Symptom-Targeted Randomized Intervention for Distress and Adherence to Adjuvant Endocrine Therapy (STRIDE) Among Breast Cancer Survivors: A Pilot Feasibility Trial
Phase: NA
Conditions: Breast Cancer, Adherence, Medication
Sponsor: Massachusetts General Hospital

 
 
PROTOCOL TITLE: 
Symptom-Targeted Randomized Intervention for Distress and Adherence to Adjuvant Endocrine Therapy 
(STRIDE) among Breast Cancer Survivors: A pilot feasibility trial  
 
PRINCIPAL INVESTIGATOR: 
Jamie M. Jacobs, Ph.D. 
Center for Psychiatric Oncology and Behavioral Sciences 
617-643-1777 
jjacobs@mgh.harvard.edu 
VERSION NUMBER: 
1.6 
DATE: 
01/03/2022 

 
Table of Contents 
1.0 
Objectives ................................................................................................................ 4 
2.0 
Background .............................................................................................................. 5 
3.0 
Inclusion and Exclusion Criteria .............................................................................. 9 
4.0 
Study-Wide Number of Subjects ............................................................................. 9 
5.0 
Study-Wide Recruitment Methods ........................................................................ 10 
6.0 
Multi-Site Research ............................................................................................... 12 
7.0 
Study Timelines ..................................................................................................... 13 
8.0 
Study Endpoints ..................................................................................................... 13 
9.0 
Procedures Involved ............................................................................................... 14 
10.0 Data and Specimen Banking .................................................................................. 19 
11.0 Data Management* and Confidentiality ................................................................ 19 
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects .......................... 21 
13.0 Withdrawal of Subjects .......................................................................................... 22 
14.0 Risks to Subjects .................................................................................................... 24 
15.0 Potential Benefits to Subjects ................................................................................ 25 
16.0 Vulnerable Populations .......................................................................................... 25 
17.0 Community-Based Participatory Research ............................................................ 26 
18.0 Sharing of Results with Subjects ........................................................................... 26 
19.0 Setting .................................................................................................................... 26 
20.0 Resources Available ............................................................................................... 26 
21.0 Prior Approvals ...................................................................................................... 26 
22.0 Recruitment Methods ............................................................................................. 26 
23.0 Local Number of Subjects ..................................................................................... 26 
24.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 26 
25.0 Compensation for Research-Related Injury ........................................................... 27 
26.0 Economic Burden to Subjects ................................................................................ 27 
27.0 Consent Process ..................................................................................................... 27 
28.0 Process to Document Consent in Writing .............................................................. 28 
29.0 Drugs or Devices .................................................................................................... 28 
 
 
 

 

 
Objectives 
1.1 
Overview 
Development and testing of an evidence-based, videoconference, tailored intervention to enhance 
adherence to adjuvant endocrine therapy, improve symptom management, and reduce distress for 
breast cancer survivors 
The majority of breast cancer is hormone sensitive and treated with 10 years of adjuvant endocrine therapy 
(AET) (i.e., tamoxifen, aromatase inhibitors) to reduce risk of recurrence and improve survival; however, 
adherence to AET among breast cancer survivors (BCS) is overwhelmingly poor, with half of women becoming 
non-adherent within five years. Difficulty coping with symptoms and psychosocial distress (i.e., depression or 
anxiety) are major barriers to adherence. There is a dearth of efficacious interventions targeting the needs and 
adherence challenges of BCS prescribed AET. To address this gap, the proposed study employs a mixed-
methods design to develop and test an evidence-based, psychosocial videoconference intervention (STRIDE) to 
enhance adherence to AET, improve symptom management, and reduce distress in s at Massachusetts General 
Hospital Cancer Center and three community satellite sites. Phase 1 included (1) semi-structured interviews 
with BCS on AET (n=30) and intervention development with psychologists and oncology clinicians (DF/HCC 
Protocol #17-201). Phase 2 will entail a run-in phase (Arm A; n=5) to evaluate acceptability and refine the 
intervention and a randomized controlled trial (Arm B; n=100) to assess the feasibility of comparing the 
STRIDE intervention to a medication monitoring control with assessments and adherence monitoring over the 
course of six months. This study lays the groundwork for a full-scale randomized controlled trial to assess 
efficacy of the psychosocial videoconference intervention to improve symptom management, enhance 
adherence to AET, and reduce distress for BCS.  
 
Theoretical basis for proposed intervention The 
proposed study aims are based on guidelines for 
developing behavioral interventions to manage chronic 
diseases: the Obesity-Related Behavioral Intervention 
Trials (ORBIT) Model, put forth by NIH and the Office 
of Behavioral and Social Sciences Research.1 ORBIT is a 
progressive 
framework 
that 
encourages 
ongoing 
adjustment to the intervention as the study unfolds, which 
is distinct from testing of a fixed protocol. The model 
emphasizes 1) designing or adapting the behavioral 
intervention based on drivers of behavior that are 
treatment targets and refining practical intervention 
aspects (i.e., mode of delivery, duration) using methods 
such as qualitative data collection to evaluate and revise 
content (Phase 1 of the proposed study, DF/HCC Protocol 
#17-201) using proof-of-concept and feasibility pilot 
studies to justify a behavioral efficacy trial (Phase 2 of 
the proposed study: this protocol). The design is informed by a framework for medication adherence,2,3 the 
Cognitive Model of Adjustment to Cancer,4 and the Health Belief Model3,5,6 (HBM; see Figure 1). Step 1 is 
informed by Murray’s2 framework for medication adherence. The proposed intervention will address patient 
and treatment factors with strategies for reducing distress, monitoring and managing side effects, and addressing 
the interaction between psychological and medical adherence concerns.4 The HBM, in the context of cancer and 
adherence,7 maintains that the health behavior (i.e. taking medication) will be adopted if the patient perceives 
(a) risk for a condition, (b) that the medication will reduce risk/severity, (c) that benefits outweigh costs, and (d) 
self-efficacy for taking medication.3,5 In line with this model, the proposed intervention aims to improve 
medication-taking behavior by addressing perceived risk and medication efficacy. 
 
SES, cost, 
financial 
distress 
Depression 
Anxiety 
Side effects (pain, 
hot flashes) 
Beliefs 
Knowledge 
Attitudes  
Patient-
provider 
relationship 
Figure 1. Conceptual Model       
Perceived 
need/illness 
perception 
Self-efficacy 
Adherence 

 
Innovation of proposed study 
This will be the first study to develop and test an evidence-based intervention that is flexible, portable, 
and tailored to address AET adherence barriers unique to BCS. The proposed strategy implements a 
mixed-methods design based on the ORBIT model,1 integrates a comprehensive conceptual framework, adapts 
an established, evidence-based treatment, and employs novel technologies in the following three ways: 1) 
Tailored intervention content. 2) Videoconferencing. The use of tele-mental health ZOOM technology limits 
barriers to treatment such as cost, time, and travel, thereby increasing access to behavioral health interventions.8 
We  will extend the use of videoconferencing to BCS reporting difficulty managing their AET. 3) Objective, 
electronic measurement. Since self-report methods tend to yield overestimates of adherence;9-12 We will use the 
Medication Event Monitoring System (MEMS13) in addition to self-report measures. Thus, this study employs 
existing technologies in a novel setting to model longitudinal change in AET adherence in the intervention and 
control groups.13  
 
Specific Aims 
1. 
Primary Aim.  To examine the feasibility and acceptability of a tailored, small-group, Telehealth 
intervention (STRIDE) compared to a medication monitoring control for survivors of breast 
cancer taking AET. 
Hypothesis 1: The study will be feasible, defined by recruitment (enrollment rate > 50%), retention 
(follow-up assessment completion rate > 70% of all participants who complete baseline) and 
attendance (attendance rate of at least 70% of participants completing at least 4 of 6 sessions [67%]). 
 
Hypothesis 2: The study will be acceptable demonstrated by >75% of participants reporting average 
satisfaction scores greater than the scale’s mid-point (Client Satisfaction Questionnaire). 
2. 
Secondary Aim: To assess effects of the STRIDE intervention on adherence to AET, symptom 
distress, and satisfaction with AET. 
Hypothesis 2: We hypothesize that participation in the STRIDE intervention will be associated with an 
increase in adherence and satisfaction with AET and a decrease in symptom distress at 12-weeks 
compared to the medication monitoring control, and that these improvements will maintain at 24-week 
follow-up.  
3. 
Exploratory Aims: 
a. To assess the effects of the STRIDE intervention on several psychosocial constructs, 
exploring potential mediator and moderators of the intervention.  
Exploratory Hypothesis: We will explore whether participation in the STRIDE intervention is 
associated with an increase in quality of life (QOL) and medication-taking self-efficacy and a 
decrease in distress (anxiety and depression) at 12-weeks compared to the medication monitoring 
control, and whether these improvements are maintained at 24-week follow-up. We will also 
explore mediators of the intervention such as coping skills or beliefs about medicine, and 
demographic and treatment-related moderators of the intervention.  
b. To examine reasons for deciding not to participate in this social behavioral trial.  
Exploratory Hypothesis: In efforts to inform future studies and gain insight into barriers to 
participate in this study, we will examine participant reasons for choosing not to participate. It is 
hypothesized that participants approached about the study who choose not to participate will do 
so for a variety of reasons, such as time constraints. 
2.0 
Background 
Female breast cancer is the most commonly diagnosed cancer in the U.S.; 1 in 8 women (12%) will develop 
breast cancer in her lifetime.14 Approximately 60-75% of breast malignancies are hormone sensitive (i.e., 

 
hormone receptor-positive)15 and are treated with AET, a critical component of prevention in patients with 
early-stage breast cancer.16 AET (tamoxifen or an aromatase inhibitor) significantly improves outcomes for 
early-stage, hormone-receptor positive BCS.15 A meta-analysis showed that breast cancer recurrence and 
mortality were reduced by approximately 50% and 30%, respectively, with tamoxifen.17 However, despite 
overwhelming clinical benefits, half of women are non-adherent within five years of initiating AET.18 A 
systematic review showed that adherence to tamoxifen and AIs ranged from 41-88%, and 50-91%, 
respectively.19 Strikingly, adherence declines continuously each year following therapy initiation.20  
Poor adherence to AET is detrimental for BCS. Non-adherence in women with early-stage breast cancer is 
associated with increased breast cancer recurrence,21 breast cancer mortality,22 and overall mortality.23 Non-
adherence is also associated with increased physician visits, higher hospitalization rates, longer hospital stays,24 
and poor patient-provider relationships.11 While women with hormone receptor-positive breast cancer were 
previously prescribed five years of AET, recent studies showed that continued therapy up to 10 years further 
reduces risk of recurrence and mortality.25 With this new evidence, the American Society of Clinical Oncology 
(ASCO) now recommends 10 years of AET for many BCS.15 This prolonged administration will likely 
compound existing adherence problems and highlights the critical need for patient-centered interventions to 
address adherence challenges for BCS.  
Surprisingly, few intervention trials have addressed AET adherence in BCS. These interventions did not 
target well-established factors that influence AET adherence and generally did not improve adherence.10,26-28 
Given the dearth of interventions to target AET adherence, women are not receiving the support needed to 
optimize breast cancer outcomes. Tailored interventions are warranted that address modifiable predictors of 
non-adherence. These predictors include patient, disease, treatment, and provider/healthcare system factors (see 
Figure 1 in previous section). Patient-related factors are the most significant correlates of non-adherence and 
include perceptions of low recurrence risk,29 necessity for AET,30 and low self-efficacy in taking medication.29 
Patient sociodemographic factors include age,20 out-of-pocket medication costs,31 financial distress,29 and health 
literacy.32 Disease factors include having a recurrent cancer or a larger invasive ductal carcinoma.33 On the 
treatment level, AET-related side effects (e.g, joint pain, hot flashes, sleep difficulties, cognitive symptoms) 
negatively influence adherence.34 With regard to provider/healthcare system factors, suboptimal patient-
physician communication is associated with worse adherence to AET.29 In order to improve adherence, 
interventions must address several of these modifiable factors. 
Additionally, depression and anxiety are significant risk factors for treatment non-adherence.35 BCS 
commonly experience distress following treatment, with approximately 33% reporting depressive symptoms36 
and 18% reporting anxiety.37 Significant AET-related side effects and toxicities such as joint pain, hot flashes, 
fatigue, and sexual dysfunction often underlie the emotional distress reported by BCS.34 Importantly, BCS who 
report negative emotions related to AET and distress related to side effects are less likely to be adherent.29 A 
recent meta-analysis concluded that management of depression may enhance adherence to AET and improve 
cancer outcomes.38 Thus, it is imperative that an evidence-based intervention addresses each individual’s 
depressive or anxiety symptoms and the potential sources of distress such as AET-related side effects and side 
effect-related interference with daily functioning.  
With regard to intervention development, ASCO guidelines advocate for an approach that meets the 
psychosocial needs of patients based on the severity of their symptoms.39 In addition, interventions should be 
efficient and accessible given that BCS are re-entering their lives post-treatment and struggling with ongoing 
challenges.40 To address this timely public health concern, we propose to develop and test a theoretically and 
empirically informed, videoconference, tailored intervention to enhance AET adherence, improve symptom 
management, and reduce distress for BCS. The intervention will be referred to as STRIDE: Symptom-Targeted 
Randomized Intervention for Distress and Adherence to Adjuvant Endocrine Therapy among Breast Cancer 
Survivors.  
In this study, early-stage, hormone receptor-positive BCS with distress related to AET, adherence difficulties, or 
side effects, will be offered participation. The STRIDE intervention will include cognitive-behavioral strategies 
for adherence, distress, and symptom management with adaptations from CBT for Adherence and Depression,41 

 
which is shown to improve adherence via integration of adherence counseling and skills-based treatment for co-
occurring psychiatric symptoms.41 To minimize burden and increase access, we propose to deliver the STRIDE 
intervention via ZOOMTM software. ZOOM is a HIPAA-secure Massachusetts General Hospital (MGH)-
approved skype-like modality that will be used in psychiatry department for group virtual visits. Following 
semi-structured interviews and intervention development (completed Phase 1), we will test acceptability in a 
run-in phase and feasibility in a pilot RCT with guidance from mentors and advisors. Findings will inform 
future research and the planning and implementation of a full-scale efficacy trial. In the long-term, results may 
have implications for breast cancer survivorship care plans and the provision of efficient support for BCS on 
AET. Ultimately, improved adherence may optimize disease-related outcomes for BCS. 
Preliminary Studies 
Cognitive-behavioral interventions can lower depressive symptoms and cancer-specific distress in breast 
cancer. Based on findings that a 10-week Cognitive Behavioral Stress Management (CBSM) intervention 
combining CBT and relaxation training is beneficial during treatment for early-stage breast cancer,42,43 I studied 
the long-term effects of CBSM.44,45 At five-year follow-up, BCS (N=130) who received CBSM post-surgery 
reported fewer depressive symptoms than the control group (p=.030). At the 11-year follow-up (N=100), 
participation in the CBSM group was associated with better quality of life (p=.040) and fewer depressive 
symptoms (p=.030).45 My colleagues and I studied the differential benefits of a brief, five-week CBT 
intervention compared to a five-week relaxation training intervention and an attention-matched control group 
during treatment for early-stage breast cancer.46 Women with breast cancer in the CBT intervention reported 
less cancer-specific distress compared to the attention control (p=.004). Our findings show that cognitive-
behavioral interventions are beneficial for reducing cancer-specific distress during breast cancer treatment and 
may improve distress symptoms for BCS in the short- and long-term. 
 
