedures.
General Approach: We have developed a comprehensive data and safety monitoring plan for the 
proposed project. Throughout the award period, weekly meetings will take place with the 
research team: Jennifer Temel, MD and Beverly Moy, MD, MPH, and study staff. Specifically, 
meetings will include ongoing review of study protocol, assessment procedures, and issues

20
related to recruitment, data collection, and management. Study staff will also discuss any human 
subject issues that arise.
General Roles and Responsibilities: We will use several coordinated strategies to monitor study 
recruitment, enrollment, and retention, as described in the following table. We will also closely 
track collection of patient-reported assessments, as these measures are an essential aspect of our 
study procedures and outcomes. For all strategies identified in the table, we will develop study 
tracking forms that will be reviewed at the weekly team meetings. Study tracking forms will be 
used to create a record of all decisions made and actions taken. I will send a report ahead of the 
meeting detailing study progress and setting the agenda. The following monitoring and reporting 
steps will be taken for each study activity:
Study 
Activity
Monitoring and Reporting Mechanism
Recruitment
The designated CRC will generate a weekly report outlining the number of patients 
approached and reasons for ineligibility or disinterest in study participation.
Informed 
Consent
The CRC will generate a weekly report detailing the number of participants who 
consented to the study.
The PI will go through any issues related to informed consent with the CRC weekly or 
earlier if urgent.
Enrollment
The CRC will generate a weekly enrollment report.
Assessments
The CRC will conduct a review for completeness and accurate data entry.
The CRC will maintain participant records of distress levels at each timepoint and 
follow Reaction Management if required.
Intervention
The CRC will contact patients to test the videoconferencing technology.
The PI and trained study staff will review at least 10% of audio-recorded treatment 
sessions.
The CRC will maintain a record of participant progress in sessions, including 
attendance.
Retention
The CRC will generate a weekly report detailing completion of follow-up assessments 
and retention strategies implemented for each participant.
The CRC will generate a weekly report of all participants who withdraw from study.
Analysis
The PI will work closely with study biostatistician, Nora Horick (scientific advisor in 
biostatistics), on all qualitative and quantitative analyses.
Specific PI Roles and Responsibilities
I will be responsible for all aspects of conducting the protocol; I will:

Oversee the coordination, development, submission, and approval of the protocol to the DF/HCC as well 
as subsequent amendments.

Ensure that the investigators and study staff are qualified and appropriately resourced to conduct the 
protocol.

Carry out a Data and Safety Monitoring Plan as detailed in this document.

Ensure that each participating study staff member receives adequate protocol training prior to enrolling 
participants and throughout the trial’s conduct as needed.

Monitor progress and overall conduct of the study.

Conduct review of 10% of intervention sessions for process and content fidelity.

Conduct weekly supervision for clinical protocol interventionists.

Review data and maintain timely submission of data for study analysis.

21

Ensure compliance with all requirements as set forth in the Code of Federal Regulations, DF/HCC, 
HIPAA requirements, and the approved protocol.

Commit to provisions that the protocol will not be rewritten or modified by anyone other than the 
overall PI.

Monitor accrual and address concerns if accrual goals are not met.
The Massachusetts General Hospital Cancer Center is expected to comply with all applicable federal 
regulations and requirements, the protocol and HIPAA requirements. Specifically, it will:

Oversee the data collection process.

Maintain documentation of Serious Adverse Events (SAE) reports and deviations/violations.

Maintain regulatory documents which include but are not limited to the following: IRB 
approvals/notifications, confirmation of Federal wide Assurances (FWAs), all SAE submissions, 
screening logs, and IRB approved consents.

Conduct regular communications with the PI and maintain documentation of relevant communications.

Document the delegation of research specific activities to study personnel.

Maintain regulatory files.

Have office space, office equipment, and internet access that meet HIPAA standards.

Participate in quality assurance activities and meet with monitors or auditors at the conclusion of a visit 
to review findings.

Promptly provide follow-up and/or corrective action plans for any monitoring queries or audit findings.
Informed Consent Requirements. The DF/HCC approved informed consent document will serve as a template 
for the informed consent.
Protocol Confidentiality. All documents, investigative reports, or information relating to the participants are 
strictly confidential. Confidentiality is assured as participants will be identified on all study materials only by 
participant number, visit number, and date of visit. By recording the study data in this manner, the information 
can be considered 'de-identified,' and therefore compliant with the Standards for Privacy of Individually 
Identifiable Health Information ("Privacy Rule") of HIPAA. Participants’ data will be kept in a computer file 
that is password protected and this password will be changed whenever the staff changes. This password- 
protected file will be stored on the encrypted MGH network drive on hospital computers. Only the Principal 
Investigator and study staff will have access to the data. We will keep a link between participant number and 
participant’s name in a separate file, also password protected (with a different password).
Data Management Organizational Structure Data. Study forms will undergo a systematic and rigorous editing 
process prior to being keyed into the database. The research assistant will routinely evaluate the data and discuss any 
problems and questions with the study staff, myself, and mentors at the regular weekly team meetings. Data 
management formal reports on record status across the three following domains will be employed: entered, verified, 
and edited. These reports of data records will be evaluated once a month during the final team meeting of the month. 
All study data (including data from the Electronic Health Record) will be stored on the encrypted MGH network 
drive on hospital computers and will be password protected. To ensure data protection, backup copies automatically 
generated by MGH computer systems will be available.
Data Safety and Monitoring Plan. The following procedures will be followed, in compliance with NIH 
requirements, to ensure the safety of study participants and the validity and integrity of data:
Data Repository: The MGH Cancer Outcomes Research Program (CORE) has coordinated research initiatives 
over the past ten years that have established procedures and technologies for data collection and management. 
I will oversee all aspects of data collection for the study and the research assistant will have the operational 
responsibility of data management. We will develop a study specific data management protocol and standard 
operating procedures for the creation and testing of all study forms, data collection, quality control, and data 
extraction. These forms will be standardized. We will provide ongoing oversight of data management 

22
throughout the study, and will be responsible for generating reports and datasets for quality control and data 
analysis. All data management activities will utilize REDCap, a HIPAA-secure, web-based survey application 
for electronic collection and management of research and clinical trial data. REDCap data collection projects 
rely on a thorough study-specific data dictionary defined in an iterative self-documenting process by all 
members of the study staff with planning assistance from Partners HealthCare Research Computing, 
Enterprise Research Infrastructure & Services (ERIS) group. REDCap provides an intuitive interface for users 
to enter data and have real time validation rules (with automated data type and range checks) at the time of 
entry. Data management reports will be generated weekly and discussed during the study staff meetings.

Serious Adverse Events: Expedited review will occur for all events meeting the Food and Drug 
Administration (FDA) definition of a SAE (i.e., any fatal event, immediately life-threatening event, 
permanently or substantially disabling event, event requiring or prolonging inpatient hospitalization, 
Unanticipated Problems [UPs], or any congenital anomaly). This also includes any event that a study 
investigator judges to impose a significant hazard, contraindication, side effect, or precaution. For purposes of 
this study, all SAEs will be required to be reported to the PI, the DF/HCC IRB, and federal agencies (National 
Cancer Institute, FDA, and the NIH Office of Biotechnology Activities), regardless of any judgment of their 
relatedness to the study. All relevant information will be reported to the study investigators for each SAE 
including information about the event and its outcome, study condition, concomitant medications, the 
subject’s medical history and current conditions, and all relevant laboratory data. Notification by secure e-
mail of all related study forms shall be made to the DF/HCC IRB within 24 hours of the occurrence of any 
SAE. Information will be reviewed and a determination made of whether there was any possible relevance to 
the study interventions. Reporting to NIH will be made according to their respective regulations governing 
SAE reporting.