Psychiatric symptoms are highly prevalent in BCS prescribed AET. Of the 240 women who participated in 
the CBSM study, 67% were prescribed AET. One-year post-surgery, 27.6% of these women reported elevated 
depressive symptoms, and 37.0% reported elevated anxiety. These findings are comparable to population rates, 
highlighting the need to mitigate distress in BCS taking AET. Furthermore, preliminary data from our ongoing 
studies in the Cancer Outcomes Research Program, co-directed by Dr. Jennifer Temel and Dr. Joseph Greer, 
suggest that the proportion of MGH patients with breast cancer and depression and/or anxiety is congruent with 
published estimates of up to 33% of BCS reporting anxiety or depressive symptoms.73,74  Specifically, in a 
current Patient-Centered Outcomes Research Institute-funded study (PI: Greer) to improve adherence and 
symptom management in patients with cancer prescribed oral chemotherapy, 27% of women with breast cancer 
at MGH reported clinically elevated levels of anxiety, and 12% reported clinically elevated levels of depression 
on the Hospital Anxiety and Depression Scale. After completion of active treatment, these women will become 
eligible for participation in the proposed study. Furthermore, in a survivorship needs assessment survey 
completed by 130 MGH BCS (PI: Dr. Jeffrey Peppercorn and Dr. Elyse Park), 46% of women reported 
experiencing anxiety symptoms “sometimes,” and 22% reported experiencing anxiety symptoms “most of the 
time” or “always”. In addition, 35% of MGH BCS reported experiencing sadness “sometimes,” and 9% 
experienced sadness “most of the time” or “always.” Of these MGH BCS who were prescribed AET, 57% 
reported experiencing anxiety symptoms “sometimes,” 22% reported experiencing anxiety symptoms “most of 
the time” or “always,” 51% reported experiencing depressive symptoms “sometimes”, and 5% reported 
depressive symptoms “most of the time” or “always.” 
 
Systematic review finds few interventions for AET adherence. I collaborated with Dr. Joseph Greer to 
publish a systematic review of adherence to oral cancer therapy,12 which identified three of the RCTs with 
interventions to improve adherence to AET in early-stage breast cancer. Interventions were atheoretical and not 
efficacious.10,26,27 Conclusions underscore the need for theoretically- and evidence-based interventions targeting 
AET adherence in BCS.  
 

 
Qualitative interviews with BCS emphasize need and directly informed STRIDE intervention for 
symptom management, adherence, and distress. The tailored, evidence-based STRIDE intervention to be 
tested through this protocol is directly informed by a qualitative study phase involving semi-structured 
interviews with BCS at the MGH Center for Breast Cancer (DF/HCC Protocol #17-201). Between 11/2017-
11/2018, 36 interviews were conducted to explore experiences of BCS taking AET. BCS were recruited to 
reflect a representative sample of women who may benefit most from such an intervention. Twenty interviews 
were conducted with BCS with low adherence to AET, 10 interviews were conducted with BCS with high 
adherence to AET yet moderate to severe side effect burden, and 6 interviews were conducted with BCS who 
had been prescribed AET within the past four weeks. Additionally, 30% of BCS (n=9) who completed 
interviews indicated high levels of distress (as determined by a score of ≥8 on the PHQ-9 and ≥10 on the GAD-
7). We gathered feedback related to (1) experiences with and perceptions of AET (including side effects, 
adherence, and distress), (2) interest in a supportive, psychosocial intervention; (3) applicability of intervention 
content; (4) intervention length, timing, and delivery; and (5) anticipated challenges to participation. After 
interviews were complete, we created a thematic coding framework to analyze these qualitative data and made 
modifications to the STRIDE intervention based on results. Ultimately, qualitative findings indicate that BCS 
need and desire a supportive intervention for taking AET. While the initial primary focus was on adherence, we 
added foci of symptom management and distress to ensure patient-centeredness based on BCS reported 
experiences. In addition, while we originally planned a stepped-care intervention in the proposed grant with 
flexibility to modify this based on this qualitative phase, it became apparent that this model would not 
adequately support the needs of these women and we revised it to be a brief intervention for all women with 
distress related to AET, adherence, or symptoms/side effects. Taking preferences into account, the STRIDE 
intervention was modified to be group-based with the option of individual sessions. We retained 
videoconference delivery with an option for in-person sessions at the preference of the participant. We 
shortened the sessions from the originally planned 8-11 to a total of five weekly 60-minute sessions with two 
follow-up phone check-ins. We also shortened the overall study length from eight months to six months. 
Feedback was also solicited from clinicians and experts as planned, including Drs. Joseph Greer (primary 
mentor and expert in intervention development), Jennifer Temel (secondary mentor and expert in cancer 
outcomes research), Steven Safren (advisor with adherence expertise), Ann Partridge and Jeff Peppercorn 
(breast oncologists with expertise in adherence to AET and survivorship), and Elyse Park (expert in qualitative 
methodology). A review of the STRIDE intervention was also conducted with oncology clinicians and nurse 
practitioners that work directly with this BCS population. Following our 5-person run-in phase, we finalized the 
intervention by incorporating participant feedback. The intervention is now a 6-session, group-based, virtual 
intervention with two follow-up phone check-ins. Finally, breast cancer survivors who participated in the 
STRIDE program and self-identified as part of a minority racial/ethnic population (e.g. Black, Asian, Latinx, 
etc.) will be offered the opportunity to participate in an exit interview provide feedback. Previous studies (e.g. 
#17-201) have successfully administered exit interviews to modify and improve patient-centered interventional 
programs utilizing participant feedback. This interview will lake approximately 15 minutes. Our goal is to 
understand areas of our current program that could be more relevant to breast cancer survivors who are part of 
racial/ethnic minority populations, as interventions to improve AET adherence should be culturally sensitive. 
  
 
 
Summary. Taken together, these studies highlight (a) the need for development and testing of interventions 
based on theory and evidence to enhance adherence to AET, improve symptom management, and reduce 
distress for BCS; (b) the ongoing high levels of distress reported by BCS on AET regimens; and (c) the 
potential for a cognitive behavioral intervention to be a promising modality for addressing distress in BCS. 
With the knowledge from my prior work and qualitative phase of this mixed-methods study, the proposed 
research aims to test the feasibility and acceptability of the STRIDE intervention compared to a medication 
monitoring control.  
 

 
3.0 
Inclusion and Exclusion Criteria 
3.1 
Screening Procedures 
Study staff will recruit BCS from the MGH Center for Breast Cancer. Study staff will screen 
BCS’ electronic health records (EHR) for demographic and clinical eligibility criteria and 
request permission from the oncology clinician to approach patients at clinic appointments 
(HIPAA waiver detailing EHR access has been submitted to DF/HCC IRB). Specifically, study 
staff will email the cancer care team (i.e., oncologist, nurse practitioner) to inquire if they have 
any reservations about the study team approaching the patient for study participation at the next 
scheduled clinic visit. Clinicians will be sent an email containing the patient’s name, EHR 
number, and date of her appointment (Appendix 30.1). This email will include an informative 
handout for clinicians to familiarize themselves with study aims and relevant procedures to 
assist in informing their decision on granting permission for study staff to approach a patient 
(Appendix 30.2). If a clinician does not respond to the email soliciting reservations about 
approaching the patient, study staff will approach the provider in-person to request approach 
permission. If study staff are unable to approach a potentially eligible patient in-clinic, study 
staff will attach a study flyer to the patient’s chart for them to receive at the visit, and thus 
initiate a passive introduction to the study. To ensure providers are aware of study staff intent to 
re-approach the patient at a later date, study staff will send the clinician and additional email 
prior to any future patient approach. If any aspect of patient eligibility or ineligibility is unclear 
from patient screening, trained study staff will communicate with oncology clinicians verbally 
or via email to clarify the eligibility status of a patient. Additionally, if not found in the EHR, 
study staff may clarify the Eastern Cooperative Oncology Group (ECOG) performance status 
score with the patient using the brief questionnaire in Appendix 30.27. Study staff will finalize 
assessment of patient eligibility upon approach, as detailed in Section 5.0 of this protocol. 
3.2 
Inclusion & Exclusion Criteria 
Eligibility criteria (Table 1) will maximize homogeneity, reflect study focus, enhance rigor, and 
consider limitations. The intervention targets adherence barriers identified in women, as male 
BCS face different challenges.47 While patients with metastatic cancer are also treated with 
endocrine therapy, there are different facilitators and barriers to adherence with incurable 
disease. Therefore, the focus on early-stage BCS preserves the intervention scope. BCS with 
Ductal Carcinoma In Situ (DCIS) or Lobular Carcinoma In Situ (LCIS) will be eligible as they 
experience distress related to breast cancer and adherence challenges to AET as well. The 
recruitment window of 1 week to 36 months maximizes the likelihood that women have initiated 
AET and aims to improve adherence in the initial years that are most clinically beneficial.17 Up 
to 105 women will be enrolled to ensure that at least 4-5 participants complete the run-in period 
and that at least 60 participants will complete study participation. Participants who self-identify 
as part of a minority racial/ethnic population will be offered the opportunity to participate in a 
qualitative, semi-structured exit interview to explore patient feedback on the cultural awareness 
relevance of the STRIDE study, regardless of randomization. This interview will last 
approximately 15 minutes. 
3.3 
Special Populations 
No special populations, including adults unable to consent, individuals who are not yet adults, 
pregnant women, or prisoners, will not be included in this study. 
Table 1.  
Inclusion Criteria 
1. Female 
2. Age 21 or older 
3. Diagnosis of early-stage (Stage 0-IIIb), hormone receptor + breast cancer 

 
4.0 
Study-Wide Number of Subjects 
We propose a four-center run-in period (n=5) and randomized-controlled trial (n=100) of an 
evidence-based telehealth intervention for a total of 105 BCS taking AET. Our original accrual 
goal for the RCT was 75, but due to successful enrollment and additional time for conducting the 
study, we decided to expand accrual to 100 in order to increase our ability to detect group 
differences in secondary outcomes. 
5.0 
Study-Wide Recruitment Methods 
5.1 Recruitment and Enrollment Procedures 
The following recruitment procedures will be executed by the lead site, MGH Boston, at all MGH-
affiliate study sites. The three MGH-affiliate 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.  
Participants will be recruited through the following three methods: 
• EHR Screening: As detailed above (Section 3.1), study staff will screen the MGH Center for 
Breast Cancer clinic schedules at the MGH Boston, MGH Northshore, MGH Waltham, and 
Newton-Wellesley satellite site for potentially eligible patients (under the use of a HIPAA 
waiver, submitted to the DF/HCC IRB). If a study staff member is attempting to recruit a 
potentially eligible patient through an affiliate site, they will utilize the study screening and 
telephone scripts (Appendices 30.3 & 30.4) 
• The Partners Rally Recruitment Portal: Study staff will submit a recruitment advertisement to the 
Partners Rally Recruitment Portal (advertisement detailed in Appendix 30.5). Through this 
portal, interested and potentially eligible patients will be able to send their contact information to 
the study team. The study team will then reach out to interested patients and use the study 
screening and telephones scripts to assess fit and eligibly for the study (Appendices 30.3 & 30.4). 
• Provider & Self-Referral: Patients may be referred to contact the study staff by receiving a study 
flyer (Appendix 30.6), seeing a study flyer posted in-clinic, or by hearing about the study by an 
oncology provider. Study site-PIs may also consent patients for the study. If a patient reaches out 
to the study staff, the study team will use the study screening and telephones scripts to assess fit 
and eligibly for the study (Appendices 30.3 & 30.4).  
For patients meeting initial eligibility criteria and with clinician approval, trained study staff 
will approach the patient at their clinic visit to explain the study and conduct the informed 
4.Within 1 week-36 months of starting adjuvant endocrine therapy  
5. Ability to read and respond in English  
6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 
7. Currently taking adjuvant endocrine therapy (i.e. if took recent break, has taken within the past 2 
weeks) 
8. Completed primary treatment (i.e., chemotherapy, surgery, and/or radiation) for early-stage breast 
cancer 
9. Indicates a score ≥4 on one of the three NCCN adapted distress thermometer study screening 
questions 
Exclusion criteria 
1. Uncontrolled psychosis, active suicidal ideation, or psychiatric hospitalization within the past year 
2. Cognitive impairment that prohibits participation in the study 
3. Enrollment in a different clinical trial for breast cancer 
4. Current participation in formal group psychotherapy or other psychosocial intervention trial 
5. Undergoing primary treatment for other cancer (i.e., advanced stage cancer) 

 
consent discussion. Study staff will use Appendix 30.1 to notify the patient’s clinician of the 
intended approach. The study staff will initially introduce the study to patients and ask if they 
are currently taking their AET. If the patient indicates that they are not interested in the study, 
study staff will collect the reason for refusal, for the purposes of documentation and future study 
reporting. If the patient indicates that they are interested in the study and are currently taking 
their AET, the study staff will screen the potentially eligible patient using the study staff 
screening script (Appendix 30.3). The brief screening questions are intended to assess the fit of 
the patient for the study. The participant will screen in to the study if she indicates an answer of 
4 or above on any of the three brief screening questions. If a patient screens out of the study, 
study staff may ask the patient for permission to re-approach her some point in the future, as 
distress and adherence challenges may come and go at different points throughout the course of 
the medication. If the patient screens in, she will be presented with a detailed, HIPAA-
compliant consent form to be signed by each participant following explanations by study staff. 
The consent form will include all of the study procedures, information about potential risks and 
benefits of participation, and information regarding who they can contact for further questions 
(PI: Jacobs). It also will state that participation is voluntary, participants can refuse to answer 
any questions, participants can withdraw from the study at any time, and study participation is 
in no way related to their medical care. If a participant is unable to be approached in-person or 
consented in-clinic due to external factors, such as lack of clinic space or patient time 
constraints, the study team may reach out to potential participants over the phone. Prior to 
initiating phone contact, the study team will utilize the same provider email to assess if the 
provider has any reservations about the study staff contacting the patient (Appendix 30.1). If the 
patient does not have an upcoming appointment in clinic, study staff may call the potentially 
eligible patient using the recruitment phone script and screening script to gauge interest and 
eligibility (Appendices 30.3 & 30.4). Study staff will not call more than three times total or 
leave more than two voice messages (Appendix 30.7). If the patient expresses interest and 
screens in, the study team will begin the electronic informed consent (EIC) process outlined in 
Section 27.0. 
5.2 
Participant Communication 
Study staff will ask for preferred participant communication methods upon time of approach. 
Participants will fill out the Participant Locator Form (Appendix 30.12) to indicate best contact 
and backup contacts. Potential communication includes in-person, by phone, email, or SMS 
Text Messaging. Phone and email communication have been successful strategies to 
communicate with patients in prior psychosocial studies, and email templates intended for study 
use can be found in Appendix 30.14. 
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 scheduling, reminders, and follow-up. Participants will be provided with the number 
for SMS study-related communications. Study staff will follow the templates as outlined in 
Appendix 30.13 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. Further 
procedures on this opt-out process can be found in Section 27.0 on Electronic Informed 
Consent.   
6.0 
Multi-Site Research 
6.1 
Multi-Site Study Conduct 
This study will be conducted at MGH Boston, lead site, and at three MGH satellite sites, 
Newton-Wellesley Hospital, MGH North Shore, and MGH Waltham. All affiliate sites are on 
record by the DF/HCC IRB. As detailed in Section 5.0, the study staff at MGH Boston will 
maintain full responsibility of recruitment and enrollment at MGH Boston and at the MGH-
affiliate sites. The MGH Boston study team will communicate with providers at Newton-
Wellesley Hospital, MGH North Shore, and MGH Waltham regarding permission to approach 
patients over the phone, as detailed in section 3.0, and on the progress of the study or any 
protocol updates. Site-PIs and peripheral study staff at the satellite site may assist with referrals 
but that is the extent of their role in study conduct. All participants will be registered and 
enrolled on OnCore through MGH Boston, regardless of where a participant’s primary 
oncologist is located. All participants will complete the intervention and all study procedures 
through study staff at MGH Boston. A HIPAA waiver was submitted to the DF/HCC and 
authorization approved for all sites to which the study is open. 
6.2 
Multi-Site Communication 
Study staff at the lead site will periodically communicate via phone or email with the satellite 
site to update sites on study progress or any modifications to study protocol. 
6.3  
Multi-Site Confidentiality 
All study data will be stored and maintained by study staff at the lead study site, MGH Boston. 
There will be no transmission of study data (e.g., study assessments, exit interview transcripts) 
from MGH-affiliate sites to MGH Boston. As detailed above, MGH Boston study staff will be 
responsible for all recruitment and enrollment, including the completion and storage of all 
participant and study data. This study does not involve any collection of participant specimens. 
 