Non-Serious Adverse Events: At weekly meetings, the study staff will discuss summaries of the numbers and 
rates of adverse events by treatment group. These reports will include types of events, severity, and treatment 
phase.

Other Safety-Related Reports: At weekly meetings, the study staff will discuss summary reports of treatment 
retention and reasons for dropout or withdrawal by treatment group.

Study Stopping Rules: We do not have a pre-specified stopping rule given the low-risk nature of the proposed 
study. However, if at any point the DF/HCC or the study investigators judge that the risks of study procedures 
outweighs the benefits, the project will be stopped immediately.

Procedures to ensure confidentiality, preparation of reports, minutes, and recommendations: We will work 
with the CRC to prepare study reports and circulate them to the study staff during the weekly scheduled 
project meetings. These reports will include overall study progress and safety data. At the conclusion of each 
research group meeting, the investigators will determine whether any changes in the conduct of the trial are 
recommended.
7.0 Statistical Analyses
7.1 Primary and Secondary Endpoints
Our primary endpoint of this phase of feasibility and acceptability will be measured by rates of enrollment 
(>50%), participant retention (70%), intervention attendance (>70% attending at least 1 of 2 sessions), and 
intervention satisfaction (>75% reporting satisfaction greater than the CSQ’s midpoint).
Our secondary aim is to assess intervention-related changes in primary and secondary outcomes at one- and 
three- months post-baseline. We will explore changes in satisfaction with patient-physician communication, 
perceived social support, self-efficacy for symptom management, and quality of life.
7.2 Sample Size
To determine feasibility in a single-arm pilot trial (up to N=35), estimate effect size, and finalize the 
intervention and study protocol to apply for an NIH grant to conduct a full-scale efficacy trial.
7.3 Early Stopping Rules
Study participation will be terminated at any time upon the participant’s request.

23
7.4 Definition of Allowance in Design for Unevaluable/Ineligible Participants
Not applicable.
7.5 Analysis Plan
Aim 1: Feasibility and acceptability will be measured by rates of enrollment (>50%), participant retention 
(>70%), intervention attendance (>70% attending at least 1 of 2 sessions), and intervention satisfaction (>75% 
reporting average satisfaction greater than the CSQ’s midpoint).
Aim 2: First, data will be analyzed with the intention-to-treat principle and assessed for statistical assumptions 
and patterns of missingness, implementing Multiple Imputation with maximum likelihood if appropriate.
Sample size justification. We may over-accrue to ensure that a total of up to 45 BCS complete the study. This 
pilot study will provide a preliminary estimate of the rate of AET initiation within one month from baseline. 
With up to 30 participants, the width of the exact 95% confidence interval (CI) for the rate of AET initiation at 
one month will be at most 37.4% (i.e., +/- 18.7%). If at least 24% of participants initiate AET within one month, 
the study will rule out a post-intervention initiation rate of lower than 10% based on the lower limit of the exact 
95% CI. We will conduct exploratory analyses to examine whether participants’ baseline characteristics are 
associated with AET initiation at one month using Fisher’s exact tests and unpaired t-tests. For secondary 
outcomes, we will conduct paired samples t-tests to assess intervention-related changes in satisfaction with 
communication with clinicians and treatment, Necessity-Concerns Framework, perceived support, self-efficacy 
for managing side effects, and QOL from baseline to one-month post-baseline. In addition, we will use linear 
mixed effects regression models to evaluate the change in secondary outcomes across all three assessment time 
points. We will interpret 95% Confidence Intervals and Cohen’s d effect sizes (D=[(Mean 1)–(Mean 2)]/pooled 
Standard Deviation), with magnitudes of 0.3, 0.5, and 0.8 for small, medium, and large effects, respectively. We 
will conduct sensitivity analyses to examine whether changes in outcomes are differ among racial and ethnic 
groups.
Participants will be given the opportunity to receive a summary of study results at the completion of the study. 
If a request is made, the study staff will provide the participant with an abstract of the study at the end of data 
collection and analysis.
7.6 Handling of Missing Data in the Analysis
The analyses for this study will focus on study completers to estimate the effect of the 2-session, patient 
centered intervention. The primary endpoint will be based on acceptability and feasibility aspects of the study. 
We will use the intention-to-treat principle for analyses with all participants. After we examine patterns of 
missingness, we will use maximum likelihood with multiple imputation to account for missing data.

24
8.0 References
1. Burstein HJ, Lacchetti C, Griggs JJ. Adjuvant Endocrine Therapy for Women With Hormone Receptor- 
Positive Breast Cancer: ASCO Clinical Practice Guideline Focused Update. J Oncol Pract. 
2018;15(2):106-7. Epub 2018/12/05. doi: 10.1200/JOP.18.00617. PubMed PMID: 30523754.
2. Davies C, Godwin J, Gray R, Clarke M, Cutter D, Darby S, et al. Relevance of breast cancer hormone 
receptors and other factors to the efficacy of adjuvant tamoxifen: patient-level meta-analysis of 
randomised trials. Lancet. 2011;378(9793):771-84. doi: 10.1016/S0140-6736(11)60993-8. PubMed 
PMID: 21802721; PubMed Central PMCID: PMC3163848.
3. Neugut AI, Hillyer GC, Kushi LH, Lamerato L, Leoce N, Nathanson SD, et al. Non-initiation of 
adjuvant hormonal therapy in women with hormone receptor-positive breast cancer: The Breast Cancer 
Quality of Care Study (BQUAL). Breast cancer research and treatment. 2012;134(1):419-28.
4. Demissie S, Silliman RA, Lash TL. Adjuvant tamoxifen: predictors of use, side effects, and 
discontinuation in older women. J Clin Oncol. 2001;19(2):322-8. PubMed PMID: 11208822.
5. Pini T, Griggs J, Hamilton A, Katz S. Patterns and correlates of adjuvant breast cancer endocrine 
therapy use. Journal of Clinical Oncology. 2011;29(15_suppl):510-.
6. Kimmick G, Anderson R, Camacho F, Bhosle M, Hwang W, Balkrishnan R. Adjuvant hormonal therapy 
use among insured, low-income women with breast cancer. Journal of Clinical Oncology. 
2009;27(21):3445.
7. Zavala VA, Bracci PM, Carethers JM, Carvajal-Carmona L, Coggins NB, Cruz-Correa MR, et al. 
Cancer health disparities in racial/ethnic minorities in the United States. Br J Cancer. 2021;124(2):315-
32. Epub 2020/09/09. doi: 10.1038/s41416-020-01038-6. PubMed PMID: 32901135; PubMed Central 
PMCID: PMCPMC7852513.
8. Reeder-Hayes KE, Meyer AM, Dusetzina SB, Liu H, Wheeler SB. Racial disparities in initiation of 
adjuvant endocrine therapy of early breast cancer. Breast Cancer Res Treat. 2014;145(3):743-51. Epub 
2014/05/01. doi: 10.1007/s10549-014-2957-z. PubMed PMID: 24789443; PubMed Central PMCID: 
PMCPMC5499377.
9. Livaudais JC, Hershman DL, Habel L, Kushi L, Gomez SL, Li CI, et al. Racial/ethnic differences in 
initiation of adjuvant hormonal therapy among women with hormone receptor-positive breast cancer. 
Breast Cancer Res Treat. 2012;131(2):607-17. Epub 2011/09/16. doi: 10.1007/s10549-011-1762-1. 
PubMed PMID: 21922245; PubMed Central PMCID: PMCPMC3375495.
10. Emerson, MA, Achacoso, NS, Benefield HC, Troester MA, Habel LA. Initiation and adherence to 
adjuvant endocrine therapy among urban, insured American Indian/Alaska Native breast cancer 
survivors. Cancer. 2021;127(11): 1847-1856. PMID: 33620753.
11. Makubate B, Donnan PT, Dewar JA, Thompson AM, McCowan C. Cohort study of adherence to 
adjuvant endocrine therapy, breast cancer recurrence and mortality. Br J Cancer. 2013;108(7):1515-24. 
doi: 10.1038/bjc.2013.116. PubMed PMID: 23519057; PubMed Central PMCID: PMCPMC3629427.
12. Sabate E, De Geest S. Adherence to long-term therapies management: a call for cardiovascular nursing 
managers and policymakers. Prog Cardiovasc Nurs. 2004;19(1):28-9. PubMed PMID: 15017153.
13. Kroenke C, Hershman DL, Adams S, Kwan ML, Kushi LH. Social support at diagnosis and 
noninitiation, discontinuation, and nonadherence to adjuvant hormonal therapy in the Pathways Study. 
American Society of Clinical Oncology; 2017.
14. Shelton RC, Clarke Hillyer G, Hershman DL, Leoce N, Bovbjerg DH, Mandelblatt JS, et al. 
Interpersonal influences and attitudes about adjuvant therapy treatment decisions among non-metastatic 
breast cancer patients: an examination of differences by age and race/ethnicity in the BQUAL study. 
Breast Cancer Res Treat. 2013;137(3):817-28. Epub 2012/12/22. doi: 10.1007/s10549-012-2370-4. 
PubMed PMID: 23263696; PubMed Central PMCID: PMCPMC3563273.
15. Liu Y, Malin JL, Diamant AL, Thind A, Maly RC. Adherence to adjuvant hormone therapy in low- 
income women with breast cancer: the role of provider-patient communication. Breast Cancer Res 
Treat. 2013;137(3):829-36. doi: 10.1007/s10549-012-2387-8. PubMed PMID: 23263740; PubMed 
Central PMCID: PMC3553239.