6.4 
Institution Change of Previous Study Member 
Emily Walsh is a predoctoral psychology trainee in the University of Miami Department of Psychology. 
Ms. Walsh was previously engaged in this research study as the primary clinical research coordinator of 
the study (e.g., recruitment, enrollment, and completion of participant study interviews) from September 
2017 to June 2019, at which time she moved to the University of Miami. Dr. Jamie Jacobs will assume 
PI duties at the MGH Cancer Center while Ms. Walsh’s role will be to conduct research activities (data 
interpretations and discussions) at the University of Miami. Ms. Walsh’s research activities will also be 
monitored by Dr. Michael Antoni, a PI and faculty member at the University of Miami. All data 
activities will be completed with deidentified participant transcripts for qualitative analysis under the 

 
direct supervision of Dr. Jacobs and Dr. Antoni and will be for use only by Ms. Walsh under Dr. 
Antoni’s supervision at the University of Miami.  
 
7.0 
Study Timelines 
Table 2 depicts the expected overall study timeline: 
Time Point 
Study Procedure 
Months 0-6 
• Finalize and submit Institutional Review Board application for approval 
• Train study staff in study procedures, recruitment, and data collection 
• Conduct run-in period (n=5) to refine study procedures and intervention 
Months 7-33 
• Enroll and randomly assign up to 100 patients to receive either the STRIDE 
intervention vs. the medication monitoring plus standard care control 
• Weekly-meetings of study staff to review study progress and address any 
study issues 
Months 34-36 
• Complete data analysis and submit manuscripts 
• Prepare and submit grant proposal for large-scale randomized trial 
Each subject will be enrolled for approximately 24 weeks total. 
8.0 
Study Endpoints* 
8.1 
Primary Endpoint: 
The primary endpoint is feasibility and acceptability as measured by participant rates of 
enrollment (>50%), participant retention (>70%), intervention attendance (>70% attending at 
least 4 of 6 sessions), and intervention satisfaction (>75% reporting average satisfaction greater 
than the scale’s midpoint). 
8.2 
Secondary Endpoints: 
The secondary endpoints of the study are as follows: 
• Changes in adherence between groups on objective MEMS Caps and self-report MARS-5* 
at 12-weeks and 24-weeks post-baseline (changes in MEMS Caps adherence will be 
compared across the entire 24-week period). 
• Changes in self-reported satisfaction with AET on the CTSQ* between groups at 12-week 
and 24-weeks post-baseline. 
• Changes in self-reported symptom distress on the BCPT* between groups at 12-week and 
24-weeks post-baseline. 
Secondary endpoints will also be examined using social support (MSPSS*) and 
demographic and treatment-related factors (e.g., age, stage, time since AET initiation) as 
potential covariates. 
8.3 
Exploratory Endpoints: 
• Changes in distress levels (HADS*), quality of life (FACT-B*), and medication self-
efficacy (SEAMS*) between groups at 10- and 24-weeks post-baseline, as well as potential 
mediation of secondary and exploratory endpoints through changes in beliefs about adjuvant 
endocrine therapy (BMQ-AET*), self-efficacy for managing AET symptoms (Self-Efficacy 
For Symptoms) and/or perceived coping skills (MOCS*). Potential demographic or 
treatment related moderators will also be explored (e.g., age, type of AET medication, 
cognitive functioning [PROMIS*]). 
*All study instruments are explained in full in Section 9.3. 

 
9.0 
Procedures Involved* 
9.1 
Study Design 
This is a multi-site randomized control trial of a tailored, telehealth intervention (STRIDE) 
versus standard care plus medication monitoring in up to 105 BCS taking AET (run-in period, 
n=5; RCT, n=100). To ensure balanced representation between the two study groups, we will 
stratify randomization by participant level of distress (high vs. low), determined by HADS 
administered at baseline (Appendix 30.8). A participant will be considered high distress if they 
answer with a score of ≥ 8 on the HADS. Furthermore, participants who self-identify as part of a 
minority identifying racial/ethnic group will be offered the opportunity to participate in a 
qualitative exit interview to gather patient feedback on the study’s cultural awareness and 
relevance. This interview will take approximately 15 minutes. 
9.2 
The STRIDE Intervention 
Run-in Period. We will recruit up to 5 early-stage, hormone receptor-positive BCS who meet eligibility 
criteria to participate in the run-in period of the study, an approach to ensure smooth operation of study 
procedures.48,49 These participants will complete the entire intervention through the 3-month assessment 
(see Protocol Schema prior to Table of Contents). Participants will complete acceptability ratings of ease 
and usefulness (0-10 scale) at each session (Appendix 30.9). Participants will complete an additional 
STRIDE acceptability measure (including the CSQ) about their experience in the program as a whole 
after they complete the intervention (Appendix 30.18). At the 3-month assessment, we will conduct 
individual, semi-structured exit interviews to solicit feedback about the intervention, study procedures, 
and the assessment battery and ensure acceptability (Appendix 30.10).50 Qualitative data will be 
recorded, transcribed, and thematically analyzed. Results will inform modifications such as refinement 
of the intervention, assessment battery, and study methods for feasibility testing in a pilot RCT. Any 
revisions made at that time to the intervention content or assessment battery will be re-submitted as 
amendments to the protocol and IRB approval will be obtained prior to beginning of the RCT.  
 
STRIDE Intervention. The intervention content is included in Appendix 30.11. STRIDE is a brief, 
group-based, videoconference intervention with six weekly one-hour sessions and two follow-up 15-30-
minute phone check-ins at month four and five.  The STRIDE intervention incorporates aspects of CBT 
for Adherence and Depression,41 employing symptom management, cognitive restructuring, behavioral 
activation, and skills-based methods to address adherence and psychiatric symptoms. The first three 
sessions entail an assessment of patient, treatment, and healthcare system/provider barriers to adherence, 
followed by psychoeducation about breast cancer risk and benefits and risks of AET. We will employ 
specific interventions to target patient-identified barriers. For example, cognitive reframes will be 
applied to optimize accuracy related to recurrence risk perception and clinical necessity for therapy. 
Problem-solving will be implemented for management of financial distress (e.g., develop plan with 
social work and oncology team). To target healthcare system/provider barriers, the protocol will teach 
assertiveness skills for adopting an active role with clinicians and increasing self-efficacy. The last three 
tailored sessions will target treatment factors; patients will receive training in symptom management and 
coping strategies specific to the side effects or symptoms that they endorse. CBT is effective in helping 
patients manage cancer-related side effects such as pain, fatigue, and menopausal symptoms such as hot 
flashes. CBT strategies will address individual sources of distress, such as difficulty managing 
symptoms, or financial concerns around medication cost that are interfering with adherence and 
exacerbating distress. In extenuating circumstances, participants may be scheduled for individual 
sessions if we cannot schedule them for a group session within a reasonable amount of time. 
 
Participants in the STRIDE intervention will continue to monitor medication-taking with the MEMS 
Caps throughout the 24-week study period. As part of the intervention, participants will practice 
relaxation training using study recordings through the study’s website portal 

 
(stridestudy.mgh.harvard.edu). The structure of each website post can be viewed in Appendix 30.25. 
The website will move into production after IRB approval. This is a website created with the support of 
IT at MGH/HMS and is viewable to those with the link to the website URL. The website will contain no 
advertisements or other content. It will only contain the relaxation file, and the individual sessions from 
the work book that the intervention participants receive, so that they can also have an electronic version 
accessible for the future. Study staff will provide instructions for participants to access this website via 
email as part of the intervention session reminders (Appendix 30.14). In addition to the overall study PI, 
Dr. Jacobs, trained clinical psychology practicum students, clinical psychology fellows, licensed 
psychologists or social workers on the study team at MGH will deliver the intervention, to ensure 
successful administration of the intervention. Interventionists will complete a post-intervention survey 
for each group intervention, which will document process variables such as session length, session 
interventionist, and session attendance. Dr. Jacobs has ample experience delivering this type of 
intervention and was a protocol therapist on several NIH-funded CBT-based studies. She will conduct 
weekly clinical supervision with trained interventionists. 80% of sessions will be audio-recorded and at 
least 10% randomly selected, stratified by interventionist, and reviewed with Dr. Greer 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%.51 Feedback will be given to interventionists to enhance 
adherence to the protocol.  
 
 
Finally, participants who identify as part of a racial/ethnic minority population will be offered the 
opportunity to participate in a qualitative exit interview to provide feedback on the STRIDE program. 
 
Medication Monitoring Control. Participants in the comparison condition will not receive the STRIDE 
intervention; however, they will monitor medication-taking with MEMS Caps and undergo standard 
care with oncology follow-up. 
Rationale: Although we considered an attention-matched condition to control for nonspecific 
intervention effects, we decided against this approach because medication monitoring is likely to 
improve adherence alone.52 Additionally, requesting participation in a placebo intervention adds undue 
burden to BCS who are coping with emotional and physical sequelae. Finally, an attention control 
should only be employed if attention would affect the primary outcome. Since no data suggest that 
attention would improve AET adherence, an attention control would be an added expense and 
unethical.52 Finally, participants who identify as part of a racial/ethnic minority population will be 
offered the opportunity to participate in a qualitative exit interview to provide feedback on the STRIDE 
study. 
 
Retention. Strategies to promote retention will include accurate explanations of study expectations 
during the recruitment process,53 collection of locator information and a secondary contact (Appendix 
3.12), a phone check-in to ensure use of MEMS Caps, branding of study materials for project identity, 
and reimbursement for time ($20/assessment). Intervention participants will receive a text reminder one 
day prior to the scheduled ZOOM session (See Section 5.2 detailing Participant Communication). 
 
 
9.3 
Study Instruments 
The following questionnaires have been specifically selected to reflect the theoretical 
intervention targets and aims of the study. All participants will complete the baseline 
questionnaires within four weeks of documented informed consent. If a participant does not 
complete the baseline questionnaires within this timeframe, she will be re-screened and re-
consented, restarting the four-week window. Follow-up assessments will be completed at 12-
week (+/- 2 weeks) and 24-week (+/- 2 weeks) from time of baseline completion (Appendix 
30.16) Table 3 details the schedule for administering all study instruments. Patient assessments 
can be found in Appendix 30.16. We anticipate that 15-20% of 12-week assessments will be out 

 
of window for intervention participants, given the occasional delay of coordinating multiple 
patients’ schedules to arrange the intervention groups.  
 
Screening: 
Adapted National Comprehensive Cancer Network (NCCN) Distress Thermometer (Included as part of 
Study Screening Script in Appendix 30.3 and independently in Appendix 30.17): The NCCN Distress 
Thermometer is a valid, one-item measure for assessing distress in many cancer populations.54 This 
Instrument/Measure: 
Screening 
Baseline (4-
week window 
from consent) 
12-week s post-
baseline (+/- 2-week 
window) 
*24-weeks post-
baseline (+/- 2-
week window) 
Chart review 
X 
 
 
 
Adapted NCCN Distress Thermometer 
X 
 
 
 
Medication Event Monitoring System 
(MEMS Caps) 
 
To be used throughout the 24-week study period 
Demographics 
 
X 
 
 
Medication Adherence Report Scale 
(MARS-5) 
 
X 
X 
X 
Breast Cancer Prevention Trial 
Symptom Checklist (BCPT) 
 
X 
X 
X 
Cancer Therapy Satisfaction 
Questionnaire (CTSQ) 
 
X 
X 
X 
Hospital Anxiety and Depression Scale 
(HADS) 
 
X 
X 
X 
Functional Assessment of Cancer 
Therapy (FACT-B) 
 
X 
X 
X 
Measure of Current Status (MOCS) 
 
X 
X 
X 
Beliefs About Medications 
Questionnaire – Adjuvant Endocrine 
Therapy (BMQ-AET) 
 
X 
X 
X 
Multidimensional Scale of Perceived 
Social Support (MSPSS) 
 
X 
X 
X 
Self-Efficacy in Appropriate Medication 
Use Scale (SEAMS) 
 
X 
X 
X 
Self-Efficacy For Managing 
Symptoms and Taking AET 
Questionnaire (Self-Efficacy For 
Symptoms) 
 
X 
X 
X 
Patient-Reported Outcomes 
Measurement Information System 
(PROMIS) – Cognitive Function – 
Short Form 4a  
 
X 
X 
X 
Client Satisfaction Questionnaire 
(CSQ)** 
 
 
X 
 
Supplemental Medication Diary 
To serve as optional as-needed supplement to MEMS Caps (e.g., on vacation) 
Session Rating Form 
To be administered during the run-in period after each intervention session  
Intervention Acceptability Form 
To be administered during the run-in period at 3-months post-baseline 
Semi-structured Exit Interview 
To be conducted during the run-in period at 3-months post-baseline 
Semi-structured Exit Interview 
To be conducting during the RCT period after participants complete their 
participation in the STRIDE program. 
*Run-in participants will not complete a 24-week assessment 
**CSQ will be administered to intervention participants only 
 

 
measure is scored on a range of 0 (no distress at all) to 10 (extremely distressed), and a score of 4 has 
been identified as an appropriate cut-off to measure significant distress.55 This measure has been 
modified in this study for the purpose of screening BCS for distress related to taking AET, distress 
related to breast cancer symptoms/side effects, and distress related to adherence to AET. Participants 
who indicate a score of ≥ 4 on any of the three distress thermometers will be eligible for participation. 
 
 
Secondary Outcomes: 
Medication Event Monitoring System (MEMS Caps):13 MEMS Caps will be used to electronically 
monitor AET daily dose and timing of dose administration. MEMS Caps are widely used in adherence 
monitoring including for patients with breast cancer.34,56,57 Prescribed medication, dose, and timing will 
be identified in the Electronic Health Record and verified by the patient. Adherence will be calculated as 
the percentage of medication taken of the total prescribed. A total monthly and weekly adherence score 
will be calculated to examine changes over time. 
 
Supplemental Medication Diary (Appendix 30.23): The Supplemental Medication Diary will be used per 
participant discretion alongside their use of the MEMS Caps. The diary will allow participants to 
document any instance in which they take their AET without opening the MEMS Cap. For example, a 
participant would document use in the diary if they took out two doses to be taken for the next two days, 
without opening their MEMS again.  
 
Medication Adherence Report Scale (MARS-5): The MARS-5 assesses adherence to treatment and has 
been used specifically in the context of AET adherence. The scale consists of five items that ask about 
suboptimal adherence behaviors, such as “I stop taking my adjuvant endocrine therapy medicine for a 
while.” Each item is answered on a scale of 1 (Always) to 5 (Never).58  
 
Cancer Therapy Satisfaction Questionnaire (CTSQ): The Cancer Therapy Satisfaction Questionnaire 
(CTSQ) is a previously published 21-item measure that evaluates patients’ beliefs about the following 
aspects of medical care: expectations of the effectiveness of cancer therapy, feelings about side effects, 
oral cancer therapy adherence, satisfaction with cancer therapy, stopping cancer therapy, and reasons for 
non-adherence.59  
 
Breast Cancer Prevention Trial Symptom Scale (BCPT): The BCPT is a symptom checklist used to 
document physical and psychological symptoms associated with ET use.60 The measure includes several 
clinically-relevant symptom subscales and has been used broadly in previous studies on symptom 
distress in breast cancer patients. The BCPT asks participants to rate how much they have been bothered 
by several symptoms over the past week on a scale of 0 (Not at all bothered) to 4 (Extremely bothered).  
 
 
Exploratory Outcomes: 
 
 
Hospital Anxiety and Depression Scale (HADS):61 The HADS is a valid self-report measure for 
assessing anxiety and depressive symptoms among patients in non-psychiatric hospitals.62 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.    
 
Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B): 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 scale of 0 (not at all) to 5 (very 
much).63  
 
Self-Efficacy for Appropriate Medication Use Scale (SEAMS):64 The SEAMS will be used to measure 
patient self-efficacy in taking medication. The SEAMS was developed specifically for patients with 
chronic disease taking long-term medication.64 Two factor structures are created: self-efficacy for taking 
medication under difficult circumstances and under changing circumstances. Each item is answered on a 
scale of 1 (not confident) to 3 (very confident). 
 
Covariates: 
EHR Factors: The following information will be collected from participant EHR: MGH Main vs. 
Affiliate site, health insurance type, breast cancer stage, treatment (e.g., surgery, chemotherapy, 
radiation), ET type, time since treatment completion, menopausal status, psychotropic medications, and 
medical or psychological co-morbidities. 
 
Demographic Questionnaire: Participants will self-report their age, gender, race/ethnicity, marital status, 
education level, and relationship status. 
 
Multidimensional Scale of Perceived Social Support (MSPSS):65 The MSPSS is a validated, reliable 
scale used to capture levels of perceived social support. The scale consists of 12 items, such as “my 
family really tries to help me,” and is measured on a 7-point Likert scale. 
 
Potential Mediators 
Beliefs about Medicines Questionnaire – Adjuvant Endocrine Therapy (BMQ-AET):66 The BMQ-AET 
will be administered to assess beliefs about the need for AET. The BMQ-AET has been used in studies 
measuring endocrine therapy adherence.67 This study will use one of the two scales, which is computed 
measuring perceived need for medication and concerns about disruptive medication effects.  
 
 
Measure of Current Status (MOCS): 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). 
 
Self-Efficacy For Managing Symptoms Questionnaire (Self-Efficacy For Symptoms):68 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.  
 
Potential Moderator 
Patient-Reported Outcomes Measurement Information System (PROMIS) – Cognitive Function – Short 
Form 4a:69 The PROMIS short-form measure will be used to assess patient-perceived changes in 
cognitive function.70 The 4-item measure asks patients to response to each statement on a scale from 1 
(very often) to 5 (never) over the past 7 days.  
 
 
Intervention Acceptability: 
Client Satisfaction Questionnaire (CSQ):71 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 12-week  
assessment to evaluate intervention participants only to examine intervention acceptability. 
 
Run-in participants only: 
Session Rating Form (Appendix 30.9): This 5-item measure will be given to run-in participants to 
capture their thoughts and perceptions of the usefulness of each STRIDE intervention session. An 
example of a question is, “how enjoyable was today’s session?” Each question will be answered on a 
scale of 1-10. 
 
Intervention Acceptability Measure (30.17): This measure will be given to run-in participants only at the 
10-week post-baseline question. The goal of this measure is to capture participant thoughts and 
experiences having gone through the STRIDE Intervention. An example of an item is “how satisfied are 
you with the number of sessions (5) that you received?” and is to be answered on a scale of 1 (quite 
dissatisfied) to 4 (very satisfied). 
 
Semi-Structured Interview (Appendix 30.10): At the end of the run-in period, participants will complete 
a brief semi-structured interview to assess the STRIDE Intervention. This interview will be conducted 
with a study staff member not involved with the delivery of the intervention and will be used to inform 
and adapt the STRIDE Intervention for the RCT. 
 
Semi-Structured Interview (Appendix 30.11): At the end of the RCT period, participants who identify as 
part of a racial/ethnic minority population will complete a brief semi-structured interview to assess the 
STRIDE Intervention. This interview will be conducted with a study staff member not involved with the 
delivery of the intervention and will be used to inform and adapt the STRIDE Intervention for the next 
phase of the study to increase its cultural awareness and relevance. 
 
9.4 
Data Collection 
Participants will be given the option to complete the above instruments either on paper or over a 
secure REDCap portal. 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 assigned to the intervention arm will additionally receive a copy of the Intervention 
Manual, a welcome letter with study expectations (Appendix 30.11), and a study timeline 
document (Appendix 30.15) to better their understanding of what time points to expect 
throughout the study. 
Patients randomized to the usual care arm will follow standard care of Massachusetts General 
Hospital Cancer Center. They will also receive a study timeline document (Appendix 30.15). 
10.0 Data and Specimen Banking: Not applicable 
11.0 Data Management* and Confidentiality 
11.1 
Data Analysis 
To determine feasibility in a pilot randomized controlled trial (N=100), estimate effect size, and finalize 
the intervention and study protocol to plan a full-scale, adequately powered efficacy trial. 
 
Power calculation. The primary objective of this pilot study is to demonstrate feasibility, defined as (1) 
enrollment rate > 50%, (2) retention rate > 70%, and (3) attendance rate ≥ 70% (i.e. ≥ 70% of 
participants complete at least 4 of 6 sessions). At the time of the original protocol approval, we 

 
estimated an accrual goal of 80 (75 in RCT and 5 in run-in phase) participants; therefore, the following 
power estimates are based on that number. We estimated that the enrollment rate will be 60%. If 134 
patients are approached and 80 are enrolled, the lower limit for an exact, one-sided 95% confidence 
interval for the estimated enrollment rate will be 53%. Furthermore, we anticipate that the retention and 
attendance rates will both be 80%, and with 80 enrolled participants, the lower limit for an exact, one-
sided 95% confidence interval for the retention and attendance rates will be 71%. Thus, based on our 
estimates of the feasibility parameters, the study will demonstrate feasibility of the adherence 
intervention. We have now expanded our accrual goal to 100 participants, which serves to only increase 
our power and rates of enrollment, retention, and attendance. 
 
Primary Aim. To examine the feasibility and acceptability of a tailored, small-group, 
Telehealth intervention (STRIDE) compared to a medication monitoring control for 
survivors of breast cancer taking adjuvant endocrine therapy.  
Hypothesis 1: The study will be feasible, defined by recruitment (enrollment rate > 50%), retention 
(completion rate of follow-up assessments > 70% of all participants who complete baseline) and 
attendance (attendance rate of at least 70% of participants completing at least 4 of 6 sessions [60%]). 
 
Hypothesis 2: The study will be acceptable demonstrated by >75% of participants reporting average 
satisfaction scores greater than the scale’s mid-point (Client Satisfaction Questionnaire). 
 
Secondary Aim. To assess effects of the STRIDE intervention on adherence to AET, 
symptom distress, and satisfaction with AET. 
Hypothesis 1. We hypothesize that participation in the STRIDE intervention will be associated with an 
increase in adherence and satisfaction with AET and a decrease in symptom distress at 12-weeks 
compared to the medication monitoring control, and that these improvements will maintain at 24-week 
follow-up.  
 
Data will be assessed for patterns of missingness72 and statistical assumptions. We will conduct mixed 
effects models with repeated measures data and relevant covariates such social support (MSPSS) and 
demographic and treatment-related factors (e.g., age, stage, time since AET initiation) as potential 
covariates. Longitudinal analyses will include all time points and a cross-sectional analysis for each 
time point. Given that this pilot is not powered to detect statistically significant group differences, we 
will examine mean differences and sample variability. Effect sizes (Cohen’s d) will be calculated for 
changes in outcomes from baseline to four and eight months, as (Mean change score [intervention arm] 
– Mean change score [control arm])/SD pooled, where 0.3 indicates a small effect, 0.5 a medium effect, 
and 0.8 a large effect.73 Effect sizes will be used in a power analysis to estimate the necessary sample 
size to conduct a full-scale efficacy trial with power >80%. We will also verify the needed sample size 
based on ability to detect a clinically meaningful difference and references to existing literature.74  
 
Exploratory Aim. To assess the effects of the STRIDE intervention on several psychosocial 
constructs, exploring potential mediator and moderators of the intervention. 
Exploratory Hypothesis: We will explore whether participation in the STRIDE intervention is associated 
with an increase in QOL and medication-taking self-efficacy, and a decrease in distress (anxiety and 
depression at 12-weeks compared to the medication monitoring control, and whether these 
improvements are maintained at 24-week follow-up. 
We will use the same procedure to assess changes in secondary outcomes in the intervention 
group. We will explore potential mediation of secondary and exploratory endpoints through 
changes in beliefs about adjuvant endocrine therapy (BMQ-AET) and/or perceived coping skills 
(MOCS), as well as self-efficacy for managing symptoms (Self-Efficacy For Symptoms). 

 
Potential demographic or treatment related moderators will also be explored (e.g., age, type of 
AET medication, cognitive functioning [PROMIS]). We will conduct moderated regressions to 
examine whether a group difference in adherence is moderated by age, social support (MSPSS), 
employment status, menopausal status, medication type, or other patient/treatment factors. We 
will explore alternative models using dichotomous outcomes over time. 
 
Findings will inform the planning of an R01 to evaluate the efficacy of a videoconference, tailored 
intervention in improving ET adherence for BCS. If the current study is not found to be feasible or 
acceptable, we will have acquired valuable information to proceed in the identification of a patient-
centered intervention for BCS. For example, feedback from the final assessment can be used to modify 
the intervention, such as the addition of a systems-based intervention component if findings show that 
low health literacy or cost barriers influence intervention effects. Differences in adherence, feasibility, 
or acceptability based on demographic or clinical characteristics can help determine which individuals 
may benefit. Ultimately, this project will contribute to the understanding of BCS’ needs related to ET. 
Future studies based on these findings have the potential to influence survivorship care plans, and 
videoconferencing is a modality that can be widely disseminated. Improved adherence to ET may 
prevent recurrence and mortality, extending the lives of BCS. 
11.2 Missing Data 
The analyses for this study will focus on study completers to estimate the effect of the 
virtual, tailored 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 randomized subjects. After we examine patterns of missingness, we will use 
maximum likelihood with multiple imputation to account for missing data. 
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects 
12.1 
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 Joseph Greer, PhD, and study staff (clinical research 
coordinator [CRC] and interventionist). Specifically, meetings will include ongoing review of 
study protocol, assessment procedures, and issues 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 signed informed consent. 
• 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 conduct regular checks of MEMS Caps adherence 
data and contact patients once in the initial set-up to verify use of 
MEMS Caps. 
• 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 Dr. Greer (Study Co-Investigator, PI Co-Mentor) 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 team members 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 team 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. 
• 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 Federalwide 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 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 research team 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 team 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 research team 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 research team 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 research team 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. 
 