25
16. Friese CR, Pini TM, Li Y, Abrahamse PH, Graff JJ, Hamilton AS, et al. Adjuvant endocrine therapy 
initiation and persistence in a diverse sample of patients with breast cancer. Breast Cancer Res Treat. 
2013;138(3):931-9. doi: 10.1007/s10549-013-2499-9. PubMed PMID: 23542957; PubMed Central 
PMCID: PMC3633703.
17. Heiney SP, Parker PD, Felder TM, Adams SA, Omofuma OO, Hulett JM. A systematic review of 
interventions to improve adherence to endocrine therapy. Breast Cancer Res Treat. 2019;173(3):499-
510. Epub 2018/11/01. doi: 10.1007/s10549-018-5012-7. PubMed PMID: 30387003.
18. Fisher TL, Burnet DL, Huang ES, Chin MH, Cagney KA. Cultural leverage: interventions using culture 
to narrow racial disparities in health care. Med Care Res Rev. 2007;64(5 Suppl):243S-82S. doi: 
10.1177/1077558707305414. PubMed PMID: 17881628; PubMed Central PMCID: PMCPMC2505343.
19. Finitsis DJ, Vose BA, Mahalak JG, Salner AL. Interventions to promote adherence to Endocrine 
Therapy among breast cancer survivors: A meta-analysis. Psycho‐Oncology. 2018.
20. Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005;353(5):487-97. doi: 
10.1056/NEJMra050100. PubMed PMID: 16079372.
21. Siminoff LA, Ravdin P, Colabianchi N, Sturm CMS. Doctor-patient communication patterns in breast 
cancer adjuvant therapy discussions. Health expectations. 2000;3(1):26-36.
22. Mott-Coles S. Patients' cultural beliefs in patient-provider communication with African American 
women and Latinas diagnosed with breast cancer. Clin J Oncol Nurs. 2014;18(4):443-8. doi: 
10.1188/14.CJON.443-448. PubMed PMID: 25095298.
23. Jacobs JM, Pensak NA, Sporn NJ, MacDonald JJ, Lennes IT, Safren SA, et al. Treatment Satisfaction 
and Adherence to Oral Chemotherapy in Patients With Cancer. J Oncol Pract. 2017:JOP2016019729. 
Epub 2017/04/11. doi: 10.1200/JOP.2016.019729. PubMed PMID: 28398843.
24. Bluethmann SM, Murphy CC, Tiro JA, Mollica MA, Vernon SW, Bartholomew LK, editors. 
Deconstructing decisions to initiate, maintain, or discontinue adjuvant endocrine therapy in breast cancer 
survivors: a mixed-methods study. Oncology nursing forum; 2017: NIH Public Access.
25. Heisig SR, Shedden-Mora MC, von Blanckenburg P, Schuricht F, Rief W, Albert US, et al. Informing 
women with breast cancer about endocrine therapy: effects on knowledge and adherence. 
Psychooncology. 2015;24(2):130-7. doi: 10.1002/pon.3611. PubMed PMID: 24953538.
26. Pan Y, Heisig SR, von Blanckenburg P, Albert U-S, Hadji P, Rief W, et al. Facilitating adherence to 
endocrine therapy in breast cancer: stability and predictive power of treatment expectations in a 2-year 
prospective study. Breast cancer research and treatment. 2018;168(3):667-77.
27. Golden SD, Earp JA. Social ecological approaches to individuals and their contexts: twenty years of 
health education & behavior health promotion interventions. Health Educ Behav. 2012;39(3):364-72. 
Epub 2012/01/20. doi: 10.1177/1090198111418634. PubMed PMID: 22267868.
28. Jacobs JM, Walsh EA, Rapoport CS, Antoni MH, Park ER, Post K, et al. Development and Refinement 
of a Telehealth Intervention for Symptom Management, Distress, and Adherence to Adjuvant Endocrine 
Therapy after Breast Cancer. J Clin Psychol Med Settings. 2020. Epub 2020/11/21. doi: 
10.1007/s10880-020-09750-4. PubMed PMID: 33219901.
29. Jacobs JM, Ream ME, Pensak N, Nisotel LE, Fishbein JN, MacDonald JJ, et al. Patient experiences with 
oral chemotherapy: Adherence, symptom, and quality of life. J Natl Compr Canc Netw. In 
Press/Forthcoming.
30. Greer JA, Amoyal N, Nisotel L, Fishbein JN, MacDonald J, Stagl J, et al. A systematic review of 
adherence to oral antineoplastic therapies. Oncologist. 2016;21(3):354-76. doi: 
10.1634/theoncologist.2015-0405. PubMed PMID: 26921292.
31. Stagl JM, Lechner SC, Carver CS, Bouchard LC, Gudenkauf LM, Jutagir DR, et al. A randomized 
controlled trial of cognitive-behavioral stress management in breast cancer: survival and recurrence at 
11-year follow-up. Breast Cancer Res Treat. 2015;154(2):319-28. doi: 10.1007/s10549-015-3626-6. 
PubMed PMID: 26518021.
32. Stagl JM, Bouchard LC, Lechner SC, Blomberg BB, Gudenkauf LM, Jutagir DR, et al. Long-term 
psychological benefits of cognitive-behavioral stress management for women with breast cancer: 11-

26
year follow-up of a randomized controlled trial. Cancer. 2015;121(11):1873-81. doi: 
10.1002/cncr.29076. PubMed PMID: 25809235; PubMed Central PMCID: PMC4441540.
33. Peipert JD, Beaumont JL, Bode R, Cella D, Garcia SF, Hahn EA. Development and validation of the 
functional assessment of chronic illness therapy treatment satisfaction (FACIT TS) measures. Qual Life 
Res. 2014 Apr;23(3):815-24. doi: 10.1007/s11136-013-0520-8. Epub 2013 Sep 24. PMID: 24062239.
34. Brett J, Hulbert-Williams NJ, Fenlon D, Boulton M, Walter FM, Donnelly P, Lavery B, Morgan A, 
Morris C, Horne R, Watson E. Psychometric properties of the Beliefs about Medicine Questionnaire- 
adjuvant endocrine therapy (BMQ-AET) for women taking AETs following early-stage breast cancer. 
Health Psychol Open. 2017 Nov 17;4(2):2055102917740469. doi: 10.1177/2055102917740469. PMID: 
29379627; PMCID: PMC5779943.
35. Zimet GD, Powell SS, Farley GK, Werkman S, Berkoff KA. Psychometric characteristics of the 
Multidimensional Scale of Perceived Social Support. J Pers Assess. 1990 Winter;55(3-4):610-7. doi: 
10.1080/00223891.1990.9674095. PMID: 2280326.
36. Calderón, C., Asensio-Martínez, E., Ferreira, E., Manzano-Fernández, A., Rogado, J., Antoñanzas-Basa, 
M., Palacín-Lois, M., Fernández-Montes, A., Gómez-Sánchez, D., Lorenzo-Seva, U., Ferrando, P. J., & 
Jiménez-Fonseca, P. (2021). Escala Multidimensional de Apoyo Social Percibido (MSPSS) en pacientes 
con cáncer: propiedades psicométricas e invariancia de medida. Psicothema, 33(Número 1), 131-138. 
Recuperado a partir de https://reunido.uniovi.es/index.php/PST/article/view/17080
37. Gray LA, Wailoo AJ, Hernandez Alava M. Mapping the FACT-B Instrument to EQ-5D-3L in Patients 
with Breast Cancer Using Adjusted Limited Dependent Variable Mixture Models versus Response 
Mapping. Value Health. 2018 Dec;21(12):1399-1405. doi: 10.1016/j.jval.2018.06.006. Epub 2018 Aug
9. PMID: 30502783; PMCID: PMC6288064.
38. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 
Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x. PMID: 6880820.
39. De Las Cuevas Castresana C, Garcia-Estrada Perez A, Gonzalez De Rivera Jl. "Hospital Anxiety and 
Depression Scale" y Psicopatología Afectiva. Anales De Psiquiatría. 1995, 126-130.
40. Shelby RA, Edmond SN, Wren AA, Keefe FJ, Peppercorn JM, Marcom PK, Blackwell KL, Kimmick
GG. Self-efficacy for coping with symptoms moderates the relationship between physical symptoms and 
well-being in breast cancer survivors taking adjuvant endocrine therapy. Support Care Cancer. 2014 
Oct;22(10):2851-9. doi: 10.1007/s00520-014-2269-1. Epub 2014 May 13. PMID: 24821365.
41. Antoni, M. H., Lechner, S. C., Kazi, A., Wimberly, S. R., Sifre, T., Urcuyo, K. R., Phillips, K., Gluck, 
S., & Carver, C. S. (2006). How stress management improves quality of life after treatment for breast 
cancer. Journal of Consulting and Clinical Psychology, 74, 1143-1152.
42. Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations 
with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 
10.1016/0149-7189(82)90074-x. PMID: 10259963.

27
9.0 Appendices
9.1 Clinical Email Template – Request to Approach
9.2 Clinician Handout
9.3 Rally Recruitment Portal Advertisement – English
9.4 Rally Recruitment Portal Advertisement – Spanish
9.5 Recruitment and Eligibility Screening Phone Script – English
9.6 Recruitment and Eligibility Screening Phone Script – Spanish
9.7 Recruitment Voicemail Script – English
9.8 Recruitment Voicemail Script – Spanish
9.9 Screening Question – English
9.10 Screening Question - Spanish
9.11 Recruitment Flyer – English
9.12 Recruitment Flyer – Spanish
9.13 Suggested Consent Form Email Template – English
9.14 Suggested Consent Form Email Template – Spanish
9.15 Participant Locator Form – English
9.16 Participant Locator Form - Spanish
9.17 Suggested Participant Email Reminder Templates – English
9.18 Suggested Participant Email Reminder Templates – Spanish
9.19 Suggested Participant SMS Reminder Templates – English
9.20 Suggested Participant SMS Reminder Templates – Spanish
9.21 INITIATE Welcome Letter – English
9.22 INITIATE Welcome Letter – Spanish
9.23 Study Roadmap – English
9.24 Study Roadmap – Spanish
9.25 Intervention Manual
9.26 Interventionist Post-session survey
9.27 Semi-structured interview guide
9.28 Remuneration Form
9.29 Source Documentation Certified Copy Cover Sheet
9.30 Suggested Social Media posts (Facebook, Instagram, Twitter)

28
9.1 Suggested Clinician Email Template: Request to Approach
Addressing Non-Initiation of Recommended Adjuvant Endocrine Therapy for Patients with a Culturally 
Informed Intervention
PI: Jamie Jacobs, Ph.D.
Dear [Dr./NP/PA PROVIDER NAME],
I am a research coordinator working with Dr. Jamie Jacobs on a study to promote the initiation of endocrine 
therapy with a virtual, 2-session, culturally informed intervention for breast cancer survivors. Participants must 
be fluent in English or Spanish.
Your patient(s) may be eligible for the study:
Name
MRN
DOB
I would like to approach her regarding the study. Please let me know at your earliest convenience if I should 
refrain from approaching this patient for any reason. If I do not hear from you, I will follow-up in person to 
request permission.
Study participation does not preclude you and the rest of the patient’s care team from medically treating the 
patient’s symptoms per your clinical judgment.
Please feel free to let me know if you have any questions or concerns. Additionally, I have included a brief 
attachment with more study information.
Thank you,
[name of study staff]
[name of study staff]
Clinical Research Coordinator 
Massachusetts General Hospital 
[study staff email]
[study phone number]

29
9.2 Clinician Handout
Addressing Non-Initiation of Recommended Adjuvant Endocrine Therapy for Patients with a Culturally Informed 
Intervention
Study Rationale

Up to 30% of BCS do not initiate AET as recommended.

BCS of a racial or ethnic minority are disproportionately less likely to initiate AET.

AET initiation is a modifiable health behavior with established predictors, with some being more salient for 
minority BCS.

Interventions to improve initiation to AET are needed and should be culturally sensitive.

Based on a qualitative study, we developed a culturally competent, two-session, nurse-led intervention to 
promote AET initiation in a diverse sample of early-stage, hormone receptor-positive BCS who have delayed 
initiation or have hesitations about initiating.
Study Specifics

This is a single-arm pilot study in which up to 35 patients will be recruited to participate in a two-session 
intervention with purposeful recruitment of racial/ethnic minorities.

We will aim to have one-third of the participants identifying as a racial or ethnic minority, in order to enroll a 
representative sample of experiences and concerns.

The intervention consists of 2, one-hour sessions delivered over videoconferencing with a nurse practitioner. 
If necessary, these sessions can be delivered in person or via phone.

All patients will be asked to complete assessments at baseline, 1-month, and 3-months after enrollment.
What Is Needed from You as the Clinician?

Approve or deny study staff request to approach potentially eligible participants

Refer patients you think may be eligible and a good fit for the study

Provide care as usual
Patient Inclusion and Exclusion Criteria

Female, age 21 or older, ability to read and respond in English or Spanish

Diagnosis of early-stage (Stage I-IIIB), hormone-receptor positive breast cancer

Recommended to start AET at least 3 weeks prior and not currently taking AET OR recommended to start 
AET in the future and reports hesitations to start AET as determined by a score of >/= 4 (range =0-10) when 
asked "How hesitant are you about starting your recommended hormonal therapy? (0=Not at all hesitant and 
10 = Extremely hesitant)"

Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Does not have Stage 0 (DCIS) breast cancer

May not have psychiatric or cognitive impairment

May not have a psychiatric hospitalization within the past year

Is not currently undergoing primary treatment for other cancer (i.e., advanced stage cancer)

Is not participating in a clinical trial involving AET
Study Contact Information:

Please send potentially eligible patients to the study coordinator [name and email] or to the study PI, Dr. Jamie 
Jacobs, at jjacobs@mgh.harvard.edu.