13.0 Withdrawal of Subjects 
We do not anticipate that any research participants will be withdrawn from the research study 
without their consent. If a participant requests to withdraw from the study, we will ask if they 
are comfortable sharing the reason for withdrawing to ensure that there are no necessary serious 
adverse events to report to the IRB. Subsequently, we will ask the participant if they are still 
willing to permit the study team to continue to access their EHR. 
14.0 Risks to Subjects 
14.1 
Reporting Adverse or Unanticipated Events 
We do not anticipate any harm with our study procedures. While some topics probed in study 
assessments and the STRIDE Intervention may be sensitive in nature, 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. 
14.2 Anticipated Reaction 
As this is a low-risk, social/behavioral study, 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 questions in the questionnaire or 

 
content in the intervention to be emotionally upsetting, and if so, they may experience some 
distress. 
14.3 Reaction Management 
The consent form will include all the study procedures, information about potential risks and 
benefits of participation, and information regarding whom the participant can contact for further 
questions.  It also will state that participation is voluntary, that participants can refuse to answer 
any question, 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 or exit interviews, 
they will be reassured by the clinician or study staff member conducting the intervention visit or 
interview that they can stop at any time and that they do not need to continue participating in 
content or answer interview 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, Dr. Greer, a licensed clinical 
psychologist, Amy Corveleyn, a licensed clinical social worker, as well as qualified clinical 
psychology practicum students and 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 assessment completion. 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 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.  
15.0 Potential Benefits to Subjects* 
Challenges associated with AET, including side effects, distress, or difficulties with adherence, 
are common among BCS. We anticipate the STRIDE Intervention will provide potential benefit 
to participants by teaching and reinforcing skills to manage these challenges. The intervention 
was directly informed by qualitative interviews with BCS taking AET to ensure the intervention 
is beneficial and patient-centered. Additionally, run-in period feedback will be used to further 
inform the intervention for maximum benefit for participants in the RCT. The risk from 
participation in the study is small (and will be minimized by the procedures outlined above), and 
the overall risk to benefit ratio is favorable. 
16.0 Vulnerable Populations: Not applicable 

 
17.0 Community-Based Participatory Research: Not applicable  
18.0 Sharing of Results with Subjects 
If a participant expresses interest in learning the results of the study, their contact information 
will be collected and securely stored by study staff. Upon completion of data collection for the 
study, study staff will provide interested participants with an abstract of study results. 
19.0 Setting 
19.1 
Location 
As previously stated in recruitment and enrollment procedures (Section 5.1), participants will be 
approached in-person in the MGH Center for Breast Oncology outpatient clinic in the Yawkey 
Center for Outpatient Care or called after receiving permission from their care team. Participants 
from other sites will be contacted via phone. Upon approach, in-person or over the phone, study 
staff will ensure complete confidentiality of all study information and procedures.  
20.0 Resources Available 
20.1 
Team Qualifications 
The PI, Dr. Jacobs, is responsible for full oversight of the project at MGH and participating 
institutions. She will be meeting with the CRC on weekly basis (and more often as urgent issues 
arise) to ensure the study process is being followed accurately and to address potential challenges 
or issues as they may arise. Dr. Jacobs is a member of the MGH Cancer Outcomes Research 
Program (CORe).  CORe has extensive experience conducting multi-site randomized clinical 
trials of supportive care interventions in oncology and has the necessary expertise to ensure the 
success of the proposed project. 
20.2 
Site Resources 
On an average year, 517 women with newly diagnosed breast cancer were treated with AET at 
the MGH Cancer Center. Based on literature and our initial findings from Phase 1 of this study, 
we expect up to 40% will have poor adherence and between 20-25% will have distress. Patients 
will screen in if they are experiencing distress related to AET, adherence, or side effects, they 
would be eligible for the study; therefore, we estimate the number of eligible patients may range 
from 104-208 patients per year. 
21.0 Prior Approvals: Not applicable 
22.0 Recruitment Methods 
As described in Section 5.0, all recruitment methods will be centrally located and executed by 
study staff at the lead site, MGH Boston. Recruitment strategies include EHR screening, the 
Partners Rally Recruitment Portal, and Provider Referral.  
As detailed in Section 26.0, participants will be provided with compensation of up to $60 total 
($20/assessment) throughout the study for their time to complete study assessments (Appendix 
30.19). 
23.0 Local Number of Subjects 
Each MGH-affiliate site will have a local accrual goal of 10 participants. The lead site, MGH 
Boston, will have a goal of 75 participants. The overall study accrual goal will be up to 105 
participants (run-in, n=5, RCT n=100). 
24.0 Provisions to Protect the Privacy Interests of Subjects 

 
As detailed in the Data Safety Monitoring Plan (Section 12.0), all subjects will receive a 
confidential number identifier. All participants will be identified on study assessments by their 
number identifier. 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. 
25.0 Compensation for Research-Related Injury 
We do not anticipate any research-related injury due to involvement in this supportive care trial 
 
26.0 Economic Burden to Subjects 
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. 
Additionally, study participants will be compensated for their time to complete the three study 
questionnaire batteries (baseline, 12-weeks post-baseline, and 24-weeks post-baseline). 
Participants will be compensated up to $60 ($20/assessment completed) in the form of a check 
(Appendix 30.19). 
27.0 Consent Process 
As stated previously, study staff will consent patients either in-person or over the phone using 
study scripts. We will follow all the requirements of SOP: Informed Consent Process (CON-100) 
in obtaining informed consent for study participants. 
Electronic Informed Consent Process (EIC): In the event that a potentially eligible patient 
expresses interest over the phone but will not be in clinic in the near future or receives care at an 
MGH-affiliate site, study staff will begin the EIC process. Patients will be asked to provide 
verbal permission and a preferred email address to be sent an email with a link through REDCap 
(Appendix 30.20). The REDCap link will direct patients to an encrypted REDCap portal; the 
Electronic/Paperless Consent Template Project will be used. Screen captures of what the EIC 
REDCap portal looks like are included in Appendix 30.21. This process begins with the patient 
verifying their date of birth and full name in order to enter the portal. Additionally, this portal 
will have the electronic (paperless) consent form, exactly identical in content to the paper 
version, to guide the patient through the consent discussion with study staff over the phone. At 
any point, if a patient would prefer to receive a hard copy of the consent form, the EIC process 
will stop and study staff will send the patient two copies of the consent form in the mail with a 
prepaid envelope to send it back. The patient will be given ample opportunity to ask questions 
and take their time to consider their participation. From there, patients will digitally sign and date 
the consent form. The study staff will then sign and date the consent form as the consenting 
investigator and send a digital or paper copy of the signed consent form per the participant’s 
preference, sent via Send Secure email if digitally or informed and given the opportunity to opt-
out of Send Secure using the Partners Send Secure opt-out language. This process has been 
found to be highly efficient among other psychosocial research studies, including DF/HCC 
Protocol #17-201 which directly informed this study, and minimizes burden to patients, study 
staff, and providers. 
Enrollment Procedures. DF/HCC institutions will register eligible participants in the Clinical Trials 
Management System (CTMS) Oncore as required by DF/HCC SOP REGIST-101. Registration must 
occur prior to the initiation of protocol-specific procedures or assessments.  
 
For registration of patients from DF/HCC institutions, which will be all participants in this study, study 
staff will complete the DF/HCC protocol-specific eligibility checklist using the eligibility assessment 

 
documented in the participant’s EHR and/or research chart. Study staff will confirm that the participant 
meets all inclusion criteria as described in this protocol and the criteria on the eligibility checklist. Study 
staff will be responsible for self-randomization of participants (Biostatistician-generated Randomization 
Scheme: Appendix 30.8) per ODQ request to decentralize non-therapeutic studies under the DF/HCC. 
MGH study staff will follow DF/HCC Standard Operating Procedure for Human Subject Research 
Titled Subject Protocol Registration (SOP #: REGIST-101) and register the participant on the protocol.  
 
28.0 Process to Document Consent in Writing 
As stated previously, all participants will provide written informed consent to partake in the study. 
 
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 30.22) 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 #17-201. If a patient is 
consented electronically, the completed version of their digital consent form will be saved as the 
completed, original source document and no certified copy cover sheet will be used. 
 
29.0 Drugs or Devices: Not Applicable 
 
 

 
30.0 Appendices 
30.1 Clinician Approach Email 
30.2 Clinician Study Information Handout 
30.3 Study Screening Script 
30.4 Study Telephone Recruitment Script 
30.5 Partners Rally Recruitment Advertisement 
30.6 Study Recruitment Flyer 
30.7 Study Recruitment Voicemail Script 
30.8 Study Randomization Scheme 
30.9 Session Rating Form 
30.10 Semi-Structured Run-In Interview Script 
30.11 Semi-Structured RCT Interview Script 
30.12 The STRIDE Intervention 
30.13 Patient Locator Form 
30.14 SMS Text Message Templates 
30.15 Study Email Templates 
30.16 Study Timeline Document 
30.17 Baseline, 12-week, & 24-week Post-Baseline Assessment 
30.18 Patient Screening Questions 
30.19 Session Acceptability Measure 
30.20 Remuneration Form 
30.21 EIC REDCap Invitation 
30.22 EIC REDCap Portal Screen Captures 
30.23 Source Document Certified Copy Cover Sheet 
30.24 Supplemental Medication Diary 
30.25 MEMS Participant Instructions 
30.26 Relation Recording Website Draft (Screenshots) 
30.27 Approach Chart Flyer 
30.28 ECOG Screener 
30.29 STRIDE Introduction Note Content 
30.30 Telehealth How-to 
 
 

 
30.1 
Clinician Approach Email 
 
Clinician Opt-out Email Template 
 
 
Symptom-Targeted Randomized Intervention for Distress and Adherence  
PI: Jamie Jacobs, Ph.D. 
 
Dear [Dr./NP/PA PROVIDER NAME], 
 
I am a research coordinator working with Dr. Jacobs on a symptom-targeted randomized study for symptom 
management, distress, and adherence among breast cancer survivors on adjuvant endocrine therapy.   
 
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 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) 
 
 

 
30.2 Clinician Study Information Handout 
 
Symptom-Targeted Randomized Intervention for Distress and Adherence among Breast Cancer 
Survivors on Adjuvant Endocrine Therapy (STRIDE): 
A pilot feasibility trial 
K07 Funded by the National Cancer Institute 
PI: Jamie Jacobs, Ph.D. 
Study Rationale 
• 
This study aims to enhance adherence, improve symptom management, and reduce distress among 
early-stage breast cancer survivors taking adjuvant endocrine therapy (AET) 
• 
AET improves clinical outcomes for hormone-sensitive breast cancer, yet adherence among survivors 
is poor 
• 
Barriers to adherence are well-established and modifiable; including concerns about adverse side 
effects, low appraisal of recurrence risk and need for therapy, and high distress (anxiety or depressive 
symptoms)  
• 
Surprisingly, few interventions have been tested to promote adherence to AET, and none have 
addressed these modifiable factors 
• 
Based on a qualitative study with breast cancer survivors, experts in hormonal symptoms, breast 
oncology clinicians, and behavioral psychologists, we developed a patient-centered, evidence-based 
intervention to improve symptom management, mitigate distress, and enhance AET adherence 
Study Specifics 
• 
This is a pilot randomized controlled trial in which patients will be randomized to receive either the 
STRIDE intervention or usual care 
• 
The intervention consists of 6, one-hour sessions delivered over videoconferencing with a psychologist, 
psychology trainee/fellow, or social worker and two check-in phone calls (15-30 minutes) 
• 
Patients in the control group will receive care as usual 
• 
All patients will be asked to store their AET in study-provided, electronic pill bottles to monitor 
adherence and complete assessments at baseline, 12 weeks, and 24 weeks 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 
• 
Lives within the state of Massachusetts 
• 
Diagnosis of early-stage (stage 0-IIIb), hormone-receptor positive breast cancer 
• 
Completed any primary treatment 
• 
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 
• 
Within 1 week to 36 months of initiating AET and is currently taking AET 
o 
If took a recent break, has taken AET within the past two weeks 
• 
May not be on another clinical trial requiring medication monitoring 
• 
May not have psychiatric or cognitive impairment 
• 
Is not currently undergoing active primary treatment for other cancer (i.e. advanced stage cancer) 
 
Study Contact Information: 
• 
Please send potentially eligible patients to the study coordinators, Katina Massad 
(kmassad@mgh.harvard.edu) or Julia Cohn (jgcohn@mgh.harvard.edu), or to the study PI, Dr. Jamie 
Jacobs, at jjacobs@mgh.harvard.edu 

 
 
 
0.3 Study Screening Script 
 
Hi, my name is [study staff] and I am a research assistant in the Cancer Center at MGH. I work on a 
study you might be interested in. Your oncologist said it would be alright if we speak with you about 
this study. This study offers a program for women who are taking a hormonal therapy and consists of 
6 weekly, small-group, virtual visits with a cancer center clinician to address any concerns or 
challenges you may be experiencing while taking this medication. These visits would take place over 
a secure videoconferencing software with up to 2 other breast cancer survivors who are also taking 
hormonal therapy. Does this sound like something you might be interested in? 
 
Each question is scored on a scale of 0-10. The first question is, on a scale of 0 being not bothered at 
all to ten being extremely bothered, how bothered are you by side effects from your hormonal 
therapy? 
 
My next question is, on a scale of 0 being not upset at all to ten being extremely upset, how upset are 
you by having to take hormonal therapy? 
 
My last question is, on a scale of 0 being not difficult at all to 10 being extremely difficult, how difficult 
is it for you to take your hormonal therapy medication every day? 
 
IF A SCORE OF 4 OR ABOVE ON ONE OR MORE: Thank you for going through those 
questions with me. It sounds like you would be a good fit for this study. The next step is to go 
through the consent form, which I can send you over email. What is the best email address to 
send it to? 
 
IF A SCORE OF 3 OR LESS ON ALL THREE: Thank you for going through those questions 
with me. It sounds like you are doing well with taking the hormonal therapy medication right 
now and you screen out for the study. Would it be alright if I were to check in with you at some 
point in the future to see how you’re doing? 
IF YES: [Collect best contact information and thank for their time], continue to 
Part E 
IF NO: Thank you for speaking with me today. You are always welcome to reach 
out if you have any questions about anything we spoke about today, but we will 
not reach out in the future. 
 
 
 
 

 
30.4 Study Telephone Recruitment Script 
 
Hi, this is [Study Staff Name] calling from Massachusetts General Hospital. How are you today? 
A1. Self-referral call-back: Thank you for reaching out to our study team regarding your interest 
in the STRIDE 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 F.] 
A2. Recruitment call: I am calling regarding a research study you might be eligible for and may 
have received a study flyer for while in-clinic last. Is now a good time that I could give you a 
brief overview of the study? 
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 F.] 
 
B. Study Description 
This study offers a program for women who are taking a hormonal therapy and consists of 6 
weekly, small-group, virtual visits with a cancer center clinician to address any concerns or 
challenges you may be experiencing while taking this medication. Your oncologist said it would 
be alright if we speak with you about this study. These visits would take place over a secure 
videoconferencing software with a few other breast cancer survivors who are also taking 
hormonal therapy. Does this sound like something you might be interested in? 
 
IF YES: Continue to Section C. 
 
IF NO: Continue to Section F. 
 
C. Eligibility Screening 
Thank you for your interest; so, I have a few initial questions we like to ask to get a sense of if 
this study might be a good fit for you. All of these questions are optional and completely 
confidential. 
Each question is scored on a scale of 0-10. The first question is, on a scale of 0 being not 
bothered at all to ten being extremely bothered, how bothered are you by side effects from 
your hormonal therapy? 
My next question is, on a scale of 0 being not upset at all to ten being extremely upset, how 
upset are you by having to take hormonal therapy? 
My last question is, on a scale of 0 being not difficult at all to 10 being extremely difficult, how 
difficult is it for you to take your hormonal therapy medication every day? 
IF A SCORE OF 4  OR ABOVE ON ONE OR MORE: Thank you for going through 
those questions with me. It sounds like you would be a good fit for this study. The next 
step is to go through the consent form, which I can send you over email. What is the 
best email address to send it to? 
 
IF A SCORE OF 3 OR LESS ON ALL THREE: Thank you for going through those 
questions with me. It sounds like you are doing well with taking the hormonal therapy 
medication right now and you screen out for the study. Would it be alright if I were to check in 
with you at some point in the future to see how you’re doing? 
IF YES: [Collect best contact information and thank for their time], continue to 
Part E 
IF NO: Thank you for speaking with me today. You are always welcome to reach 
out if you have any questions about anything we spoke about today, but we will 
not reach out in the future. Continue to Part E. 
 

 
 
D. Consent Form Access and the Informed Consent Discussion 
Okay, I have sent the consent form to the email you provided. You should expect an email with 
the subject line “MGH STRIDE Study.” This email will be sent from me and will include a link at 
the bottom. When you receive this email, please click this link to be directed to the consent 
form. The portal will prompt you to enter your full name and birthday to verify who you are to 
see the consent form.  
 [Informed Consent Discussion] 
 
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.  
 
 
 
 

 
30.5 Partners Rally Recruitment Advertisement 
 
Headline: STRIDE: Symptom-Targeted Randomized Intervention for Distress on Endocrine Therapy 
 
Summary (240 characters): If you were diagnosed with breast cancer and are currently taking a hormonal 
therapy, you may be eligible to participate in this research study. Participants are randomized to complete a 6-
week, small-group, virtual intervention. 
 