30
9.3 Rally Recruitment Portal Advertisement
Headline: Addressing Non-Initiation of Recommended Hormonal Therapy for Patients with a Culturally 
Informed Intervention
Summary: If you were diagnosed with breast cancer and have not yet begun taking a hormonal therapy, you 
may be eligible to participate in this research study. Participants will complete a brief, 2-session, culturally 
informed intervention.
Project Title: Addressing Non-Initiation of Recommended Hormonal Therapy for Patients with a Culturally 
Informed Intervention
Categories: Breast Cancer, Cancer, Medicines 
Project Image:
Funding Source: Electronic Space Systems Corporation
Institutions conducting research: Massachusetts General Hospital, Dana-Farber Cancer Institute 
IRB Organization: DF/HCC Dana Farber Cancer Institute
Recruitment start date: TBD 
Recruitment end date: 5/1/2023
What are you studying?
We are studying a tailored, patient centered, culturally informed intervention for women who have not yet 
started taking hormonal therapy for breast cancer. This program will address challenges and barriers of 
beginning hormonal therapy.
Why is it important?
Patients diagnosed with breast cancer can experience a variety of challenges and barriers around beginning 
hormonal therapy. This program will allow women to explore and manage their specific concerns around 
starting these medications with a cancer center clinician.

31
9.4 Rally Recruitment Portal Advertisement - Spanish
Titular: Enfrentando a la Falta de Iniciación de Tratamiento Hormonal que es Recomendado a Pacientes, con 
una Intervención Fundamentada por la Cultura
Resumen: Si usted una sobriviente con cáncer de mama y aun no ha comenzado tratamiento hormonal, puede 
ser elegible para participar en este estudio de investigación. Los participantes completarán una breve 
intervención de 2 sesiones, culturalmente informada.
Titulo del Proyecto: Enfrentando a la Falta de Iniciación de Tratamiento Hormonal que es Recomendado a 
Pacientes, con una Intervención Fundamentada por la Cultura
Clasificaciones: Cáncer de Mama, cáncer, Medicinas 
Imagen del Proyecto:
Fuente de Fondos: Electronic Space Systems Corporation
Instituciones Conduciendo el Estudio: Massachusetts General Hospital, Dana-Farber Cancer Institute 
Organización del IRB: DF/HCC Dana Farber Cancer Institute
Reclutamiento Empieza: TBD 
Reclutamiento Termina: 5/1/2023
¿Qué están investigando?
Estamos investigando la viabilidad y eficacia de una intervención adaptada, centrada en el paciente y 
culturalmente informada para mujeres que aún no han comenzado a tomar tratamiento hormonal para el cáncer 
de mama o tienen reservaciones sobre empezarlo. Este programa abordará los desafíos y las barreras de 
comenzar el tratamiento hormonal.
¿Cuál es la importancia?
Sobrevivientes del cáncer de mama pueden enfrentar una variedad de desafíos y barreras al comenzar el 
tratamiento hormonal. Este programa les permitirá a estas mujeres explorar y enfrentar sus preocupaciones 
específicas sobre el inicio de estos medicamentos con una clínica del centro oncológico.

32
9.5 Suggested Recruitment and Eligibility Phone Script
Hi, this is [Study Staff Name] calling from Massachusetts General Hospital/Dana-Farber Cancer Institute. Is 
this [Patient Name]?
A1. Self-referral call-back: Thank you for reaching out to our study team regarding the study. I would be 
happy to give you a brief overview of the study if you have a few minutes. Is now a good time?
IF YES: Continue to Section B.
IF NO: Is there a better time in the coming days I could give you a call back? [Continue to 
Section E.]
A2. Recruitment call: I am calling regarding a research study you might be eligible for that your 
oncologist, [provider name], thought you might be interested in. Is this a good time I could give you a 
brief overview of the study?
IF YES: Continue to Section B. 
If NO: Continue to Section E.
B. Study Description
This is a study about starting hormonal therapy, a type of medication that your oncologist recommended 
you take for breast cancer. This program consists of 2 sessions with a nurse over Zoom, to address any 
challenges or concerns you may be experiencing around beginning this medication. These visits would 
take place over a secure videoconferencing software Zoom. Does this sound like something you might 
be interested in?
IF YES: Continue to Section C. 
IF NO: Continue to Section E.
C. Eligibility Pre-Screening
Thanks for your interest. To determine whether this study is a good fit for you, I am wondering, have 
you started taking the hormonal therapy prescribed to you by your oncologist?
IF YES: Continue to Section E. 
IF NO: Continue in Section C.
On a scale of 0-10, with 0 indicating that you aren’t at all hesitant and 10 indicating that you are 
extremely hesitant, how hesitant are you about starting your hormonal therapy?
IF >/=4: Continue in Section D. 
IF <4: Continue to Section E.
D. Consent Form Access and the Informed Consent Discussion
The next step is for us to go through the verbal consent process over the phone and I will send you a 
copy over email for your records.
IF YES: [Proceed to complete the verbal consent process]
IF NO: Okay, we can also complete the informed consent process through the mail. I will send 
you two copies of the consent form through the mail for you to sign both and send one back to 
me using a prepaid envelope I’ll include. Additionally, I’ll include the screening measures to 
verify your eligibility. [Collect address and continue to Section E]
E. Not Interested, Refusal, Paper-Consent Preference, Ineligible Outcome
Thank you so much for your time today. Please feel free reach out with any questions or concerns 
related to the study.

33
9.6 Suggested Recruitment and Eligibility Phone Script - Spanish
Hola, mi nombre es [Study Staff Name] estoy llamando por parte de Massachusetts General Hospital/Dana- 
Farber Cancer Institute. Es usted [Patient Name]?
A1. Llamada de Autorreferencia: Muchas gracias por contactar a nuestro equipo sobre nuestro estudio. 
Si tiene algunos minutos, me encantaría darle un resumen corto sobre nuestro estudio. ¿Está disponible?
SI DICE “Sí”: Continúe a la Sección B.
SI DICE “No”: ¿Tendría algún momento en los próximos días en el pueda contactarme otra vez 
con usted? [Continúe a la Sección E.]
A2. Llamada de Reclutamiento: Estoy llamando sobre un estudio en el puede ser elegible para 
participar, y que su oncólogo, [provider name], pensó que a lo mejor le pudiera interesar. Si tiene 
algunos minutos, me encantaría darle un resumen corto sobre nuestro estudio. ¿Está disponible?
SI DICE “Sí”: Continúe a la Sección B. 
SI DICE “No”: Continúe a la Sección E.
B. Descripción del Estudio
Este estudio esta relacionado con el comienzo del tratamiento hormonal, un tipo medicación que su 
oncólogo le ha recomendado que tome para cáncer de mama. Este programa incluye 2 sesiones con una 
enfermera a través de Zoom, individuales y culturalmente informadas para enfrentar cualquier desafío o 
preocupaciones que pueda estar teniendo al comenzar a tomar este medicamento. Estas visitas se 
realizarían a través de un software de videoconferencia segua utilizando Zoom. ¿Le interesaría 
participar?
SI DICE “Sí”: Continúe a la Sección C. 
SI DICE “No”: Continúe a la Sección E.
C. Preselección de Elegibilidad
Muchas gracias por su interés. ¿Para determinar si este estudio es una buena opción para usted, le quería 
preguntar si usted ha empezado a tomar el medicamento de tratamiento hormonal que le prescribió su 
oncólogo?
SI DICE “Sí”: Continúe a la Sección E. 
SI DICE “No”: Continúe a la Sección C.
En una escala del cero al diez, cero indicando que no tiene duda en absoluto y diez indicando que está 
sumamente indecisa ¿Qué tan indecisa está usted de comenzar su tratamiento hormonal?
Si ≥4: Continúe a la Sección D. 
Si <4: Continúe a la Sección E.
D. Acceso al Formulario de Consentimiento y Discusión Sobre el Consentimiento Informado
El próximo paso es de que revisemos el formulario de consentimiento y le enviaré una copia por correo 
electrónico para sus registros.
SI DICE “Sí”: Continúe en la Sección D. [Proceed to complete the verbal consent process]
SI DICE “No”: No hay problema, también se puede completar este proceso por el correo. Le 
mandare dos copias del formulario por el correo para que usted firme las dos y me mande una 
copia devuelta usando un sobre prepagado que también le enviare. Adicionalmente, incluiré los 
requisitos de selección para verificar su elegibilidad. [Obtener su Dirección y Continúe a la 
Sección E]