Project Title: Symptom-Targeted Randomized Intervention for Distress and Adherence to Adjuvant Endocrine 
Therapy (STRIDE) among Breast Cancer Survivors: A pilot feasibility trial 
 
Categories: Breast Cancer, Cancer, Medicines 
 
Project Image: 
 
 
 
 
CT.gov Identifier: To be assigned 
Funding Source: NIH 
 
Institutions conducting research: MGH, Newton-Wellesley, MGH North Shore, MGH Waltham 
IRB Organization: DF/HCC Dana Farber Cancer Institute 
 
Recruitment start date: 2/1/2019 
Recruitment end date: 5/1/2022 
 
What are you studying? 
We are studying the feasibility and effectiveness of a tailored program for women currently taking hormonal 
therapy for breast cancer to reduce distress and improve side effect management and adherence. 
 
Why is it important? 
A variety of challenges can arise around taking hormonal therapy, which can interfere with daily living and 
ability to take the medication. This program will allow women to explore and manage these concerns in a small-
group with other breast cancer survivors and a cancer center clinician.  
 
 
 
 

 
30.6 Study Recruitment Flyer 
 
 
 
 
 

 
30.7 Study Recruitment Voicemail Script 
 
Hi, this is [study staff contact] calling from Massachusetts General Hospital. 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. 
 
 
 

 
30.8 Study Randomization Scheme 
 
Randomization sheet for 18-603 - Elevated Distress 
 
 
 
Symptom Targeted Randomized Intervention for Distress and Adherence to Adjuvant Endocrine 
Therapy among Breast Cancer Survivors 
Stratification factors: Distress (elevated or not 
elevated) 
 
 
 
Treatment codes 
 
 
 
 
Arm B:  
Intervention 
Arm C:  
Control 
 
 
 
 
Distress level 
Patient name 
Sequence no. 
Date 
entered 
 Treatment 
assignment 
 
Elevated 
 
 
 
Arm B 
 
Elevated 
Arm C 
Elevated 
 
 
 
Arm C 
 
Elevated 
Arm B 
Elevated 
 
 
 
Arm C 
 
Elevated 
 
 
 
Arm B 
 
Elevated 
 
 
 
Arm C 
 
Elevated 
 
 
 
Arm B 
 
Elevated 
 
 
 
Arm C 
 
Elevated 
 
 
 
Arm B 
 
Elevated 
 
 
 
Arm B 
 
Elevated 
Arm C 
Elevated 
 
 
 
Arm B 
 
Elevated 
Arm C 
Elevated 
 
 
 
Arm B 
 
Elevated 
Arm C 
Elevated 
 
 
 
Arm B 
 
Elevated 
 
 
 
Arm C 
 
Elevated 
 
 
 
Arm C 
 
Elevated 
 
 
 
Arm B 
 
Elevated 
 
 
 
Arm C 
 
Elevated 
 
 
 
Arm B 
 
Elevated 
 
 
 
Arm B 
 
Elevated 
Arm C 
Elevated 
 
 
 
Arm C 
 
Elevated 
Arm B 
Elevated 
 
 
 
Arm B 
 
Elevated 
Arm C 
Elevated 
 
 
 
Arm B 
 
Elevated 
 
 
 
Arm C 
 
Elevated 
 
 
 
Arm C 
 
Elevated 
 
 
 
Arm B 
 
Elevated 
 
 
 
Arm B 
 

 
Elevated 
 
 
 
Arm B 
 
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Arm C 
 
Elevated 
 
 
 
Arm C 
 
Elevated 
 
 
 
Arm C 
 
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Arm C 
 
Elevated 
 
 
 
Arm B 
 
Elevated 
 
 
 
Arm B 
 
Elevated 
 
 
 
Arm B 
 
Elevated 
 
 
 
Arm B 
 
Elevated 
 
 
 
Arm C 
 
Elevated 
 
 
 
Arm C 
 
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Arm B 
 
Elevated 
 
 
 
Arm B 
 
Elevated 
 
 
 
Arm C 
 
Elevated 
 
 
 
Arm C 
 
Elevated 
 
 
 
Arm C 
 
Elevated 
 
 
 
Arm C 
 
Elevated 
 
 
 
Arm B 
 
Elevated 
 
 
 
Arm B 
 
Elevated 
 
 
 
Arm C 
 
Elevated 
 
 
 
Arm B 
 
Elevated 
 
 
 
Arm C 
 
Elevated 
 
 
 
Arm B 
 
Elevated 
 
 
 
Arm B 
 
Elevated 
 
 
 
Arm C 
 
Elevated 
 
 
 
Arm B 
 
Elevated 
 
 
 
Arm C 
 
Elevated 
 
 
 
Arm C 
 
Elevated 
 
 
 
Arm B 
 
Elevated 
 
 
 
Arm B 
 
Elevated 
 
 
 
Arm C 
 
Elevated 
 
 
 
Arm C 
 
Elevated 
 
 
 
Arm B 
 
Elevated 
 
 
 
Arm C 
 
Elevated 
 
 
 
Arm B 
 
Elevated 
 
 
 
Arm C 
 
Elevated 
 
 
 
Arm C 
 
Elevated 
 
 
 
Arm B 
 
Elevated 
 
 
 
Arm B 
 
Elevated 
 
 
 
Arm B 
 
Elevated 
 
 
 
Arm C 
 
Elevated 
 
 
 
Arm B 
 
Elevated 
 
 
 
Arm C 
 
Elevated 
 
 
 
Arm C 
 
Elevated 
 
 
 
Arm B 
 

 
Elevated 
 
 
 
Arm B 
 
Elevated 
 
 
 
Arm C 
 
Elevated 
 
 
 
Arm C 
 
Elevated 
 
 
 
Arm B 
 
Elevated 
 
 
 
Arm C 
 
Elevated 
 
 
 
Arm B 
 
Elevated 
 
 
 
Arm C 
 
Elevated 
 
 
 
Arm B 
 
Elevated 
 
 
 
Arm B 
 
Elevated 
 
 
 
Arm C 
 
Elevated 
 
 
 
Arm C 
 
Elevated 
 
 
 
Arm B 
 
Elevated 
 
 
 
Arm B 
 
Elevated 
 
 
 
Arm C 
 
Elevated 
 
 
 
Arm B 
 
Elevated 
 
 
 
Arm C 
 
Elevated 
 
 
 
Arm B 
 
Elevated 
 
 
 
Arm C 
 
Elevated 
 
 
 
Arm C 
 
Elevated 
 
 
 
Arm B 
 
Elevated 
 
 
 
Arm C 
 
Elevated 
 
 
 
Arm B 
 
Elevated 
 
 
 
Arm B 
 
Elevated 
 
 
 
Arm C 
 
 
Randomization sheet for 18-603 - Not Elevated Distress 
 
 
Symptom Targeted Randomized Intervention for Distress and Adherence to Adjuvant Endocrine 
Therapy among Breast Cancer Survivors 
Stratification factors: Distress (elevated or not 
elevated) 
 
 
 
Treatment codes 
 
 
 
 
Arm B:  
Intervention 
 
 
 
 
Arm C:  
Control 
 
 
 
 
 
 
 
 
 
 
Distress level 
Patient name 
Sequence no. 
Date entered 
 Treatment 
assignment 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm B 
 

 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm C 
 

 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm B 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm B 
 

 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm C 
 
Not elevated 
 
 
 
Arm B 
 
 
 

 
30.9 Session Rating Form 
 
Session 1 
Your study ID _______________ 
Please rate the following 5 items on a scale from 1 (Not at all) to 10 (Extremely so) 
1. How enjoyable was today’s session?    ________ 
2. How convenient was today’s session?  _______ 
3. How helpful was today’s session? ________ 
4. How likely are you to use skills/information from today’s session in the future? _________ 
5. How would you rate your overall satisfaction with today’s session? _________ 
 
Session 2 
Your study ID _______________ 
Please rate the following 5 items on a scale from 1 (Not at all) to 5 (Very much) 
1. How enjoyable was today’s session?    ________ 
2. How convenient was today’s session?  _______ 
3. How helpful was today’s session? ________ 
4. How likely are you to use skills/information from today’s session in the future? _________ 
5. How would you rate your overall satisfaction with today’s session? _________ 
 
 
Session 3 
Your study ID _______________ 
Please rate the following 5 items on a scale from 1 (Not at all) to 5 (Very much) 
1. How enjoyable was today’s session?    ________ 
2. How convenient was today’s session?  _______ 
3. How helpful was today’s session? ________ 
4. How likely are you to use skills/information from today’s session in the future? _________ 
5. How would you rate your overall satisfaction with today’s session? _________ 
 
 
Session 4 
Your study ID _______________ 
Please rate the following 5 items on a scale from 1 (Not at all) to 5 (Very much) 
1. How enjoyable was today’s session?    ________ 
2. How convenient was today’s session?  _______ 
3. How helpful was today’s session? ________ 
4. How likely are you to use skills/information from today’s session in the future? _________ 
5. How would you rate your overall satisfaction with today’s session? _________ 
 
Session 5 
Your study ID _______________ 
Please rate the following 5 items on a scale from 1 (Not at all) to 5 (Very much) 
1. How enjoyable was today’s session?    ________ 
2. How convenient was today’s session?  _______ 
3. How helpful was today’s session? ________ 
4. How likely are you to use skills/information from today’s session in the future? _________ 
5. How would you rate your overall satisfaction with today’s session? _________ 
 

 
30.10 Semi-Structured Interview Script 
 
Introduction 
Hello, my name is ___. You have been asked to participate in this interview to share your experiences going 
through the STRIDE 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 15-30 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? 
 
 
(TURN ON RECORDER) 
 
1. 
How did you feel about the number of STRIDE 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 group structure? 
6. 
How did you feel about the individual structure? 
7. 
How did you feel about the videoconference? 
8. 
How did you feel about attending sessions in person? 
9. 
How did you feel about storing your medication in the bottle that we gave you? 
Probe: Was this difficult? 
Probe: Did anything get in your way of storing the medication there? 
10. 
How did you feel about the packet of questionnaires? 
Probe: Too long? 
Probe: Was anything confusing? 
11. 
How did you feel about the number of times we asked you to complete the questionnaires? 
12. 
How did you feel about the phone check-ins that we did after the sessions? 
13. 
Do you have any suggestions for how to improve our program? 
14. 
Did anything get in the way of you being able to participate? 
15. 
Would you recommend this to other women on hormonal therapy? 
 
 

 
30.11 Semi-Structure RCT Interview Script 
Semi-structured Interview Guide: 
Introduction 
Nice to speak with you, my name is ____ and thank you for being a part of this study! As a reminder, in (fill in) 
year, you participated in a study that was evaluating a program to support women on hormonal therapies after 
breast cancer. Now, we are conducting this final interview to understand how we can improve our study 
activities to be more sensitive and relevant for people from all cultural, racial, and ethnic backgrounds. We are 
hoping to expand this study to include more women who identify as Black, Latina, or Asian women, and want 
to make sure the program meets the needs of women from every background, 
 
There are no right or wrong answers, and everything that you share is completely confidential. None 
of your answers will get back to your doctors or nurses, and your answers will not affect your future 
participation in studies or the care you receive here at MGH. We are asking all women the same 
questions, because the goal of this interview is to understand how we can make sure this program is 
relevant for women of different races, ethnicities, and cultures. So, I will also ask you a few questions 
about the program, whether you believe it would be helpful to women in the future, and if you have 
any concerns or suggestions to improve it.  
 
The interview will take about 15-30 minutes. I will be moving us along so that we make sure to cover 
all of the questions. 
 
As a reminder, I will be audio-recording this interview to make sure that I capture your thoughts and 
feelings in your own words. We will destroy the recording once we have transcribed it and no 
identifying information, such as your name or names of others, will be included in the transcript. Do I 
have permission to record this interview? 
 
Do you have any questions before we start? 
 
 
(START RECORDING) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
1. Can you share with me, how do you identify yourself (for example, as a Black Hispanic woman, as a 
Chinese American)? 
 
2. Was there anything that got in the way of you participating in this study?  
 
3. Was there anything that got in your way of participating that relates to your race, ethnicity, culture, or 
other way you identify yourself? 
a. Offer examples: were the questions in the survey relevant to you? were the examples in the 
workbook relevant to you (only for intervention participants)? 
 
4. What did you like about this study/program? 
 
5. What did you dislike about this study/program? 
 
6. Was there anything related to your race, ethnicity, or cultural background that got in the way of you 
taking your hormonal therapy medication every day? 
a. Offer example: some groups might question how well these medications work, some may have 
less trust in their doctors and nurses. 
 
7. Was there anything related to your race, ethnicity, or cultural background that got in the way of your 
ability to manage side effects from the medication?  
a. Offer example: some groups might question how well these medications work, some may have 
less trust in their doctors and nurses. 
 
8. Have you been able to talk with your doctors and nurses about any issues you have had with your 
hormonal therapy? 
 
9. Do you feel that your experience, or concerns about this medication, are the same or different from 
other women in a similar position? 
a. Probe: how about women from different backgrounds? 
 
10. How do you think we could make this program meet the needs of women of different backgrounds?   
 
11. If we translated the program into Spanish, do you foresee any issues with Spanish-speaking women 
participating?   
 
12. Is there anything you can think of, that could help support you to continue to take the medication? 
 
 
 
 
 

 
30.12 The STRIDE Intervention 
[See separately attached appendix item; will be given to all intervention arm participants.] 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
30.13 Patient Locator Form 
PARTICIPANT LOCATOR FORM 
 
Participant name:  
__________________________________________________  
 
 
 
 
 
 
Mailing address:  
__________________________________________________ 
 
 
   
(Street)  
     
 
 
 
(Apt.) 
 
 
 
 
__________________________________________________ 
 
 
   
(City, State, Zip) 
 
     
 
 
 
 
 
Preferred phone:  
Please indicate:        Mobile      Home      Work      Other  
 
__________________________________________________ 
 
Alternate phone:  
Please indicate:        Mobile      Home      Work      Other  
 
__________________________________________________ 
 
If you would like to receive SMS text messaging reminders, please check the box below: 
• 
I give permission to the STRIDE 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. 
 
By checking this box, I understand and give my permission to contact me through SMS messaging. 
 
Email address:  
__________________________________________________ 
 
If you would like to receive emails without encryption, please check the box below:  
• 
I understand that any communication using non-encrypted emails with the study team is NOT HIPAA-compliant 
and does not guarantee confidentiality. 
 
By checking this box, I understand and give my permission for the study team to contact me through 
non-encrypted email messaging. 
 
Circle preferred survey delivery method:  
email   
via hard-copy mail 
 
 
Can study staff leave voicemails regarding your participation in the study (Please circle one)?  
      Y 
      N 
 
 
 
IN CASE WE HAVE TROUBLE REACHING YOU, PLEASE PROVIDE ONE OTHER PERSON WE COULD CONTACT 
(This is optional and will not affect your participation in the research study). 
 