34
E. Ningún Interés, Rechazo, Prefiere Copia del Consentimiento en Papel, No es elegible.
Muchísimas gracias por su tiempo. Si usted tiene alguna preocupación o pregunta acerca del estudio, por 
favor no dude en contactarnos.

35
9.7 Suggested Recruitment Voicemail Script
Hi, this is [study staff contact] calling from Massachusetts General Hospital/ Dana-Farber Cancer Institute. I am 
calling to get in contact with [patient name] about a program you may be interested in. Please give me a call 
back when you have the chance. You may reach me at [study staff contact information]. Thank you.

36
9.8 Suggested Recruitment Voicemail Script - Spanish
Hola, me llamo [study staff contact] estoy llamando por parte de Massachusetts General Hospital/ Dana-Farber 
Cancer Institute, para contactar a [patient name] sobre una oportunidad que le podría interesar. Por favor 
devuélvame la llamada cuando tenga tiempo. Me puede contactar al [study staff contact information]. Muchas 
gracias.

37
9.9 Patient Screening Question
How hesitant are you about starting your recommended hormonal therapy? 
(0=Not at all hesitant, 10=Extremely hesitant)

38
9.10 
Patient Screening Question - Spanish
¿Qué tan indecisa está usted acerca de comenzar su tratamiento hormonal recomendado? 
(0=Para nada indecisa, 10=Sumamente indecisa)

39
9.11 
Recruitment Flyer
The Mass General Cancer Outcomes Research Program
is conducting a research study to support women who are given 
hormonal therapy after breast cancer treatment.
If you:
  Are at least 21 years old
  Have hesitations or worries about starting hormonal therapy 
 Have not yet started taking medication such as Tamoxifen,
Arimidex, Letrozole, Exemestane.
You may be eligible to participate in a two-session virtual
intervention program to discuss and problem solve challenges 
to beginning hormonal therapy.
If you would like to learn more about this research study, 
please tell your oncologist or contact the study coordinator, 
[study staff name], at [study staff phone] or at [study staff 
email].
In i t iate
Barriers to beginning hormonal 
therapy after breast cancer

40
9.12 
Recruitment Flyer – Spanish
El Programa de MGH Cancer Outcomes Research esta 
conduciendo un estudio para apoyar a mujeres puestas en 
tratamiento hormonal después de recibir tratamiento para 
cáncer de mama.
Si usted:
  Tiene 21 o mas años
  Tiene dudas sobre comenzar su trataiento hormonal
 No ha empezado a tomar medicamentos como Tamoxifen, 
Arimidex, Letrozole, Exemestane.
Puede ser eligible para participar en un programa de
intervención virtual con dos sesiones para discutir y resolver 
desafíos relacionados con el comienzo del tratamiento
hormonal.
Si quiere aprender mas sobre este estudio, por favor dígale a su 
oncólogo o contacte a la coordinador(a) del estudio [study staff 
name], al [study staff phone] o por [study staff email].
In i t iate
Comenzar el Tratamiento Hormonal 
después de Cáncer de Mama.

41
9.13 
Suggested Email Template for Sending a Copy of the Verbal Consent and HIPAA 
Authorization
Subject line: “INITIATE Study at MGH/DFCI” 
Hello [participant name],
Thank you for your participation in the INITIATE study. Please see attached a copy of the consent form for 
your records. If you have any questions or concerns, please do not hesitate to reach out.
Thanks!
[Study staff name]
[Study Staff Contact Information]
Suggested Electronic HIPAA Authorization Email Template 
Subject line: “INITIATE Study HIPAA Authorization”
Hi [participant name],
Thank you for participating in our research study! To allow study staff to access health information, I’ve 
included a link to the HIPAA authorization form. All information is kept confidential for only trained study 
staff and will be stored securely.
Thanks,
[Study Staff Name]
[Study Staff Contact Information] 
[REDCap-generated link]

42
9.14 
Suggested Email Template for Sending a Copy of the Verbal Consent and 
HIPAA Authorization - Spanish
Subject line: “El estudio INITIATE en MGH/DFCI” 
Saludos [participant name],
Le agradecemos por su interés en nuestro nuevo estudio conducido en Massachusetts General Hospital. Por favor 
consulte adjunta una copia del formulario de consentimiento para sus registros. Por favor, no dude en contactarnos 
si usted tiene alguna pregunta o preocupación.
Gracias,
[Study Staff Name]
[Study Staff Contact Information]
Suggested Electronic HIPAA Authorization Email Template - Spanish 
Subject line: “El estudio INITIATE HIPAA Autorización”
Saludos [participant name],
Le agradecemos por su participacion en nuestro studio. Para permitir que el personal del estudio acceda a la 
información de salud, he incluido un enlace al formulario de autorización de HIPAA. Toda la información se 
mantiene confidencial solo para el personal capacitado del estudio y se almacenará de forma segura.
Gracias,
[Study Staff Name]
[Study Staff Contact Information] 
[REDCap-generated link]

43
9.15 
Participant Locator Form– English
1. Participant Name
2. Mailing Address
3. Preferred phone number

Mobile

Home

Work

Other
4. Phone number
5. Can study staff leave voicemails regarding your participation in the study?

Yes

No
6. If you would like to receive SMS text messaging reminders, please check the box below

I give permission to the INITIATE study team to contact me regarding this research study, using 
the mobile phone number provided.

I understand that any communication using SMS with the study team is NOT HIPAA-compliant, 
not encrypted, and does not guarantee confidentiality.

I understand that this number is not monitored regularly and should not be used for urgent or 
emergency situations.

Yes, I understand and give my permission for the INITIATE study to SMS message me.

No, I do not give my permission.
7. Best e-mail address to reach you at
8. Preferred survey delivery method

Email

Via hard-copy mail
9. The Partners HealthCare standard is to send email securely. This requires you to initially set up and 
activate an account with a password. You can then use the password to access secure emails sent to you 
from Partners HealthCare.
If you prefer, we can send you "unencrypted" email that is not secure and could result in the 
unauthorized use or disclosure of your information. If you want to receive communications by encrypted 
email despite this risks, Partners HealthCare will not be held responsible. Your preference to receive 
unencrypted email will apply to emails sent from this research group/study only.
Would you prefer to receive encrypted or unencrypted emails from the study team?

Encrypted

Unencrypted

44
9.16 
Participant Locator Form– Spanish
1. Nombre de participante
2. Dirección de envoi
3. Teléfono preferido para contactarle:

Celular

Casa

Trabajo

Otro
4. Número del teléfono
5. ¿Podemos dejar mensajes con respeto a su participación del estudio?

Sí

No
6. Si quiere recibir mensajes de SMS como recordatorio, por favor selecciona la opción adecuada:

Le doy permiso al equipo de estudio, INITIATE, contactarme al número de teléfono proveído 
con respeto al estudio

Yo entiendo que el equipo de estudio, INITIATE, no garantiza la confidencialidad: cualquier 
comunicación usando SMS con el equipo de estudio no cumple con el HIPPA y no está 
encriptado

Yo entiendo que este número de teléfono no está monitoreado con frecuencia y no debe ser 
usado en situaciones urgentes o de emergencia
i. Sí, yo entiendo las condiciones y le doy permiso al equipo de estudio, INITIATE, 
contactarme a través de mensajes de SMS.
ii. No, no quiero darte permiso.
7. El mejor correo electrónico para contactarla/o:
8. Método preferido de entrega para una encuesta

Correo electrónico

Copia impresa por el correo
9. El estándar de Partners HealthCare es enviar corroes electrónicos de forma segura. Para asegurar nuestro 
estándar, requerimos que usted cree su propia cuenta con una contraseña segura. Usted puede usar esta 
contraseña para acceder correos electrónicos seguros de Partners HealthCare.
Si prefiere, nosotros podemos enviar correos electrónicos inseguros que no son encriptados. Si elige 
usar corroes electrónicos que no son encriptados es posible que resulte en el uso desautorizado y la 
diseminación de tu información. Si quiere correr el riesgo de usar correos electrónicos inseguros, 
Partners HealthCare no asumirá responsabilidad. Su preferencia de recibir correos electrónicos inseguros 
aplicará solo a correos electrónicos entre usted y el equipo de estudio.
¿Preferiría recibir correos electrónicos del equipo de estudio encriptados o no encriptados?

Encriptados

No encriptados

45
9.17 
Suggested Participant Email Reminder Templates
Email Reminder Templates
[The following templates will be used for emailing depending on context and status of a participant through the 
protocol. Under the discretion of trained study staff and extenuating circumstances, study staff may stray from 
the following templates to address scheduling/reminder situations not covered by the following. Under no 
circumstances will study staff ever screen or discuss personal medical history, exchange personal health 
information, or other sensitive information via email. If a participant introduces sensitive information, including 
but not limited to the examples just listed, into an email, the study staff member will direct the participant to call 
them to discuss it further over the phone.]
Intervention session reminder:
Hello 
,
We are reaching out regarding the INITIATE study at MGH/DFCI. This is a reminder that you have an 
INITIATE session tomorrow at 
. Please sign on to the session using the Telehealth link sent to you over 
email. Please contact [study staff contact] if you have any questions.
Thank you,
[Study Staff Member]
Questionnaire reminder:
Hello 
,
We are reaching out regarding the INITIATE study at MGH/DFCI. This is a reminder that it is time to complete 
the [1-month/3-month] questionnaire, which will take roughly 20 minutes. You have received the questionnaire 
via [email/mail]. Please contact [study staff contact] if you have any questions.
Thank you,
[Study Staff Member]

46
9.18 
Suggested Participant Email Reminder Templates - Spanish
Recordatorio de la sesión de intervención:
Hola 
,
Nos estamos comunicando con respecto al estudio INITIATE en MGH/DFCI. Este es un recordatorio de que 
tiene una sesión de INITIATE mañana a las 
. Ingrese a la sesión utilizando el enlace de telesalud que se le 
envió por correo electrónico. Comuníquese con [study staff contact] si tiene alguna pregunta.
Gracias,
[Study Staff Member]
Recordatorio de cuestionario:
Hola 
,
Nos estamos comunicando con respecto al estudio INITIATE en MGH/DFCI. Este es un recordatorio de que es 
hora de completar el cuestionario del (Primer mes/Tercer mes) [1-mes/3-mes], que durara unos 20 minutos.
Usted ha recibido el cuestionario por [correo electrónico / correo]. Comuníquese con [study staff contact] si 
tiene alguna pregunta.
Gracias,
[Study Staff Member]

47
9.19 
Suggested Participant SMS Text Reminder Templates
Text Message Reminder Templates
[The following templates will be used for SMS messaging depending on context and status of a participant 
through the protocol. Under the discretion of trained study staff and extenuating circumstances, study staff may 
deviate slightly from the following templates to address scheduling/reminder situations not covered by the 
following. Under no circumstances will study staff ever screen or discuss personal medical history, exchange 
personal health information, or other sensitive information via SMS message. If a participant introduces 
sensitive information, including but not limited to the examples just listed, into a SMS message conversation, 
the study staff member will direct the participant to call them to discuss it further over the phone.]
Intervention reminder:
Hello 
, this is a message from the INITIATE study at MGH/DFCI. This is a reminder that you 
have an INITIATE session tomorrow at    . Please sign on to the session using the Telehealth link sent to 
you over email. Please contact [study staff contact] if you have any questions. Thank you.
Questionnaire reminder:
Hello 
, this is a message from the INITIATE study at MGH/DFCI. This is a reminder that it is 
time to complete the [1-month/3-month] questionnaire. You have received the questionnaire via [email/mail]. 
Please contact [study staff contact] if you have any questions.
Thank you.
[Study Staff Member]

48
9.20 
Suggested Participant SMS Text Reminder Templates - Spanish
Recordatorio de intervención:
Hola, este es un mensaje del estudio INITIATE en MGH/DFCI. Este es un recordatorio de que tiene una sesión 
de INITIATE mañana a las 
. Ingrese a la sesión utilizando el enlace de telesalud que se le envió por 
correo electrónico. Comuníquese con [study staff contact] si tiene alguna pregunta.
Gracias,
[Study Staff Member]
Recordatorio de cuestionario:
Hola 
,
Nos estamos comunicando con respecto al estudio INITIATE en MGH/DFCI. Este es un recordatorio de que es 
hora de completar el cuestionario del (Primer mes/Tercer mes) [1-mes/3-mes]. Comuníquese con [study staff 
contact] si tiene alguna pregunta.
Gracias,
[Study Staff Member]

49
9.21 
INITIATE Welcome Letter – English 
Dear [patient name],
Please find your INITIATEworkbook enclosed here for your upcoming first session.
Asa reminder, you are scheduled for your INITIATEsessions[session 1 date at time]
and [session 2 date at time].
Please feel free to contact [study staff name] at [study staff email] or [study staff
phone]. Alternatively, you can also contact the principal investigator of the study,
Dr. Jamie Jacobs, at jjacobs@mgh.harvard.edu or at 617-643-1777 with any 
related questions.
Thank you so much for your participation in the INITIATEstudy and we look forward
to having you in the program!
The INITIATE Study
MassachusettsGeneral Hospital
Dana-Farber Cancer Institute
55 Fruit Street
Yawkey Center, Suite 10B
Boston, MA 02114
(617) 643-1777
[patient name]
[patient address]
[patient address]
Sincerely,
Jamie Jacobs, Ph.D.
Leticia Varella, M.D.
[study staff name]

50
9.22 
INITIATE Welcome Letter – Spanish
Estimado/a [patient name],
Por favor Encuentre su libro de trabajo INITIATE incluido aquí para su primera
sesión.
Como recordatorio, usted está programado para sus sesiones INITIATE el [session
1 date at time] y [session 2 date at time].
Por favor siéntase libre de contactar [study staff name] al [study staff email] o
[study staff phone]. Alternativamente, también puede comunicarse con la
investigadora principal del estudio, Dra. Jamie Jacobs, a
jjacobs@mgh.harvard.edu o al 617-643-1777 con cualquier pregunta
relacionada.
¡Muchas gracias por su participación en el estudio INITIATE y esperamos contar
con su participación en el programa!
The INITIATE Study
MassachusettsGeneral Hospital
Dana-Farber Cancer Institute
55 Fruit Street
Yawkey Center, Suite 10B
Boston, MA 02114
(617) 643-1777
[patient name]
[patient address]
[patient address]
Sinceramente,
Jamie Jacobs, Ph.D.
[study staff name]
Leticia Varella, M.D.