Contact name:  
 
 
__________________________________________________  
 
 
 
 
(Last)  
     
  
(First)      
 
 (M.I.) 
 
Relationship to participant:  
__________________________________________________ 
 
Preferred phone:  
 
 
__________________________________________________ 
 
 
Alternate phone:  
 
 
__________________________________________________  
 
 
 
 
 
30.13 SMS Text Message Templates 

 
 
Text Message Reminder Templates 
Symptom-Targeted Randomized Intervention for Distress and Adherence  
PI: Jamie Jacobs, Ph.D. 
 
[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.] 
 
MEMS Caps reminder: 
Hello ___________, this is a message from the STRIDE study at MGH. Our records indicate you have received 
the MEMS bottle. Please reply “Y” to indicate that you have received the bottle. Please begin using the bottle 
right away and contact [study staff contact information] if you have any questions. Thank you. 
 
Questionnaire reminder: 
Hello ____________, this is a message from the STRIDE study at MGH. This is a reminder that it is time to 
complete the [12-week/24-week] questionnaire. This questionnaire will take roughly 30 minutes. You have 
received the questionnaire via [email/mail]. Please contact [study staff contact] if you have any questions. 
Thank you. 
 
Intervention session reminder: 
Hello ____________, this is a message from the STRIDE study at MGH. This is a reminder that you have a 
STRIDE 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. 
 
 

 
30.15 Study Email Templates 
 
Email Reminder Templates 
Symptom-Targeted Randomized Intervention for Distress and Adherence  
PI: Jamie Jacobs, Ph.D. 
 
[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.] 
 
MEMS Caps reminder: 
Hello ___________,  
We are reaching out regarding the STRIDE study at MGH. Our records indicate you have received the MEMS 
bottle. Please begin using the bottle right away. Please contact [study staff contact information] if you have any 
questions.  
Thank you, 
[Study Staff Member] 
 
Questionnaire reminder: 
Hello ____________,  
We are reaching out regarding the STRIDE study at MGH. This is a reminder that it is time to complete the [12-
week/24-week] questionnaire, which will take roughly 30 minutes. You have received the questionnaire via 
[email/mail]. Please contact [study staff contact] if you have any questions.  
Thank you, 
[Study Staff Member] 
 
Intervention session reminder: 
Hello ____________,  
We are reaching out regarding the STRIDE study at MGH. This is a reminder that you have a STRIDE 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.  
After the session, you can access the relaxation recordings at stridestudy.mgh.harvard.edu. 
Thank you, 
[Study Staff Member] 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
30.16 Study Timeline Document 
 
 
 

 
 
 
 
 
 
 
 

 
 
 
 
 
Demographics [ONLY TO BE GIVEN AT TIME OF BASELINE ASSESSMENT] 
Patient Demographics 
Please check the appropriate box or boxes. 
1. Age:__________ 
 
2. Ethnicity 
¨ Hispanic or Latino 
¨ Not Hispanic or Latino 
 
30.17 Baseline, 12-week, & 24-week Post-Baseline Assessment 
[Instruments given only at specific timepoints are indicated 
 
 
STRIDE: Symptom-Targeted Randomized Intervention for 
Distress on Endocrine Therapy  
(Patient Questionnaires) 
 
 
 
 
 
 
 
 
 
Assessment Time Point:     Baseline / Post-Week: 
 
 
 
 
 
Study ID: __ __ __  
 
 
 
 
 
Research Assistant Initials: __ __ __ 
 
 
 
 
 
Assessment Date: __ __/ __ __/ __ __ __ __ 
 
 
 
 
 
 
 
 
 
  
 
 
 
IF FOUND, PLEASE RETURN TO: 
Jamie Jacobs, Ph.D. 
Dept. of Psychiatric Oncology, Yawkey 10B 
Massachusetts General Hospital 
55 Fruit Street, Boston, MA  02114-3117 
Phone: 617-643-1777 
JJACOBS@mgh.harvard.edu 

 
 
3. Gender: ______________ 
 
4. Race (please check all that apply) 
¨ American Indian or Alaskan native 
¨ Asian 
¨ African American or Black 
¨ Native Hawaiian or other Pacific Islander 
¨ White 
¨ Other (please specify):_____________ 
 
5. Current relationship status 
¨ Married or living with someone as if married 
¨ Non-cohabiting relationship 
¨ Single, never married 
¨ Divorced/Separated 
¨ Loss of long term partner/Widowed 
 
6. Please indicate your highest or current education level 
¨ 11th grade or less 
¨ High school graduate or GED 
¨ 2 years of college/Associate’s degree/ Technical school training 
¨ College graduate (BA or BS) 
¨ Master’s degree 
¨ Doctorate/Medical degree/Law degree 
 
7. What is your annual combined household income? 
¨ Less than $25,000 
¨ $25,000 – $49,999 
¨ $50,000 – $99,999 
¨ $100,000 – $149,999 
¨ $150,000 or greater 
 
8. Current employment status 
(please check all that apply):  
¨ Employed (full-time or part-time) 
¨ Caring for home or family (not currently working and not looking for paid work) 
¨ Unemployed and looking for work 
¨ Unable to work due to illness or disability 
¨ Retired 
¨ Student 
¨ Other (please specify):_____________ 
 
 

 
Medication Adherence Report Scale (MARS-5)  
Answers: 1: Always, 2: Often, 3: Sometimes, 4: Rarely, 5: Never 
1. I forget to take my adjuvant endocrine therapy (AET) medicine 
2. I alter the dose of my AET medicine 
3. I stop taking my AET medicine for a while 
4. I decide to skip one of my AET tablets 
5. I take AET less than prescribed 
 

 
Breast Cancer Prevention Trial Symptom Checklist (BCPT)  
Physical Symptoms - BCPT 
 
We are interested in knowing how much you have been bothered by any of the following problems 
during the PAST WEEK. (Check one box on each line.  If you do not have the problem, check “not at 
all”.) 
 
During the past week, how much were you bothered by: 
 
 
Not at 
all 
 
Slightly 
 
Moderately 
 
Quite 
a bit 
 
Extremely 
 
1.   Hot flashes 
 
 0 
 
1 
 
2 
 
3 
 
4 
2.   Nausea 
 
 0 
 
1 
 
2 
 
3 
 
4 
3.   Vomiting 
 
 0 
 
1 
 
2 
 
3 
 
4 
4.   Difficulty with bladder control 
when laughing or crying. 
 
 0 
 
1 
 
2 
 
3 
 
4 
5.   Difficulty with bladder control 
at other times 
 
 0 
 
1 
 
2 
 
3 
 
4 
6.  Vaginal dryness 
 
 0 
 
1 
 
2 
 
3 
 
4 
7.  Pain with intercourse 
 
 0 
 
1 
 
2 
 
3 
 
4 
8.  General aches and pains 
 
 0 
 
1 
 
2 
 
3 
 
4 
9.  Joint pains 
 
 0 
 
1 
 
2 
 
3 
 
4 
10.  Muscle stiffness 
 
 0 
 
1 
 
2 
 
3 
 
4 
11.  Weight gain 
 
 0 
 
1 
 
2 
 
3 
 
4 
12.  Unhappiness with the 
appearance of your body 
 
 0 
 
1 
 
2 
 
3 
 
4 
13.  Forgetfulness 
 
 0 
 
1 
 
2 
 
3 
 
4 
14.  Night sweats 
 
 0 
 
1 
 
2 
 
3 
 
4 

 
15.  Difficulty concentrating 
 
 0 
 
1 
 
2 
 
3 
 
4 
16.  Being easily distracted 
 
 0 
 
1 
 
2 
 
3 
 
4 
17.  Arm swelling (lymphedema) 
 
 0 
 
1 
 
2 
 
3 
 
4 
18.  Decreased range of motion 
in arm on surgery side 
 
 0 
 
1 
 
2 
 
3 
 
4 
19.  Vaginal discharge 
 
 0 
 
1 
 
2 
 
3 
 
4 
20.  Vaginal bleeding or spotting 
 
 0 
 
1 
 
2 
 
3 
 
4 
21.  Genital itching/irritation 
 
 0 
 
1 
 
2 
 
3 
 
4 
22.  Lack of energy 
 
 0 
 
1 
 
2 
 
3 
 
4 
23. Tiredness 
 
 0 
 
1 
 
2 
 
3 
 
4 
24. Lack of interest in sex 
 
 0 
 
1 
 
2 
 
3 
 
4 
25. Low sexual enjoyment 
 
 0 
 
1 
 
2 
 
3 
 
4 
26. Difficulty sleeping 
 
 0 
 
1 
 
2 
 
3 
 
4 
 
 

 
Cancer Therapy Satisfaction Questionnaire (CSTQ) (21-item)  -  
Cancer Therapy Satisfaction Questionnaire 
• The following pages ask some questions about your hormonal therapy (pills).  
• 
Please read each question and answer as honestly as you can without the help of anyone. 
• 
There are no right or wrong answers; the answers should be based on your own personal experiences. 
• 
All of your answers will remain confidential. 
• 
This questionnaire will take about 10 min to complete. 
 
Your Thoughts about Hormonal Therapy (pills) 
 
The following statements ask you to share your thoughts about cancer therapy (IV/pills). Please answer each question 
below by checking the box that best represents your opinion (check only one box per question). 
--------------------------------------------------------------------------------------------------------------------------------- 
In general, in the last four weeks, how often 
did you feel: 
 
 
 Always       Most of the time      Sometimes      Rarely      Never 
------------------------------------------------------------------------------------------------------------------------------------ 
1. That hormonal therapy (pills) would help 
     ¨5   
  ¨4 
 
  ¨3 
        ¨2           ¨1 
you to return back to a normal life? 
 
2. That hormonal therapy (pills) would get         ¨5 
  
  ¨4 
 
  ¨3 
        ¨2           ¨1 
rid of the cancer? 
 
3. That hormonal therapy (pills) would help       ¨5 
  
  ¨4 
 
  ¨3 
        ¨2           ¨1 
prevent the cancer from coming back? 
 
4. That hormonal therapy (pills) would stop       ¨5 
  
  ¨4 
 
  ¨3 
        ¨2           ¨1 
the cancer from spreading? 
 
5. That your hormonal therapy (pills)                 ¨5 
  
  ¨4 
 
  ¨3 
        ¨2           ¨1 
limited your daily activities? 
 
6. Upset about the side effects?  
     ¨5   
  ¨4 
 
  ¨3 
        ¨2           ¨1 
 
7. That hormonal therapy (pills) was worth 
     ¨5   
  ¨4 
 
  ¨3 
        ¨2           ¨1  
taking even with the side effects? 
 
8. That hormonal therapy (pills) would 
     ¨5   
  ¨4 
 
  ¨3 
        ¨2           ¨1 
help you live longer? 
 
9. In general, in the last four weeks, how often  ¨5 
  
  ¨4 
 
  ¨3 
        ¨2           ¨1 
did you think about stopping your hormonal therapy (pills)? 
 
In general, in the last four weeks, how often 
did you: 
 
    
 
 
 
 
Always      Most of the time       Sometimes        Rarely      Never 
__________________________________________________________________________________________ 
10. Have trouble remembering to take                   ¨5 
  
  ¨4 
 
  ¨3 
        ¨2           ¨1 
your hormonal therapy pills? 
Always      Most of the time       Sometimes        Rarely      Never 
__________________________________________________________________________________________ 
 
11. Take your hormonal therapy exactly 
 
     ¨5                 ¨4 
 
  ¨3 
        ¨2           ¨1 
as directed by your doctor? 
 
If you answered “always” to question 11, please skip question 12 and continue with question 13.  
12. If you did not always take hormonal therapy pills as directed, why didn’t you?  
(Please check all that apply)  
¨1  
I forgot 

 
¨2 
It was inconvenient 
¨3 
I felt I needed a break 
¨4 
I felt I did not need it 
¨5 
Side effects 
 
Satisfaction with Hormonal Therapy (pills) 
The following statements are about your satisfaction with your hormonal therapy (pills). Please answer each question below 
by checking the box that best describes your level of satisfaction (check only one box per question). 
13. Overall, how inconvenient was it for you to take your hormonal therapy (pills)? 
¨5 
                   ¨4  
          ¨3 
       
   ¨2 
     
         ¨1 
Very convenient 
Convenient 
Neither convenient 
Inconvenient 
Very Inconvenient 
 
 
 
 
 
Nor inconvenient 
14. Overall, how bothered were you by the amount of time it took to take your hormonal therapy (pills)? 
¨5 
                   ¨4  
          ¨3 
       
   ¨2 
     
         ¨1 
  Very bothered 
    Quite bothered 
       Moderately bothered        A little bothered       Not bothered at all 
15. Overall, how worthwhile was your hormonal therapy (pills)? 
¨5 
                   ¨4  
          ¨3 
       
   ¨2 
     
         ¨1 
      Very  
                Quite  
  Moderately        
  
A little     
      Not 
       worthwhile 
          worthwhile 
    
worthwhile 
           worthwhile             worthwhile at all 
16. Overall, was taking hormonal therapy (pills) as difficult as you expected? 
¨5 
                   ¨4  
          ¨3 
       
   ¨2 
     
         ¨1 
Much more difficult          Somewhat more   As difficult as I       Somewhat easier 
   Much easier 
than I thought it 
            difficult than I 
thought it would be    than I thought it 
 than I thought it 
      Would be 
         thought it would be 
 
 
       would be 
 
     would be 
17. Overall, how well did the benefits of hormonal therapy (pills) meet your expectations? 
¨5 
                   ¨4  
          ¨3 
       
   ¨2 
     
         ¨1 
Much better than        Somewhat better 
      Met my 
     Somewhat worse         
Much worse 
my expectations             than my  
my expectations 
 
than my 
   than my 
  
                       expectations 
 
 
                        expectations              expectations 
18. Overall, were the side effects of hormonal therapy (pills) as you expected? 
¨5 
                   ¨4  
          ¨3 
       
   ¨2 
     
         ¨1 
Much better than        Somewhat better 
      Exactly as      Somewhat worse         
Much worse than 
I expected 
              
than I expected    
       I expected       than I expected 
    I expected                    
19. How satisfied were you with the form of your hormonal therapy (pills)? 
¨5 
       ¨4  
                    ¨3        
 
   ¨2 
     
         ¨1 
Very satisfied 
Satisfied 
 
Neither satisfied nor dissatisfied  Dissatisfied 
Very dissatisfied 
20. Overall, how satisfied were you with your most recent hormonal therapy (pills)? 
¨5 
       ¨4  
                    ¨3        
 
   ¨2 
     
         ¨1 
Very satisfied 
Satisfied 
 
Neither satisfied nor dissatisfied  Dissatisfied 
Very dissatisfied 
21. Taking everything into consideration, if given the choice again, would you decide to take this hormonal therapy? 
¨5 
             ¨4 
 
      ¨3        
 
   ¨2 
     
         ¨1 
Yes, definitely 
    Probably Yes                I don’t know 
        Probably not 
              Definitely not 
 
 
 

 
Hospital Anxiety and Depression Scale 
 
HADS 
 
INSTRUCTIONS: Read each item and please select the answer which comes closest to how you have been feeling, 
on the average, IN THE PAST WEEK. 
 