51
9.23 
Participant Road Map
Welcome to the INITIATE Study! Here is a roadmap of what to 
expect as a participant in this study.
If you have any questions please contact [study coordinator names] 
at [study coordinator emails] or at [study phone number].
Enrollment
Intervention
Second
Survey
Third
Survey
Week 0
Week 1-3
Week 4
Week 12
-Enroll in Study
-Survey 1
-Session 1 at Week 1
-Session 2 at Week 3
-Survey 2 at [Date]
-Survey 3 at [Date]

52
9.24 
Participant Road Map - Spanish
¡Bienvenido al estudio INITIATE! Esto es lo que puede esperar 
como una participante en este estudio.
Si tiene alguna pregunta, comuniquese con [study coordinator 
names] en [study coordinator emails] o en [study phone number].
Inscripción
Intervención
Segundo
cuestionario
Tercer
cuestionario
Semana 0
Semana 1-3
Semana 4
Semana 12
-
Inscripcion en el
estudio
-
cuestionario 1
-Sesión 1 en Semana #1
-Sesión 2 en Semana #3
- Cuestionario 2 en
[Date]
-Cuestionario 3 en
[Date]

53
9.25 
INITIATE Manual
[See separately attached appendix item; will be given to all participants.]

54
9.26 
Interventionist Post-session Survey
INITIATE post-session survey
-
Participant study ID
-
Interventionist
-
Date of session
-
Session administered
-
How long was the session approximately (in minutes)?
-
Session Notes
o
Please note anything important about the session or scheduling
-
Review of Homework Practice
o
Was the participant assigned homework for this session?
o
Please rate the patient’s overall adherence to the homework:

1. Did not complete

2.

3. Does some homework

4.

5. Satisfactory job

6.

7. Excellent compliance

55
9.27 
Semi-structured Interview Guide
Introduction
Hello, my name is 
. You have been asked to participate in this interview to share your experiences going through the 
INITIATE program. I will ask you a variety of questions about your experiences during the study. I greatly appreciate 
your willingness to participate in this study.
This interview will take 15 minutes.
Everything that you share with me today is confidential, and your answers will not affect your future 
participation in studies or your access to medical services.
There are no right or wrong answers to these questions. It is very important for us to hear your thoughts and 
feelings on the program, so we can improve it for the future.
I would like to audio-record this interview because I will not be able to write all this information down. The 
interview will be transcribed word for word and will allow us to capture your thoughts and feelings in your own 
words. No identifying information, such as your name or names of others, will be included in the transcript.
Additionally, your responses will never be reviewed individually. Responses will be collected and combined 
from all participants for feedback to the study team.
Do I have permission to record this interview?
Before we start, do you have any questions about what we are doing here today? 
(START RECORDING)
1.
How did you feel about the number of INITIATE sessions?
2.
How did you feel about how long each session lasted?
3.
How satisfied were you with the information you received?
4.
Have you used any of the skills that you learned?
• Probe: Relaxation skills, skills for coping with symptoms, etc.
5.
How did you feel about the individual structure?
6.
How did you feel about the videoconference?
7.
How did you feel about the packet of questionnaires? 
• Probe: Too long?
•
Probe: Was anything confusing?
8.
How did you feel about the number of times we asked you to complete the questionnaires?
9.
Do you have any suggestions for how to improve our program?
10.
Did anything get in the way of you being able to participate?
11.
Would you recommend this to other women experiencing hesitation about starting hormonal therapy?
Questions related to cultural background:
•
Can you share with me, how do you identify yourself (for example, as a Black Hispanic woman, as Chinese 
American)?
•
Was there anything that got in the way of you participating in this study?

56
•
Was there anything that got in your way of participating that relates to your race, ethnicity, culture, 
or other way you identify yourself?
•
Offer examples: were the questions in the survey relevant to you? were the examples 
in the workbook relevant to you (only for intervention participants)?
•
What did you like about this study/program?
•
What did you dislike about this study/program?
•
Is there anything related to your race, ethnicity, or cultural background that might get in the way 
of you taking your hormonal therapy medication every day?
•
Offer example: some groups might question how well these medications work, some 
may have less trust in their doctors and nurses.
•
Is there anything related to your race, ethnicity, or cultural background that might get in the way of 
your ability to manage side effects from the medication?
•
Offer example: some groups might question how well these medications work, some 
may have less trust in their doctors and nurses.
•
Do you feel you will be able to talk with your doctors and nurses about any questions you have 
had with your hormonal therapy?
•
Do you feel that your experience, or concerns about this medication, are the same or different from 
other women in a similar position?
•
Probe: how about women from different backgrounds?
•
How do you think we could make this program meet the needs of women of different backgrounds?
•
Is there anything you can think of, that could help support you to take the medication?

57
9.31
Remuneration Form
DF/HCC Protocol #XX-XXX
Remuneration Form
Remuneration for study participation.
Participant Name
Participant MRN
SSN or ITIN
Mailing Address
For study team:
 Baseline Assessment - $10
Date completed: 
 1-month Assessment - $10
 3-month Assessment - $10
Date paid: 

58
9.32
Source Documentation Certified Copy Cover Sheet
Cancer Outcomes Research Program (CORE) 
Yawkey Building, Suite 10B
32 Fruit Street, Boston, MA 02114 
Source Documentation – Certified Copy Cover Sheet
Type of Document: 
 
Pages (including cover sheet): 
This form serves to verify that the following scanned copy is of the exact original document, includes all pages, 
is legible, and confirms all wet-ink signatures.
Location Scanned: 
Time & Date Scanned: 
Scanned by:
Signature
Date
Printed
Title

59
9.33
Suggested Social Media posts (Facebook, Instagram, Twitter, Reddit)
Option 1: Have you been diagnosed with breast cancer and are you worried about starting your hormonal 
therapy (anastrozole, letrozole, tamoxifen)? If so, you may be eligible to participate in this research study at the 
Massachusetts General Hospital (MGH) Cancer Center.
We have created a culturally sensitive program to help you manage stress and worry about starting the 
medication. We are recruiting women of diverse racial and ethnic backgrounds (for example, Black, 
Latinx/Hispanic, Asian) who speak English and/or Spanish.
If enrolled, you will complete two 1-hour sessions over Zoom with a nurse practitioner from the MGH breast 
oncology department. You will be asked to complete 3 surveys over the course of the study and will be 
compensated for your time. Contact the study team to learn more at [contact information] [insert relevant 
hashtags]
Option 2: If you were diagnosed with breast cancer and have worries about taking your recommended hormonal 
therapy, you may be eligible to participate in this research study. Participants will complete a virtual, 2-session 
program with a nurse practitioner from the breast oncology department at Massachusetts General Hospital. If 
you are interested in participating, contact the study team at [contact information] [insert relevant hashtags]
Option 3: New #research at the Mass General Cancer Center and Dana-Faber Cancer Institute, led by clinical 
psychologist Dr. Jamie Jacobs, is offering a virtual program for women who have been recommended hormonal 
therapy after breast cancer treatment. If you are interested in participating, contact the study team at [contact 
information] [insert relevant hashtags]
Accompanied by flyer or logo.