01. I feel tense or "wound up."  
1. ¨  Most of the time 
2. ¨ A lot of the time 
3. ¨ From time to time, occasionally 
4. ¨ Not at all 
 
02. I still enjoy the things I used to enjoy. 
1. ¨ Definitely as much 
2. ¨ Not quite as much 
3. ¨ Only a little 
4. ¨ Hardly at all 
 
03. I get a sort of frightened feeling as if something  
      awful is about to happen.  
1. ¨ Very definitely and quite badly 
2. ¨ Yes, but not too badly 
3. ¨ A little, but it doesn't worry me 
4. ¨ Not at all 
 
04. I can laugh and see the funny side of things. 
1. ¨ As much as I always could 
2. ¨ Not quite so much now 
3. ¨ Definitely not so much now 
4. ¨ Not at all 
 
05. Worrying thoughts go through my mind.  
1. ¨ A great deal of the time 
2. ¨ A lot of the time 
3. ¨ From time to time but not too often 
4. ¨ Only occasionally 
 
06. I feel cheerful.  
1. ¨ Not at all 
2. ¨ Not often 
3. ¨ Sometimes 
4. ¨ Most of the time 
 
07. I can sit at ease and feel relaxed. 
1. ¨ Definitely 
2. ¨ Usually 
3. ¨ Not often 
4. ¨ Not at all 
 
 
08. I feel as if I am slowed down.  
1. ¨ Nearly all the time 
2. ¨ Very often 
3. ¨ Sometimes 
4. ¨ Not at all 
 
09. I get a sort of frightened feeling like  
      "butterflies" in the stomach. 
1. ¨ Not at all 
2. ¨ Occasionally 
3. ¨ Quite often 
4. ¨ Very often 
 
10. I have lost interest in my appearance.  
1. ¨ Definitely 
2. ¨ I don't take so much care as I should 
3. ¨ I may not take quite as much care 
4. ¨ I take just as much care as ever 
 
11. I feel restless as if I have to be on the move.  
1. ¨ Very much indeed 
2. ¨ Quite a lot 
3. ¨ Not very much 
4. ¨ Not at all 
 
12. I look forward with enjoyment to things. 
1. ¨ As much as I ever did 
2. ¨ Rather less than I used to 
3. ¨ Definitely less than I used to 
4. ¨ Hardly at all 
 
13. I get sudden feelings of panic.  
1. ¨ Very often indeed 
2. ¨ Quite often 
3. ¨ Not very often 
4. ¨ Not at all 
 
14. I can enjoy a good book or radio or TV  
      program. 
1. ¨ Often 
2. ¨ Sometimes 
3. ¨ Not often 
4. ¨ Very seldom

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Measure of Current Status (MOCS): 
 
        0 = Strongly Disagree 
         1 = Mostly Disagree 
         2 = Neutral--neither agree nor disagree 
         3 = Mostly Agree 
         4 = Strongly Agree  
 
1. I am able to use muscle relaxation techniques to reduce any tension I experience 
 2. I become aware of any tightness in my body as soon as it develops 
 3. I can clearly express my needs to other people who are important to me 
 4. I can easily stop and re-examine my thoughts to gain a new perspective 
 5. It's easy for me to decide how to cope with whatever problems arise 
 6. I can easily recognize situations that make me feel stressed or upset 
 7. When problems arise I know how to cope with them 
 8. I notice right away whenever my body is becoming tense 
 9. It's easy for me to go to people in my life for help or support when I need it 
 10. I am able to use mental imagery to reduce any tension I experience 
 11. I am confident about being able to choose the best coping responses for hard 
situations 
 12. I can come up with emotionally balanced thoughts even during negative times 
 13. I can ask people in my life for support or assistance whenever I need it 
 
 
 

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Beliefs about Medicines Questionnaire – Adjuvant Endocrine Therapy (BMQ-AET)  
BMQ-AET 
This next set of questions asks about your personal views about medicines prescribed for your 
breast cancer. 
 
• These are statements other people have made about their hormonal therapy medication. 
• Please indicate the extent to which you agree or disagree with them by placing a cross in 
the appropriate box. 
• There are no right or wrong answers. We are interested in your personal views. 
• Please only cross one box per question. 
 
 
1) I sometimes worry about long-term effects of taking hormone treatment 
 
Strongly agree  
agree  
uncertain 
 
disagree 
strongly disagree 
 
2) Having to take hormone treatment worries me 
 
Strongly agree  
agree  
uncertain 
 
disagree 
strongly disagree 
 
3) I sometimes worry about having hormone treatment over a long period of time  
 
Strongly agree  
agree  
uncertain 
 
disagree 
strongly disagree 
 
4) Taking hormone therapy disrupts my life 
 
Strongly agree  
agree  
uncertain 
 
disagree 
strongly disagree 
 
 
5) Hormone therapy is a mystery to me 
 
Strongly agree  
agree  
uncertain 
 
disagree 
strongly disagree 
 
 
6) Taking hormone treatment makes me feel I am taking positive steps to remain well  
 
Strongly agree  
agree  
uncertain 
 
disagree 
strongly disagree 
 
 
7) Without taking hormone treatment, I would be more likely to develop breast cancer again  
 
Strongly agree  
agree  
uncertain 
 
disagree 
strongly disagree 
 
 
8) My health at present depends on me taking hormone treatment 

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Strongly agree  
agree  
uncertain 
 
disagree 
strongly disagree 
 
 
9) Hormone treatment protects me from becoming ill 
 
Strongly agree  
agree  
uncertain 
 
disagree 
strongly disagree 
 
 
10) My health in the future will depend on me taking hormone treatment 
 
Strongly agree  
agree  
uncertain 
 
disagree 
strongly disagree 
 
 
 
 

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Multidimensional Scale of Perceived Social Support (MSPSS) 
Multidimensional Scale of Perceived Social Support Instructions:  
 
We are interested in how you feel about the following statements.  
Read each statement carefully. Indicate how you feel about each statement.  
Circle the “1” if you Very Strongly Disagree  
Circle the “2” if you Strongly Disagree  
Circle the “3” if you Mildly Disagree  
Circle the “4” if you are Neutral  
Circle the “5” if you Mildly Agree  
Circle the “6” if you Strongly Agree  
Circle the “7” if you Very Strongly Agree 
1. There is a special person who is around when I am in need. 1 2 3 4 5 6 7  
2. There is a special person with whom I can share joys and sorrows. 1 2 3 4 5 6 7  
3. My family really tries to help me. 1 2 3 4 5 6 7  
4. I get the emotional help & support I need from my family. 1 2 3 4 5 6 7  
5. I have a special person who is a real source of comfort to me. 1 2 3 4 5 6 7  
6. My friends really try to help me. 1 2 3 4 5 6 7  
7. I can count on my friends when things go wrong. 1 2 3 4 5 6 7  
8. I can talk about my problems with my family. 1 2 3 4 5 6 7  
9. I have friends with whom I can share my joys and sorrows. 1 2 3 4 5 6 7  
10. There is a special person in my life who cares about my feelings. 1 2 3 4 5 6 7  
11. My family is willing to help me make decisions. 1 2 3 4 5 6 7  
12. I can talk about my problems with my friends. 1 2 3 4 5 6 7 
 
 
 

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Self-Efficacy For Managing Symptoms and Taking AET Questionnaire (Self-
Efficacy for Symptoms) (8-item) 
 
Self-Efficacy for Symptoms 
We would like to know how confident you are that you can manage symptoms associated with your 
medication. For each of the following questions, please circle the one number that best describes how 
certain you are that you can manage each side effect regularly at the present time.  
How confident are you that you can decrease or control the side effects of your medication… 
1. If you have aches or pains in your muscles or joints? 
Not at all 
confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Very 
confident 
2. If you have hot flashes or sweating? 
Not at all 
confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Very 
confident 
3. If you feel sad, depressed, or anxious? 
Not at all 
confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Very 
confident 
4. If you have difficulty sleeping? 
Not at all 
confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Very 
confident 
5. If you feel tired or fatigued? 
Not at all 
confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Very 
confident 
6. If you feel bloated? 
Not at all 
confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Very 
confident 
7. If you gain weight? 
Not at all 
confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Very 
confident 
8. If you experience sexual side effects? 
Not at all 
confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Very 
confident 

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Self-Efficacy for Appropriate Medication Use Scale (13-item) 
 
How confident are you that you can take your medications correctly: 
 
 
 
 
 
 
 
 
 
 
Answer options: Not 
confident at all, 
somewhat confident, 
very confident 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Patient-Reported Outcomes Measurement Information System (PROMIS) – 
Cognitive Function – Short Form 4a 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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CSQ-3 [ONLY AT 12-WEEK POST-BASELINE ASSESSMENT]  
Please help us improve our program by answering some questions about the services you have 
received. We are interested in your honest opinions, whether they are positive or negative. 
Please answer all of the questions. We also welcome your comments and suggestions. Thank 
you very much; we really appreciate your help. 
 
1. To what extent has 
our program met 
your needs? 
 
 4  
3  
2  
1  
Almost all of my 
needs have been met  
Most of my needs 
have been met  
Only a few of my 
needs have been met  
None of my needs 
have been met  
 
2. In an overall, 
general sense, how 
satisfied are you with 
the skills (e.g. 
relaxation skills, 
coping skills) you 
have learned?  
 
4  
3  
2  
1  
Very satisfied  
Mostly satisfied  
Indifferent or mildly 
dissatisfied  
Quite dissatisfied  
 
3. If you were to seek 
help again, would 
you come back to our 
program?  
 
1  
2  
3  
4  
No, definitely not  
No, I don’t think so  
Yes, I think so  
Yes, definitely  
 
 
 

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30.18 Patient Screening Questions 
 
Distress Thermometer 
 
How upset are you by having to take hormonal therapy? 
(0 = not upset at all, 10 = extremely upset) 
 
 
 
 
 
 
 
 
 
How bothered are you by symptoms or side effects? 
(0 = not bothered at all, 10 = extremely bothered) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
How difficult is it for you to take your hormonal therapy medication every 
day? 
(0 = not difficult at all, 10 = extremely difficult) 
 
 
 

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30.19 Session Acceptability Measure 
 
Rate the following on a scale of 1-4 (1 = quite dissatisfied, 2 = mildly disappointed, 3 = mostly 
satisfied, 4 = very satisfied)  
 
How satisfied are you with the amount of time (60 minutes) spent on each session? 
 
How satisfied are you with the number of sessions (5) that you received? 
 
How comfortable were you in the group sessions? 
 
How satisfied were you with the virtual delivery (videoconference) of the sessions? 
 
How satisfied are you with the length of the study questionnaires you completed? 
 
Is there anything else that you would have liked to cover in these sessions? [Following are open-
ended] 
 
Is there anything that you found helpful? 
 
Is there anything that you found to be unhelpful? 
 
 
 

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30.20 Remuneration Form 
 
DF/HCC Protocol #XX-XXX 
 
 
 
Remuneration Form 
 
Participant Name____________________________________________________ 
 
Participant MRN____________________________________________________ 
 
SSN or ITIN____________________________________________________ 
 
Mailing Address____________________________________________________ 
 
____________________________________________________ 
 
____________________________________________________ 
 
 
 
 
 
For study team: 
c  Baseline Questionnaires - $20 Date completed: __________________ 
c  12-week Post Questionnaires - $20 Date completed: __________________ 
c  24-week Post Questionnaires - $20 Date completed: __________________ 
Date paid: _______________________ 
 
 

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30.21 EIC REDCap Invitation 
Subject: MGH STRIDE Study 
 
Dear [patient name], 
Thank you for your interest the STRIDE study at Massachusetts General Hospital! Please click 
the link below to access the informed consent form.  
 
Thank you, 
[study staff member] 
[study staff contact information] 
 
 
 

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30.22 EIC REDCap Portal Screen Captures 
 
Portal Entry: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Digital Signature: 
 
 
Consent Copy Form: 
 
 
 
 
 
 

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30.23 Source Document 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 
 
 
 

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30.24 Supplemental Medication Diary 
 
 
Please record any day you take a dose of medication without opening the pill bottle cap with a brief explanation. For example, taking two doses 
out of the bottle at the same time and keeping one in your pocket for a later time. 
Month:  
Sunday 
Monday 
Tuesday 
Wednesday 
Thursday 
Friday 
Satruday 
Example: 
12/ 1 
Refilled 
prescription, took 
one prior to 
refilling 
electronic pill 
bottle 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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30.25 MEMS Participant Instructions 
 
 

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30.26 Relaxation Recording Website (Screenshots) 
 
 
 

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30.27 Approach Chart Flyer 
 
FOR CLINICIAN ONLY: 
Reminder that a research assistant will be approaching this patient for 
participating in a supportive care study for endocrine therapy. 
 
Please remember to let the patient know about the approach and 
recommend participation if appropriate.  
 
 

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30.28 ECOG Screener 
 
 
 
Performance Status Questionnaire 
 
 
Which of the following functional ratings best describes your past week?  
(Please Choose ONE) 
 
 
 
Description 
0 
Fully active, able to carry on all pre-disease performance without 
restriction 
1 
Restricted in psychically strenuous activity but ambulatory and able to 
carry out work of a light or sedentary nature, e.g. light house work, 
office work 
2 
Ambulatory and capable of all selfcare but unable to carry out any work 
activities. Up and about more than 50% of waking hours 
3 
Capable of only limited selfcare, confined to bed or chair more than 50% 
of waking hours 
4 
Completely disabled. Cannot carry on any selfcare. Totally confined to 
bed or chair 
 
 
 
 
 

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30.29 Study Introduction Note Content 
[This general content will be included with participants’ MEMs bottle at the start of the study, 
prior to randomization, to introduce them to the study and study team and may be tailored 
further during the study run-in phase.] 
 
 
 

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30.30 Telehealth How-to 
[This content will be given to intervention-arm participants to instruct them on Telehealth use.] 
 
Welcome and thank you for your participation in the STRIDE study! The following steps are to 
help you download and prepare for your upcoming virtual STRIDE sessions. 
If you ever have difficulty getting into a virtual group session, please reach out to our study staff, 
at [study staff contact info], who will be on-call to assist you. 
To join the virtual group session: 
Step 1: Join session via email 
Our study staff will send you a unique link over email to join the videoconference for 
each session.  
The email should look like the image below. 
Once you have received it, click “Join Zoom Meeting”  
 
 
 
Step 2: Click “Run” and wait for Zoom to download 
 
After clicking the link, a box like the one shown below will appear.  
 
 
 
Click 
Choose to “run” the 
program to 
download the 
videoconference 
from your internet 
browser.  

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After selecting “Run”, a loading box should appear like this:  
 
 
 
Wait for the meeting to fully load.  
 
Step 3: Press “Join with Computer Audio”   
 
Once fully loaded, Zoom will ask you to select a username.  
 
After typing a username of your choice, a box like this will appear:  
 
 
 
 
 
Press “Join with Computer Audio”  
 
Make sure you are under “Computer Audio” and do not press “Phone Call”   
 
 
 
 
Step 4: Starting the session 
Press 
h

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